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1
Pinsuwan, Sirirat 1961. "Stability kinetics of 4-dedimethylamino sancycline, a new anti-tumor drug, in aqueous solutions." Diss., The University of Arizona, 1998. http://hdl.handle.net/10150/282753.
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4-Dedimethylamino sancycline (col-3) is a new antitumor antibiotic of the tetracycline family. Preformulation studies have indicated that col-3 is not stable in aqueous solutions. The overall purpose of this research project is to investigate the stability kinetics of this drug in aqueous solutions. The physicochemical properties of col-3, including melting point, UV spectrum, mass spectrum, dissociation constants and solubility were determined. Col-3 is an acidic compound with two pKₐ values of 5.9 (pKₐ₁) and 8.1 (pKₐ₂). It is slightly soluble in water (0.01 mg/mL) and readily soluble in organic solvents such as polyethylene glycol and benzyl alcohol. Although the solubility of col-3 increases with increasing pH, its stability decreases with increasing pH. A HPLC assay was developed to quantitate col-3 and separate its degradation products. Four major degradation products of col-3 were detected under alkaline conditions. These degradates were identified by their elution times and their UV-absorption spectra. The kinetics of degradation of col-3 in aqueous solution at 25°C were investigated by HPLC over the pH-range of 2-10. The Influence of pH, buffer concentration, light, temperature and some additives on the degradation rate were studied. The degradation of col-3 was found to follow first-order kinetics at 25°C. A rate expression covering the degradation of the various ionic forms of the drug was derived and shown to account for the shape of the experimental pH-rate profile. Under basic conditions, the degradation of col-3 involves oxidation, which is catalyzed by metal ions. The separation of the four initial degradation products of col-3 was investigated. Partial separation of these compounds is achieved by liquid-liquid extraction. However, due to the instability of these compounds, their complete isolation cannot be successful. The UV spectroscopic analysis of these compounds shows that an absorbance at 360 nm is partially decreased in degradates I and II and totally absent in degradates III and IV. These results suggest that the phenolic diketone moiety, which produces this absorption band, has been altered upon degradation.
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Kerr, Helen Rosemary. "The surface properties of hyaluronic acid solutions in relation to joint lubrication." Thesis, University College London (University of London), 1985. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.308428.
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Lawson, Sarah, and Stacy Brown. "Stability of Oral Vitamin K Solutions Stored in Amber Plastic Syringes." Digital Commons @ East Tennessee State University, 2018. https://dc.etsu.edu/asrf/2018/schedule/102.
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Oral vitamin K is administered to patients who have very high INR lab values and are on warfarin therapy. Due to the inability of some patients to swallow tablets, and the commercial formulation of vitamin K being available only as a tablet or an injectable emulsion, it may be necessary to compound an oral liquid formulation. When compounding batches of oral solutions, it is sometimes convenient to measure the product in unit doses. In this project, we compared liquid vitamin K in sterile water (1mg/mL) verses liquid vitamin K in Ora-Sweet (1mg/mL) stored in amber plastic syringes. Vitamin K is light sensitive and is best stored in amber containers. Vitamin K is also lipophilic and may adsorb to the plastic syringes. In this study, we investigated the feasibility of bulk compounding oral vitamin K solutions, and aliquoting them for storage in amber plastic syringes. The Vitamin K in sterile water syringes were made by mixing 45 mL of sterile water and 5 ampules, each containing 10mg/mL of vitamin K emulsion, together in an amber glass bottle for a final concentration of 1mg/mL. Thirty 1mL plastic amber syringes were filled with the mixture, capped, and placed in the refrigerator. The same process was repeated using Ora-Sweet instead of sterile water to fill thirty more plastic amber syringes. Three syringes of vitamin K in sterile water mixture, three syringes of vitamin K in Ora-Sweet mixture, and one Vitamin K reference standard were all analyzed using HPLC-UV on the day of compounding, and at day 1, 2, 4, 7, 14, 21, 30, 60, and 90. If stability is defined as 90-110% active ingredient, then Vitamin K in sterile water is stable to fourteen days, 95.3±3.5% recovery, but some samples fell below 90% recovery after 14 days. By day ninety, the recovery in SWFI syringes was 84.2±8.9%. For vitamin K in Ora-Sweet, the within-day variability was very high due to limitations in drug dissolution; as such the average concentration was not consistently above 90%. On the day of compounding, the percent recovery in the Ora-Sweet syringes was 92.7±9.9%, despite 1 hour of stirring. In conclusion, the Vitamin K in sterile water mixture can be stored in refrigerated, amber oral plastic syringes for 14 days, but plastic amber syringes were not appropriate for storage of the Vitamin K in Ora-Sweet mixture.
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Riley, Christine Marie 1964. "The effect of triacetin on solubility of diazepam and phenytoin." Thesis, The University of Arizona, 1990. http://hdl.handle.net/10150/277304.
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The effect of triacetin in combination with common cosolvents on the solubility of phenytoin and diazepam was studied. The cosolvents were PEG 400 and propylene glycol. In addition, the data were used to test the following model: UNFORMATTED EQUATION FOLLOWS: log Sᵈ(c,p,w) = log Sᵈ(w) + f(c)σᵈ(c) + [Sᵖ(w)10(f(c)σᵖ(c))/D(p)] σᵈ(p). UNFORMATTED EQUATION ENDS. The term on the left side of the equation is the solubility of a drug in the ternary system. This is related to the aqueous solubility of the drug, the solubility of the drug in a completely miscible organic solvent (CMOS), and the solubility of the partially miscible organic solvent (PMOS). This model was proposed by Gupta et al. (1989) and predicts the solubility of a ternary system composed of a CMOS and PMOS. The results indicate the triacetin does increase the solubility of the two poorly water-soluble drugs. There is good correlation between the observed and predicted increase in the solubility of the drugs.
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El-Dahiyat, Faris Abdelrahim. "A cost evaluation analysis to identify solutions for affordable medicines in Jordan : a comparative study with the UK." Thesis, Kingston University, 2013. http://eprints.kingston.ac.uk/27794/.
