Dissertations / Theses: 'Tablets (Medicine)'

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Rashed, Abdulhameed M. "Characterisation and profiling of ecstasy tablets." Thesis, University of Glasgow, 2000. http://theses.gla.ac.uk/6339/.

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In addition to identifying the presence of a specific controlled drug in an exhibit and measuring its concentration, forensic drug laboratories are requested in certain cases or as a routine to provide additional information that may be helpful to the investigation process. On the basis of their chemical and physical characteristics, seized drugs may be profiled and linked to common sources or routes of distribution. Chapter 1 is an introduction to the illicit drug production from cultivation to manufacturing and trafficking. Chapter 2 describes the role of the drug chemist and includes characterisation of seizures, that is identification, quantification, and comparison of illicit drugs. Chapter 3 provides a literature review of the different analytical methods used in the area of drug profiling. This project has been on the subject of drug profiling with focus on the ringsubstituted amphetamine, 3,4 methylenedioxymethamphetamine (MDMA) or ecstasy as it is widely called. Among the main objectives of this study was the development and optimisation of a new extraction procedure, solid phase extraction, for impurities in seized ecstasy tablets. The instrumental analysis of impurities found in ecstasy tablets usually require a preliminary process to extract, isolate, and concentrate these impurities from the total tablet content. In the process, interfering materials are removed, and the required substances are concentrated into a solvent that is suitable for introduction into the instrument. Chapter 4 describes the development of a solid phase extraction (SPE) procedure and also an evaluation of a comparison procedure of liquid-liquid extraction (LLE) and SPE for extracting impurities in ecstasy tablets for profiling purposes. Solid phase extraction of impurities in ecstasy tablets proved to be more efficient than the traditional liquidliquid extraction. SPE provided impurity peaks with higher intensities than did LLE and a shorter extraction time. Another area of research was the use of infrared technology as an additional tool for profiling ecstasy tablets as seen in Chapter 5. Infrared method can serve as an elimination or screening step for gross clustering or grouping of exhibits. In chapter 6 the synthesis of MDMA using different synthetic routes to acquire authentic samples of impurities which are usually present in street samples were performed. These authentic samples were analysed and their mass spectra and retention indices were used to identify impurities in actual street samples to determine their route of synthesis. In chapter 7 ecstasy tablets confiscated within the UK were analysed to establish their route(s) of synthesis using the data of the authentic compounds synthesised earlier. The main contributions of this project were: 1. Developing a solid phase extraction procedure as an alternative to the conventional liquid-liquid extraction procedure. SPE provided extraction with no cross contamination of phases and no emulsion problem, as with LLE, due to the presence of fatty acids in ecstasy tablets. 2. Developing a simple and fast infrared method as a screening or elimination tool for ecstasy profiling. 3. Study of the synthetic routes of ecstasy samples within the UK with the aid of route-specific authentic impurity compounds synthesised in-house.

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Graben, Roger Dale Parsons Daniel L. "Promethazine orally disintegrating tablet." Auburn, Ala., 2006. http://hdl.handle.net/10415/1317.

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Murty, Aruna Mummini. "Evaluation of potential multi-particulate drug delivery systems /." View online ; access limited to URI, 2006. http://0-wwwlib.umi.com.helin.uri.edu/dissertations/dlnow/3225324.

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Olsson, Helena. "Particle interactions and internal tablet structure : factors affecting the mechanical strength of pharmaceutical compacts /." Uppsala, Sweden : Uppsala University : Distributed by Uppsala University Library, 2000. http://w3.ub.uu.se/diss/eng/abstract.cfm?ISBN=91-554-4725-2.

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Verner, Jennifer Joan. "Formulation and dissolution assessment of a novel repeat action tablet containing a decongestant and an antihistamine." Thesis, Rhodes University, 2001. http://hdl.handle.net/10962/d1003276.

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Controlled and sustained release dosage forms are the focus of worldwide research. These dosage forms facilitate patient compliance by simplifying the dosage regimen, and decrease the risk of adverse effects by reducing large fluctuations in the plasma concentration of the drug. The objective of this study was to formulate a repeat-action tablet to provide a sustained release dose of pseudoephedrine sulfate (PSS), and an immediate release dose of both PSS and loratadine. The release profile was compared to that of a commercially available preparation, Clarityne-D®. This formulation developed presents a novel mechanism of sustaining the release of PSS. The prototype tablet consisted of a sustained release core coated with an ethylcellulose dispersion to introduce a lag phase into the release profile and a second outer film coat incorporating PSS and loratadine. The core comprised an ethylcellulose granulation of PSS compressed into a hydroxypropyl methylcellulose matrix. The release of PSS from prototypes was assessed using USP Apparatus 3, as this apparatus was more representative of in vivo conditions and discriminated more effectively between the different tablet compositions produced during development. All dissolution samples were analysed for PSS and loratadine using validated highperformance liquid chromatographic methods. The prototype sustained release cores were found to be more resistant than the reference product to elevated temperature and humidity (40°C/87% RH) with fewer observed changes to the release profiles following storage for up to six months. This study was a feasibility study to obtain proof of concept. The release profile obtained from the prototype tablets was similar (f₂ = 50.0) to that of the reference product. Further development and optimisation of this dosage form is necessary, including evaluation of the choice of hydrophobic polymer, the effect of compression force and tablet geometry and characterisation of the release mechanism from the coated matrix. Assessment of these factors is necessary in order to optimise the formulation with respect to the desired therapeutic objectives.

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Khamanga, Sandile Maswazi Malungelo. "Formulation and assessment of verapamil sustained release tablets." Thesis, Rhodes University, 2005. http://hdl.handle.net/10962/d1018236.

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The oral route of drug administration is most extensively used due to the obvious ease of administration. Verapamil hydrochloride is a WHO listed phenylalkylarnine, L-type calcium channel antagonist that is mainly indicated for cardiovascular disorders such as angina pectoris, supraventricular tachycardia and hypertension. Due to its relatively short half-life of approximately 4.0 hours, the formulation of a sustained-release dosage form is useful to improve patient compliance and to achieve predictable and optimized therapeutic plasma concentrations. Direct compression and wet granulation were initially used as methods for tablet manufacture. The direct compression method of manufacture produced tablets that exhibited formulation and manufacturing difficulties. Mini-tablets containing veraparnil hydrochloride were then prepared by wet granulation using Surelease® E-7-19010.and Eudragit® NE 30D as the granulating agents after which the granules were incorporated with an hydrophilic matrix material, Carbopol® 974P NF. Granule and powder blends were evaluated using the angle of repose, loose and tapped bulk density, Can's compressibility index, Hausner's ratio and drug content. Granules with good flow properties and satisfactory compressibility were used for further studies. Tablets were subjected to thickness, diameter and weight variation tests, crushing strength, tensile strength, friability and content uniformity studies. Tablets that showed acceptable pharmaco-technical properties were selected for further analysis. Drug content uniformity and dissolution release rates were determined using a validated isocratic HPLC method. Initially, USP apparatus 1 and 3 dissolution apparatus were used to determine in-vitro drug release rates from the formulations over a 22-hour period. USP apparatus 3 was finally selected as it offers the advantages of mimicking, in part, the changes in the physicochemical environment experienced by products in the gastro-intestinal tract. Differences in release rates between the test formulations and a commercially available product, Isoptin® SR were observed at different pH's using USP apparatus 1. The release of veraparnil hydrochloride from matrix tablets was pH dependent and was markedly reduced at higher pH values. This may be due, in part, to the poor solubility of veraparnil hydrochloride at these pH values and also the possible interaction of verapamil hydrochloride with anionic polymers used in these formulations. Swelling and erosion behaviour of the tablets were evaluated and differences in behaviour were observed which may be attributed to the physico-chemical characteristics of the polymers used in this study. In-vitro dissolution profiles were characterized by the difference (j1) and similarity factor (j2) and also by a new similarity factor, Sct. In addition, the mechanism of drug release from these dosage forms was mainly evaluated using the Korsmeyer-Peppas model and the kinetics of drug release assessed using other models, including Zero order, First order, Higuchi, HixsonCrowell, Weibull and the Baker-Lonsdale model. Dissolution kinetics were best described by application of the Weibull model, and the Korsmeyer-Peppas model. The release exponent, n, confirmed that drug release from these dosage forms was due to the mixed effects of diffusion and swelling and therefore, anomalous release kinetics are predominant. In conclusion, two test batches were found to be comparable to the reference product Isoptin® SR with respect to their in-vitro release profiles.

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Vander, Werf Karie. "Pharmacokinetics and pharmacodynamics of oral meloxicam tablets in healthy horses." Thesis, Kansas State University, 2013. http://hdl.handle.net/2097/15314.

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Master of Science
Department of Clinical Sciences
Elizabeth Davis
The first aim of the current study was to investigate the pharmacokinetics of oral meloxicam tablets and the gastrointestinal and renal effects after a 14-day treatment period. Meloxicam was orally administered to six adult horses once daily at a dosage of 0.6 mg/kg for 14 consecutive days. Blood was collected prior to each administration and at 20 and 40 min, and 1, 2, 4, 8, 12, and 24 hours after administration on days 1, 7, and 14 for the determination of meloxicam plasma concentrations by mass spectrometry. In addition, trough samples were taken on days 3 and 10. Complete blood count, serum biochemical analysis, urinalysis, and gastroscopy were performed at baseline and conclusion of the investigation. Complete blood count, serum chemistry, and urinalysis results were unchanged through the study period. Gastroscopy scores were not significantly increased. The Cmax was 1.82 ± 0.80 µg/mL at Tmax 3.48 ± 3.30 hr on day 1, 2.07 ± 0.94 µg/mL at Tmax 1.24 ± 1.24 hr on day 7, and 1.81 ± 0.76 µg/mL at 1.93 ± 1.30 h on day 14 (p = 0.30). The mean half-life was 4.99 ± 1.11 h. The second aim of the study was to compare the analgesic effects and gastrointestinal and renal adverse effects of oral meloxicam tablets (0.6 mg/kg) to oral phenylbutazone tablets (4.4 mg/kg) orally once daily for 4 days in induced and naturally occurring lameness in adult horses. The study was performed on 4 healthy but lame adult horses. Complete blood count, serum biochemistry, urinalysis, and gastroscopy were performed prior to entrance to the study. Lameness was exacerbated in two horses using lipopolysaccharide (LPS; E. coli O55:B5) injected into the right metacarpophalangeal joint. The remaining two horses had Grade 3 or Grade 4 lameness due to naturally occurring laminitis. Meloxicam or phenylbutazone was administered to two horses each in a blinded, randomized manner once daily for four days. Lameness was evaluated using a pressure mat system and contact pressure, force, and stride length were evaluated at baseline and twice daily. Complete blood count, serum chemistry, and urinalysis were unremarkable for all four horses except one horse with an increased GGT. This horse experienced hepatic rupture secondary to amyloidosis the final day of the study. Gastric ulcer scores did not change during the study period. Phenylbutazone administration resulted in a greater response (force and contact area) in the right front and left hind limbs compared to meloxicam administration. There were not enough data points to evaluate the other two limbs. A third aim of the study was two-fold and first evaluated the effects of ex vivo stimulation of peripheral blood mononuclear cells (PBMCs) with LPS on cyclooxygenase (COX) messenger RNA (mRNA) expression. The second portion documented the effects of LPS-induced joint inflammation and treatment with non-steroidal anti-inflammatory drugs on the mRNA and protein expression of COX-2 in PBMCs. The results indicate that LPS upregulates COX-2 gene expression in PBMCs. Additionally, injection of LPS into the metacarpophalangeal joint increases both COX-2 mRNA and protein expression in PBMCs at 24 hours after injection. The relative expression of COX-2 after treatment with meloxicam or phenylbutazone indicates a stronger inhibition with phenylbutazone; however, further study with additional horses is needed. Pharmacokinetic analysis of the oral tablet formulation of meloxicam indicates the pharmacokinetics are similar to the oral suspension formulation. Meloxicam appears to be inferior to phenylbutazone in its analgesic properties for induced lameness and naturally occurring laminitis, however the small sample size used in the study makes interpretation difficult.

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Maclean, Aldritt Allister. "Comparison of two granulation processes with the view to reduce manufacturing cost." Thesis, Port Elizabeth Technikon, 2004. http://hdl.handle.net/10948/210.

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Aspen Pharmacare, one of the leading pharmaceutical manufacturers in South Africa has embarked on a programme of improving the production processes currently employed at their Port Elizabeth site. With the introduction of new technology at the site and the move towards globalization, it became imperative that Aspen remain competitive in the market. The product of interest in this research, Degoran Plus tablets, is one of the company’s leading brand sellers. Upon investigation, it became apparent that this product created opportunity for process improvement using the new technology. The manufacture of Degoran Plus entails granulation, compression and coating of the product. Most opportunity for improvement was possible in the granulation stage because of the laborious nature of the present process. Degoran Plus tablets had a history of analytical failures, especially with regard to the dissolution rate of the final product, as well as other quality related issues. The product was not considered to be a “through-runner”, which resulted in bad production output, due to continual repeats of not only analysis but also reworks in production. A strategic decision was taken to manufacture Degoran Plus using the Collette Gral granulator as the equipment offered superior mixing capability when compared to the Bear planetary granulator. It was assumed that the granulation process would result in more uniform distribution of the actives. Upon producing a better granule, a final product of superior quality would be attained. The validation protocol stipulates that three samples be taken and tested from the powder mix. Nine samples taken from granulated bulk are treated in the same manner. The validation protocol further stipulates that the first three batches manufactured utilise the new process, and tested according to the protocol. The results obtained from the analysis are evaluated statistically and a conclusion and recommendation were derived based on the evaluation.

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Patel, Fathima. "The development and assessment of a generic carbamazepine sustained release dosage form." Thesis, Rhodes University, 2006. http://eprints.ru.ac.za/1339/.

