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DeDonato, Bethany M., Lisa I. Bickford i Ryan J. Gates. "Microbial Growth in Neonatal Intravenous Fat Emulsion Administered Over 12 Versus 24 Hours". Journal of Pediatric Pharmacology and Therapeutics 18, nr 4 (1.12.2013): 298–302. http://dx.doi.org/10.5863/1551-6776-18.4.298.
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OBJECTIVES To determine whether an extended infusion time (24 hours) of intravenous fat emulsion is associated with an increase in microbial growth, versus a shorter infusion time (12 hours). METHODS Samples were collected from intravenous fat emulsions (n=132), from intravenous fat emulsions prepared in the current 24-hour infusion method (n=55), and from intravenous fat emulsions prepared in the twice-daily (12-hour infusion) method (n=55). In addition, samples were collected from pharmacy (n=22) to test for possible contamination. RESULTS No growth was observed in either arm of the study. CONCLUSIONS Current Kern Medical Center policy of preparation and administration of neonatal intensive care unit intravenous fat emulsion is safe and effective in regard to microbial growth.
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Janů, Michal, Helena Brodská, Marek Vecka, Ruta Masteiková, Eva Kotrlíková, Robertas Lažauskas, Rimantas Pečiūra i Jurga Bernatonienė. "Comparison of Long-Term Stability of Parenteral All-in-One Admixtures Containing New Lipid Emulsions Prepared Under Hospital Pharmacy Conditions". Medicina 47, nr 6 (28.06.2011): 46. http://dx.doi.org/10.3390/medicina47060046.
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All-in-one (AIO) admixtures for parenteral nutrition are common in hospital pharmacy practices. They are extemporaneously prepared and should be stable during preparation, storage, and administration. Lipid emulsion is a clinically important and very susceptible component of instability. The objective of study was to evaluate the long-term stability of AIO admixtures containing modern lipid emulsions. Material and methods. AIO admixtures with two different emulsions (SMOFlipid and Lipoplus) containing the same amount of glucose and complex amino acid solution, and variable amounts of ions were prepared. Samples were evaluated at 2, 5, 8 and 30 days after preparation. The main indicator of AIO system stability was the amount of lipid globules greater than 5 μm in diameter, which is limited by pharmacopoeia. Optical microscopy was used for particle size measurement. Results. All prepared AIO admixtures remained stable during observation. The counts of overlimit lipid particles were within pharmacopeial limit nevertheless tended to increase in time. After 30-day storage, their value was influenced mainly by concentration of calcium ions, which at lower concentrations had a greater impact on SMOFlipid-based admixtures, whereas at the highest concentration on Lipoplus-based admixtures. The concentration of ions and osmolarity remained without changes; pH of admixtures slightly decreased. Conclusions. Both lipid emulsions were found to be suitable for preparation AIO admixtures with different concentrations of electrolytes. The formulations were stable even if contained high concentrations of divalent ions. The comparison of emulsions revealed the superiority of Lipoplus – electrolyte concentrations and duration of storage had a greater impact on admixtures with SMOFlipid.
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Dourado, Douglas, Camilla Barreto, Rafaela S. Fernandes, Ian M. R. Blanco, Danilo Oliveira, Neila Pereira i Mateus F. Leite. "Development and evaluation of emulsifying systems of the material grease from Brazilian flora". Journal of Pharmacy & Pharmacognosy Research 3, nr 1 (1.01.2015): 130–40. http://dx.doi.org/10.56499/jppres15.069_3.5.130.
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Context: Oils and butter of seed from Brazilian biodiversity are extending the range of innovative products for cosmetics development. They have a fat potential similar to skin composition, leading to the improved performance of these product. Aims: Improve the emulsions spreadability through prior screening of grease composition and studying the viscosity, and the emulsions accelerated stability. Methods: Emulsions were formulated using oils from semiarid plants from Bahia: Syagrus coronate, Pachira retusa, and Pachira aquatica, so as to compare them with oils already standard in the production of cosmetics. Spreadability and stability tests were made comparing the results. The same criteria were used with Amazon seed butter: Virola surinamensis, Butyrospermum parkii, Astrocaryum murumuru, Theobroma cacao and Theobroma grandiflorum. For the emulsions screening and performance, a system was developed for oil/ butter, following tests of accelerated stability, viscosity, and spreadability. Results: The combined system of spreadability was optimized using screening. Emollients containing oleic and palmitic acids, and light chain fatty acids obtained good spreadability. The oil emulsion containing Pachira retusa and Virola surinamensis butter had a higher viscosity. Conclusions: With high content of fatty acids such as oleic, palmitic or the light chain fatty acids obtain an appropriated appearance, texture, and spreadability for cosmetic use. Thus, oils with a low fatty acid content may be combined with butter that have a high fatty acid content and vice-versa. Analyzing and strategically combining grease composition, one can optimize the performance of cosmetic formulations.
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de la Paz, Nilia, Dania Pérez, Mirna Fernández, Caridad M. García, Vivian Martínez, Antonio Nogueira i Oscar García. "In vitro release of dibucaine hydrochloride from chitosan semisolid vehicles: emulsion and hydrophilic gels". Journal of Pharmacy & Pharmacognosy Research 5, nr 1 (1.01.2017): 96–105. http://dx.doi.org/10.56499/jppres16.164_5.2.96.
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Context: Chitosan has received attention as a functional, sustainably renewable, nontoxic and biodegradable biopolymer for pharmaceutical applications. Aims: To evaluate the release of dibucaine hydrochloride from semisolid vehicles of oil/aqueous type emulsion and aqueous gels, stabilized by using chitosan (CH) or chitosan acetate (CHAc). Methods: Emulsions were developed by varying the emulsifying agent: polysorbate 80, CH or CHAc and by combining CH with polysorbate 80 or CHAc with polysorbate 80. The hydroxypropylmethyl cellulose F4M was added as a stabilizing agent in gel formulations. The release rates of model drug from semisolid vehicles were measured by using a dialysis sac. Drug release was also quantified by using a validated UV-VIS spectrophotometric method. Results: The pH values showed minimal changes for emulsion and gel formulations. The drug is a cationic salt, and it is not able to bind polymer cations by electrostatic repulsion. The rheological property of the vehicle type emulsion was adjusted to plastic and pseudo-plastic fluid to the gels. The drug release was independent of the viscosity of vehicles. Dibucaine release from both types of formulation was found to follow a square-root-of-time kinetic model, but a higher rate of release was obtained from gel formulations. Conclusions: It was shown that chitosan was adsorbed to the surface of polysorbate 80-coated droplets, and that the electrostatic attraction between the non-ionic surfactant and the drug retarded its release from a semisolid system. The multilayer emulsions showed more influence of the release of drug than CH or CHAc single layer emulsion.