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Background: Health is a core human right. The right of health care includes access to affordable medicines. Affordability of medicines by individual patients in low-income countries is a significant factor influencing access to care and treatment. However, drug prices in low income countries are found to be higher than those in high-income countries. Although the health care system in Jordan is quite advanced in comparison to neighbouring countries, the access to affordable medicines remains problematic. It was reported that almost 80% of the public in Jordan pay for their medications through out-of-pocket payments. High medicine prices are of a great concern to patients and their finances, which can result in poor compliance. Moreover, non-compliance can lead to reduced productivity and increased medical costs. In fact, several studies found that the high out of pocket-costs can be a significant obstacle to medical adherence with prescription medication regimens. Aims: The aim of this thesis is to research medicine prices and policies in Jordan, in order to recommend feasible solutions to make these affordable. To measure the affordability of medicines in Jordan and to assess the extent by which the cost of medicines is high, prices and factors affecting them were compared with the United Kingdom (UK), a high income developed country. Methods: A mixed-method approach was used in this thesis to research medicine prices and policies. The thesis reviewed the relevant literature, followed by reviewing the health care and pharmaceutical systems in both countries and their impact on medicine prices. Quantitative studies to measure the affordability of medicines in Jordan were conducted to assess the extent by which the cost of medicines is high in comparison to the UK and the factors that may affect medicine prices. This was followed by a qualitative study on how and why high unaffordable prices occur in Jordan. Finally, a quantitative survey exploring patients', pharmacists' and prescribing physicians' opinions towards measures that could be used to achieve greater clinical effectiveness and economic efficiency from drug prescribing was conducted. All the findings from the thesis were synthesised to form policy recommendations, designed to ensure affordable medicines for the Jordanian population. Results and discussion: Factors that influence prices of medicines over time were identified. These included; competition, marketing strategies, time in the market, regulations and pricing policy, change of clinical guidelines, epidemiology of disease, change in therapeutic use/value and exchange rate. Although the income per capita is much lower in Jordan (almost 7 fold less) than the one the UK, the studies conducted within this thesis demonstrated that medicine prices were significantly higher in Jordan compared to the UK. Generic medicines are three fold more expensive than the equivalent prices of the same drugs in the UK. However, the difference in prices for many drugs was significantly higher than the 3 fold difference. For example, the average price of pravastatin and amlodipine generics was more than eight fold higher than the UK price. Moreover, the average price of omeprazole, citalopram and fluoxetine generics were around 10 fold higher than the comparable UK price. Additionally, originator brand medicines prices were also found to be 1.5-fold more expensive in Jordan compared to the UK. Many originators were extremely higher than this average. For example, the Jordanian price of misoprostol originator tablets was around 19 times the comparable UK price. The price of ranitidine originator in Jordan was more than seven times the UK price and lansoprasole originator was around 6 times more than the price in the UK. The current pricing policy and its application are believed to be the root causes for the high prices of medicines in Jordan, as revealed by the qualitative interviews. The expected patients' saving by using generic medicines instead of originators in Jordan ranged from 32% up to 74%. The median saving in Jordan was -30.65% compared to - 71.43% in UK. The average savings were 32.68% and 43.54% in both Jordan and UK respectively. This increased to 54.96% in the UK when one outlier was removed. However, the saving calculated in both countries would have been higher if the lowest priced generic was used. An extra saving of 6.86% was identified in Jordan if the lowest priced generics were used for cardiovascular diseases (the calculated saving increased from 32.71% when using the average generic price compared to 39.57% when using the lowest priced generic). The findings also showed a positive attitude of all stakeholders (patients, pharmacists and prescribing physicians) towards generic medications and their willingness and acceptance of strategies that encourage generic utilisation in Jordan such as generic substitution, lnternational. Non-proprietary Name (INN) prescribing and Electronic Prescribing (EP). Such measures will help reduce the high expenditure on drugs in Jordan which accounts for around one-third of the national health care budget. Conclusion: A range of policy measures and changes are required to improve access to medicines in Jordan. Recommendations made included amendments to pharmaceutical policies, better enforcement of the current regulations, encouraging the use of generic medicines by introducing measures such as generic prescribing, generic substitution and public awareness education programs. These changes should result in more affordable medicines in Jordan.
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Mishra, Dinesh Shyamdeo. "Solubility of organic compounds in nonaqueous systems." Diss., The University of Arizona, 1989. http://hdl.handle.net/10150/184667.
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Solubility of drugs in non-aqueous systems is very important in understanding the partitioning and transport behavior. The present study was undertaken to evaluate the entropic and enthalpic contribution to activity coefficient of organic compounds (polycyclic aromatic hydrocarbons, aliphatic acids, aliphatic alcohols etc.) in non-aqueous solvents. The activity coefficient can be written as: ln γ₁ = ln γ₁ᶜ + ln γ₁ʳ where superscript "c" and "r" denote entropic (combinatorial) and enthalpic contribution respectively. We selected three solvent systems: benzene, triolein and octanol. The different models considered in this study were Flory-Huggins, Scatchard-Hildebrand, UNIQUAC combinatorial and UNIFAC residual. A combination of Flory-Huggins and Scatchard-Hildebrand which accounts for both the entropic and enthalpic effects gives the best predictions in all the solvents considered.
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Thomas, P. H. "Studies on the pharmaceutical and clinical problems associated with the storage and administration of intravenous solutions." Thesis, Cardiff University, 1986. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.372586.
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Sari, Peyami, and n/a. "Isotropic medium chain mono- and diglyceride systems : vehicles for subcutaneous injection in sheep." University of Otago. School of Pharmacy, 2005. http://adt.otago.ac.nz./public/adt-NZDU20070405.160443.
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Purpose: To develop an approach to formulating an injectable solution containing both hydrophilic and lipophilic drugs for subcutaneous administration. Based on the literature survey, isotropic medium chain mono-and diglyceride (MCMDG) systems were chosen for study. For this purpose, analytical methods were developed and validated. In vitro assessments of the MCMDG systems, and in vitro release and in vivo studies were conducted.
Methods: The phase diagrams of the isotropic MCMDG systems were constructed with systems comprising two and three components. The isotropic region was examined by visual inspection and confirmed using polarized light microscopy. Viscosities of formulations were measured. The validated HPLC assay methods were developed for determination of levamisole and abamectin in liquid formulations and in sheep plasma. The HPLC assay was capable of evaluating stability of abamectin and levamisole in liquid formulations. Solubilities of levamisole hydrochloride or levamisole phosphate and abamectin were determined in the isotropic MCMDG formulations using a HPLC assay method. Stabilities of levamisole phosphate and abamectin were conducted in the isotropic MCMDG formulations at 60�C for 10 days. In vitro release studies for levamisole phosphate were carried out for selected formulations using modified Franz diffusion cells. Based on stability and in vitro release studies, one formulation (MCMDG/propylene glycol (PG):glycerol formal (GF), 20/20:60 % w/w) was selected for a preliminary in vivo study. The selected MCMDG/PG:GF (20/20:60) formulation containing both levamisole phosphate and abamectin was injected subcutaneously into sheep, and the injection site was examined after subcutaneous injection. Pharmacokinetic profiles were determined. A correlation between in vitro fraction released (FR) and in vivo fraction absorbed (FA) for levamisole phosphate from the MCMDG/PG:GF (20/20:60) formulation was assessed.