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Chillas, Stephanie M. "The Formulation and Evaluation of Orally Disintegrating Tablets: Diphenhydramine HCl." University of Toledo Health Science Campus / OhioLINK, 2013. http://rave.ohiolink.edu/etdc/view?acc_num=mco1371774622.

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Munday, Dale Leslie. "Design, development and evaluation of encapsulated oral controlled release theophylline mini-tablets." Thesis, Rhodes University, 1991. http://hdl.handle.net/10962/d1003255.

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Conventional solid dosage forms often lead to fluctuations which exceed the maximum safe therapeutic level and/or decline below the minimum effective level. It is recognised that many drugs for chronic administration should be administered on a schedule that maintains plasma drug concentration within the therapeutic window. Research in controlled release dosage forms aims at designing a system with a zero-order input (eg, ideally to deliver 8.33% of the dose per hour over a 12 hour duration), producing steady state plasma drug levels. Oral dministration of drugs prepared as a controlled release formulation is extremely popular, and has attracted the attention of pharmaceutical scientists during the last decade. This has been due to the simultaneous convergence of various factors (eg, discovery of novel polymers and devices, better understanding of formulation and physiological constraints, expiration of existing patents, prohibitive cost of developing new drug entities), involved in the development of these delivery systems. Controlled release oral products can be formulated as single or multiple unit dosage forms and the relative merits of multiple unit forms with their own rate controlling systems are well established. This work describes the development of a relatively inexpensive multiple-unit capsule dosage form of theophylline containing coated mini-tablets for drug delivery throughout the gastrointestinal tract. Preformulation studies on theophylline anhydrous included solubility and dissolution rate determinations. Techniques including X-ray powder diffraction, differential scanning colorimetry and infrared spectroscopy provided no evidence of true polymorphism after recrystallisation from various solvents. However, scanning electron micrographs showed the effects of solvent polarity and cooling rate on the size and shape of recrystallised particles. Theophylline granules were manufactured by using various binders and were film coated by fluidised bed technology with various proportions of ethylcellulose, containing varying amounts of PEG 1540. In vitro release rates were dependent upon coating thickness and the proportion of PEG, which, being water soluble, created pores in the coating during dissolution studies as observed by a scanning electron microscope. However, substantial proportions of the drug remained unreleased from the granules. In order to overcome the problems of drug retention, plain granules were used and theophylline mini-tablets (3 mm diameter, weighing 15 - 20 mg) were manufactured and film coated with various Eudragits ® and other polymeric mixtures (soluble and insoluble). In vitro dissolution profiles from samples enclosed in hard gelatin capsules were determined using the USPXXI paddle apparatus in test media at pH 1.2 (HCI), pH 5.4 and 7.4 (phosphate buffers) at 37'C. Monitoring of in vitro theophylline release over 12 h, under identical hydrodynamic conditions, showed that the dissolution rate at pH 1.2 is substantially greater (95% of total drug content released in < 10 h) than that in phosphate buffers. The maximum release after 12 h was approximately 20 and 30% of total drug content of the tablet at pH 5.4 and 7.4, respectively. However, in vivo bioavailability after oral administration of tablets to rabbits corresponded to over 95% of total drug, compared with the same dose administered intravenously. The retarded drug release during in vitro dissolution in phosphate buffer was attributed to a possible interaction of phosphate ions with theophylline molecules at the tablet core-coat interface. These findings indicate that both rate and extent of theophylline release from the slow release coated mini-tablets are highly sensitive to phosphate buffers. The data also emphasise the usefulness of an animal model for assessment of in vivo drug release and subsequent absorption during the development of modified release dosage forms. Mini-tablets were subjected to isothermal and cyclic stresses to reach conditions for up to 6 months at different temperatures and relative humidity. The film integrity was maintained but ageing of the coating occurred which impeded dissolution. Reduced drug release was temperature related while the effect of relative humidi% was insignific~t. Encapsulated mini-tablets (uncoated and coated with Eudragit RL and RS 2% w/w) equivalent to a 300 mg dose, were evaluated both in vitro and in vivo using beagle dogs. The pharmacokinetic parameters from single and multiple dose studies showed several advantages over Theo-Dur® 300 mg tablets. Precise dosage titration is possible by careful adjustment of the number of encapsulated mini-tablets. This multiple unit mini-tablet delivery system will allow for greater flexibility in dosage adjustment compared to the currently available preparations, allowing individualised fine dose titration in those patients requiring therapeutic drug monitoring. The developmentof the multiple unit mini-tablet formulation appears to provide an optimal dosage form with maximum flexibility in respect of dose, duration range and ease of production.

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Kieser, Leith Faye. "Formulation and assessment of monolithic beta blocker sustained release tablets prepared by direct compression." Thesis, Rhodes University, 2002. http://hdl.handle.net/10962/d1003242.

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Beta blockers are commonly prescribed for the chronic treatment of hypertension, one of the most prolific disease states worldwide. The beta blockers selected for this study include acebutolol hydrochloride, labetalol hydrochloride, metoprolol tartrate oxprenolol hydrochloride and propranolol hydrochloride. All of these compounds have a short elimination half-life, necessitating multiple dose per day regimens and therefore the development of sustained release dosage forms incorporating these agents was considered beneficial in terms of extending the dosing interval, with the aim of improving patient compliance and subsequent therapeutic outcomes. Preformulation studies that were conducted included moisture content analysis by Karl Fischer titration, and DSC, a method used to predict potential interactions between the drugs and tablet excipients. Tablets were manufactured by both wet granulation and direct compression techniques, and the resultant drug release characteristics were evaluated using the USP Apparatus 3(BIO.DIS). A validated isocratic HPLC method, capable of separating the five drug candidates simultaneously, was developed and used for the analysis of drug samples. Tablet quality was assessed using analyses that included the physical assessment of weight, diameter, thickness, hardness and friability, as well as content uniformity of tablets, before and after dissolution testing. Direct compression tablet formulations containing each of the five beta blockers were successfully adapted from a prototype wet granulation matrix tablet containing metoprolol tartrate, and various formulation variables were investigated to establish,their effect on the rate and extent of drug release from these tablets. The grade and quantity of ethylcellulose used in the wet granulation and direct compression formulae influenced the release rate of some drug candidates. In addition, an alternative formulation method, involving freeze-drying of the drug with an ethylcellulose dispersion, was shown to have potential for altering release rates further. Anti-frictional agents, talc and colloidal silicon dioxide, did not affect drug release from these matrices,however, they affected the physical character:istics such as tablet weight and thickness, of the resultant tablets. All of the matrix tablets formulated were shown to release drug according to square root of time kinetics, in a sustained manner over a 22 hour period.

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Nofrerias, Roig Isaac. "Aplicació de la simulació de compressió a l’estudi del comportament i optimització de comprimits elaborats per compressió directa utilitzant el sistema expert SeDeM." Doctoral thesis, Universitat de Barcelona, 2019. http://hdl.handle.net/10803/668064.

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El comprimit és la forma farmacèutica més freqüent al mercat. El procés tecnològic d’elaboració de comprimits d’elecció és la compressió directa perquè permet un estalvi en el nombre d’etapes. Tanmateix, aquest procés requereix que les pólvores presentin unes característiques adequades per la compressió per se. La necessitat de dissenyar ràpidament una fórmula farmacèutica que compleixi els estàndards de compressió i l’escalat a producció industrial, ha portat a la creació de sistemes experts i simuladors de compressió. En la present tesis, s’optimitza el sistema expert de diagrama SeDeM i es contrasta amb compressions industrials amb el simulador Styl’One. En primer lloc, es proposa una modificació en la metodologia per la determinació del paràmetre de l’Índex de cohesivitat del diagrama SeDeM, l’únic paràmetre que té en compte la compactabilitat de la mescla. Aquest paràmetre presentava desviacions per les mescles pulverulentes amb una densitat aparent molt elevada o molt baixa. També s’augmenta el nombre de paràmetres del SeDeM, afegint dos paràmetres mecànics en relació a la lubrificació. Aquests paràmetres són el punt de fusió (Mp) i la força d’ejecció (Fe). Els resultats del sistema expert de diagrama SeDeM són contrastats amb els resultats de compressió en condicions industrials. Cinc formulacions diferents es comprimeixen sota diferents perfils de compressió utilitzant un simulador de compressió industrial Styl’One. Els resultats indiquen que un ajust del pes del comprimit en funció de la densitat aparent de la pólvora permet la obtenció de comprimits de dimensions similars, evitant les desviacions esmentades. Fet demostrat en el desenvolupament d’una formulació la comparació de cel·luloses microcristal·lines de diferents fabricants i graus o tipus. També s’ha establert una metodologia ràpida i accessible per la determinació dels dos nous paràmetres mecànics i una conversió del valor experimental al valor radi. Fet que permet la seva integració en el sistema SeDeM. Els dos paràmetres integrats han demostrat tenir una rellevància en els resultats de la compressió i han permès augmentar el valor de l’índex de fiabilitat del SeDeM. Finalment, tres fórmules dissenyades per compressió directa i dues per granulació via humida es comprimeixen amb l’Styl’One simulant diferents perfils de compressió (Korsch XL 400, Fette 2909, Fette 3100, Kilian RX 47 i Kilian S 250) de màquines de comprimir rotatòries sota condicions de compressió diferents. Els resultats de la compressió demostren la precisió dels resultats previs obtinguts en els diagrames SeDeM i indiquen una relació entre valors deficients per l’Índex de Carr i l’Índex d’esponjositat i problemes d’exfoliació durant la compressió. L’addició d’una força de precompressió permet solucionar els problemes d’exfoliació en la majoria de les Referències. Els resultats indiquen que les referències desenvolupades per compressió directa presenten uns resultats equiparables o superiors a les referències per granulació via humida, amb un impacte econòmic menor (temps i costos) en el seu desenvolupament. En conclusió, s’ha optimitzat el sistema SeDeM, corregint desviacions i augmentant l’índex de fiabilitat. El simulador de compressió Styl’One ha posat de manifest la precisió i robustesa del sistema SeDeM en la selecció de la formulació més òptima i permet seleccionar les condicions de compressió més òptimes, maximitzar l’eficiència del procés i facilitar l’escalat.
Tablets are the most common solid oral dosage forms. Direct Compression (DC) is a good methodology due to its low manufacturing times and a reduced number of steps. However, this methodology requires powders which display adequate properties in order to be compressible. The need of a swift design of pharmaceutical formulations which fulfill the compression standards and the scale-up led to create expert systems and press simulators. In this thesis, the expert system SeDeM is optimized: a new methodology to determine the Cohesion Index is stablished and two new mechanical parameters are introduced (Melting point and Ejection Force). Then, the results obtained from the SeDeM diagram are compared against the results obtained from the Styl’ONE press simulator in simulated industrial conditions. The results indicates that the new methodology is more accurate and it has been demonstrated in the development of a formula, and the comparison of different Microcrystalline Celluloses from different manufacturers. The inclusion of the two new mechanical parameters has increased the SeDeM’s reliability index. Then, three formulas developed by DC and two developed by wet granulation were compressed by means of Styl’One press simulator. Five different rotatory press’ compression profiles were simulated (Korsch XL 400, Fette 2090, Fette 3100, Kilian RX 47 I Kilian S 250) under different compression conditions. The results show the accuracy of SeDeM system and seems to indicate a correlation between Carr’s Index and Inter particle porosity Index, low radius values and capping phenomenon during the compression process. These issues where solved by applying a pre-compression force. Moreover, the DC formulas display results similar or higher than the wet granulation formulas. In conclusion, the SeDeM expert system has been optimized, correcting the Cohesion Index deviations and increasing the reliability index by adding two mechanical parameters. The Styl’One press simulator has enabled to highlight the SeDeM system’s accuracy and robustness on choosing the most optimal formulation as well as the most optimal compression conditions in order to maximize the process’ efficiency and the scale-up.

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Dagnolo, Bianca. "The development of an orodispersible sildenafil citrate tablet intended for paediatric use." Thesis, Rhodes University, 2012. http://hdl.handle.net/10962/d1003229.

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Sildenafil citrate (SC) is a phosphodiesterase-5 inhibitor that is used to treat pulmonary hypertension (PH) in paediatric patients. The purpose of these studies was to develop a formulation and manufacture an orodispersible tablet (ODT) that can be easily administered to neonates and children with PH. The advantages of ODT dosage forms include ease of administration, rapid dissolution of the API, SC. Furthermore the dosage form can be taken without water which is beneficial to patients without immediate access to potable fluids. A simple, rapid, accurate, precise and selective reversed-phase HPLC method was developed and validated in accordance with International Conference on Harmonization (ICH) guidelines and was successfully used for the analysis of SC as raw material and in SC containing pharmaceutical dosage forms. Preformulation studies were performed on SC, alone and in combination with potential excipients that could be used to make tablets. Investigations into potential interactions between SC and the excipients were performed using Differential Scanning Calorimetry (DSC) and Infrared Spectroscopy (IR). DSC results revealed that SC was compatible with all potential excipients except mannitol and magnesium stearate. However these interactions were not observed with IR and therefore it was concluded that the interactions were induced by the high temperatures that DSC operates at. Particle size and shape was also established by use of Scanning Electron Microscopy (SEM) and flow properties were monitored by calculating Carr’s Index (CI) and the Hausner Ratio (HR). Direct compression was used as the method of manufacture for SC tablets as this approach is simple and the most economic production approach. The powder blends were assessed for bulk and tapped density and the CI and HR were used to determine the flowability of the blends. The quality attributes of the resultant tablets that were monitored included uniformity of weight, friability, crushing strength, tensile strength, disintegration, wetting and in vitro dispersion times. Design of Experiments is an efficient statistical approach that has become a popular tool used in the pharmaceutical industry to optimize formulation compositions, as it allows for the investigation of several input factors at the same time whilst not using the tedious and traditional “ modification of one variable at a time” approach. A Central composite experimental design was chosen as the most appropriate means to optimize the formulation as it produces more accurate results as opposed to other experimental designs approaches as input factors are investigated at five different levels. Through the use of mathematical modelling, optimum concentrations of disintegrant(s) and an appropriate blending time were established. Analysis of the data from the experimental design and mathematical modelling studies reveal that no changes in disintegrant concentration or blending time altered the disintegration time of the formulation to any significant extent. This result is most likely due to the fact that the critical disintegrant concentration has been reached and increasing the disintegrant concentration further has no effect on disintegration time. It was also established that a change in the concentration of CMS and CRP altered the wetting time of the tablet significantly. Finally it was noted that there was a linear relationship between blending time and the uniformity of content of the tablets produced in these studies. The optimized product was a white tablet with a diameter of 7.31 mm with a thickness of 2.80mm.The dosage form had no visible cracks or evidence of picking or sticking. The tablet exhibits suitable friability and tensile strength while exhibiting a disintegration time of only 8s. Therefore an orodispersible tablet containing SC intended for paediatric use has been successfully developed, manufactured and optimized through the use of preformulation studies, appropriate quality control monitoring and mathematical modelling. These formulations require further optimization in respect of addition of flavours and or additional sweetening agents.