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Yarnykh, Tetyana, Oleksandr Kotenko, Olga Rukhmakova, Julia Levachkova i Volodymyr Kovalev. "INTRODUCTION OF LEARNING INNOVATIVE ELEMENTS ON THE LESSON EXAMPLE "PREPARATION OF EMULSIONS"". Science and Education 2021, nr 1 (marzec 2021): 45–49. http://dx.doi.org/10.24195/2414-4665-2021-1-6.
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Improving the quality of education is one of the most important tasks facing the teacher. An indicator of the effectiveness of training is its compliance with conditions in which the future specialist will work. University graduates often face the difficult task of adapting the knowledge gained in the learning process to the realities of the workplace. Teachers of the National University of Pharmacy, in particular those who work at the Drugs Technology Department, try to introduce into the educational process classes in which applicants of higher education can see and participate in the work of modern pharmacies. The purpose of such classes is to increase the interest of applicants of higher education in training, demonstration and practice of using modern equipment, increase the efficiency of teamwork and others. The publication presents the experience of conducting classes on the preparation of emulsions using modern equipment with the participation of pharmacy staff who prepare extemporaneous medicines. To compare the efficiency of modern devices, applicants of higher education were divided into two groups, which prepared the emulsion by classical technology and using a homogenizer “Silent Crusher-M”. The result of this lesson is to increase the interest of applicants of higher education in the use of modern telecommunications equipment and devices, increase interest in obtaining theoretical knowledge due to the clarity of their practical implementation, increase awareness of professional development. Applicants for higher education were able to compare the effectiveness of the use of mechanization for the preparation of medicines; the need to acquire skills for further work in the pharmaceutical field, which increases their responsibility to learn.
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Leal, Guilherme Carneiro, Isabela Mazarim da Costa, Jéssica Bassi da Silva, Rafaela Said dos Santos, Marcos Luciano Bruschi, João Carlos Palazzo de Mello, Celso Vataru Nakamura i Audrey Alesandra Stinghen Garcia Lonni. "Development, characterization, and evaluation by cutaneous bioengineering of a natural emulsion, to provide a standardized vehicle base for topical compounded preparations". Research, Society and Development 11, nr 16 (16.12.2022): e509111638290. http://dx.doi.org/10.33448/rsd-v11i16.38290.
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The use of products containing natural and sustainable substances has shown a remarkable growth in the pharmaceutical and cosmetic market, such as in the compounding pharmacy. This research aimed to develop, characterize, and evaluate the cutaneous bioengineering of natural and sustainable emulsions, providing a vehicle base for topical preparations. Nine O/W emulsions were developed changing the nonionic self-emulsifying wax (Cetearyl Olivate (and) Sorbitan Olivate, Cetearyl Glucoside (and) Cetearyl Alcohol, Candelilla/Jojoba/Rice Bran Polyglyceryl-3 Esters (and) Glyceryl Stearate (and) Cetearyl Alcohol (and) Sodium Stearoyl Lactylate), with or without the anionic co-emulsifier (Sodium Stearoyl Glutamate). They were characterized through preliminary stability tests, rheology and accelerated physicochemical stability study. Four formulations were approved (FB1, FB2, FB3 and FB5), but only FB1 (Cetearyl Olivate (and) Sorbitan Olivate with Sodium Stearoyl Glutamate) was considered stable, being selected for preservative efficacy evaluation and the cutaneous bioengineering. The hydration and transepidermal water loss (TEWL) of stratum corneum were analyzed comparing with a conventional topical vehicle (Emulsifying Wax NF). The clinical study showed that FB1 improved the skin hydration with no significant changes for TEWL, but demonstrated considered values. The FB1 could be classified as “skin friendly” and represents a promising natural and sustainable vehicle in compounded pharmacy preparations.
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Sampiev, A. M., M. P. Semenenko, A. A. Parfenyuk, E. V. Kuzminova, P. V. Miroshnichenko i C. S. Polegayeva. "Pharmaceutical evaluation of applicability of bentonite clays appointments in ointments for veterinary purpose". Legal regulation in veterinary medicine, nr 2 (21.07.2023): 79–84. http://dx.doi.org/10.52419/issn2782-6252.2023.2.79.
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Bentonite clays, especially those with a high content of montmorillonite, are widely used in the oil refining, winemaking, agricultural, and cosmetic industries. Such a wide and multidirectional use is primarily due to their unique physicochemical properties. The presence of these properties in bentonites arouses interest in them in pharmacy as excipients (emulsifiers, stabilizers, structure formers, etc.) as part of various dosage forms. However, despite the direct mention in the current State Pharmacopoeia of the Russian Federation of the possibility of using bentonites as excipients, a substance officially permitted for these purposes in Russia is not registered and is not produced. In this regard, the urgent task was to conduct a preliminary pharmaceutical assessment of bentonite from a domestic field for the potential possibility of using it in veterinary pharmacy. The study was carried out on a modified sodium form of bentonite, processed to a homogeneous fine powder in comparison with the original alkaline earth form. The assessment was carried out according to indicators for pharmacopoeia analysis: description, authenticity, pH of an aqueous suspension, weight loss on drying, the content of arsenic, iron, calcium, carbonate chlorides, the presence of coarse particles, microbiological purity, swelling, gelling, emulsifying ability and stability emulsions. The evaluation of the emulsifying ability, emulsion stabilization, gelling properties and a number of pharmacopoeia indicators of good quality demonstrated the potential possibility of using domestically deposited bentonite in veterinary pharmacy (using the example of the Kantemirovskoye deposit in the Voronezh region) as excipients in the composition of dosage forms for veterinary use, in particular, heterogeneous ointments. In this regard, the sodium modification of bentonite seems to be more promising for further in-depth study.
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Sah, Hitarth, i Prof (Dr ). G. Ganarajan. "Microspheress Types Preparation Evaluation and Applications: A Review". International Journal for Research in Applied Science and Engineering Technology 11, nr 6 (30.06.2023): 260–67. http://dx.doi.org/10.22214/ijraset.2023.53612.
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Abstract: Microspheres, also known as microspheres or “monolithic spheres” are small spherical particles that usually range from 1 to 1000 micrometres (µm). This multi-particulate drug delivery system is used in order to obtain controlled and prolonged drug delivery, thus improving the stability, bioavailability, and site specificity at a desired and predetermined rate. There are various methods in order to prepare/formulate the microspheres, such as emulsion-solvent evaporation, extraction of solvent, spray drying, Coacervation, Electrostatic or Electrodynamic, Template or Moulding methods and various other methods that include Thermally Induced Phase Separation (TIPS) and Supercritical Fluid Extraction of Emulsions (SFEE). Every method has its own benefits and disadvantages therefore, the selection of appropriate method is critical in achieving the desired microsphere characteristic. This review covers the different methods used to prepare the microspheres, the variety of parameters used in order to evaluate their effectiveness and their applications in the field of pharmacy.