Results: The isotropic systems of the MCMDG systems containing two or three components were characterized through phase diagrams and viscosity. The solubility of the levamisole hydrochloride in the isotropic MCMDG/sesame oil/water formulations was higher in the absence of abamectin than in combination with abamectin. Solubility of levamisole phosphate was higher in the MCMDG system containing GF or PG compared to the MCMDG/SO/water system. The isotropic MCMDG/PG:GF systems allowed preparations of levamisole phosphate/abamectin solution dose forms containing more than the usual dosage of levamisole. Stability of both levamisole phosphate and abamectin in MCMDG/PG:GF formulations was higher compared with MCMDG/PG:GF/water formulations. Levamisole phosphate degraded in the presence or absence of abamectin in the MCMDG/PG:GF (20/20:60) formulation at 60�C for 10 days. Abamectin alone was found to be stable in the formulation at 60�C for 10 days. In vitro release of levamisole phosphate from water and the MCMDG formulations tested displayed first-order kinetics. Water from the receptor compartment was observed to pass through the membrane into the donor compartment. Therefore, an advancing layer of turbidity occurred in the donor phase. A highly significant decrease in release rate of levamisole phosphate was obtained in MCMDG/GP:GF (20/20:60) formulation compared to water and the other formulations. Pharmacokinetic studies of subcutaneous injection of MCMDG/PG:GF 20/20:60) formulation showed the tmax values of 2.2 h and 4.2 days for levamisole phosphate and abamectin, respectively. The Cmax was 0.94 [mu]g/ml for levamisole phosphate and 6.24 ng/ml for abamectin while the formulation displayed the AUC value was 5.2 [mu]g�h�ml⁻1 for levamisole phosphate and 84.7 ng�day�ml⁻1 for abamectin. No inflammatory reaction was observed at the injection site. Linear regression analysis showed that a significant relationship between the FR (in vitro) and FA for the subcutaneously injected formulation.
Conclusion: The study carried out in this thesis introduces a new approach to formulating an injectable solution of the isotropic MCMDG/PG:GF systems containing both levamisole (hydrophilic drug) and abamectin (lipophilic drug) for subcutaneous administration, and presents the development of the HPLC assay methods for determination of levamisole and abamectin in liquid MCMDG formulations and plasma, in order to investigate in vitro and in vivo release from the isotropic MCMDG/PG:GF formulations. The MCMDG/PG:GF formulations may represent an alternative to the more traditional formulations for both lipophilic and hydrophilic drugs.
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Boca, Madalina Brindusa. "Research into process validation in pharmaceutical companies, with specific reference to Roche, South Africa." Pretoria : [s.n.], 2009. http://upetd.up.ac.za/thesis/available/etd-10132009-181630/.
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Lawson, Sarah, Stacy D. Brown, Paul Lewis, and Gina Peacock. "Comparative Stability of Oral Vitamin K Solutions Stored in Refrigerated Amber Plastic Syringes." Digital Commons @ East Tennessee State University, 2018. https://dc.etsu.edu/etsu-works/5264.
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Purpose: Vitamin K1 (phytonadione) is a fat-soluble vitamin and an essential cofactor for the synthesis of clotting factors II, VII, IX, X, protein C, and protein S. Vitamin K antagonists deplete vitamin K reserves effectively preventing the synthesis of these clotting factors leading to anticoagulation. Overly excessive anticoagulation, as evidenced by INRs greater than 5, may necessitate vitamin K for reversal of warfarin depending on bleeding risk factors. For elevated INR without bleeding, the oral route is preferred. Orally administered vitamin K1 tablets are only supplied by a single manufacturer, and only available as a 5 mg tablet. Concerns with availability of this tablet, lack of dosing options for treatment requiring less than 5 mg, and delivery options for patients unable to swallow whole tablets have prompted the exploration of alternative dosing strategies using the 10 mg/mL injectable emulsion compounded into an oral liquid. The possibility of storing the oral liquid in unit-doses adds a layer of convenience, and is common practice in many hospital pharmacies. In this project, we compared oral liquid vitamin K1 in sterile water for injection (SWFI) to oral liquid vitamin K1 in Ora-Sweet, simple syrup, cherry syrup, and Syrpalta stored in amber plastic oral syringes.
Methods: Batches of 1 mg/mL vitamin K1 were prepared in SWFI, Ora-Sweet, simple syrup, cherry syrup, and Syrpalta and drawn up by 1-mL aliquots into amber plastic oral syringes. Syringes were capped and stored in a laboratory refrigerator (4.9-5.4oC). for the duration of the study. On each study day (0, 1, 2, 4, 7, 14, 21, 30, 60, and 90), three syringes from each vehicle were removed, and the contents diluted with ethanol to achieve a 0.5 mg/mL assay concentration. Additionally, USP reference material was used on each study day to prepare a fresh 0.5 mg/mL reference solution. The samples and reference were analyzed using a previously validated HPLC-UV method. Results were compared using a 2-way ANOVA (p = 0.05) with post-hoc Tukey’s correction for multiple comparisons. Product stability was defined as 90-110% labeled amount.
Results: Of the vehicles tested, SWFI was the most suitable vehicle for longer-term storage of unit-dosed vitamin K1. The 1 mg/mL vitamin K1 in SWFI, when stored in amber plastic oral syringes, remains within the acceptable 90 – 110% range for 21 days. The Syrpalta preparation demonstrated the next highest BUD of 7 days, with one syringe (2 injections) falling outside the 90% potency at the 14 day time point. Cherry syrup allowed for very limited stability, with a BUD of 24 hours. By the 48-hour time point, two of the three samples were below the 90% potency cutoff. For the vitamin K oral solutions prepared in simple syrup and Ora-Sweet, the recovery of vitamin K was not within acceptable limits, even on the day of compounding. The initial recovery for vitamin K in simple syrup was only 86.8%. Similarly, the preparation in Ora-Sweet, was not at acceptable potency on the day of compounding, (92.7 ± 9.9%). While the average recovery in Ora-Sweet exceeded 90%, the variability between samples suggests a lack of homogeneous distribution of drug through the vehicle. Statistically significant differences were detected between the SWFI preparation and all other vehicles in a 2-way ANOVA with Tukey’s multiple comparison post-test (p-value of 0.05). This difference was most pronounced between SWFI and Ora-Sweet and SWFI and simple syrup (both p < 0.0001). Cherry syrup was also vastly different from SWFI (p = 0.0002), and the difference between SWFI and Syrpalta was less pronounced, yet still significant (p = 0.0442).