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Amela, Navarro Joaquín. "Aportación tecnológica de comprimidos efervescentes de ácido ascórbico." Doctoral thesis, Universitat de Barcelona, 1994. http://hdl.handle.net/10803/672804.

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El objetivo de este trabajo ha sido la obtención de comprimidos efervescentes estables de ácido ascórbico mediante la técnica de compresión directa. Primero se caracterizaron físicamente componentes habituales en la elaboración de comprimidos efervescentes por observación microscópica, determinación de densidades aparentes, granulometría, humedad, higroscopicidad y electricidad estática. En los estudios de formulación se escogieron diferentes excipientes y sus proporciones en los comprimidos a partir de las características farmacotécnicas, comportamiento tecnológico y compatibilidad con ácido ascórbico. Es de destacar el gran efecto estabilizante que ejerce el ácido fumárico sobre el ácido ascórbico. Los comprimidos se mantuvieron estables tanto física como químicamente después de 6 meses de conservación en tubos de aluminio con Silicagel a 25 grados Cº/60% H.R. y 40 grados Cº/75% H.R.

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Galí, Serra Albert. "Optimización en la fabricación de medicamentos según ICH Q8, Q9 y Q10: aplicación a comprimidos recubiertos mediante diseño experimental de datos retrospectivos." Doctoral thesis, Universitat de Barcelona, 2015. http://hdl.handle.net/10803/360840.

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El proyecto de esta tesis doctoral se basa en las metódicas de trabajo descritas en las guías ICH Q8, Q9 y Q10, que permiten establecer una estrategia de pruebas para optimizar los recursos existentes y acortar los tiempos de las etapas del desarrollo y mejora de proceso de fabricación de un producto, minimizando el número de pruebas y mejorando el conocimiento obtenido. El trabajo llevado a cabo en esta tesis doctoral se centra en los procesos de recubrimiento pelicular y en la aplicación de las herramientas estadísticas para la optimización del proceso de fabricación de un producto ya comercializado que presenta problemas de calidad, ya que ha sido desarrollado siguiendo la metodología tradicional de ensayo-error. Se pretende plantear una optimización del proceso de recubrimiento que permitirá abaratar costes de producción y mejorar ciertos atributos de calidad, así como aportar una sistemática de estudio apta para aplicar en la mejora de procesos de producción de medicamentos. Con la optimización de los tiempos de proceso se pueden reducir los costes de producción, debido a una menor ocupación de la maquinaria de producción, estando por tanto disponibles para la fabricación de otros lotes comerciales u otros productos que se recubran en el mismo equipo. A su vez, también hay una disminución de horas necesarias (horas de máquina y de mano de obra directa) para la elaboración de un lote comercial, es decir, una optimización de tiempos. También hay que tener en cuenta que al mejorar la calidad de producto final se reducen las horas destinadas a reprocesar el lote para eliminar los comprimidos que presentan defectos de calidad. En general, la optimización de los procesos de recubrimiento requiere trabajos experimentales exhaustivos, no obstante la hipótesis del trabajo es comprobar si se pueden alcanzar mejoras sin necesidad de invertir mucho tiempo en recursos ni pruebas adicionales a nivel galénico para mejorar los procesos y que esto se traduzca en una mayor eficiencia en la fabricación de campañas comerciales. Es decir, para optimizar procesos comerciales no es necesario volver a la fase de desarrollo galénico, ya que con la información de los propios lotes comerciales anteriores se podrían plantear las mejoras. Se pretende en este caso aplicar la metodología a un proceso más complejo como es el recubrimiento de comprimidos. Este proyecto ha permitido identificar los parámetros críticos de proceso de la fase de recubrimiento de un producto comercial mediante un estudio retrospectivo de lotes comerciales. Por tanto, se demuestra que se pueden mejorar los procesos existentes mediante una evaluación de un histórico de datos sin necesidad de realizar pruebas de desarrollo del producto de nuevo. Mediante el análisis estadístico retrospectivo se han establecido los parámetros de proceso para mejorar los defectos de calidad estudiados, sin necesidad de llevar a cabo un diseño experimental con una batería de pruebas asociada. Se han aportado técnicas de mejora del proceso actual, desde un punto de vista tecnológico, que han permitido optimizar el proceso de recubrimiento sin implementar cambios en el proceso de fabricación y reducir los defectos de calidad estéticos. Mediante los datos evaluados retrospectivamente se ha podido llevar a cabo un diseño de experimentos que ha permitido seleccionar el mínimo número de factores que influyen para optimizar el proceso. Gracias al diseño factorial y a la posterior validación, se ha establecido un espacio de diseño que permite tener un proceso de recubrimiento que garantiza un medicamento producible, seguro, eficaz y de calidad. En la posterior validación industrial se ha demostrado que estos parámetros son los óptimos para obtener un producto con la calidad adecuada. También se ha alcanzado una reducción de costes, directos e indirectos, en el proceso de recubrimiento de comprimidos, mejorando simultáneamente los atributos de calidad del medicamento, ya que un espacio de diseño se puede establecer mediante una inversión mínima en experimentos, porque los datos retrospectivos de los lotes comerciales pueden ser evaluados y tratados estadísticamente. Mediante la validación comercial, los resultados demuestran que una evaluación retrospectiva de datos es una herramienta muy útil para mejorar los procesos de recubrimiento de productos comerciales. Por consiguiente, se ha establecido una sistemática de investigación apta para la mejora de procesos de producción de medicamentos, que da cumplimiento a las normativas ICH Q8, Q9 y Q10.
Although tablet coating processes are widely used in the pharmaceutical industry, they often lack adequate robustness. Up-scaling can be challenging as minor changes in parameters can lead to varying quality results. The aim of this study is to improve the current coating process of a commercial product, from a technological point of view, in order to optimize the coating process and decrease coating aesthetic defects. Then, to establish a design space, which would allow to obtain reproducible between-batch results. We describe the manufacturing process of the selected product and compile the process parameters of several commercial batches and analyze them retrospectively to establish the design space, based on the previously identified quality ranges. Without implementing changes to the process, the aim of this study is to identify the most adequate working ranges in order to reduce the number of aesthetic defects and avoid variations that are not within the registered product specifications. The main objective is to select critical process parameters (CPP) using retrospective data of a commercial product and to establish a design of experiments (DoE) that would improve the robustness of the coating process. A retrospective analysis of data from 36 commercial batches was carried out. Batches were selected based on the quality results generated during batch release, some of which revealed quality deviations concerning the appearance of the coated tablets. The product is already marketed and belongs to the portfolio of a multinational pharmaceutical company. The data were statistically processed to determine critical process parameters in order to propose new working ranges. This study confirms that it is possible to determine the critical process parameters and create design spaces based on retrospective data of commercial batches. This type of analysis is thus converted into a tool to optimize the robustness of existing processes. Our results show that a design space can be established with minimum investment in experiments, since current commercial batch data are processed statistically.

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Goole, Jonathan. "Développement et évaluation de mini-comprimés flottants à libération prolongée." Doctoral thesis, Universite Libre de Bruxelles, 2008. http://hdl.handle.net/2013/ULB-DIPOT:oai:dipot.ulb.ac.be:2013/210505.

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Parmi toutes les voies d’administration, la voie orale a toujours suscité un grand intérêt. Les formes prises par voie orale présentent une grande facilité d’administration pour le patient, tandis que pour les chercheurs, la physiologie du système gastro-intestinal peut être facilement modélisable. Malheureusement, son importante variabilité, liée principalement au temps de vidange gastrique, peut conduire à une mauvaise reproductibilité des effets thérapeutiques et à une diminution de la biodisponibilité. Ce problème est surtout rencontré dans le cas des principes actifs présentant une fenêtre d’absorption étroite au niveau de l’intestin supérieur [Deshpande et col. 1996]. Une solution a été de développer des formes galéniques à libération prolongée caractérisées par un temps de résidence gastrique accru. Ainsi, le principe actif est libéré progressivement en amont de sa fenêtre d’absorption. Dans cette optique, plusieurs systèmes ont été développés :des formes bioadhésives, expansibles, gonflantes ou à hautes densités [Singh et Kim, 2000]. Mais parmi toutes ces formes, ce sont les systèmes flottants qui semblent offrir la protection la plus efficace contre une vidange gastrique précoce [Moës, 1989]. Seth et Tossounian ont ainsi développé une gélule flottante à libération prolongée, basée sur le gonflement d’un dérivé cellulosique. Etant une forme monolithique, sa vidange gastrique était soumise au phénomène de tout ou rien. De plus, cette forme présentait un inconvénient majeur puisqu’elle était sujette à des fractionnements intra-gastriques, diminuant de ce fait la reproductibilité inter- et intra-individuelle [Seth et Tossounian, 1984].

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Doctorat en Sciences biomédicales et pharmaceutiques
info:eu-repo/semantics/nonPublished

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Puñal, Peces Daniel. "Aplicación del sistema experto SeDeM a la optimización de la fabricación de medicamentos según ICH Q8, Q9 y Q10." Doctoral thesis, Universitat de Barcelona, 2014. http://hdl.handle.net/10803/283703.

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Se ha seleccionado una formulación comercial existente en el catálogo terapéutico actual, que actualmente estuviera elaborada siguiendo la forma más popular y común de fabricación de comprimidos: granulación por vía húmeda. El producto seleccionado es un producto de uso en la terapia antimigrañosa como agonista de serotonina. Primeramente se ha estudiado a fondo el proceso actual de fabricación, evaluando los parámetros del proceso actual y relacionándolos con los atributos de calidad y sus tendencias, a fin de poder elaborar un espacio de diseño para el proceso de fabricación actual (acorde a las indicaciones de la guía ICH Q8: Desarrollo Farmacéutico). Posteriormente, mediante el sistema de experto en preformulación de comprimidos SeDeM, se han caracterizado una serie de parámetros concretos del principio activo almotriptán, a fin de evaluar su idoneidad o no para ser elaborado mediante compresión directa. A través de dicha evaluación se van a elaborar una serie de factores de incidencia e índices de aceptación, que servirán para realizar un cálculo final: el Índice de Buena Compresibilidad (IGC), a través del cual podemos evaluar y cuantificar la idoneidad o no del principio activo (API) para ser elaborado mediante compresión directa. Tras dicha evaluación, se ha conseguido evaluar los puntos fuertes y débiles del producto desde un punto de vista de capacidad para ser comprimido. Paralelamente se ha realizado un estudio exhaustivo de diferentes excipientes existentes en el mercado usando la misma metodología que la empleada en la caracterización del API. Se han caracterizado los mismos parámetros que componen el diagrama SeDeM y posteriormente se han elaborado los mismos factores, índices e IGC. A continuación, se pasa a una fase cuyo objetivo es desarrollar una fórmula (una por cada excipiente que potencialmente puede ser empleado como excipiente único de compresión directa). Mediante los cálculos descritos en el diagrama SeDeM y usando la información obtenida del principio activo objeto y de los excipientes incluidos en el estudio, se diseñan las fórmulas teóricas que tendrían que elaborarse. De forma teórica, empleando también el sistema SeDeM, se evalúa el IGC que tendría esa mezcla de excipiente y principio activo para establecer a priori cuál de las posibles combinaciones y fórmulas teóricas propuestas son viables de fabricar y cuáles no. Con las tres fórmulas consideradas como viables se han fabricado lotes piloto. Durante la fabricación de los lotes, se ha seguido un programa de control de proceso de dureza y peso. Posteriormente, se ha sometido a todos los lotes fabricados a una parte de los ensayos de producto final verificar si los nuevos comprimidos obtenidos son equivalentes a los comprimidos del producto original. Tras la revisión de los controles en proceso y de los resultados de los ensayos de producto final, se concluye que las nuevas fórmulas obtenidas con la herramienta SeDeM son equivalentes al medicamento original y que por tanto el sistema de experto SeDeM es adecuado para la reformulación de comprimidos para poder ser elaborados por compresión directa.
It has been selected an existing commercial formulation in the current therapeutic catalog, which currently it’s manufactured by compression after wet granulation. First of all, it has been studied the actual manufacturing process, evaluating the current process parameters and relating them to quality attributes and trends, in order to develop a design space for the current manufacturing process (according to ICH Q8 guidance: Pharmaceutical Development). With the expert system SeDeM for preformulation, it has been characterized a number of specific parameters of the active ingredient (API) almotriptan, to assess their suitability or not to be prepared by direct compression. With these results, it has been calculated some impact factors and acceptance rates, which will serve to make a final calculation: Index of Good Compression (IGC). With this evaluation, it has been possible to assess the strengths and weaknesses points of the product from the point of view of ability to be compressed. At the same time, it has been performed an exhaustive study of different excipients using the same methodology as that used in the characterization of the API. It has been characterized the same parameters of the SeDeM diagram and it has been calculated the same factors, index and IGC. Then it proceeds to develop a formula (one for each excipient which potentially can be used as direct compression excipient). With the calculations described in the SeDeM diagram and using the information obtained from the API and the excipients included in the study, it has been developed the theoretical formulas for the manufacturing. Using the SeDeM system, the IGC of the blends have been calculated to establish a priori which formulas are viable to manufacture and which not. Only three formulas were considered viable for manufacturing pilot batch. During manufacture of batches, it has followed a program of in process control of tablet hardness and weight. Then, all the manufactured batches have been analyzed following some of the final product test to verify if the new tablets obtained are equivalent to the original product or not. After reviewing all the in process controls and the results of final product tests, it is concluded that the new formulas obtained with the SeDeM tool are equivalent to the original drug and therefore SeDeM expert system is suitable to reformulate tablets to be prepared by direct compression.