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Navarro-Pérez, Yisel M., Elisa Cedeño-Linares, Osvaldo Norman-Montenegro, Vivian Ruz-Sanjuan, Yunisley Mondeja-Rivera, Ana M. Hernández-Monzón i Mirtha M. González-Bedia. "Prediction of the physical stability and quality of O/W cosmetic emulsions using full factorial design". Journal of Pharmacy & Pharmacognosy Research 9, nr 1 (1.01.2021): 98–112. http://dx.doi.org/10.56499/jppres20.908_9.1.98.
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Context: Full factorial design is effective in predicting the properties optimization and processing conditions of cosmetic emulsions. However, in most factorial designs, the technological quality and accelerated stability tests of emulsions are not included together as dependent variables. Aims: To predict the technological quality and physical stability of model cosmetic emulsions from the combination of formulation and processing factors using a 23 full factorial design. Methods: A 23 full factorial design with 95 % of confidence was generated in order to evaluate the influence of critical factors during the manufacture of cosmetic emulsions on their quality and physical stability. Emulsifier, concentration of stearic acid (formulation factors) and type of cooling (processing factor) were the independent variables, whereas spreadability, bulk density and pH were dependent variables for technological quality and centrifugation, heating-cooling and freeze-thaw cycles were dependent variables for physical stability of the emulsions. All cosmetic emulsions were prepared with a low stirring speed of 100 rpm. Results: The formulation containing 1% w/w sodium lauryl sulfate, 1.05% w/w stearic acid and prepared with continuous cooling, did not show indicative changes of physical instability by visual inspection after accelerated physical stability tests. These results were confirmed with emulsions stored for 12 and 24 months using real storage conditions. However, formulations containing an emulsifier blend composition (Tween 80: Sodium lauryl sulfate, 2:1 w/w), showed signs of creaming after these tests. Conclusions: Sodium lauryl sulfate at 1 % w/w, increased the physical stability of the emulsions by increasing their consistency and by other possible mechanisms. Real storage conditions confirmed the stability prediction performed using the combination of accelerated stability tests (centrifugation/cooling-heating/freeze-thaw cycles), aided by the purposed full factorial design.
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Gura, Kathleen M. "The Power of Networking and Lessons Learned From Omegaven". Journal of Pediatric Pharmacology and Therapeutics 25, nr 8 (1.11.2020): 663–74. http://dx.doi.org/10.5863/1551-6776-25.8.663.
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As more meetings become virtual, the impact of “live” meetings is being reevaluated. Here one example of how a chance meeting at a national pharmacy meeting led to the development of a new drug therapy that reinvented how parenteral nutrition is provided to infants and children is described. Along the way, many lessons were learned both in the lab and at home. Addressing the challenges raised by others, understanding how the FDA works, and the power of parental involvement are all considered. Until 2013, the only FDA-approved lipid emulsions were those composed of pure soybean oils. Starting with compassionate use protocol in 2004, it took 18 years and hundreds of patients to bring a pure fish oil lipid emulsion to the US market. First used off label to treat a soy-allergic patient dependent on parenteral nutrition, researchers at Boston Children's Hospital later conducted animal studies on its role in treating and preventing intestinal failure associated with liver injury and later translated it into clinical trials that led to the drug's approval in 2018. This is a recount of those efforts.
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Santos, A. C., B. K. Souza, A. F. T. Souza, N. C. Lubi i T. F. B. X. Silva. "Stability assessment of Lanette Lotion of a magistral pharmacy in the region of Curitiba". Scientific Electronic Archives 13, nr 5 (29.04.2020): 69. http://dx.doi.org/10.36560/1352020913.
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Emulsions are heterogeneous systems, thermodynamically unstable, formed by the combination of hydrophilic and lipophilic substances through agents of surface tension. The product quality control is handled as the most important to study the stability of the final product which determines the length of time that can be considered stable, that means, able to keep up with the same characteristics which have been developed. The study aimed to evaluate the physical and chemical parameters, by determining the pH, viscosity and organoleptic characteristics (color, odor and appearance) of the lotion Lanette used in a magistral pharmacy in Curitiba. The formulation commonly used in the pharmacy was stored at temperatures of 4 ° C ambient and 45 ° C over a period of 90 days which was divided into 6 times to carry out aspects of analysis. In the preliminary stability study there was no change, but in the accelerated there was a slight modification in appearance, this change was more intense in the formulation conditioned at room temperature and 4 ° C. The pH has had a significant change at all temperatures. Concluding that against accelerated stability tests Lanette lotion, even with the changes, showed good stability.
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Al-Hussaniy, Hany A., Yasir Q. Аlmajidi, Amjad I. Oraibi i Abdulwahhab Нameed Alkarawi. "Nanoemulsions as medicinal components in insoluble medicines". Pharmacia 70, nr 3 (27.07.2023): 537–47. http://dx.doi.org/10.3897/pharmacia.70.e107131.
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Background: Medicine’s success relies on solubility, which is the process of dissolving a solid substance in a fluid phase to create a uniform molecular dispersion. However, hydrophobic active medicinal components exhibit poor solubility in water, limiting their effectiveness and incorporation into medications. Aim: This review explores the potential of nanoemulsions as a solution for delivering hydrophobic medicinal components with low solubility. The study investigates the benefits of nanoemulsions, including enhanced absorption, effective targeting, controlled release, and protection of encapsulated bioactive ingredients. Materials and methods: Nanoemulsions are formulated by combining two immiscible liquids with emulsifying agents within a thermodynamically stable colloidal dispersion system. The review categorizes various preparation techniques into high-energy and low-energy spontaneous emulsification methods. The choice of preparation procedures and materials used significantly affects the stability of nanoemulsions over time. Evaluation of nanoemulsions includes studying medication release in vitro, in vitro permeation, stability and thermodynamic stability, shelf life, viscosity, interfacial tension, pH, and osmolarity. Results: Nanoemulsions, such as Celecoxib (Phase Inversion), acetylsalicylic acid (Ultrasonication), and Flurbiprofen (Homogenization and Ultrasonication), offer distinct advantages for medications with low solubility compared to conventional emulsions. These nanoemulsions comprise small droplets with a larger surface area, promoting enhanced absorption. They demonstrate effective targeting, controlled release, and protection of encapsulated bioactive ingredients. Moreover, the diminutive droplet sizes of nanoemulsions contribute to their reduced susceptibility to issues like flocculation, coalescence, sedimentation, or creaming. Conclusion: Nanoemulsions hold great promise in overcoming the solubility limitations of hydrophobic medicinal components. They provide enhanced absorption, effective targeting, controlled release, and protection of bioactive ingredients. The choice of preparation techniques and materials plays a crucial role in ensuring the stability of nanoemulsions over time. Further studies are warranted to optimize their use and explore their potential applications in drug delivery systems.
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Klimovitskaya, Mariya, Polina Skvortsova, Olga Zueva i Yuriy Zuev. "Thermal stability of water-in-oil microemulsions containing solubilized nutritional protein gelatin". BIO Web of Conferences 116 (2024): 03016. http://dx.doi.org/10.1051/bioconf/202411603016.