Conclusion: Vitamin K1 in sterile water and Syrpalta was stable for 21 days and 7 days, respectively, when stored in amber plastic syringes. Vitamin K1 in cherry syrup was only stable for 24 hours in the syringes. For vitamin K1 in Ora-Sweet and simple syrup, the within-day variability was very high due to limitations in drug dissolution; as such the average recovery was not consistently above 90%, even on the day of compounding. Statistically significant differences were detected between the SWFI formulation and all other vehicles. Several factors appear to affect the potency and stability of vitamin K1 in different vehicles. Because the stability of vitamin K1 oral solution differs between storage in amber glass bottles and oral syringes, vitamin K1 may have the potential to adsorb to polypropylene (PPE). The pH of the vehicle may contribute to degradation of vitamin K1, and the viscosity of the vehicle may affect the achievable potency of certain mixtures. The viscosity of the mixture also appears to affect maintenance of a homogenous mixture, but the presence of alcohol in the vehicle may help aid in solubilizing the vitamin K1 in Syrpalta. Vitamin K1 in SWFI appears to be the most suitable vehicle for longer-term storage of unit-dosed vitamin K, but Syrpalta and cherry syrup may also be appropriate for more immediate use.
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Hagemeier, Nicholas E., J. Nile Barnes, and Kasey Strey. "The Prescription Opioid Epidemic: How it Happened and Solutions." Digital Commons @ East Tennessee State University, 2017. https://dc.etsu.edu/etsu-works/1414.
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Rates of prescription drug misuse in Texas are alarmingly high. One in five Texas high school students have taken prescription drugs without a doctor’s prescription. In 2015, Texas had the second highest total healthcare costs from opioid abuse in the nation ($1.96 billion), and Texas is home to four of the top 25 cities in the U.S. for opioid abuse. Meanwhile, only one in three prescribers is using the statewide Prescription Drug Monitoring Program (PDMP), leading to a massive loss of data. There is substantial need for increased infrastructure and prevention measures in Texas, especially related to the emergence of prescription drug misuse.
This panel will describe the current landscape of prescription drug misuse and its consequences, discuss strategies to turn down misuse, and explain the proactive approach Texas is taking to enhance misuse prevention and data infrastructure across the state.
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Brown, Stacy D., and Paul Lewis. "Stability Evaluation of Unit-Dose Vancomycin Hcl Oral Solutions in Plastic Capped Oral Syringes and Plastic Sealed Dosing Cups." Digital Commons @ East Tennessee State University, 2018. https://dc.etsu.edu/etsu-works/5263.
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Purpose:
Oral vancomycin is a first-line treatment for Clostridium difficile-associated diarrhea. Preparation of oral vancomycin solutions historically has been facilitated by extemporaneous compounding, using various formulas or compounding kits, such as FIRST® - Vancomycin. More recently, FIRVANQ™ (vancomycin HCl) for oral solution was approved by the FDA, replacing the FIRST® compounding kits. Preparation and storage of unit-doses of oral solutions can expedite delivery of the medication to the patient and reduce opportunity for dosing errors. In this study, we evaluated the stored stability of two preparations of vancomycin HCl oral solution (FIRST® – Vancomycin and FIRVANQ™), stored in oral syringes and dosing cups at refrigerated and room temperatures.
Methods:
Triplicate batches of vancomycin HCl oral solution (50 mg/mL) were prepared using FIRST® - Vancomycin and FIRVANQ™, aliquoted into plastic oral syringes and sealed dosing cups, and stored at refrigerated and room temperatures for a total of six batches. Additionally, remaining samples from FIRVANQ™ batches were unit-dosed in clear Luer-Lok™ syringes and stored under refrigeration as a seventh batch. Samples were removed and analyzed for vancomycin recovery using a previously validated high-performance liquid chromatography with ultraviolet detection (HPLC-UV) method over a 30-day period. Recovery was quantitatively assessed by comparing to a freshly prepared United States Pharmacopoeia (USP) reference standard on each day of sampling.
Results:
Stability was defined as recovery of 90 - 110% of labeled amount. For all tested samples, the chemical potency remained within the therapeutically acceptable window for the entire study period of 30 days. At room temperature, the FIRST® syringes and cups both retained 95% potency after 30 days. Under refrigeration, this product retained 100% potency and 91% potency in syringes and cups, respectively. Similarly, the FIRVANQ™ room temperature syringes were at 99% recovery and the room temperature cups at 95% recovery after 30 days. Refrigerated FIRVANQ™ retained a potency of 102% potency in the dosing cups after 30 days, and the both syringes types (clear and amber) were 97% and 101%, respectively, recovery during the study period.
Conclusion:
The percent recovery of vancomycin in each test group remains within 90 – 110% of the labeled amount throughout duration of study (0 – 30 days). Based on this study, unit-dosing has been shown to have a 30-day chemical stability. In this case, unit-dosing not only may be used to improve workflow and reduce dosing errors, but may also have an impact of reducing drug waste due to avoidance of discarding appropriately potent drug product. Additionally, stability within the study period was independent of storage container and condition. Finally, this unit-dosing practice for FIRVANQ™ is equally acceptable in the classic luer-slip amber plastic syringes, and the newer Luer-Lok™ clear plastic syringes.
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Alyousif, Abdulmohsen A. "Examining the most economical ways in which medicines can be both presribed and dispensed in Saudi outpatient hospitals : a study carried out, exclusively in Saudi Arabian Hospitals, to determine the consraints, problems and possible solutions to effective medicines supply for outpatients." Thesis, University of Bradford, 2012. http://hdl.handle.net/10454/5696.
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Backround. Based of my personal observations when employed as a pharmacist in a Saudi hospital it was clear that there were problems with medicine supply to outpatients. This thesis was designed to scientifically investigate the types of shortages, the reason(s) for such problems and potential solutions to the problem. Methods . This study was undertaken using a variety of experimental techniques to determine the views and perceptions of patients, pharmacists, physicians and administrative staff of the hospital under examination. To establish the scale of the problem: focus groups (n=25), structured questionnaires, structured interviews/meetings for health care professionals and a national survey (n=650) were the research tools used to objectively determine the relevant data. The data were analyzed by appropriate statistical methods. Results and Discussion That there was a real problem was quickly established in the data obtained from patients. A similar finding was made for each of the 'professional groups'. The central problem was one of shortages of medicines for prescriptions presented by outpatients. It was not a case the medicines were simply not available because they were never stocked but rather a simple shortage in the dispensary stock. It was established the lack of medicines was not due to central budget arrangements but involved prescribing quantities outside of the hospital guidelines which no degree of planning could accommodate. There was also the very unexpected finding that a prescription could be filled in a variety of hospital dispensaries as individuals could access more than one hospital or they could consult more than one physician for the same condition and obtain effectively double the supplies. Communications between the hospital and patients and the health care professionals could all be improved by perhaps increasing the knowledge of the patient about the correct use of medicines. Recommendations. A series of recommendations for future work is provided
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Melton, Sarah, and Nicholas E. Hagemeier. "Prescription Drug Abuse: Regional Realities and Recommendations." Digital Commons @ East Tennessee State University, 2016. https://dc.etsu.edu/etsu-works/1419.
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Djelloul, Eric. "Contrôle particulaire des solutions injectables." Paris 5, 1988. http://www.theses.fr/1988PA05P246.
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Michon, Chantal. "Assurance de la qualité des solutions pour nutrition parentérale." Paris 5, 1990. http://www.theses.fr/1990PA05P080.