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Saurí, Duran Jaume. "Desenvolupament i caracterització de comprimits matricials hidròfils de captopril." Doctoral thesis, Universitat de Barcelona, 2015. http://hdl.handle.net/10803/316030.

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L’objectiu de la tesi doctoral ha estat el desenvolupament i la caracterització de comprimits matricials hidròfils de captopril. Actualment no existeix una forma farmacèutica d’alliberació modificada de captopril en el mercat, ja que el captopril és inestable al pH bàsic intestinal. La inestabilitat en l’intestí, juntament amb l’elevada solubilitat en aigua que presenta, fa que el captopril sigui un principi actiu molt difícil de formular en sistemes d’alliberació modificada. Com a conseqüència de la recerca bibliogràfica realitzada, en aquesta tesi doctoral s’han elaborat uns sistemes matricials per compressió directa que es retinguin a l’estómac per tal d’assegurar una òptima estabilitat durant l’alliberació del captopril. La recerca del treball ha consistit en l’elaboració de formulacions amb diferents perfils de dissolució aplicant la metodologia Quality by Design (QbD), i la seva caracterització mitjançant el diagrama SeDeM i tècniques microscòpiques, les quals han estat utilitzades per primer cop en la caracterització de matrius hidròfiles. La metodologia utilitzada ha estat la combinació d’una recerca bibliogràfica molt exhaustiva, que juntament amb l´ús de tècniques microscòpiques avançades (Microscòpia de Força Atòmica, Microscòpia Electrònica de Rastreig, Angle de Contacte, i Microscòpia Confocal), s’han relacionat els paràmetres fisicoquímics de les matrius hidròfiles amb els paràmetres microscòpics. Els resultats de la recerca han estat l’obtenció d’unes metodologies que suposen un avenç científic en la caracterització de matrius hidròfiles. Els resultats obtinguts en aquesta tesi doctoral poden donar lloc a un ampli ventall d’estudis en el camp de la Tecnologia Farmacèutica, ja que els conceptes adquirits són potencialment aplicables en altres sistemes d’alliberació de fàrmac
The aim of the thesis has been the development and characterization of hydrophilic matrix tablets of captopril. Currently, there is no any modified release dosage form of captopril in the market, since captopril is unstable under basic intestinal pH conditions. The instability in the intestine, combined with a high water solubility, makes very difficult to formulate modified release systems of captopril. As the result of the bibliographic research carried out in this thesis, controlled release matrix tablets of captopril have been developed by direct compression with the aim to retain the dosage form in the stomach in order to ensure an optimal stability during the release of captopril. The research of this work has consisted in the preparation of formulations with different dissolution profiles applying the methodology Quality by Design (QbD) and their characterization using the SeDeM diagram, and microscopic techniques that have been used for the first time in the characterization of hydrophilic matrix tablets. The methodology used has been the combination of a very comprehensive bibliographic search and with the use of advanced microscopic techniques (Atomic Force Microscopy, Scanning Electron Microscopy, Contact angle, and Confocal Microscopy), it has been obtained a relationship between the physicochemical parameters of the hydrophilic matrices with the microscopic parameters. The results obtained in this thesis have been the obtaining of methodologies that represent a scientific breakthrough in the characterization of hydrophilic matrices. The results from this research can lead to a wide range of studies in the field of Pharmaceutical Technology, since the concepts acquired are potentially applicable to other drug delivery systems.

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Ruiz, Xivillé Núria. "Desenvolupament, caracterització i avaluació d’una nova forma farmacèutica basada en micro-comprimits d’alliberació modificada." Doctoral thesis, Universitat de Barcelona, 2019. http://hdl.handle.net/10803/667919.

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El metilfenidat HCl (MPH) és un fàrmac clàssic per al tractament del TDAH en nens a partir dels 6 anys, quan altres mesures resulten insuficients. Aquest trastorn es manifesta principalment durant la infància i l’adolescència però pot mantenir-se al llarg de tota la vida del pacient i generalment afecta entre un 2 i un 7 % de la població infantil, sent més comú en nens que en nenes. La molècula pertany al grup farmaco-terapèutic dels psicoestimulants, del tipus amfetamina. Els seus efectes són immediats, començant a notar-se als 30-60 minuts i disminuint al cap de 3-6 hores, comportant una administració continuada al llarg del dia per a aconseguir l’efecte terapèutic adequat. En front aquest problema, Products&Technology planteja el desenvolupament d’un nou medicament que permeti l’alliberació prolongada del MPH de manera que els pacients només requereixin una única dosi diària. L'objectiu principal de la tesi és el desenvolupament d'una nova forma farmacèutica del MPH basada en micro-comprimits d'alliberació modificada, complint el perfil d'alliberació especificat per l'empresa. El nou medicament es presenta com a genèric del producte de referència escollit. S'ha dut a terme una investigació complerta dels principis actius de diferents proveïdors i s’han explorat noves vies de formulació que permeten l’alliberació desitjada. Després de molts assajos amb diferents excipients, s’aconsegueix una nova formulació fonamentada en una càpsula que conté dos tipus de comprimits de 4,5 mm de diàmetre: uns d’alliberació immediata i uns altres de recoberts amb una capa d’alliberació modificada. Aquesta composició ha estat patentable i proporciona un mètode de fabricació simple per a què l’empresa pugui fabricar fàcilment diferents dosis del producte acabat (PA). Al mateix temps, s’han desenvolupat i validat els mètodes analítics tant pels intermedis com PA. Paral·lelament, s’han realitzat tots els estudis necessaris per a assegurar un producte segur, eficaç, estable i de qualitat que es pugui utilitzar en estudis pilot de farmacocinètica. Així doncs s’ha investigat: la compatibilitat del principi actiu amb els excipients escollits, el poder discriminatori del test de dissolució, la fotoestabilitat i l’estrès dels principis actius i dels comprimits, l’estabilitat del producte acabat a diferents condicions de temperatura i humitat seguint els consells de les ICH i la robustesa del procés de fabricació. Finalment, s’han realitzat dos estudis pilot de bioequivalència: en dejú i amb presència d’aliments. Aquests han estat realitzats al centre CIM de l’Hospital de Sant Pau amb 16 voluntaris sans. Els resultats han demostrat una lleugera infra-bioequivalència de la formulació testada degut a un dels paràmetres estudiats en ambdós estudis. Addicionalment, s’ha corroborat la seguretat i la tolerabilitat dels tractaments sense notificacions de cap efecte advers greu. En conclusió, s’ha pogut desenvolupar un nou medicament d’alliberació modificada amb les especificacions corresponents i un procés de fabricació robust. Aquest nou fàrmac ha demostrat ser estable durant 3 anys conservant per sota de 30 ºC. Amb els resultats dels estudis pilot de farmacocinètica es creu necessari modificar lleugerament la formulació per a continuar amb els estudis pivotals i amb la presentació del producte a les agències regulatòries.
Methylphenidate HCl is a classic drug used to treat attention deficit hyperactivity disorder (ADHD) in children from the age of 6, when other measures result insufficient. This disorder principally appears during childhood and adolescence though it could endure the entire patient's life. Generally, it approximately affects from 2 to 7 % of child population, being more common among boys than girls. The molecule belongs to the pharmaco-therapeutic group of CNS stimulants, as a type of amphetamine. Its effects are immediate, starting 30-60 minutes after administration and decreasing between 3 to 6 hours later, implying a continuous administration along the day to achieve the adequate therapeutic effect. Against this problem, Products&Technolgy propose the development of a new medication which allows the prolonged release of MPH so that the patient only requires a unique daily dose. The main goal of the present thesis is the development of a new pharmaceutical form of MPH based on modified release micro tablets, reaching the release profile specified by the company. The new medicine is presented as a generic of a chosen reference product. A complete investigation of active principle ingredients from different suppliers has been carried on and new formulations' ways have been explored leading to the desired release. After plenty of trials with different excipients, a new formulation is accomplished on the basis of a capsule containing two types of tablets of a 4.5 mm diameter: some immediate release and some others coated with a modified release layer. This composition has been patented and it has provided a simple manufacturing method for the company to be able to easily produce different doses of the drug product (DP). At the same time, analytical methods for intermediates and DP have been developed and validated. Concurrently, all the studies needed to ensure a safe, effective, stable and quality product which could be used in pilot pharmacokinetic studies have been conducted. Therefore, the research included: the compatibility between API and chosen excipients, the discriminatory power of the dissolution test, the photostability and stress testing of API and tablets, the stability of the drug product at different conditions of temperature and relative humidity following the ICH guidelines and the robustness of the manufacturing process. Finally, two bioequivalence pilot studies have been carried out: fasting and fed conditions. These have been conducted by CIM centre of Hospital de Sant Pau with 16 healthy volunteers. The results have demonstrated a slight infra-bioequivalence of the tested formulation due to one of the studied parameters in both studies. Additionally, security and tolerability of the treatments have been confirmed without any serious adverse effect notification. Conclusively, it has been possible to develop a new modified release drug product with the corresponding specifications and a robust manufacturing process. This new medication has demonstrated to be stable for 3 years keeping it below 30 ºC. With the results from pilot pharmacokinetic studies it seems necessary to slightly modify the current formulation to continue with pivotal bioequivalence studies and the submission of the drug product to the regulatory agencies.

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Westberg, Annica. "Characterization of mini-tablets : Evaluation of disintegrationand dissolution methods." Thesis, Umeå universitet, Farmakologi, 2019. http://urn.kb.se/resolve?urn=urn:nbn:se:umu:diva-157876.

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Xia, Hui. "Visual medical decision-making: Bipartite graphs vs. interactive tables." Thesis, University of Ottawa (Canada), 1996. http://hdl.handle.net/10393/9562.

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Most of the current medical diagnosis support systems are based on a textual design. In this thesis we present a model that uses a different design. It uses visualization to aid home diagnosis of common diseases in a user-friendly way. The model clearly displays the diagnostic results on the screen. A way of organizing the information into a picture of all symptoms, diseases, and the complex relationships between them (especially the combination of symptoms onto a single screen to give a global view) is presented. The purpose of designing this model is to bring complicated medical knowledge to the ordinary user. We believe that the simplified and economic display can demystify medicine, and empower the user to take better care of himself. By this convenient software tool people can discover quickly at home whether their symptom is serious or not, and then decide whether it is necessary to see the doctor; also people can compare the diagnosis the model makes with the doctors'. This model does not recommend treatment or therapy.

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Breña, Figueroa Mirtha Rocío. "Diseño y desarrollo de una formulación para Gemfibrozilo 600 mg. tableta recubierta." Bachelor's thesis, Universidad Nacional Mayor de San Marcos, 2005. https://hdl.handle.net/20.500.12672/2603.

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En el presente trabajo se han evaluado tres formulaciones para Gemfibrozilo 600 mg tableta recubierta, una realizada por compresión directa y dos por granulación húmeda, de las cuales se ha seleccionado a la formulación que cumple los parámetros establecidos para el dosaje, disolución y los factores de deferencia (F1) y similitud (F2), estos factores fueron determinados a través de la comparación por perfil de disolución con respecto al producto innovador. Se realizó el estudio de estabilidad acelerada (40ºC ± 2 ºC / 75% de humedad relativa ± 5%.), estabilidad a largo plazo (25 ºC ± 2 ºC / 60% ± 5% de humedad relativa) y estabilidad intermedia (32 ºC C ± 2 ºC / 65% de humedad relativa ± 5%. ) de la formulación que cumplió las especificaciones anteriormente mencionados, en dos tipos de empaque primario (Blister de Aluminio y PVC 250 um y 300 um) y al producto de referencia, los periodos de tiempo de los análisis fueron al iniciar el estudio de estabilidad (tiempo inicial), a los 3 meses, 6 meses y en el caso de la estabilidad a condiciones ambientales hasta los 12 meses. La metodología utilizada para el análisis fisicoquímico se basó en la Farmacopea de los Estados Unidos (USP 26 – NF 21) y la Farmacopea Británica (BP 2003) y el análisis microbiológico se basó en la European Pharmacopoeia 4ta Ed. 2002, los análisis que se realizaron en los distintos periodos de tiempo a las muestras sometidas a estabilidad fueron pruebas fisicoquímicas como: descripción, peso promedio, dureza, humedad, desintegración, disolución, dosaje y uniformidad. Finalmente por medio del estudio comparativo de los datos obtenidos del estudio de estabilidad con el producto de referencia se determinó que la formulación seleccionada para Gemfibrozilo 600 mg tableta recubierta cumple con todos los parámetros de calidad establecidos por las farmacopeas oficiales de referencia a temperaturas de almacenamiento de 25 ºC e inclusive a 32 ºC. Palabras claves: Gemfibrozilo tableta recubierta, compresión directa, granulación húmeda, estabilidad acelerada, estabilidad natural, estabilidad intermedia, factores de deferencia (F1) y similitud (F2)
Three Gemfibrozil 600 mg coated tablet formulations were evaluated, one manufactured by direct compression and two by wet granulation, it has been selected the one that fulfill the established parameters for dosage, dissolution, and the difference (F1) and similitude (F2) factors, these two factors are determined by comparison of the dissolution profile respect of the innovator product. It was developed the accelerated (40 °C ± 2 °C / 75% ± 5% relative humidity), long term (25 °C ± 2 °C / 60% ± 5% relative humidity) and intermediate (32 °C ± 2 °C / 65% ± 5% relative humidity) stability studies in two types of primary container (Aluminum blister and 250 um and 300 um PVC) and for the innovator product, the analysis was at the beginning of the stability study (zero time), in the third and sixth month and in the case of the environmental condition stability even the twelfth month. The methodology used for the physico-chemical and microbiological analysis was based on the United States Pharmacopoeia (USP 26 – NF 21) and the British Pharmacopoeia (BP 2003), the microbiology analysis was based European Pharmacopoeia 4ta Ed. 2002, the analysis that were performed to the stability-submit samples in the different periods of time were physicochemical tests: description, average weight, hardness, humidity, disintegration, dissolution, dosage and uniformity. Finally, through the comparative study of the stability data obtained with the innovator product it was determinate that the selected formulation for Gemfibrozilo 600 mg coated tablet complies all the quality parameters established by official reference pharmacopoeias at storage temperature of 25°C and even at 32 °C. Key words: Gemfibrozil 600 mg coated tablet, direct compression, wet granulation, accelerated stability, long term stability, intermediate stability, the difference (F1) and similitude (F2) factors.
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Molina, Rodríguez Lucía Pamela, and Aching Juan Manuel Ramírez. "Diseño y desarrollo de una formulación por compresión directa para tabletas de diltiazem 60 mg." Bachelor's thesis, Universidad Nacional Mayor de San Marcos, 2007. https://hdl.handle.net/20.500.12672/1107.