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To develop new food and pharma technologies, various combinations of encapsulation and delivery of biological macromolecules are used. Proteins, polysaccharides, fats and lipids must be conveyed inside living organism, protecting them during the stages of storage and preparation from exposure of aggressive external environment. Some of the most common food protein compositions are various gels and emulsions. In the present study, we focused our attention on the influence of protein molecules on the properties and dynamical stability of water-inoil microemulsion. Microemulsions, the oil dispersion of surfactant-based reverse micelles, each carrying nanosized water core with embedded protein. We studied the result of protein encapsulation in the water core of surfactant reverse micelles, namely, the fish and mammalian gelatin. The method of electric conductivity was explored to detect the properties of reverse micelles as containers for food proteins. We have shown that a rather high protein content does not destroy microemulsion structure, which retain reverse micelles, though the properties of the system undergo definite alterations, in particular, it substantively lost thermal stability accelerating exchange processes between reverse micelles at lower temperatures which have to be taken into account in nutritional and pharmacy objectives.
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Buzzo, Celia Maria Vargas da Costa, Attilio Converti, José Alexsandro da Silva i Alexsandra Conceição Apolinário. "Quality by design enabled the development of stable and effective oil-in-water emulsions at compounding pharmacy: the case of a sunscreen formulation". Pharmaceutical Development and Technology 26, nr 10 (18.10.2021): 1090–101. http://dx.doi.org/10.1080/10837450.2021.1990946.
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KHAIBULLINA, Karina Shamilevna, Lyaisan Rustamovna SAGIROVA i Mikhail Sergeevich SANDYGA. "SUBSTANTIATION AND SELECTION OF AN INHIBITOR FOR PREVENTING THE FORMATION OF ASPHALT-RESIN-PARAFFIN DEPOSITS". Periódico Tchê Química 17, nr 34 (20.03.2020): 541–51. http://dx.doi.org/10.52571/ptq.v17.n34.2020.565_p34_pgs_541_551.pdf.
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Currently, most oil fields are under the late stage of development, which is associated with some challenges during the production of reservoir products, including the formation of asphalt-resin-paraffin deposits (ARPD) in the “well – bottom-hole formation zone” system. Even though the problem of organic deposits creation has existed for more than 60 years, it is still relevant today. Currently, to prevent the formation of ARPD, inhibitors divided into methods based on the use of wetting agents, modifiers, depressors, and dispersants are widely used infield practice. The composition of inhibitors often includes surfactants, and according to field experience, nonionic surfactants, namely, polyesters, are widely used to prevent the formation of ARPD. However, little is known about inhibitors with a combined effect, for example, possessing depressor-dispersing properties concerning ARPD. Proceeding from the above, the work is aimed to develop a combined inhibitor with depressor-dispersing properties to prevent the formation of ARPD. The dispersing property of the prepared reagent for asphaltene particles was determined using capillary and photocolorimetric methods. The studies were conducted to assess the impact of the reagent on the freezing point. A quantitative assessment of the sedimentation process using the “Cold rod” installation was performed, and the results of studies of the developed ARPD reagent-inhibitor corrosion resistance were presented. Two methods determined the temperature of oil saturation with paraffin: the direct approach – visual observation (Axio Lab A1 microscope) and the indirect approach – rheogoniometry to determine the kinematic viscosity of oil (HVM-472 viscosity analyzer (Walter Herzog GmbH, Germany)). Thus, an ARPD inhibitor (IN-1), comprising a copolymer of ethylene with α-olefins or polymers of acrylic, methacrylic, or cyanoacrylic acid esters, an emulsifier of inverted oil-in-water emulsions and a solvent, was developed. The developed inhibitor, having depressor-dispersing properties, is capable of reducing oil-freezing point in winter and of slowing down the precipitation of paraffin crystals in well equipped and in the bottom-hole formation zone (BHFZ).
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Whitfield, Phillip D., Peter T. Clayton i David P. R. Muller. "Effect of Intravenous Lipid Emulsions on Hepatic Cholesterol Metabolism". Journal of Pediatric Gastroenterology and Nutrition 30, nr 5 (maj 2000): 538–46. http://dx.doi.org/10.1002/j.1536-4801.2000.tb02790.x.
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ABSTRACTBackgroundTotal parenteral nutrition offers the chance of survival to children who have had extensive gut resections or gut failure. However, in infants it is often associated with serious complications including cholestatic liver disease. The causes of these complications remain unclear, although it has been suggested that the lipid emulsions used in total parenteral nutrition may be responsible.MethodsAn in vitro system was developed to study the effect of lipid emulsions on hepatic cholesterol metabolism using cultured hepatocytes.ResultsIncubations of Hep G2 cells with medium containing Intralipid (Pharmacia and Upjohn, Milton Keynes, UK) demonstrated that the fat emulsion mediated a powerful dose‐dependent but reversible inhibition of cholesterol uptake. In addition Intralipid was shown to stimulate the efflux of cholesterol from Hep G2 cells. The component or components of the Intralipid responsible for these effects and the mechanism by which they act remain to be established.ConclusionsIntravenous lipid emulsions may interfere with hepatic cholesterol metabolism in vivo. This may have implications for the development of total parenteral nutrition–associated cholestasis in neonates.
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Cada, Dennis J., Terri L. Levien i Danial E. Baker. "Clevidipine Butyrate Injectable Emulsion". Hospital Pharmacy 43, nr 11 (listopad 2008): 903–12. http://dx.doi.org/10.1310/hpj4311-903.
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Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing inservices. A comprehensive target drug utilization evaluation (DUE) is also provided each month. With a subscription, the monographs are sent in print and are also available online. Monographs can be customized to meet the needs of a facility. Subscribers to the The Formulary Monograph Service also receive access to a pharmacy bulletin board, The Formulary Information Exchange (The F.I.X). All topics pertinent to clinical and hospital pharmacy are discussed on The F.I.X. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. For more information about The Formulary Monograph Service or The F.I.X., call The Formulary at 800-322-4349. The November 2008 monograph topics are on romiplostim, rivaroxaban, golimumab, dronedarone, and degarelix. The DUE is on romiplostim.
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Lutomski, Dave M., Mary Lea Gora, Sharon M. Wright i Jill E. Martin. "Sorbitol Content of Selected Oral Liquids". Annals of Pharmacotherapy 27, nr 3 (marzec 1993): 269–74. http://dx.doi.org/10.1177/106002809302700301.