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Corswant, Christian von. "Lecithin-based microemulsions for pharmaceutical use phase behavior and solution structure /." Lund : Lund University, 1998. http://catalog.hathitrust.org/api/volumes/oclc/68945035.html.
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Chanty, François. "Apports osmotiques des solutions de nutrition parentérale pédiatrique." Paris 5, 1990. http://www.theses.fr/1990PA05P102.
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Gupta, Abhishek. "Optimizing the development and analysis of solution based metered dose inhalers." Diss., The University of Arizona, 2004. http://hdl.handle.net/10150/280513.
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The current work focuses on the development and evaluation of techniques and models that can facilitate the development of solution based metered dose inhalers. These include an online reverse phase hplc method for analyte quantitation from propellant based pressurized metered dose inhalers. The technique ( direct injection method) finds applications in determining solubility of compounds in aerosol propellants and can possibly be used for stability analysis. With the development of this technique it would be feasible to generate a solubility database in order to understand the physico-chemical factors affecting the solubility and also possibly predict the solubility of compounds in HFA 134a propellant. The regular solution theory based on solubility parameter approach was evaluated for this purpose by utilizing a set of 35 diverse compounds in HFA 134a. A new product performance evaluation tool; the Model 3320 series Aerodynamic Particle Sizer (APS) used in conjunction with Model 3320 Impactor Inlet was evaluated for analysis of solution metered dose inhalers. The Model 3320 APS series provides rapid aerodynamic size distribution data and coupled with Model 3306 Impactor Inlet allows for the chemical analysis of the Inlet port, 'respirable' mass and 'non-respirable' mass. It was shown that in order to obtain comparable results between the Model 3306 Impactor Inlet and the Andersen Cascade Impactor (ACI), an extension to the USP throat may be necessary. The solubility data generated by the direct injection method coupled with the 'respirable deposition' data generated using the APS 3320 series can be used to optimize the product performance of cosolvent based solution metered dose inhalers.
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Provenza, Bernal Nora. "Caracterización y estudio de estabilidad de fórmulas magistrales líquidas de administración oral." Doctoral thesis, Universitat de Barcelona, 2014. http://hdl.handle.net/10803/283660.
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La falta de disponibilidad de presentaciones comerciales adecuadas para la posología pediátrica todavía supone un gran problema, especialmente relevante en medicamentos con margen terapéutico estrecho, ya que puede derivar en infra o sobredosificaciones; o en niños que sufren enfermedades crónicas, condenados a tomar medicamentos mal adaptados y sufrir las consecuencias que ello supone; o en las ocasiones en las que se presentan casos de intolerancias o alergias hacia determinados excipientes. Todo ello obliga a realizar un gran número de fórmulas magistrales.
Evidentemente, para solventar este problema, las formas farmacéuticas líquidas siguen siendo la mejor alternativa a las formas farmacéuticas sólidas, ya que ofrecen una serie de ventajas:
. Versatilidad para el ajuste de dosis, frecuentemente modificada en estos pacientes en función del peso o de la respuesta clínica.
. Facilidad de administración.
. Fiabilidad de la dosificación.
. Posibilidad de administración por sonda nasogástrica.
Sin embargo, la variabilidad en el diseño de fórmulas magistrales, la falta de uniformidad en el caso de las suspensiones y el inconveniente de la menor estabilidad de las formas líquidas, conlleva la posibilidad de errores de medicación en el manejo de las dosificaciones. De aquí que la terapéutica en pacientes pediátricos o pacientes con dificultades para deglutir, dependa en gran medida de la elaboración de formulaciones magistrales adecuadas.
Algunas de las patologías que requieren la realización de estos preparados para pacientes pediátricos incluyen la hipertensión pulmonar persistente del neonato, la insuficiencia cardiaca congestiva, el síndrome de abstinencia neonatal o las convulsiones.
Por tanto, a la vista de lo anterior, en este trabajo se han desarrollado y estudiado un total de trece fórmulas magistrales líquidas de administración oral: dos fórmulas de sildenafilo, cuatro de espironolactona, dos de furosemida, tres de metadona y dos de fenobarbital. En el desarrollo de las fórmulas también se ha tenido en cuenta a la población diabética.
Una vez establecida la fórmula cuali-cuantitativa de cada una de las formulaciones, se desarrolló y validó un método sensible y rápido como técnica analítica de referencia para la cuantificación de cada principio activo, para lo cual se determinó la linealidad, la precisión y la exactitud del método analítico; asimismo se determinaron los límites de cuantificación y detección para cada uno de los principios activos objeto de estudio. Los controles físico-químicos y microbiológicos que se llevaron a cabo con el fin de caracterizar las diferentes fórmulas fueron:
1. Características organolépticas (aspecto, color, olor).
2. Cuantificación del principio activo
3. Determinación del pH
4. Comportamiento reológico y viscosidad
5. Tamaño de partícula (sólo en el caso de las suspensiones)
6. Estabilidad óptica acelerada (sólo en el caso de las suspensiones).
7. Análisis microbiológico (Ph.Eur.)
Para establecer su estabilidad, las formulaciones se almacenaron a tres temperaturas (4, 25 y 40 ºC) durante un periodo máximo de 90 días y se determinaron aquellos parámetros susceptibles de cambio a diferentes tiempos prefijados.
Por otro lado, se realizaron controles biofarmacéuticos con el objeto de determinar la influencia de los excipientes en los procesos de liberación (estudios in vitro- ensayos de disolución) y absorción (estudio de la absorción a través de intestino delgado de cerdo) del principio activo.
Los resultados obtenidos en esta Tesis Doctoral hacen posible una correcta conservación y dosificación de los principios activos estudiados (sildenafilo, espironolactona, furosemida, metadona y fenobarbital) cuando se formulan en formas líquidas de administración oral; garantizando la continuidad, la calidad y la eficacia de tratamientos pediátricos tales como la hipertensión pulmonar persistente del neonato, la insuficiencia cardiaca congestiva, el síndrome de abstinencia neonatal y las convulsiones neonatales, según corresponda.The lack of availability of age appropriate dosage forms is still a big problem, especially relevant in drugs with narrow therapeutic index, as it can lead to under-or overdosing; children with cronical diseases; or in cases of allergies to certain excipients. This requires a large number of pharmaceutical compounding. To solve this problem, the liquid dosage forms remain the best alternative to the solid dosage forms because they offer advantages: • Versatility for dosage adjustment in these patients • Easy administration. • Reliability dosing. • Possibility of gavage. However, the variability in their design and the lower stability of the liquid forms, leads to the possibility of medication errors in handling dosages. Hence the therapy in pediatric patients or patients with swallowing difficulties, depend largely on the development of appropriate formulations. Therefore, in this work thirteen liquid pharmaceutical compounding for oral administration: two formulations of sildenafil, four of spironolactone, two of furosemide, three of methadone and two of Phenobarbital have been developed, taking into account also the diabetic population. An analytical method has been developed and validated using appropriates analytical techniques for the quantification of each active ingredient (API). Linearity, precision, accuracy, and quantification and detection limits were determined. Physico-chemical and microbiological controls were performed in order to characterize the formulas: 1. Organoleptic properties 2. Quantification of the API 3. Determination of pH 4. Rheological behavior and viscosity 5. Particle size (for suspensions). 6. Optical stability (for suspensions). 7. Microbiological analysis (Ph.Eur) To establish the shelf life, the formulations were stored at three temperatures (4, 25 and 40 °C) for a maximum period of 90 days. The parameters that could change were determined at different times. Biopharmaceutical controls were performed to determine the influence of the excipients on the release (dissolution tests) and absorption (absorption studies through pig small intestine) processes of the API. Obtained results ensures the stability of sildenafil, spironolactone, furosemide, methadone and phenobarbital when formulated in oral liquid dosage forms; allowing continuity, quality and efficacy of pediatric therapies such as persistent pulmonar hypertension of the newborn, congestive heart failure, neonatal abstinence syndrome and neonatal seizures, as appropriate.