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Se desarrolló una preformulación de Clorhidrato de Diltiazem 60mg, en la que se evaluó las propiedades tanto del principio activo como de los posibles excipientes a ser usados. Los comprimidos fueron elaborados mediante el método de compresión directa, considerando durante el proceso propiedades físicas tales como dureza y friabilidad. Se preparó dos ensayos piloto con la misma fórmula cuali-cuantitativa, a ambos se realizaron estudios de estabilidad acelerada en dos empaques primarios cada uno que fue aluminio blister PVC ámbar de 250 micras y PVC/PVdC ámbar de 250/60 micras. De acuerdo a los resultados obtenidos en el estudio de estabilidad se procedió con la monitorización de la fabricación de los lotes a nivel industrial y el ingreso de uno de ellos para estudios de estabilidad acelerada, para lo cual se decidió usar el empaque primario de mayor conveniencia, aluminio blister PVC ámbar de 250 micras. Así mismo, para demostrar la similitud del comportamiento de nuestra formulación, se utilizó el concepto de los factores de similitud y diferencia respecto de un producto de referencia, en lo que concierne a perfil de disolución. Finalmente, con los resultados obtenidos tanto en el perfil de disolución como de los estudios de estabilidad realizados se determina que la formulación desarrollada para Diltiazem 60mg tabletas, cumple con las especificaciones establecidas en los libros oficiales vigentes.
-- A preformulation was developed studying the active ingredient properties and the possible excipients. Tablets were prepared by a direct compression method, considering during the process physical properties such as hardness and friability. Two formulations were developed with the same characteristics, accelerated stability studies were developed for both of the formulations using two different primary packing materials each: amber polyvinyl chloride of 250 micras and amber polyvinylidene chloride of 250/60 micras. According to the results, we carried out the manufacturing and monitoring of three industrial batches, doing stability studies for one of them, using as the primary packing for the industrial batch amber polyvinyl of 250 micras. Therefore, to demonstrate the similarity in the behaviour of our formulation, we used the factors of similitude and difference regarding a reference product, concerning the dissolution profile. Finally all the results obtained indicate that the developed formulation fulfills the parameters of the current Pharmacopeia.
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Isidro, Quispe Delia Aracelli. "Validación concurrente del proceso de fabricación de las tabletas de glibenclamida 5 mg." Bachelor's thesis, Universidad Nacional Mayor de San Marcos, 2006. https://hdl.handle.net/20.500.12672/1086.

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La validación del proceso de fabricación de las tabletas de glibenclamida 5mg, fue realizado en un laboratorio farmacéutico, durante los meses de marzo a octubre del 2005. En este período se llevó a cabo la fabricación de tres lotes consecutivos, los cuales fueron utilizados para la validación. El estudio nos permitió demostrar que la validación del proceso de fabricación de las tabletas de glibenclamida 5mg cumplió con los parámetros establecidos. Demostrándose que los equipos, etapas y las áreas estaban adecuadamente instaladas, documentadas y operativas tal como se evidenció de manera consistente y repetitiva durante todo el proceso de validación. Adicionalmente los datos obtenidos del proceso de fabricación de las tabletas de glibenclamida 5 mg; fueron procesados con el paquete estadístico SPSS 11.10; demostrándose que existe diferencia significativa con un p < 0,05 entre el inicio, medio y final de los tres lotes. Por tanto se concluye que el proceso cumplió con las especificaciones establecidas, pero no asegura que estadísticamente este bajo control; porque las herramientas estadísticas nos permitieron evaluar con un alto grado de confiabilidad el comportamiento real del proceso.
-- The validation of the manufacturing process of the tablets glybenclamide 5mg, was carried out in a pharmaceutical laboratory, during the months of March to October of the 2005. In this period was carried out the production of three serial lots, which were used for the validation. The study allowed us to demonstrate that the validation of the manufacturing process of the tablets glybenclamide 5mg completed the established parameters. Being demonstrated that the equipment, stages and the areas were appropriately installed, documented and operative just as it was evidenced in a consistent and repetitive way during the whole validation process. Additionally the obtained data of the manufacturing process of the tablets of glybenclamide 5 mg; they were processed with the statistical package SPSS 11.10; being demonstrated that significant difference exists with a p < 0,05 among the beginning, means and end of the three lots. Therefore you concludes that the process completed the established specifications, but it doesn't assure that statistically this low control; because the statistical tools allowed us to evaluate with a high grade of dependability the real behavior of the process.
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Komperlla, Mahesh Kumar. "The formulation and evaluation of rapid release tablets manufactured from Artemisia Afra plant material." Thesis, University of the Western Cape, 2004. http://etd.uwc.ac.za/index.php?module=etd&amp.

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Infusions, decoctions, alcoholic preparations and other dosage forms of Artemisia afra are frequently used in South African traditional medicine. Generally when these preparations are made without applying good manufacturing practices they do not meet microbial quality control standards, safety and toxicity criteria and encourage poor patients compliance. To overcome the aforementioned disadvantages of traditional dosage forms a sold dosage form, i.e. a table might be recommended. The first objective of this study was to formulate and manufacture a rapid release tablet dosage of Artemisia afra that would contain an amount of plant material equivalent to that found in its traditional liquid dosage forms and that would meet conventional pharmaceutical standards. The second objective was to conduct a pilot study to obtain a preliminary profile of the bioavailability of select flavonoids presents in both the tablet and traditional liquid preparation of Artemisia afra in humans.

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Rachid, Ousama. "Evaluation of the effects of non-medicinal ingredients on the in vitro characteristics and in vivo bioavailability of a sublingual tablet formulation of epinephrine." Elsevier: J Allergy Clin Immunol, 2010. http://hdl.handle.net/1993/18315.

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Objectives: To review, develop, and validate appropriate methods for quality control testing of sublingual (SL) tablets; to formulate and characterize new generations of SL tablets of epinephrine (E) for the potential first-aid treatment of anaphylaxis; and to evaluate the effects of non-medicinal ingredients (NMIs) on the in vitro characteristics and in vivo bioavailability of the formulated tablets. Methods: A custom-made apparatus and a novel method that simulates SL conditions were evaluated for dissolution testing of SL tablets. An electronic tongue (e-Tongue) was used to assess the degree of E bitterness and to demonstrate the masking effects of sweetening and/or flavoring agents. The effect of several NMIs in various properties on the in vitro characteristics of new generations of E SL tablets was evaluated. Formulations with the best in vitro characteristics, containing E 30 mg and 40 mg, were evaluated in vivo using our validated rabbit model and compared with placebo SL tablets (negative control) and E 0.3 mg intramuscular (IM) injection (positive control). Results: The novel in vitro dissolution testing resulted in accurate and reproducible data and was capable of detecting the effect of minor changes in formulations. Using the e-Tongue, E bitartrate had an extremely bitter taste which was masked to various degrees by the addition of aspartame, acesulfame potassium, and citric acid alone or in combination. Citric acid alone masked the bitter taste by >80%. The evaluation of NMIs revealed that the best formulation contained specific proportions of mannitol and coarse and fine grades of microcrystalline cellulose. Appropriate comparative testing resulted in the selection of a taste-masked E SL formulation with optimum in vitro characteristics. This formulation containing E 40 mg resulted in similar bioavailability to E 0.3 mg IM. This formulation containing E 30 mg had higher bioavailability than placebo, but lower bioavailability than E 40 mg tablets. Conclusions: Grades and proportions of NMIs carefully selected using appropriate in vitro testing resulted in successful formulations. The results of these in vitro tests enabled the development of the optimum E SL tablet formulation which was bioequivalent to the EpiPen. These tablets are potentially suitable for Phase 1 studies in humans and might transform the first-aid treatment of anaphylaxis in community settings.

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Cordero, Santana Michael Joel, and Tapia Luisa Manuela Cornejo. "Evaluación de las propiedades farmacotécnicas en el diseño y formulación de tabletas de clorfenamina por compresión directa." Bachelor's thesis, Universidad Nacional Mayor de San Marcos, 2007. https://hdl.handle.net/20.500.12672/1061.

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En la presente tesis, se evaluaron diferentes formulaciones de comprimidos de clorfenamina de 4 mg obtenidos por compresión directa, diseñadas con el objetivo de lograr una formulación que cumpla con los parámetros establecidos en la Farmacopea de los Estados Unidos XXVIII para el control de la calidad del producto terminado. A partir de cuatro excipientes principales diseñados para su utilización en compresión directa, se desarrollaron ocho formulaciones iniciales evaluándose en sus mezclas todas sus propiedades farmacotécnicas las cuales pueden clasificarse como Estáticas: tamaño y forma de las partículas, distribución granulométrica, densidad aparente, Dinámicas entre ellas la fluidez y la compresibilidad, se seleccionaron dos excipientes de compresión directa como los idóneos para nuestro desarrollo, con los cuales se realizaron dos formulaciones a diferentes porcentajes (lactosa monohidratada y celulosa microcristalina). Entre estas dos formulaciones, la denominada Fórmula A cumplió con los parámetros de calidad establecidos. Los resultados obtenidos en los diferentes materiales de empaque primario (Cloruro de polivinilo ámbar y Cloruro de polivinilideno ámbar) en el estudio de estabilidad a largo plazo de los comprimidos fabricados a escala semiindustrial demostraron que hasta 1 año posterior a la fabricación, éstas cumplen con las especificaciones establecidas en la Farmacopea, lo cual permite pasar a la fase de escalamiento a nivel industrial.
-- Various formulations of chlorpheniramine 4 mg tablets were evaluated by direct compression, designed with the purpose of obtaining a formulation that fulfills the parameters of the Pharmacopeia of the United States XXVIII for the control of the quality of the finished product. Starting from four direct compression excipients, eight initial formulations were developed being evaluated in their mixtures all their pharmacotechnical properties which can be classified as: static size and particles shape, particle size distribution, apparent and dynamic density among them the fluidity and the compressibility. Two excipients of direct compression were selected as suitable for our development from which two formulations to different percentages with the selected (lactose monohydrate and microcrystalline cellulose) excipients. Among these two formulations, the denominated Formula A fulfilled the established parameters of quality. The results obtained in the different materials of primary packing (polyvinyl chloride and polyvinylidene chloride both amber) in the long term study of stability of the tablets manufactured to scale semi industrial demonstrated that up to 1 later year to the production, these fulfill the specifications settled down in the Pharmacopeia, which let to pass to the phase of the scale up at industrial level.
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Espinoza, Cámac Nataly Valentina. "Estudio comparativo de la influencia del material de empaque primario sobre las tabletas recubiertas de lamivudina 150 mg." Bachelor's thesis, Universidad Nacional Mayor de San Marcos, 2005. https://hdl.handle.net/20.500.12672/2605.

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El presente trabajo se realizó con el propósito de evaluar la influencia de cuatro tipos de materiales de empaque que son empleados regularmente para tabletas, sobre una formulación de lamivudina 150 mg tabletas recubiertas obtenida por compresión directa. Para realizar este estudio se elaboró un lote piloto de lamivudina 150 mg tabletas recubiertas, luego se acondicionó en cuatro tipos de materiales de empaque: PVC/Aluminio, PVC/PVDC / Aluminio, Aclar / Aluminio y Alupol / Alupol, y fueron sometidos a un estudio de estabilidad acelerada de seis meses, a condiciones de temperatura y humedad recomendadas para el Perú según the United States Pharmacopeia 27 (USP 27). Para determinar el material de empaque adecuado se realizaron los respectivos ensayos fisicoquímicos durante el estudio de estabilidad. Al final del estudio, todos los materiales de empaque evaluados garantizaron la calidad del producto. A continuación, se realizó el análisis económico de cada material de empaque empleado, para establecer cuál permite ahorrar costos sin afectar la calidad de producto final. Finalmente considerando los aspectos de calidad, logísticos, costos y marketing, se concluye que el PVC es el material de empaque mas adecuado para el producto de manera integral.
The aim of this the present study was to evaluate the influence of four different primary package materials that are used regularly for tablets, over a formulation by direct compression of lamivudine 150 mg coated tablet. The pilot-size batch was packed in the next primary package material used in this study: PVC (polyvinyl chloride) / Aluminum, PVC/PVdC (polyvinylidene chloride) / Aluminum, PVC/PCTFE (Polychlorotrifluoroethylene) / Aluminum and polyethylene aluminum foil “Alupol/Alupol”. At last these product were include in an accelerated stability study during six months to conditions of recommended temperature and humidity for Peru (zone IV) according to the United States Pharmacopeia 27 (USP27). In order to determine the material of suitable packing parameters test were developed during the stability study. At the end of the study, all the evaluated materials of packing guarantee the quality of the product. Then the economic analysis of each material of used packing was achieved, to establish which material allows to save costs without affecting the quality of the product. Finally considering the aspects of quality, logistic, cost and marketing, it is concluded that the PVC is the material of suitable packaging but for the product of integral way.
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PRADO, PICHARDO JUAN ALBERTO 270080, and PICHARDO JUAN ALBERTO PRADO. "Análisis cuantitativo del temblor por medio de espirografía con tableta digitalizadora y su clasificación mediante redes neuronales." Tesis de maestría, Universidad Autónoma del Estado de México, 2017. http://hdl.handle.net/20.500.11799/79751.