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OBJECTIVE: Excipients in pharmaceuticals usually are considered inert, and may be overlooked in the differential diagnosis of diarrhea. Sorbitol-containing medicinal liquids are capable of inducing osmotic diarrhea. We reviewed the oral liquids in our formulary to determine their sorbitol content and to evaluate the availability of this information. DESIGN: The oral liquids stocked by our hospital were determined through a computer search and manual inspection of the pharmacy storeroom. Three common sources of drug information were consulted to determine each product's sorbitol content: Manufacturers' product information, American Hospital Formulary Service (AHFS) Drug Information 91, and Facts and Comparisons Drug Information. We then contacted each manufacturer by mail or telephone to verify the information. SETTING: The study was conducted at the University of Cincinnati Hospital, a tertiary-care, teaching hospital. RESULTS: A total of 129 products (98 chemical entities) were reviewed. Fifty-four (42 percent) of the products examined contained sorbitol. The frequency of sorbitol presence by liquid type was: Solutions (33 percent), suspensions (43 percent), syrups (59 percent), elixirs (43 percent), concentrates (67 percent), drops (33 percent), tinctures (0 percent), and emulsions (0 percent). The percentage of listings indicating the presence of sorbitol was: Manufacturer's product information (79 percent), Facts and Comparisons (52 percent), and AHFS Drug Information 91(13 percent). Only three of the 54 products had the exact sorbitol content stated in any source. CONCLUSIONS: Based on literature data, single doses greater than 10 g and total daily doses greater than 50 g of sorbitol would produce adverse gastrointestinal effects in a sizable number of adults. Many of the marketed products reviewed could deliver an adult laxative dose. Current labeling is insufficient for healthcare providers to assess the risk for individual patients.
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Cada, Dennis J., Terri L. Levien i Danial E. Baker. "Alvimopan". Hospital Pharmacy 43, nr 10 (październik 2008): 819–29. http://dx.doi.org/10.1310/hpj4310-819.
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Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing inservices. A comprehensive target drug utilization evaluation (DUE) is also provided each month. With a subscription, the monographs are sent to you in print and are also available online. Monographs can be customized to meet the needs of your facility. Subscribers to the The Formulary Monograph Service also receive access to a pharmacy bulletin board, The Formulary Information Exchange (The F.I.X.). All topics pertinent to clinical and hospital pharmacy are discussed on The F.I.X. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. If you would like information about The Formulary Monograph Service or The FIX., call The Formulary at 800-322-4349. The October 2008 monograph topics are on clevidipine butyrate injectable emulsion, tetrabenazine, tenofovir disoproxil fumarate tablets, ferumoxytol, and saxagliptin. The DUE is on clevidipine butyrate injectable emulsion.
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FROLOV, Vladimir Ju, Georgy G. KLASNER i Denis P. SYSOEV. "SUBSTANTIATION OF DESIGN AND STANDARD PARAMETERS OF CHOPPER OF SOAKED GRAIN OF LEGUMINOUS PLANTS (AS AN EXAMPLE OF THE SOYA GRAIN)". Periódico Tchê Química 16, nr 31 (20.01.2019): 258–67. http://dx.doi.org/10.52571/ptq.v16.n31.2019.264_periodico31_pgs_258_267.pdf.
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The most efficient way to prepare the leguminous plants’ seeds for the livestock animal food is making of the protein emulsion. There are a lot of ways of obtaining the protein emulsion. However, process operations provide for the use of large-scale, energy-intensive and expensive machines, which often cannot be afforded by the small enterprises producing more than 50% of animal and poultry products today. This way, it is necessary to develop a universal technology of making the protein emulsion applied in small holdings. The research objective is the development of a waste-free technology of making the protein emulsion for animal food. Proceeding from the patent search for technologies and designs to make a protein emulsion we offered a waste-free technology, which makes it possible to unite a whole number of technological operations (chopping, extraction, a division of suspension into fractions) into one operation through using a new facility, the RF Patent No. 2614777. Theoretical and experimental research of processes of the grain chopping and the soy protein extraction into emulsion was described. The main design and standard parameters of the device developed were substantiated theoretically and experimentally.
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Cada, Dennis J., Terri Levien i Danial E. Baker. "Aripiprazole". Hospital Pharmacy 38, nr 3 (marzec 2003): 247–56. http://dx.doi.org/10.1177/001857870303800308.
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Each month, subscribers to The Formulary Monograph Service receive five to six well-documented monographs on drugs that are newly released or are in late Phase III trials. The monographs are targeted to your Pharmacy and Therapeutics Committee. Subscribers also receive monthly one-page summary monographs on the agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation (DUE) is also provided each month. The monographs are published in printed form and on diskettes that allow customization. Subscribers to the The Formulary Monograph Service also receive access to a pharmacy bulletin board, The Formulary Information Exchange (The F.I.X.). All topics pertinent to clinical and hospital pharmacy are discussed on The F.I.X. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. If you would like information about The Formulary Monograph Service or The F.I.X., call The Formulary at 800–322–4349. The March 2003 monograph topics are adalimumab, eletriptan, cyclosporine ophthalmic emulsion, montelukast for allergic rhinitis, and icodextrin peritoneal dialysis solution. The DUE is on adalimumab.
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Cada, Dennis J., Terri Levien i Danial E. Baker. "Ezetimibe". Hospital Pharmacy 38, nr 4 (kwiecień 2003): 357–66. http://dx.doi.org/10.1177/001857870303800401.
Pełny tekst źródłaStreszczenie:
Each month, subscribers to The Formulary Monograph Service receive five to six well-documented monographs on drugs that are newly released or are in late Phase III trials. The monographs are targeted to your Pharmacy and Therapeutics Committee. Subscribers also receive monthly one-page summary monographs on the agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation (DUE) is also provided each month. The monographs are published in printed form and on diskettes that allow customization. Subscribers to the The Formulary Monograph Service also receive access to a pharmacy bulletin board, The Formulary Information Exchange (The F.I.X.). All topics pertinent to clinical and hospital pharmacy are discussed on The F.I.X. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. If you would like information about The Formulary Monograph Service or The F.I.X., call The Formulary at 800–322–4349. The March 2003 monograph topics are adalimumab, eletriptan, cyclosporine ophthalmic emulsion, montelukast for allergic rhinitis, and icodextrin peritoneal dialysis solution. The DUE is on adalimumab.
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Strus, Oksana, Nataliia Polovko i Oksana Yezerska. "Justification of technological parameters of the cream production with sapropel extract". Pharmacia 66, nr 1 (7.06.2019): 19–25. http://dx.doi.org/10.3897/pharmacia.66.e35022.
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The aim of the research was to substantiate the technological parameters of cream production with the sapropel extract and work out the technological scheme for its production. In this study, extract of sapropel from the Prybych deposit, emulsion base, containing corn oil, emulsifier No.1, cetylstearyl alcohol, nisin, euxyl K 100 and purified water were employed. To carry out the research, a set of methods to analyse colloidal and thermal stability was used. Rheological properties of the samples were determined. The method of microscopic analysis was carried out to analyse the stability of the emulsion system. It was proved experimentally that, when producing the cream, it is appropriate to use the phase inversion method, and the emulsification needs to be carried out at 5000 r/m for 20 min. Size and shape of the sample drops, obtained at 5000 r/m, were monodisperse and more uniform, most of which range from 2 to 3 microns that indicates the system stability. The following parameters of technological process were determined: mixing temperature conditions, speed of homogenisation and mixing time.