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Sawangchan, Phawanan. "The effect of aggregation state on the degradation kinetics of Amphotericin B in aqueous solution." Diss., University of Iowa, 2017. https://ir.uiowa.edu/etd/5992.
Full textAbstract:
Amphotericin B (AmB) is an amphiphile antifungal agent composed of lipophilic and hydrophilic structures and is known to aggregate in aqueous solution. The effect of substrate aggregation on the degradation kinetics of aqueous AmB was studied.
Aggregation state of AmB (0.0108 mM) in 10.0%v/v methanol aqueous solutions were pH dependent. The dissociation equilibrium constant (Kd) values suggested that monomeric form was predominant in acidic and alkaline condition and aggregated form appeared predominantly in neutral condition. At methanol concentration above 35.0%v/v, 0.0108 mM AmB in reaction mixtures presented in a monomeric form regardless of pH.
The degradation pathways of AmB were found to be pH-dependent. The effect of oxidants, antioxidants, oxidation initiators and chelators suggested that AmB was susceptible to oxidation in acidic and neutral pH regions which led spectral changes associated with the heptaene moiety. In basic conditions (pH > 9), AmB underwent hydroxide-catalyzed ring-opening lactone hydrolysis.
A degradation model describing substrate loss was constructed based on the kinetics of substrate loss. The pH-rate profile displayed three regions: specific acid-catalyzed degradation at pH below 4, a specific basic-catalyzed hydrolysis at pH above 9 and a pH-independent degradation in the neutral pH range 4 – 9. The effect of methanol on degradation kinetics in the neutral pH region indicated that aggregated AmB was more susceptible to oxidative degradation than monomeric AmB.
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Khawam, Ammar. "Application of solid-state kinetics to desolvation reactions." Diss., University of Iowa, 2007. http://ir.uiowa.edu/etd/170.
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Bassani-Linck, Valquiria. "Valorisation de formes galéniques végétales : désalcoolisation et concentration de solutions extractives sur membrane d'osmose inverse." Montpellier 1, 1990. http://www.theses.fr/1990MON13514.
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Charbonnel, Françoise. "Etude des techniques de solubilisation pour un composé peu soluble dans l'eau." Bordeaux 2, 1993. http://www.theses.fr/1993BOR2P054.
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Legendre, Jean-Yves. "Effets des β-cyclodextrines sur la barrière cutanée : conséquences sur l'administration transdermique de principes actifs." Paris 5, 1994. http://www.theses.fr/1994PA05P184.
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Koycha, Maléka. "Émulsions nutritives intraveineuses : aspects physico-chimiques et étude de stabilité." Université Joseph Fourier (Grenoble), 1991. http://www.theses.fr/1991GRE18001.
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Zong, Zhixin. "Studies on the mechanisms of solid state and solution instability of drugs." Diss., University of Iowa, 2011. https://ir.uiowa.edu/etd/2795.
Full textAbstract:
The overarching objective of this thesis is to demonstrate a systematic approach for addressing the instability issues associated with low limit degradants by developing quantitative degradation models that incorporate key instability determinants into predictive equations. Chlorhexidine was used as model compound in aqueous solution to demonstrate the application of the predictive models to issues of formulation design and manufacturing. Chorhexidine degrades to p-chloroaniline, a well-established toxicant, by various pH-dependent pathways. In acidic conditions, the direct formation of p-chloroaniline from chlorhexidine is the major pathway whereas the indirect formation of p-chloroaniline via p-chlorophenylurea is the main alkaline pathway. Rate laws and mechanisms for each pathway were presented. Shelf life predictions equations for chlorhexidine formulations were derived based on the kinetics of p-chloroaniline appearance as a function of formulation strength, solution pH, bulk chlorhexidine purity and storage temperature. The pH range for optimal shelf-life was 5.0 to 5.5. Simple extraction procedures used during formulation preparation were identified to improve bulk chlorhexidine purity and thereby extend product shelf-life. Gabapentin degrades directly to gabapentin-lactam in the solid-state. The established limit on gabapentin-lactam in gabapentin pharmaceutical formulations is <0.5% w/w thus gabapentin instability was studied as a model compound for solid state formulation applications. Mechanical stress associated with drug product manufacturing in unit operations such as milling increased the subsequent lactamization rate upon storage due to increased gabapentin crystal disorder. The effect of environment moisture was to decrease the rate of gabapentin-lactam formation due to competitive recovery of gabapentin crystallinity which was accelerated by humidity. A degradation model that combined both physical and chemical instability pathways including autocatalytic branching, spontaneous intra-molecular cyclization and moisture-induced physical transformation steps was shown to be consistent with lactamization kinetics as a function of both environmental (temperature and humidity) and manufacturing-related effects. This kinetic model was used to predict the shelf-life of gabapentin tablets prepared under various exemplary manufacturing conditions thereby demonstrating the ability of the model to link manufacturing variation and shelf-life stability in for solid-state drug formulations.
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Tanaff, Karine. "Etude des impuretés et produits de dégradation des solutions injectables de chlorhydrate de morphine fabriquées par la pharmacie centrale des hôpitaux de Paris." Paris 5, 1997. http://www.theses.fr/1997PA05P113.
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Archibald, Timothy, Paul Lewis, and Stacy Brown. "Stability of Vancomycin Hydrochloride for Oral Solution Stored in Unit Doses at Room and Refrigerated Temperatures." Digital Commons @ East Tennessee State University, 2018. https://dc.etsu.edu/etsu-works/5262.
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Lavigne, Hélène. "Hémodialyse : contamination microbiologique et pyrogénique du dialysat." Bordeaux 2, 1992. http://www.theses.fr/1992BOR2P088.