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Tesis de Maestría. Análisis cuantitativo del temblor por medio de espirografía con tableta digitalizadora y su clasificación mediante redes neuronales.
En el presente trabajo de investigación se desarrolló una plataforma y se definió un protocolo de experimentación, para detectar la fatiga muscular de los miembros superiores mediante el dibujo de la espiral de Arquímides utilizando un estilete y una tableta digitalizadora comercial

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Moyano, Leandro Gabriel. "Análisis de procesos y proposición de un tablero de comando integral." Bachelor's thesis, Universidad Nacional de Cuyo. Facultad de Ciencias Económicas, 2020. http://bdigital.uncu.edu.ar/15739.

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Son muchos los casos de las organizaciones que no cuentan con herramientas de gestión que faciliten conocer la situación actual de la empresa. Así sucede con FUESMEN, por lo que, en la presente investigación, se propone analizar de manera profunda los procesos de la institución y acercar un modelo de Tablero de Comando Integral que permita conocer la situación actual de FUESMEN y proponer una gestión por objetivos. Mediante una investigación documental, observaciones y entrevistas a miembros de la gerencia y la organización, se pudo comprender en qué lugar se encuentra hoy FUESMEN y hacia dónde se debe dirigir. La participación activa de los miembros de la institución permitió obtener como resultado una propuesta de mejora para su proceso central, así como la proposición de un Tablero de Comando Integral, acompañado de acciones concretas para resolver las principales problemáticas en el corto plazo.
Fil: Moyano, Leandro Gabriel. Universidad Nacional de Cuyo. Facultad de Ciencias Económicas.

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Pastor, Bautista Lily Lorena. "Diseño, formulación y estabilidad de preparados galénicos de captopril a partir de tabletas." Bachelor's thesis, Universidad Nacional Mayor de San Marcos, 2013. https://hdl.handle.net/20.500.12672/14700.

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Publicación a texto completo no autorizada por el autor
Evalúa tres preparados galénicos líquidos para captopril 0,75 mg/mL, a partir de tabletas, empleando para ello vehículos de uso común en los hospitales. Se evaluó la estabilidad en uso de los preparados galénicos en envases de vidrio ámbar, sometidos a refrigeración (2 a 8 ºC). Se utilizaron los siguientes vehículos: (1) agua estéril para inyección + solución de ascorbato de sodio al 1% y (2) solución de dextrosa al 5% + solución de ascorbato de sodio al 1%; para dos de los preparados galénicos se utilizó el vehículo (1), uno de los cuales fue filtrado antes de ser envasado. La determinación del porcentaje de captopril se realizó utilizando la metodología de la USP 35 (Farmacopea de los Estados Unidos). Finalmente, por medio del estudio comparativo de los datos obtenidos en los tiempos de estudio (1, 7 y 14 días), se estableció que inicialmente los tres preparados galénicos cumplieron con los parámetros de farmacopea; posteriormente, en el día 7 el porcentaje de captopril disminuyó en aproximadamente 10%. Se concluyó que el vehículo formado por agua estéril para inyección y solución de ascorbato de sodio al 1%, constituyen el mejor excipiente para la formulación de una solución líquida de captopril. La fecha límite de uso es de 3 días para el vehículo (1) sin filtrar, y dos días para el vehículo (1) filtrado y el vehículo (2).
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Silva, Junior Nelson Pereira da. "Avaliação de processos para obtenção de comprimidos de Beta-Ciclodextrina-Paracetamol /." Araraquara : [s.n.], 2006. http://hdl.handle.net/11449/91705.

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Resumo: Ciclodextrinas (CD) têm sido relatadas em inúmeros estudos por interagir com muitos fármacos para a formação de complexos de inclusão com o objetivo de aumentar a solubilidade, estabilidade e biodisponibilidade. No processo usual para obtenção de comprimidos contendo Beta-CD, as dispersões líquidas de fármaco/Beta-CD são submetidas a processos de secagem por liofilização, evaporação ou spray-drying e o material seco é incorporado a vários excipientes. O objetivo principal deste trabalho foi avaliar processos de obtenção de comprimidos de Beta-CD/paracetamol. O paracetamol foi utilizado como fármaco modelo por ser pouco solúvel em água. No primeiro processo, a dispersão líquida de Beta-CD/paracetamol foi incorporada ao amido de milho, celulose microcristalina ou lactose monoidratada e o material foi granulado e submetido à secagem em leito estático (estufa). No segundo processo, a dispersão líquida de Beta-CD/paracetamol foi incorporada ao amido de milho e o material submetido à secagem em leito fluidizado (leito de jorro). Os materiais obtidos em ambos os processos foram comprimidos. Comparando os três excipientes utilizados no primeiro processo, tanto o amido quanto celulose são os excipientes que possibilitariam a incorporação de quantidade maior de fármaco. Como resultados, os granulados obtidos a partir dos excipientes amido e celulose apresentaram boas características de escoamento e compressibilidade. O segundo processo, originou um material que apresentou boas características de compressibilidade e comprimidos que apresentaram as melhores características físicas durante o processo de compactação. Concluiu-se que ambos processos representam uma estratégia tecnologicamente viável para obtenção de comprimidos contendo Beta-CD.
Abstract: Cyclodextrins (CDs) have been reported in a number of studies in the pharmaceutical field since it interact with many drugs to form water soluble inclusion complexes, thus improving not only the solubility but also the stability and biovailability of various drugs. In order to obtain Beta-CD tablets, liquid dispersions of drug/ Beta-CD are usually submitted to different drying process, like spray drying, freeze-drying or slow evaporation and further added to several excipients. In this work we evaluated different process for the preparation of Beta-CD/ acetaminophen tablets. Due to its low solubility, we have used acetaminophen as a drug model. In the first process, an aqueous Beta-CD/ acetaminophen dispersion were added to corn starch, microcrystalline cellulose or monohydrated lactose and the material was dried in a static bed. In the second process, an aqueous Beta-CD/acetaminophen dispersion were added to corn starch and further dried in a fluidized bed (spouted bed). As a result, in the first process the use of starch or cellulose led to mixtures with higher amount of drug with good flowability and compressibility, whereas the second process led to a mixture of good compressibility and to tablets that presented the best physical proprieties. In conclusion, both process represent viable technological approaches to obtain Beta-CD tablets.
Orientador: Maria Palmira Daflon Gremião
Coorientador: Ana Dóris de Castro
Banca: Leila Aparecida Chiavacci
Banca: Osvaldo de Freitas
Mestre

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Aguirre, Torres Ketty Marly, and Mendoza Chírstel Catherine Yauri. "Diseño y desarrollo de una formulación de orfenadrina citrato 100 mg tableta de liberación prolongada." Bachelor's thesis, Universidad Nacional Mayor de San Marcos, 2014. https://hdl.handle.net/20.500.12672/10795.

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Desarrolla seis formulaciones de orfenadrina citrato 100 mg tabletas de liberación prolongada; una fue realizada por compresión directa y cinco por granulación húmeda. Se realizaron estudios de pre formulación, partiendo del conocimiento de la forma, tamaño de partícula y solubilidad del ingrediente farmacéutico activo (IFA); así como, estudios de estabilidad tipo I. Se emplearon excipientes seleccionados en base a sus características farmacotécnicas y compatibilidad con el IFA, como behenato de glicerilo para la matriz lipofílica de liberación; luego se analizaron para conseguir una formulación que cumpla con los estándares de calidad y tiempos de liberación establecidos en la Farmacopea de los Estados Unidos (USP 36). La fórmula seleccionada fue llevada a escala de lote piloto industrial, demostrando una buena reproducibilidad de resultados; se realizó también el perfil de disolución entre los lotes industriales y el producto innovador, obteniéndose resultados similares. Los tres pilotos industriales fueron empacados en blíster de aluminio y PVC ámbar, para someterlos a estudios de estabilidad acelerada y a largo plazo (zona IVA), según nuestra normativa vigente. Posteriormente se fabricaron tres lotes industriales que también se sometieron a estudios de estabilidad acelerada y a largo plazo (zona IVA). La formulación cumplió con las especificaciones establecidas en la USP 36; se realizaron análisis completos a tiempo cero, a 3 y 6 meses, que incluyeron aspecto, peso promedio, disolución, identificación y valoración de orfenadrina citrato, compuestos relacionados y ensayos microbiológicos; además de un estudio estadístico de estabilidades de Análisis de Covarianza (ANCOVA), con lo que se evaluó la similaridad de lotes, estimación del tiempo de vida útil y se evaluó la estabilidad del medicamento respecto de los porcentajes de disolución obtenidos a 1, 4 y 12 horas. Se concluye que la fórmula elegida cumple con las especificaciones exigidas en la USP.
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Alva, Bazalar Norma Fabiola. "Evaluación del cambio de formulación y mejora del procedimiento de fabricación de tabletas de Hioscina-N-Butil bromuro de 10 mg." Bachelor's thesis, Universidad Nacional Mayor de San Marcos, 2002. https://hdl.handle.net/20.500.12672/2325.

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En el presente trabajo se ha evaluado cuatro formulaciones realizadas por compresión directa, frente a una formulación por granulación húmeda conteniendo 10 mg de hioscina-n-butil bromuro tableta. Para el efecto se fabricó cuatro lotes pilotos los que se acondicionaron en blisters de aluminio/PVC para su ensayo de estabilidad acelerada de 6 meses a condiciones de temperatura y humedad relativa recomendadas por la USP 24 para la zona climática I y II, donde se encuentra ubicado el Perú. Para obtener los resultados de las diferentes formulaciones no sólo se hicieron pruebas físico químicas como: aspecto, dimensiones, peso promedio, dureza, friabilidad, contenido de agua, pérdida por secado, desintegración, disolución, dosaje y uniformidad de contenido, sino también un estudio de costos de materias primas y procesos operativos para determinar cual de las cuatro formulaciones, obtenidas por compresión directa ofrece los mejores resultados que pueden disminuir procedimientos y ahorrar costos, reduciendo tiempos, aumentando las capacidades de sus instalaciones y generando mayor competitividad sin alterar la calidad del producto. Al finalizar el presente trabajo se encontró una formulación que cumplió con las características físico químicas y el estudio de costos mencionados anteriormente, proporcionando los beneficios de la compresión directa y permitiendo una respuesta rápida de fabricación. Palabras claves: Compresión directa, estabilidad, hioscina-n-butil bromuro.
This research work evaluates four alternative direct compression based formulations versus the original wet granulation based formule of hyoscine-n-butyl bromide 10 mg tablet. Four pilot-size batches were performed in order to test the formulations, and then they were packed in PVC / aluminun blisters. Next, they were set in a accelerated stability study for 6 months according to USP 24 conditions (temperature and relative humidity) for I and II zones, where Perú is considered in. During the stability schedule, we evaluated the following parameter: aspect, dimensions, average weight, hardness, friability, content of water, loss on drying, disintegration, dissolution, dosage and uniformity of dosage units. Besides that, we performed an economical analysis based on the cost of the raw material and manufacturing process in order to compare, evaluate and decided which of the four formulations meets both the technical and economical requirements to cause a positive impact in the new process. Finally, we will analize the results to select the best formulation and apply the knowledge to improve the efficiency and quality in the peruvian pharmaceutical industry. Key words: Direct compression, stability, hyoscine-n-butyl bromide.
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Rodovalho, Luciana Ferreira Fonseca. "Pesquisa, desenvolvimento e caracterização de comprimidos contendo entacapone, carbidoba e levodopa." Universidade Federal de Goiás, 2012. http://repositorio.bc.ufg.br/tede/handle/tede/7436.