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Chabib, Lutfi, Arman Suryani, Loly Sintia Dewi, Herdwi Noviani, Widya Husna Puspa Maharani i Aina Anasta Indraswari. "Pineapple fruit extract (Ananas comosus L. Merr) as an antioxidant and anti-acne agent made with the nano-emulsion gel delivery system". Pharmacy Education 23, nr 2 (15.05.2023): 126–32. http://dx.doi.org/10.46542/pe.2023.232.126132.
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Background: Pineapple (Ananas comosus L. Merr) contains a lot of fibre, minerals, and vitamins. Consequently, it has anti-inflammatory, antibacterial, antioxidant, and antidiabetic benefits. Objective: The purpose of this research was to produce pineapple extracts in the form of nano-emulsion gel for more effective use as an antioxidant and anti-acne. Method: The extraction was done by maceration. The resulting extracts were formulated with tween 20 and propylene glycol, while kollisolv PYR served as the oil phase. A nano-emulsion was then formed and formulated into a gel. Result: In this study, the nano-emulsion gel produced was transparent yellowish-white, slightly viscous, with a characteristic odour, a particle size of 10.8 nm ± 0.5, a polydispersity index of 0.239 Ð ± 0.1 and a zeta potential of -33.6 mV ± 1.3. The ability of this nano-emulsion gel to spread was good, 10.28 cm - 14.48 cm, with 1.31 seconds of adhesion and the result of the viscosity test of 3667.4 ± 106.03 cP. In the antioxidant test, the %RSA was produced in the range of 17.70 - 70.32% and the IC50 value was 0.1 µg/mL so it was included in the category of very strong antioxidant. While the anti-acne test has an average bacterial inhibition zone of 10.5 mm ± 0.1 which is in the category of strong anti-acne. Conclusion: It was concluded that pineapple fruit extract with a nano-emulsion gel base can produce good nanoparticle preparations, which have very strong antioxidant and anti-acne activities.
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Meaney, Calvin J., Houtan Sareh, Bryan D. Hayes i Jeffrey P. Gonzales. "Intravenous Lipid Emulsion in the Management of Amlodipine Overdose". Hospital Pharmacy 48, nr 10 (październik 2013): 848–54. http://dx.doi.org/10.1310/hpj4810-848.
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Al-otaibi, Waad. "Rosemary oil nano-emulsion potentiates the apoptotic effect of mitomycin C on cancer cells in vitro". Pharmacia 68, nr 1 (9.02.2021): 201–9. http://dx.doi.org/10.3897/pharmacia.68.e60685.
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Purpose: To formulate nano-emulsified rosemary oil (REO/NE) and determine its effect on the anticancer agent, mitomycin C (MC) when used as a carrier for the drug. Methods: The droplet size of REO/NE was markedly enlarged when mixed with MC. The cytotoxicity of the formulations on HeLa and MCF-7 cells was determined using MTT assay. The combination index (CI) values were estimated with CompuSyn software, while apoptosis was determined using DAPI fluorescent dye. Results: Treatment of MCF-7 cells and HeLa cells with REO/NE (1% v:v and 1.33% v:v, respectively) reduced the IC50 of MC 33 and 15 folds, respectively. Under fluorescent microscopy, cells treated with REO/NE+MC had more marked reduction of the nuclear area than MC-treated cells. Conclusion: These results indicate that REO/NE is an efficient carrier for MC since it enhanced MC delivery and increased its effect on the cells through the induction of apoptosis at low concentrations of MC.
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AlMotwaa, Sahar M. "Coupling Ifosfamide to nanoemulsion-based clove oil enhances its toxicity on malignant breast cancer and cervical cancer cells". Pharmacia 68, nr 4 (8.10.2021): 779–87. http://dx.doi.org/10.3897/pharmacia.68.e68291.
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The anticancer effects of chemotherapeutic agents may be accentuated, and their side effects minimized by combining them with essential oils in nanocarrier systems. This study aimed to incorporate ifosfamide (IF) into nanoemulsion-based clove oil (IF-CLV). The nano-emulsion (NE) formulas were characterized with Zetasizer. The cytotoxicity of the formulated NEs against cervical (HeLa) and breast (MCF-7) cancer cell lines was determined using MTT assay, light microscopy, and DAPI staining. The z – average diameters of NE-CLV and IF-CLV were 63.1±1.00 and 89.4±2.64 nm, while Zeta potential values were – 4.39±0.4 and – 11.65±1.1mV, respectively. Cytotoxicity studies revealed that relative to free IF, NE-CLV and IF-CLV were highly toxic on HeLa and MCF-7cells, in a dose-dependent manner. The half-maximal inhibitory concentration (IC50) values of NE-CLV against HeLa and MCF-7 have decreased 38 and 27 folds, while the corresponding IC50 values of IF-CLV have decreased 57 and 35 folds, respectively. These results suggest that the incorporation of IF into NE-based clove oil produces potent therapeutic effects against cancer cell lines.
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Kurniati, Neng Fisheri, i Almira Fathadina. "Combination of Empagliflozin and Liraglutide protects heart against isoproterenol-induced myocardial infarction in rats". Pharmacia 70, nr 1 (21.02.2023): 171–80. http://dx.doi.org/10.3897/pharmacia.70.e96975.
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Cardiovascular benefit of new anti-hyperglycemic agent such as glucagon like peptide-1 receptor agonist (GLP-1RA) or sodium glucose co-transporter-2 inhibitor (SGLT2i) has been proven, with the proposed-mechanism that might be complementary. We investigated the effects of its combination on blood glucose profile and cardiac biomarkers. The rats were given lipid emulsion for 2 weeks, followed by a single dose of streptozotocin (STZ) 35 mg/kg BW, then treated with empagliflozin and/ liraglutide for 30 days while receiving isoproterenol (ISO) 85 mg/kg on day 29 and 30. The results showed no superior improvement on fasting blood glucose (FBG) and insulin sensitivity (KITT) in the combination group compared to empagliflozin/liraglutide group. However, the combination group showed a higher inhibition in almost all biomarkers, specifically against the elevation of CK-MB compared to one of these agents alone. The histopathological examination using H&E staining even showed a minimal inflammation and gap between cardiomyocytes. These findings may indicate the combination of empagliflozin and liraglutide has a better cardiac protection effect.
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Pascual, Begoña, Ana Ayestaran, José B. Montoro, Juan Oliveras, Antero Estibalez, Antoni Julia i Andres Lopez. "Administration of Lipid-Emulsion Versus Conventional Amphotericin B in Patients with Neutropenia". Annals of Pharmacotherapy 29, nr 12 (grudzień 1995): 1197–201. http://dx.doi.org/10.1177/106002809502901201.