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Tyvenez, Dominique. "Validation de la filtration stérilisante d'un soluté injectable." Bordeaux 2, 1991. http://www.theses.fr/1991BOR2P099.
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Kirk, Loren, and Stacy D. Brown. "Beyond-Use Date Determination for Buprenorphine Buccal Veterinary Solution Using Validated High-Performance Liquid Chromatographic Method." Digital Commons @ East Tennessee State University, 2013. https://dc.etsu.edu/etsu-works/5283.
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Yu, Peng. "Studies of the adsorption of barbituric acid derivatives from solution by activated carbons - wet chemistry and computational chemistry." Diss., University of Iowa, 2019. https://ir.uiowa.edu/etd/6897.
Full textAbstract:
Adsorption processes are utilized in both medicine and industry. It is important to have an understanding of adsorption processes to better predict the outcomes and discern potential difficulties. The primary objective of this research is to further the understanding of the nature and extent of the adsorption process in solution, which is a function of the chemical composition of the adsorbates, adsorbents, and solvent.
This was accomplished by employing experimental studies as well as thermodynamic calculations and molecular dynamic simulations. Four activated carbons were used as the model adsorbents in this study. And, barbital, phenobarbital and primidone were used to elucidate the structural features of the adsorbates that were most responsible for the interaction with activated carbons. A Two-Mechanism Langmuir-Like Equation (TMLLE) was proposed to describe the independent presence of two adsorption mechanisms: non-site-specific adsorption and site-specific adsorption. The analyses of data generated by both previous investigators and current studies, suggest that the TMLLE allows an accurate analysis of the adsorption process. Based on the parameters in the TMLLE, the Modified Crisp Model and the van’t Hoff Model were employed to determine the Gibbs free energy changes for both site-specific adsorption and non-site-specific adsorption. Comparing the Gibbs free energy changes calculated by the Modified Crisp Model and the van’t Hoff Model (site-specific adsorption case), it is concluded that 5 water molecules are displaced by a phenobarbital molecule on the surface of activated carbons. And, for non-site-specific adsorption, it is concluded that 12 water molecules are displaced by a phenobarbital molecule on the nonpolar (hydrocarbon) part of the activated carbon surface. The adsorption of phenobarbital from solution by activated carbons has been simulated by employing Molecular Dynamic (MD) Modeling. The predicted differential Gibbs free energy values for site-specific adsorption at pH 2-9 were consistent with the thermodynamic calculations. And, the present MD simulations provide a good basis for the further understanding and quantitatively assessment of the adsorption driven by hydrophobic bonding. The conclusions reached in the current studies are expected to be applicable to a wide range of similar adsorption processes.
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Kirk, Loren Madden, and Stacy D. Brown. "Beyond-Use Date Determination of Buprenorphine Buccal Solution Using a Stability-Indicating High-Performance Liquid Chromatographic Assay." Digital Commons @ East Tennessee State University, 2015. https://dc.etsu.edu/etsu-works/5305.
Full textAbstract:
Objectives
The objectives of this study included developing and validating a stability-indicating high-performance liquid chromatographic (HPLC) method with ultraviolet (UV) detection for the determination of buprenorphine in a buccal solution for veterinary use, and applying that method to determine the stability of a 3 mg/ml buprenorphine preparation in room temperature and refrigerated storage conditions. This preparation, intended for buccal administration in feline patients, plays an important role in pain management in cats.
Methods
A stability-indicating HPLC method was developed and validated for system suitability, accuracy, repeatability, intermediate precision, specificity, linearity and robustness based on US Pharmacopeia (USP) General Chapter. The method was then applied to the study of potency changes over 90 days in a buccal buprenorphine solution stored at two temperatures.
Results
All HPLC-UV method data met acceptable criteria for the quantification of buprenorphine in a buccal solution formulation. The buprenorphine concentrations found in each stability sample remained within the 90–110% of label claim throughout the 90 days of study. All stability test bottles of the buprenorphine buccal solution retained their original appearance. For the room temperature bottles, some white particulate matter was noted in the threads of the container bottles starting at day 21. The pH of the preparations during the course of the study was in the range of 3.57–4.06 and 4.01–4.16 for the room temperature and refrigerated samples, respectively.
Conclusions and Relevance
Pharmacists have compounded a concentrated 3 mg/ml buccal solution to use easily in the home care or outpatient setting for treatment of feline pain. Prior to this investigation, pharmacists empirically assigned beyond-use dates to this formulation based on standards in USP General ChapterPharmaceutical Compounding – Nonsterile Preparations. This study of a 3 mg/ml buprenorphine buccal solution indicates stability through 90 days.
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Galais, Philippe. "Etude du CP1B concentré pour mélange cardioplégique : propriétés, stabilité, statut juridique." Paris 5, 1998. http://www.theses.fr/1998PA05P200.
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Beheregaray, Marie-Laure. "Problèmes posés par les conservateurs utilisés dans les collyres." Bordeaux 2, 1998. http://www.theses.fr/1998BOR2P062.
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Nguyen, Ngoc Thanh Dien. "Détermination de nouvelles constantes atomiques de lipophilie utilisables pour la prévision du log P d'une molécule." Bordeaux 2, 1996. http://www.theses.fr/1996BOR2B002.
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Hahn, Robert G. "Clinical pharmacology of infusion fluids." Linköpings universitet, Anestesiologi med intensivvård, 2012. http://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-91319.
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Fluids are used for intravenous infusion during practically all surgeries, but several different compositions are available on the market. Crystalloid fluids comprise lactated or acetated Ringer solutions, normal saline, Plasma-Lyte, hypertonic saline, and glucose. They lack allergic properties but are prone to cause peripheral tissue oedema. Their turn over is governed by physiological factors such as dehydration and drug effects. Colloid fluids include hydroxyethyl starch, albumin, dextran, and gelatin. These fluids have various degrees of allergic properties and do not promote peripheral oedema. Their half-life is usually about hours. Factors increasing the turnover rate are poorly known but might include inflammatory states. Current debates include the widespread use of normal saline, which should be replaced by Ringer’s or Plasma-Lyte in most situations, and the kidney damage associated with the use of starch in septic patients. New studies show that hypertonic saline does not improve survival or neurological damage in prehospital care.
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Rey, Jean-Baptiste. "Stabilité galénique de formules-types de mélanges ternaires destinés à la nutrition parentérale en pédiatrie/ Jean-Baptiste Rey." Paris 5, 1999. http://www.theses.fr/1999PA05P100.
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Kirk, Loren, and Stacy D. Brown. "Validated High-Performance Liquid Chromatographic Method for Buprenorphine Quantification in Oral Veterinary Solution for Application Toward a Beyond-Use Date Determination." Digital Commons @ East Tennessee State University, 2013. https://dc.etsu.edu/etsu-works/5286.