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Conselho Nacional de Pesquisa e Desenvolvimento Científico e Tecnológico - CNPq
Financiadora de Estudos e Projetos- Finep
Entacapone is a catechol-o-methyl transferase inhibitor used in association with carbidopa and L-dopa in the treatment of Parkinson’s disease. Currently, only one medication containing the association of these three substances is available on the market and it is under patent protection. The objectives of this study were the development and the physicochemical characterization of tablets containing the association of entacapone, carbidopa, and L-dopa using Stalevo® as a reference medication. The evaluation of possible incompatibilities between entacapone, carbidopa, L-dopa, and the excipients was carried out as a preformulation step. To achieve this, initially, differential scanning calorimetry (DSC) analyses were performed and, posteriorly, additional confirmatory studies were conducted using Fourier transformation-infrared spectroscopy (FTIR) and optical microscopy. The tablets were developed using the wet granulation method and the wet granulation method in a high shear mixer and physicochemical parameters were evaluated both for the granulate (moisture, density, and flow) and the oral dosage forms developed (friability, hardness, average weight, disintegration, and content of active ingredient). The dissolution profile of the tablets obtained was assessed based on Stalevo®. Tablets containing entacapone should contain pharmacotechnical elements to promote its bioavailability, since it presents low solubility and low permeability. Therefore, for the development of tablets, different batches were produced using surfactants. Entacapone associated with carbidopa, magnesium stearate, and crospovidone presented signs of degradation, according to FTIR and microscopy. Thus, these excipients should be avoided in the development of solid dosage forms containing entacapone. The batches of core tablets developed during this study were approved regarding the physicochemical criteria, including the dissolution profile. The coated tablets containing poloxamer 407 presented dissolution profile similar to the reference medication.
O entacapone é fármaco inibidor da catecol-o-metil transferase no tratamento da doença de Parkinson, utilizado na forma de comprimidos em associação com carbidopa e L-dopa. Atualmente, existe no mercado apenas um medicamento contendo a associação dessas três substâncias, o qual se encontra sob proteção patentária. Este trabalho teve como objetivos o desenvolvimento e a caracterização físico-química de comprimidos contendo a associação de entacapone, carbidopa e L-dopa utilizando Stalevo® como medicamento referência. A avaliação de possíveis incompatibilidades entre entacapone, carbidopa, L-dopa e os excipientes foi feita como etapa da préformulação. Para tanto, inicialmente, foram executadas análises por calorimetria exploratória diferencial (DSC) e, posteriormente, foram conduzidos estudos adicionais confirmatórios utilizando as técnicas de espectroscopia no infravermelho por transformada de Fourier (FTIR) e microscopia óptica. Os comprimidos foram desenvolvidos utilizando método de granulação por via úmida em misturador de alto cisalhamento e os parâmetros físico-químicos foram avaliados tanto para o granulado (teor de umidade, densidade e fluxo) quanto para os comprimidos (friabilidade, dureza, peso médio, desintegração e teor). O perfil de dissolução dos comprimidos obtidos foi avaliado tendo como referência Stalevo®. Comprimidos contendo entacapone devem conter elementos farmacotécnicos que promovam biodisponibilidade, uma vez que este apresenta baixa solubilidade e baixa permeabilidade. Sendo assim, para o desenvolvimento dos comprimidos, foram produzidos diferentes lotes utilizando tensoativos. O entacapone associado a carbidopa, estearato de magnésio e crospovidona apresentou sinais de degradação, de acordo com as análises térmicas, por FTIR e microscopia óptica. Portanto, esses excipientes devem ser evitados em comprimidos contendo entacapone. Os lotes dos núcleos dos comprimidos desenvolvidos neste trabalho foram aprovados em relação aos critérios físico-químicos, inclusive quanto ao perfil de dissolução. Os comprimidos revestidos contendo poloxamer 407 apresentaram perfil de dissolução semelhante ao medicamento referência.

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Pereyra, Cedrón Luis Jesús. "Diseño y desarrollo de una tableta de claritromicina 500 mg recubierta por el método de granulación seca activada por humedad - MADG." Bachelor's thesis, Universidad Nacional Mayor de San Marcos, 2017. https://hdl.handle.net/20.500.12672/6649.

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Desarrolla una formulación de Claritromicina 500 mg tabletas recubiertas, en la que se evaluaron las propiedades farmacotécnicas de los componentes de la formulación. Los comprimidos fueron elaborados mediante el método de Granulación Seca Activada por Humedad – MADG, evidenciando durante el proceso un buen desempeño (rendimiento y fluidez en máquina) y conformidad de resultados tanto físicos como físico-químicos. Se realizaron tres formulaciones de las cuales solo se seleccionó una. A la fórmula seleccionada se le realizó tres ensayos piloto, con la misma fórmula cualicuantitativa. Se realizaron estudios de estabilidad acelerada y largo plazo en dos empaques primarios (Blíster de aluminio PVC/PVDC incoloro y Blíster de aluminio PVC/PVDC ámbar). Así mismo, se utilizó el concepto de los factores de similitud y diferencia respecto al producto de referencia, en lo que concierne a perfil de disolución. Finalmente, con los resultados obtenidos, tanto en el perfil de disolución como en los estudios de estabilidad, se determinó que la formulación desarrollada para Claritromicina 500 mg tabletas recubiertas cumple con las especificaciones establecidas de la farmacopea USP vigente.
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Purizaca, Llajaruna Harolod. "Estudio fitoquímico, actividad antioxidante y diseño de tabletas por compresión directa a partir del extracto liofilizado de canela (Cinnamomun spp)." Bachelor's thesis, Universidad Nacional Mayor de San Marcos, 2014. https://hdl.handle.net/20.500.12672/9590.

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Publicación a texto completo no autorizada por el autor
Realiza el estudio fitoquímico, actividad antioxidante y diseño de tabletas por compresión directa a partir del extracto liofilizado de Cinnamomun spp. Se preparan cuatro extractos hidroalcohólicos (metanol/agua) al 20%, 40%, 60% y 80% v/v por el método de maceración. Se selecciona la maceración hidroalcohólica al 80% por contener la mayor actividad antioxidante al realizarse la prueba del radical DPPH y a partir de ésta se prepara un extracto liofilizado, en el que se realizan reacciones de coloración y precipitación, comprobándose la presencia mayoritaria de compuestos fenólicos, flavonoides, taninos, y triterpenos. También se realiza cromatografía en capa fina y se identifica flavonoides y compuestos fenólicos como metabolitos antioxidantes. Se cuantifica la cantidad de compuestos fenólicos a partir del extracto liofilizado de canela por triplicado por el método de FolinCiocalteau. Se cuantifica la cantidad de flavonoides a partir del extracto liofilizado de canela por el método espectrofotométrico descrito por Kostennikova Z, por triplicado. Se efectúa la medición de la actividad antioxidante in vitro a partir del extracto liofilizado de canela por el método de captación de radicales libres DPPH por triplicado. Se efectúa la medición de la actividad antioxidante in vivo a partir del extracto liofilizado de canela por el método propuesto por Reckhgel en 1967, obteniéndose como resultado el incremento de las transaminasas oxalacética y pirúvica luego del tratamiento del grupo control, y el mantenimiento de los valores de transaminasas oxalacética y pirúvica antes y después del tratamiento del grupo experimental. Por último se diseñan comprimidos convencionales, a partir del extracto liofilizado de canela por el método de compresión directa, a los cuales se evaluaron los parámetros de comprobación de calidad más importantes (tamaño, dureza, friabilidad, desintegración, porcentaje de variación de peso), obteniéndose tabletas con parámetros farmacotécnicos de calidad adecuados.
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Tello, Guerrero Miguel Angel. "Validación concurrente del proceso de recubrimiento de tabletas de naproxeno sódico 550 mg. en un equipo de recubrimiento automatizado Accela Cota." Bachelor's thesis, Universidad Nacional Mayor de San Marcos, 2008. https://hdl.handle.net/20.500.12672/1241.

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Dentro de la industria farmacéutica, el concepto de validación enmarca un concepto avanzado que trata de conseguir total dominio de la calidad. Si bien es cierto no aumenta la calidad, nos garantiza la fiabilidad y uniformidad de la misma. En el presente trabajo de tesis se realizó la validación concurrente del proceso de recubrimiento de tabletas de naproxeno sódico 550 mg en un equipo de recubrimiento automatizado modelo Accela Cota, obteniéndose una evidencia documentada de que el proceso de recubrimiento es capaz de cumplir en forma consistente y repetitiva las especificaciones establecidas durante todo el proceso. Se realizaron los análisis de validación para determinar durante tres lotes estándares consecutivos el cumplimiento de las especificaciones citadas en el proceso, los resultados obtenidos en base a la evaluación del producto terminado fueron para el primer lote una concentración de activo de 100,44%, para el segundo lote una concentración de activo de 100,33% y para el tercer lote una concentración de activo de 99,30% siendo la especificación evaluada el rango comprendido entre el 90% y el 110%; por lo tanto, los resultados obtenidos en base a la concentración de principio activo para los tres lotes se encuentran conformes.
-- Inside the pharmaceutical industry, the concept of validation frames an advanced concept that tries to obtain total domain of the quality. Though it is true it does not increase the quality, guarantees the reliability and uniformity of the same one. In the present work of thesis there carried out the competing validation of the process of covering tablet of naproxeno sodium 550 mg in an equipment of automated covering model Accela Cota, There being obtained a documented evidence of which the process of covering is capable of fulfilling in consistent and repetitive form the specifications established during the whole process. The analyses of validation were realized to determine during three standard consecutive lots the fulfillment of the specifications mentioned in the process. The results obtained on the basis of the evaluation of the finished product were for the first lot a concentration of assets of 100,44 %, for the second lot a concentration of assets of 100,33 % and for the third lot a concentration of assets of 99,30 % being the evaluated specification the range understood between 90 % and 110 %; therefore, the results obtained on the basis of the concentration of active principle for three lots are similar.
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Silva, Junior Nelson Pereira da [UNESP]. "Avaliação de processos para obtenção de comprimidos de Beta-Ciclodextrina-Paracetamol." Universidade Estadual Paulista (UNESP), 2006. http://hdl.handle.net/11449/91705.

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Made available in DSpace on 2014-06-11T19:25:27Z (GMT). No. of bitstreams: 0 Previous issue date: 2006-07-28Bitstream added on 2014-06-13T19:12:10Z : No. of bitstreams: 1 silvajunior_np_me_arafcf.pdf: 678354 bytes, checksum: 4f229eb833483c2108d5ca9ff0af89b6 (MD5)
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)
Universidade Estadual Paulista (UNESP)
Ciclodextrinas (CD) têm sido relatadas em inúmeros estudos por interagir com muitos fármacos para a formação de complexos de inclusão com o objetivo de aumentar a solubilidade, estabilidade e biodisponibilidade. No processo usual para obtenção de comprimidos contendo Beta-CD, as dispersões líquidas de fármaco/Beta-CD são submetidas a processos de secagem por liofilização, evaporação ou spray-drying e o material seco é incorporado a vários excipientes. O objetivo principal deste trabalho foi avaliar processos de obtenção de comprimidos de Beta-CD/paracetamol. O paracetamol foi utilizado como fármaco modelo por ser pouco solúvel em água. No primeiro processo, a dispersão líquida de Beta-CD/paracetamol foi incorporada ao amido de milho, celulose microcristalina ou lactose monoidratada e o material foi granulado e submetido à secagem em leito estático (estufa). No segundo processo, a dispersão líquida de Beta-CD/paracetamol foi incorporada ao amido de milho e o material submetido à secagem em leito fluidizado (leito de jorro). Os materiais obtidos em ambos os processos foram comprimidos. Comparando os três excipientes utilizados no primeiro processo, tanto o amido quanto celulose são os excipientes que possibilitariam a incorporação de quantidade maior de fármaco. Como resultados, os granulados obtidos a partir dos excipientes amido e celulose apresentaram boas características de escoamento e compressibilidade. O segundo processo, originou um material que apresentou boas características de compressibilidade e comprimidos que apresentaram as melhores características físicas durante o processo de compactação. Concluiu-se que ambos processos representam uma estratégia tecnologicamente viável para obtenção de comprimidos contendo Beta-CD.
Cyclodextrins (CDs) have been reported in a number of studies in the pharmaceutical field since it interact with many drugs to form water soluble inclusion complexes, thus improving not only the solubility but also the stability and biovailability of various drugs. In order to obtain Beta-CD tablets, liquid dispersions of drug/ Beta-CD are usually submitted to different drying process, like spray drying, freeze-drying or slow evaporation and further added to several excipients. In this work we evaluated different process for the preparation of Beta-CD/ acetaminophen tablets. Due to its low solubility, we have used acetaminophen as a drug model. In the first process, an aqueous Beta-CD/ acetaminophen dispersion were added to corn starch, microcrystalline cellulose or monohydrated lactose and the material was dried in a static bed. In the second process, an aqueous Beta-CD/acetaminophen dispersion were added to corn starch and further dried in a fluidized bed (spouted bed). As a result, in the first process the use of starch or cellulose led to mixtures with higher amount of drug with good flowability and compressibility, whereas the second process led to a mixture of good compressibility and to tablets that presented the best physical proprieties. In conclusion, both process represent viable technological approaches to obtain Beta-CD tablets.

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Belotserkovskiy, Roman. "Investigación y desarrollo de un tablero de mando para la gestión empresarial basado en el sistema de gestión estratégica Balanced Scorecard / Roman Belotserkovskiy." Bachelor's thesis, Pontificia Universidad Católica del Perú, 2005. http://tesis.pucp.edu.pe/repositorio/handle/123456789/315.

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A lo largo del presente trabajo se realiza una exhaustiva investigación de aspectos tanto teóricos como prácticos del Balanced Scorecard como sistema de gestión. En primera instancia se analiza la evolución de la ciencia administrativa evaluándose las falencias de los sistemas tradicionales de gestión en un entorno competitivo rápidamente cambiante.
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Real, Vázquez Francis. "Use of Decision Tables to Model Assistance Knowledge to Train Medical Residents." Doctoral thesis, Universitat Rovira i Virgili, 2016. http://hdl.handle.net/10803/365559.