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Objective: To evaluate the usefulness of a 20% lipid emulsion as a delivery system for amphotericin B (1 mg/mL) administered over 1 hour to patients with neutropenia with hematologic malignancies compared with amphotericin B (0.1 mg/mL) administered in dextrose 5% solution over the same time. Design: A prospective, comparative, randomized, labeled study. Setting: Hematology unit, pharmacy service, university general hospital. Participants: Twenty patients with neutropenia with hematologic malignancies and proven or suspected fungal infections, 10 in the fat emulsion group (group 1) and 10 in the dextrose 5% group (group 2). Main Outcome Measures: Clinical tolerance (i.e., fever, shaking chills, nausea, blood pressure, pulse rate) and biologic tolerance (i.e., urea, creatinine, sodium, potassium). Results: Clinical tolerance was comparable in both groups although amphotericin B in fat emulsion was better tolerated. Medication for symptoms related to the administration of amphotericin B was given in 6 cases in group 1 and in 8 cases in group 2. There was a statistically significant difference in the urea concentrations between the 2 groups (p = 0.023); there was an observed increase between the initial and the final serum urea (56.8 mg/d in group 1, 79.8 mg/dL in group 2). Statistically significant differences in creatinine serum concentrations (84.9 μmol/L in group 1, 123.8 μmol/L in group 2) (p = 0.047) were found. No differences were found in the antifungal efficacy of the treatment. However, as amphotericin B was started in the majority of cases (75%) as empiric treatment for fever unresponsive to antibiotic therapy, it is difficult to compare the efficacy of both preparations. Conclusions: The clinical tolerance of lipid-emulsion infusions is similar to that of conventionally administered amphotericin B therapy. Renal toxicity appears to be decreased when the drug is administered in a fat emulsion. This type of preparation permits the reduction of the volume and the time of administration for amphotericin B therapy.
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More, Kalpesh S., Mitesh P. Sonawan, Vedant B. Kor i Darshan B. Bhamare. "Formulation Development and Evaluation of Wax Incorporated Floating Beads of Dapagliflozin". International Journal of Pharmaceutical Sciences and Nanotechnology(IJPSN) 16, nr 5 (15.09.2023): 6953–57. http://dx.doi.org/10.37285/ijpsn.2023.16.5.3.
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Introduction: The current work's objectives are to build numerous floating drug delivery systems utilising various wax concentrations to prolong the release of dapagliflozin and to study the influence of sodium alginate on the system's buoyancy. Dapagliflozin is used as a anti diabetic drug which is used in treatment of type-2 diabetes.The goal of the study is to create sodium-based emulsion gel beads with wax incorporated utilising a modified emulsion-gelation process. Method: Emulsion gelation method used for preparation of floating beads. The Model drug was mixed with olive oil-containing sodium alginate wax before being hot-melted, homogenised, and then extruded into a calcium chloride solution. The manufactured Wax-incorporated Emulsion Gel Beads were analysed for Micromeritics investigations, entrapment efficacy, in-vitro buoyancy rate, and dissolution rate. Result: Several preformulation experiments, including bulk density, tapped density, and Carr's index, were within acceptable ranges, and highest drug release after 12 hours is 96.63% particularly for batch F2. Wax was added to the formulation to greatly extend the drug release; however, it was not enough to maintain the release of a highly water-soluble medication. Conclusion: It is possible to conclude that the usage of hydrophobic carriers such as waxes can be used to provide the desired sustained release effect. Oils and other low-density components were utilised to help the formulation's flotation. The study concluded that floating wax microspheres may use as medication carrier to prolong drug release.
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Uthaya, Sabita, Xinxue Liu, Daphne Babalis, Caroline Dore, Jane Warwick, Jimmy Bell, Louise Thomas i in. "Nutritional Evaluation and Optimisation in Neonates (NEON) trial of amino acid regimen and intravenous lipid composition in preterm parenteral nutrition: a randomised double-blind controlled trial". Efficacy and Mechanism Evaluation 3, nr 2 (marzec 2016): 1–80. http://dx.doi.org/10.3310/eme03020.
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BackgroundParenteral nutrition (PN) is central to the care of very immature infants. Early intakes of higher amounts of amino acids and the use of lipid emulsions containing fish oils are recommended by current international recommendations.ObjectiveTo confirm the safety and demonstrate efficacy of the immediate introduction of the recommended daily intake of amino acids (Imm-RDI) and soya bean oil, medium-chain triglycerides, olive oil and fish oil lipid in PN to increase non-adipose (lean) body mass and decrease intrahepatocellular lipid (IHCL) content.DesignMulticentre, double-blind, 2 × 2 factorial and randomised controlled trial (RCT).SettingNeonatal units in London and south-east England, UK.ParticipantsExtremely preterm infants born before 31 weeks of gestation without major congenital or life-threatening abnormalities who could to be randomised to receive PN within 24 hours of birth.InterventionsInfants were randomised within 24 hours of birth to receive PN containing either high [RDI of amino acids (Imm-RDI)] or low [incremental amino acids (Inc-AA) control] levels of amino acids. In addition, infants were randomised to receive either 20% SMOFlipid®(Fresenius Kabi AG, Richmond Hill, ON, Canada) or 20% Intralipid®(Fresenius Kabi AG, Richmond Hill, ON, Canada) (control). This resulted in four groups: (1) Inc-AA/Intralipid, (2) Inc-AA/SMOFlipid, (3) Imm-RDI/Intralipid and (4) Imm-RDI/SMOFlipid. The intervention was continued until infants were receiving 150 ml/kg/day of enteral feeds for 24 hours.Primary outcome measureFor the amino acid intervention, this was non-adipose or lean body mass measured by magnetic resonance imaging. For the lipid composition intervention, this was IHCL content as measured by hepatic magnetic resonance spectroscopy. Primary outcomes were measured at term age equivalent, between 37 and 44 weeks postmenstrual age.ResultsWe randomised 168 infants born before 31 weeks of gestation. We evaluated outcomes, at term, in 133 infants. There were no significant differences in non-adipose mass between the Imm-RDI and Inc-AA groups [adjusted mean difference 1.0 g, 95% confidence interval (CI) –108 to 111 g] or in levels of IHCLs between the SMOFlipid and Intralipid groups (adjusted mean SMOFlipid to Intralipid ratio 1.1, 95% CI 0.8 to 1.6). Infants receiving the Imm-RDI were more likely than Inc-AA infants to have blood urea nitrogen levels > 7 mmol/l [75% vs. 49% (p < 0.01)] and > 10 mmol/l [49% vs. 18% (p < 0.01)]. Furthermore, head circumference at term was smaller in the Imm-RDI group (mean difference –0.8 cm, 95% CI –1.5 to –0.1 cm;p = 0.02). There were no significant differences in any prespecified secondary outcomes, including adiposity, liver function tests, weight, length and mortality.LimitationsNot all eligible babies were available for recruitment, as pharmacy staff trained in clinical trial procedures were unavailable at weekends in three of the four centres. We were able to assess brain volumes in only one-third of participants, as imaging was carried out while the participants were sleeping naturally and we measured primary outcomes first and continued to brain imaging only if the infant remained asleep.ConclusionsImmediate delivery of the recommended daily intake of parenteral amino acids does not benefit body composition or growth to term and may be harmful; SMOFlipid does not affect IHCL content.Future workThe long-term functional outcomes of early administration of RDI of amino acids and the use of SMOFlipid, including neurodevelopment, body composition and metabolic health, should be evaluated.Trial registrationCurrent Controlled Trials ISRCTN29665319 and EudraCT 2009-016731-34.FundingThis project was funded by the Efficacy and Mechanism Evaluation programme, a Medical Research Council and National Institute for Health Research partnership.