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Astre, Vanessa. "Mise au point d'une solution rectale thermogélifiante et bioadhésive contenant des acides gras à chaîne courte." Paris 5, 1998. http://www.theses.fr/1998PA05P075.
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Verjat-Trannoy, Delphine. "Désinfection des générateurs d'hémodialyse : étude de l'association décalcification-chaleur." Paris 5, 1996. http://www.theses.fr/1996PA05P160.
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Benjelloun, Kawtar. "Méthodologie de la validation d'un système de production et de distribution d'eaux à usage pharmaceutique." Bordeaux 2, 1997. http://www.theses.fr/1997BOR2P078.
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Kirk, Loren, and Stacy D. Brown. "High-Performance Liquid Chromatographic Method for a Compounded Vancomycin Oral Solution for Application Toward a Beyond-Use Date Determination." Digital Commons @ East Tennessee State University, 2014. https://dc.etsu.edu/etsu-works/5278.
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Martineau, Christine. "Stabilité des vitamines dans les mélanges de nutrition parentérale en pédiatrie." Paris 5, 1990. http://www.theses.fr/1990PA05P143.
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BM, Khalid, and Priyanka Pulikanti Rani. "Impact of COVID-19 on pharmaceuticals industry to adapt digital marketing." Thesis, Högskolan i Gävle, Avdelningen för ekonomi, 2020. http://urn.kb.se/resolve?urn=urn:nbn:se:hig:diva-35234.
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This master thesis was prompted by the overall interest in Digital marketing that has been growing since the last decade. During this pandemic time, we are interested to know about the impact of COVID-19 on pharmaceutical industry. Most of the articles and the reports in the early stage were mainly about the concept of digital marketing, technology, implementation in day-to-day business. Lesser studies have been conducted keeping the pandemic in view. Covid-19 is the most influencing topic today around the world and because of this, digital marketing has become the important marketing strategy for every business to withstand in the market. We have chosen to work with the pharmaceutical company in an emerging country India to study the impact of Covid-19 on the pharmaceutical industry and how the industry is adapting digital marketing as their marketing strategy. The empirical study is designed as a qualitative method. We had conducted the interview with the employees of the marketing department, used digital marketing concepts from different literature, and applied to our study. We have also explained the selected methodology to answer our research questions. Our findings from the research have shown that digital marketing is the most effective marketing strategy for almost all businesses during this lockdown. The company we worked is believing that digital marketing has a long-run result. We had discussed about the marketing challenges faced by the pharmaceutical companies during pandemic, challenges of adopting digital transformation, strategies followed by the company to sustain customer loyalty by following the aspects of relationship marketing. Our research also focused to know about the solutions to overcome the challenges faced by the pharmaceutical companies.
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Poirier, Christel. "L'eau à l'hôpital." Bordeaux 2, 1994. http://www.theses.fr/1994BOR2P093.
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Darres, Céline. "Conservation des formes buvables multidoses pédiatriques." Paris 5, 1998. http://www.theses.fr/1998PA05P239.
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Andriamaro, Jaonarivo. "Étude in vitro de l'effet de l'eau de mer sur la vitalité de la muqueuse respiratoire." Bordeaux 2, 1995. http://www.theses.fr/1995BOR2M167.
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Gupta, Patel Salin. "MECHANISMS AND THERMODYNAMICS OF THE INFLUENCE OF SOLUTION-STATE INTERACTIONS BETWEEN HPMC AND SURFACTANTS ON MIXED ADSORPTION ONTO MODEL NANOPARTICLES." UKnowledge, 2019. https://uknowledge.uky.edu/pharmacy_etds/103.
Full textAbstract:
Nanoparticulate drug delivery systems (NDDS) such as nanocrystals, nanosuspensions, solid-lipid nanoparticles often formulated for the bioavailability enhancement of poorly soluble drug candidates are stabilized by a mixture of excipients including surfactants and polymers. Most literature studies have focused on the interaction of excipients with the NDDS surfaces while ignoring the interaction of excipients in solution and the extent to which the solution-state interactions influence the affinity and capacity of adsorption. Mechanisms by which excipients stabilize NDDS and how this information can be utilized by formulators a priori to make a rational selection of excipients is not known.
The goals of this dissertation work were (a) to determine the energetics of interactions between HPMC and model surfactants and the extent to which these solution-state interactions modulate the adsorption of these excipients onto solid surfaces, (b) to determine and characterize the structures of various aggregate species formed by the interaction between hydroxypropyl methylcellulose (HPMC) and model surfactants (nonionic and ionic) in solution-state, and (c) to extend these quantitative relationships to interpret probable mechanisms of mixed adsorption of excipients onto the model NDDS surface.
A unique approach utilizing fluorescence, solution calorimetry and adsorption isotherms was applied to tease apart the effect of solution state interactions of polymer and surfactant on the extent of simultaneous adsorption of the two excipients on a model surface. The onset of aggregation and changes in aggregate structures were quantified by a fluorescence probe approach with successive addition of surfactant. In the presence of HPMC, the structures of the aggregates formed were much smaller with an aggregation number (Nagg) of 34 as compared to micelles (Nagg ~ 68) formed in the absence of HPMC. The strength of polymer-surfactant interactions was determined to be a function of ionic strength and hydrophobicity of surfactant. The nature of these structures was characterized using their solubilization power for a hydrophobic probe molecule. This was determined to be approximately 35% higher in the polymer-surfactant aggregates as compared to micelles alone and was attributed to a significant increase in the number of aggregates formed and the increased hydrophobic microenvironment within these aggregates at a given concentration of surfactant.
The energetics of the adsorption of SDS, HPMC, and SDS-HPMC aggregate onto nanosuspensions of silica, which is the model solid surface were quantified. A strong adsorption enthalpy of 1.25 kJ/mol was determined for SDS adsorption onto silica in the presence of HPMC as compared to the negligible adsorption enthalpy of 0.1 kJ/mol for SDS alone on the silica surface. The solution depletion and HPMC/ELSD methods showed a marked increase in the adsorption of SDS onto silica in the presence of HPMC. However, at high SDS concentrations, a significant decrease in the adsorbed amount of HPMC onto silica was determined. This was further corroborated by the adsorption enthalpy that showed that the silica-HPMC-SDS aggregation process became less endothermic upon addition of SDS. This suggested that the decrease in adsorption of HPMC onto silica at high SDS concentrations was due to competitive adsorption of SDS-HPMC aggregates wherein SDS is displaced/desorbed from silica in the presence of HPMC. At low SDS concentrations, an increase in adsorption of SDS was due to cooperative adsorption wherein SDS is preferentially adsorbed onto silica in the presence of HPMC. This adsorption behavior confirmed the hypothesis that the solution-state interactions between pharmaceutical excipients such as polymers and surfactants would significantly impact the affinity and capacity of adsorption of these excipients on NDDS surfaces.