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En aquesta tesi es presenta un model de coneixement clínic basat en taules de decisió que permet representar les fases de diagnòstic, tractament i pronòstic de diferents malalties. Les taules de decisió que s'obtenen per a cada fase del model han estat utilitzades per representar malalties reals a partir de guies de pràctica clínica. En el cas del diagnòstic s'han representat les vuit causes secundàries més comuns de la hipertensió arterial. En el cas del tractament i pronòstic s'han representat set diferents xocs en emergències. Les taules de decisió que hem obtingut per a cadascuna de les malalties s'han utilitzat com a base per crear dues eines d'entrenament mèdic, dirigides a residents. Totes dues eines s'han provat a l'Hospital Clínic de Barcelona amb diferents grups de residents. Després de les proves s'ha conclòs que les taules de decisió són adequades per a la representació del coneixement mèdic en totes tres fases. A més, les eines d'aprenentatge han estat efectives a l'hora d'ensenyar els procediments mèdics, especialment als residents amb menys experiència prèvia.
En esta tesis se presenta un modelo de conocimiento clínico basado en tablas de decisión que permite representar las fases de diagnostico, tratamiento y pronostico de distintas enfermedades. Las tablas de decisión que se obtienen para cada fase del modelo han sido utilizadas para representar enfermedades reales a partir de guías de práctica clínica. En el caso del diagnóstico se han representado las ocho causas secundarias más comunes de la hipertensión arterial. En el caso del tratamiento y pronóstico se han representado siete diferentes shocks en emergencias. Las tablas de decisión que hemos obtenido para cada una de las enfermedades se han usado como base para crear dos herramientas de entrenamiento médico, dirigido a residentes. Ambas herramientas se han probado en el Hospital Clínic de Barcelona con distintos grupos de residentes. Tras las pruebas se ha concluido que las tablas de decisión son adecuadas para la representación del conocimiento medico en las tres fases. Además, las herramientas de aprendizaje han sido efectivas a la hora de enseñar los procedimientos médicos, en especial a los residentes con menos experiencia previa.
In this thesis a clinical knowledge model based on decision tables is presented. This model allows us to represent the stages of diagnosis, treatment, and prognosis of different diseases. The decision tables obtained for each phase of the model have been used to represent real diseases from clinical practice guidelines. In the case of diagnosis, we represented eight of the most common secondary causes of hypertension. For the treatment and prognosis we represented seven different emergency shocks. The decision tables obtained for each disease have been used as the basis for two medical training tools aimed to residents. Both tools have been tested in the Hospital Clínic de Barcelona with different groups of residents. After testing, it was concluded that decision tables are suitable for the representation of medical knowledge in all three phases. In addition, the learning tools have been effective in teaching medical procedures, especially for untrained residents.

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Самойленко, Аліна Миколаївна. "Фармацевтична розробка лікарського засобу противірусної дії на основі лікарської рослинної сировини у формі таблеток." Магістерська робота, Київський національний університет технологій та дизайну, 2021. https://er.knutd.edu.ua/handle/123456789/19551.

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Дипломну магістерську роботу присвячено фармацевтичній розробці складу та технології виробництва лікарського засобу противірусної дії на основі лікарської рослинної сировини. На основі проведеного аналізу асортименту противірусних препаратів на фармацевтичному ринку України встановлено доцільність розробки лікарського засобу рослинного походження вітчизняного виробництва для лікування гострих респіраторних вірусних інфекцій та грипоподібних захворювань у формі таблеток. В роботі обгрунтовано склад та проведено вибір допоміжних речовин виробництва таблеток на основі подрібненої рослинної сировини методом вологого гранулювання, проведено вивчення реологічних характеристик та технологічних показників таблеткової маси, а також досліджено фармакотехнологічні показники готового лікарського засобу, розроблено технологію виробництва препарату та специфікацію на готовий продукт, проведено вибір основного та допоміжного обладнання для здійснення технологічного процесу виробництва таблеток, запропоновано план проведення валідації технологічного процесу та визначено ризики для якості лікарського засобу.
The master's thesis is devoted to the pharmaceutical development of the composition and production technology of antiviral drugs based on medicinal plant raw materials. Based on the analysis of the range of antiviral drugs in the pharmaceutical market of Ukraine the feasibility of developing of domestic producted herbal medicine in the form of tablets for the acute respiratory viral infections and influenza-like diseases treatment was established. The research justifies the composition and the choice of excipients for the manufacturing of based on crushed herbal raw materials tablets by wet granulation method. Studies of rheological characteristics and technological parameters of the tablet mass, as well as the pharmaco-technological indicators of the finished drug were carried out. Production technology of the drug and a finished product specification were developed. The selection of the main and auxiliary equipment for the implementation of tablet manufacturing technological process was carried out. Validation plan for the manufacturing process was proposed and the quality risks of the medicinal product were identified.

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Subatkevičiūtė, Laima. "Lietuvos ir Rusijos maisto produktų sudėties lentelių palyginimas." Master's thesis, Lithuanian Academic Libraries Network (LABT), 2007. http://vddb.library.lt/obj/LT-eLABa-0001:E.02~2007~D_20070713.123702-93194.

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Darbo tikslas - Palyginti Lietuvos ir Rusijos maisto produktų sudėties lenteles. Tyrimo metodika. Maisto produktų ir patiekalų, įtrauktų į Lietuvos ir Rusijos maisto produktų sudėties lenteles, palyginimui buvo analizuojama 23 maisto produktų ir 34 patiekalų maistinė sud��tis. Šiame darbe atlikta 25-64 metų 100 Kretingos rajono gyventojų (66 moterys, 34 vyrai), atsitiktinai atrinktų iš Pirminės sveikatos priežiūros centrų sąrašų, kurie 1999 m. dalyvavo Lėtinių neinfekcinių ligų integruotos profilaktikos programoje, mitybos tyrimo duomenų analizė. Mityba buvo tiriama 24 val. apklausos metodu. Suvartoti maisto medžiagų ir energijos kiekiai buvo apskaičiuoti, naudojant Lietuvos ir Rusijos maisto produktų sudėties lenteles. Gautos dvi rezultatų grupės buvo palygintos taikant Vilkoksono (Wilcoxon) kriterijų. Maisto davinio energijos dalių, gautų iš pagrindinių maisto medžiagų, proporcijų palyginimui, buvo taikomas Z testas. Rezultatai. Lyginant pagrindinių maisto medžiagų ir energijos kiekius maisto produktuose ir patiekaluose, įtrauktuose į Lietuvos ir Rusijos maisto produktų sudėties lenteles, nustatyta, kad daugumos maisto produktų ir patiekalų sudėtis skyrėsi. Nustatyti statistiškai reikšmingi baltymų, riebalų, angliavandenių, cukrų, skaidulinių medžiagų, natrio, magnio, fosforo, geležies, vitamino A, vitamino B1, vitamino B2, vitamino PP kiekių ir energinės vertės skirtumai. Labiausiai skyrėsi vitamino A, maistinių skaidulų ir geležies kiekiai. Naudojant Rusijos maisto... [toliau žr. visą tekstą]
The aim of the study – To compare Lithuanian food composition table and Russian food composition table. Methods. For comparison of the Lithuanian and Russian food composition tables, the alimentary structure of 23 alimentary products and 34 meals was analyzed. The analysis of the data of the nutrition research was performed at this work for 100 inhabitants of the Kretinga district aged 25-64 (66 women, 34 men). These respondents were selected from registers of the Kretinga Primary Health care centers. The nutrition was researched by 24 hours dietary recall method. Nutrient and energy intake was calculated by using Lithuanian food composition table and Russian food composition table. The two sets of the results were compared according to the criterion of Wilcoxon. Z test was used to compare the proportions of the energy parts of the alimentary ration received from the main nutrients. Results. By comparing the amounts of the main nutrients and energy in the alimentary products and meals in the Lithuanian and Russian tables, it was established that the structure of the most alimentary products and meals was different. After evaluating the structure of the alimentary ration according to the Lithuanian and Russian tables, statistically significant differences of the amounts of proteins, fats, carbohydrates, sugars, fiber materials, sodium, magnesium, phosphor, iron, the vitamin A, the vitamin B1, the vitamin B2, the vitamin PP and the energetic value were found. By using Russian... [to full text]

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Brucato, Matteo. "Progettazione di un sistema per patient-reported outcome utilizzabile anche su dispositivi mobili." Bachelor's thesis, Alma Mater Studiorum - Università di Bologna, 2011. http://amslaurea.unibo.it/2722/.

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In questo elaborato prenderemo in esame la questione della progettazione di un sistema software atto a gestire alcuni dei problemi legati alla raccolta dei dati in ambito medico. Da tempo infatti si è capita l'importanza di una speciale tecnica di raccolta dei dati clinici, nota in letteratura col nome di "patient-reported outcome", che prevede che siano i pazienti stessi a fornire le informazioni circa l'andamento di una cura, di un test clinico o, più semplicemente, informazioni sul loro stato di salute fisica o mentale. Vedremo in questa trattazione come ciò sia possibile e, soprattutto, come le tecniche e le tecnologie informatiche possano dare un grande contributo ai problemi di questo ambito. Mostreremo non solo come sia conveniente l'uso, in campo clinico, di tecniche automatiche di raccolta dei dati, della loro manipolazione, aggregazione e condivisione, ma anche come sia possibile realizzare un sistema moderno che risolva tutti questi problemi attraverso l'utilizzo di tecnologie esistenti, tecniche di modellazione dei dati strutturati e un approccio che, mediante un processo di generalizzazione, aiuti a semplificare lo sviluppo del software stesso.

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Terziari, Sofia. "telechirurgia robot assistita: evoluzione e stato dell'arte delle principali strumentazioni e reti telematiche." Bachelor's thesis, Alma Mater Studiorum - Università di Bologna, 2020. http://amslaurea.unibo.it/21381/.

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La telechirurgia è una tecnica operatoria che permette al medico di eseguire interventi chirurgici su pazienti fisicamente distanti. Il chirurgo esegue l’intervento mediante un sistema robotico con abilità chirurgiche eccezionali, combinato con tecnologie di comunicazione che consentono lo scambio di dati tra le postazioni e l’ausilio di un monitor per il controllo continuo del campo operatorio. In questo lavoro sono analizzati due interventi chirurgici a distanza, con particolare attenzione alle principali strumentazioni e reti telematiche utilizzate. Il primo intervento chirurgico a distanza è stato effettuato nel 2001, con paziente e chirurgo distanti 6000km. È stata utilizzata una rete ad alta velocità dedicata ATM per la trasmissione dei dati ed il sistema robotico ZEUS. L’intervento, ritenuto rischioso, non è più stato ripetuto. Nel 2019 a Milano è stato effettuato il primo intervento chirurgico a distanza tramite connessione 5G per la trasmissione dei dati, con paziente e chirurgo distanti 15km. Le principali strumentazioni utilizzate sono: sistema CALM, laser CO2 medicale, robot Panda ed esoscopio stereo 3D VITOM lato paziente; Wacom tablet, dispositivo tattile Omega.7 e display 3D HMZ-T3 lato chirurgo. Dall’analisi risulta che per il funzionamento delle tecnologie utilizzate in telechirurgia è necessaria una connettività avanzata come quella fornita dal 5G, che garantisce tempi di risposta immediati, maggiore velocità e capacità per il trasferimento dei dati ed estrema affidabilità. Tuttavia, prima che la chirurgia tele-robotica diventi comune è necessario attuare precauzioni, controlli e standard rigorosi. Per il futuro si auspica che la possibilità di eseguire manipolazioni complesse da postazioni remote consentirà al chirurgo esperto di insegnare o sorvegliare l'esecuzione di tecniche avanzate o nuove mediante intervento in tempo reale. Si elimineranno i vincoli geografici e questo permetterà di ottenere elevate competenze chirurgiche in tutto il Mondo.

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47

Altaf, Syed Azhar. "Tablet machine instrumentation to study tablet compaction and compression of polymer-coated beads into tablets." Thesis, 1995. http://hdl.handle.net/1957/34666.

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48

Johnson, Barbara Alice. "Surface chemical aspects of aqueous polymer film coating." 1985. http://catalog.hathitrust.org/api/volumes/oclc/12264680.html.

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Thesis (Ph. D.)--University of Wisconsin--Madison, 1985.
Typescript. Vita. eContent provider-neutral record in process. Description based on print version record. Includes bibliographical references (leaves 202-218).

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49

Cook, Rebecca. "In-vitro testing of the influence of ethanol on the release rate of oral extended-release solid dosage forms." 2007. http://hdl.rutgers.edu/1782.2/rucore10001600001.ETD.13454.

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50

Ng, Aaron Soon Han Chemical Sciences &amp Engineering Faculty of Engineering UNSW. "Production of osmotic tablets using dense gas technology." 2007. http://handle.unsw.edu.au/1959.4/40727.

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The dissolution profile of orally delivered drugs can be controlled through the use of osmotically controlled drug delivery devices. The most commonly used device is the osmotic tablet, which is essentially a tablet core that is coated with a rate-limiting semipermeable membrane. The feasibility of applying a coating onto a tablet using dense gas techniques was studied. Two different coating materials, polymethymethacrylate (PMMA, Mw = 120,000 g/mol) and cellulose acetate (CA, 39.8 wt% acetyl content) were applied onto an 8 mm osmotic tablet core using the Gas Anti-solvent (GAS) process. For PMMA, the pressurisation rate, coating temperature and volumetric expansion of up to 250% had minimal effect on the coating quality. The concentration, solvent type and the use of polyethylene glycol (Mw = 200 g/mol) had a more pronounced effect on the coating. The coating process was optimised to apply a smooth and uniform coating with a 50 ??m thickness. For CA, the pressurisation rate and the coating temperature had little effect on the coating that was applied. The process was more sensitive to a change in the concentration of the solution and the volumetric expansion that was used. It was found that the concentration could not be increased too much without affecting the coating quality. A CA coating was applied onto a PMMA-coated tablet using the optimised conditions. The thickness in the tablet coating increased by 10 ??m. Dissolution tests of the uncoated and coated tablets were carried out. The CA coatings were found to be insufficient in limiting the rate of water entering the tablet and performed similarly to an uncoated tablet core. The PMMA coatings were found to limit the rate of delivery of the model drug. However, variations in the PMMA coatings resulted in an inconsistent delivery profile across batches. The tablets coated with both PMMA and CA had a delivery rate in between that of uncoated and PMMA-coated tablets, indicating that the application of the second coating had compromised the initial PMMA coating.

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Dissertations / Theses on the topic 'Tablets (Medicine)'

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