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Cohen, Michael R. "PEN Injectors: Technology is not without ImPENding Risks; IV Lipid Emulsion for Bupivacaine Toxicity". Hospital Pharmacy 42, nr 2 (luty 2007): 99–101. http://dx.doi.org/10.1310/hpj4202-99.
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Gupta, Prashant, i Dipti Patel. "A Review on nano-emulsion based gel formulations: emulgel, technology and recent advances". International Journal of Pharmaceutical Sciences and Nanotechnology 15, nr 1 (28.02.2022): 5741–62. http://dx.doi.org/10.37285/ijpsn.2022.15.1.3.
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Dermatological products are being used for treating skin infections and pain /inflammation related disease from ancient times. The topical drug delivery provides many advantages over the other routes of drug administration. Apart from conventional dosage forms like creams, powders, lotions, gels, ointments, researchers are exploring new modifications in the dosage form for improved drug penetrations and enhanced pharmacodynamic activity of poorly absorbed drugs from the skin. Existing topical formulations are associated with the problems like stability, stickiness, irritation, lower spreadability, limited drug permeability and absorption. Formulation of Nano-emulsion based gels (Emulgel) is proved to be prominent approach for overcoming the barriers associated with the conventional dosage forms. Emulgels are prepared by screening oils, surfactant and co-surfactant on the basis of drug solubility. Nano-Emulsion is prepared using suitable techniques and then embedded into the gel matrix for skin application. Drug present in the oil portion in the micelles form (less than 500nm globule size) provides more area for absorption thereby more penetration and therapeutic activity. Emulgel processes desirable properties like greaseless, spreadability, emollient, non-staining, good consistency and improved organoleptic characteristics. Permeations enhancers are also explored for enhancing the penetration of drug incorporated in the Emulgel.
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Mirkovic, Dusica, Mirjana Antunovic, Vesna Putic i Dragana Aleksic. "Stability investigation of total parenteral nutrition admixture prepared in a hospital pharmacy". Vojnosanitetski pregled 65, nr 4 (2008): 286–90. http://dx.doi.org/10.2298/vsp0804286m.
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Background/Aim. In the cases when nutrition of patients can not be orally nor enterally performed, parenteral nutrition is a method of the therapy that provides more successful and rapid recovery. In that way, hospitalization can be significantly shorter, healing costs reduced and mortality minimized. Total parenteral nutrition (TPN) admixtures are the most complex systems which contain amino acids, carbohydrates, lipid emulsion, macroelectrolytes (Na+, K+, Ca2+, Mg2+, Cl-, SO42-, PO43-), oligoelements, hydro- and liposoluble vitamines, heparin, insulin and water. Concerning the mentioned complexity, special attention should be payed to physicochemical and microbiological stability of a mixture, because of interactions among components, that can be very hard to analyze. The aim of this study was to investigate the problem of stability of TPN admixtures prepared in a hospital pharmacy. Methods. Admixture TPN was aseptically prepared in laminar air - flow environment on the basis of the specified order in supplementing components and additives to basic solutions. Solutions were kept in sterile multicompartment ethylene-vinyl-acetate bags. After preparation and slow homogenization, TPN admixtures were submitted to physicochemical and microbiological stability analyses in various period of time. The assessment of physical stability of TPN admixture was done on the basis of visual inspection, determination of pH value and measuring of particle size. The investigation of sterility and pyrogenic test were performed according to Ph. Yug. V regulations. Results. Physico-chemical and microbiological analyses were applied and no significant changes in visual sense, pH value and droplet size stability of the TPN admixture were observed during the period of 60 hours. The lipid droplets were smaller in size than 5 ?m, that is the most common pharmacopoeia requirement. Conclusion. The results of our study confirmed that a TPN admixture prepared in a hospital pharmacy can be stored without stability loss for at least 60 hours.
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PEREIRA, B. R., R. M. M. DE CARVALHO i S. T. CAETANO. "COSMETIC PRODUCTION FROM GLYCERINE THE BIODIESEL". Periódico Tchê Química 15, nr 30 (20.08.2018): 185–92. http://dx.doi.org/10.52571/ptq.v15.n30.2018.188_periodico30_pgs_185_192.pdf.
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The present study aims to produce a cosmetic emulsion containing the co-product glycerine, generated in the production of biodiesel by the transesterification of canola oil. The first part of the work consisted in the production of biodiesel by the transesterification of crude canola oil, using potassium hydroxide as catalyst, with a molar ratio of oil:methanol (1:6) and a temperature of 25 °C. The final reaction mixture had to be washed and filtered to obtain biodiesel, which was characterized and considered within the specifications of the National Oil Agency (ANP). The second step was based on the pre-purification of the glycerine by acid hydrolysis, by the addition of concentrated phosphoric acid/crude glycerin in the 2:3 molar ratio. This step was important to remove impurities such as the catalyst and fatty acids to later use the glycerine in the manipulation of the cream. Finally, the formulations of the Lanette® cream were made, one with the pharmaceutical glycerine other for the pre-purified glycerine of the biodiesel, and comparative tests were made among them, which proved the viability of the pre-purification of the residual glycerine of the biodiesel.
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Jellinek-Cohen, Samantha P., Amanda Tolento i Mary Ann Howland. "Before and after Study of Pharmacists' and Students' Knowledge of Two Novel Antidotes: High-Dose Insulin Euglycemia and Intravenous Fatty Acid Emulsion 20%". Hospital Pharmacy 50, nr 7 (lipiec 2015): 586–600. http://dx.doi.org/10.1310/hpj5007-586.
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Konuspayev, Saparkali, Batiha Kassenova, Zauresh Akhatova i Roza Nurbaeva. "Alkaline hydrolysis of wool fat (lanolin) in a medium of proton and aprotic solvents". Chemical Bulletin of Kazakh National University, nr 1 (30.03.2018): 4–9. http://dx.doi.org/10.15328/cb978.
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The raw material being studied is the woolen fat of the sheep of the Edilbay fine-fleece and Kazakh arkharomeric fine-fleece, which is excreted when washing wool in primary wool processing plants (PWP) in the regions of Kazakhstan, such as Semipalatinsk, Aktyubinsk, Zhambyl and Tokmak. Earlier we obtained anhydrous lanolin from the fat of various factories of the PWP. In both cases, positive results were obtained and a certificate of compliance of anhydrous lanolin FS RK was obtained. In terms of its chemical composition, wool fat is a mixture of C10-C16 carboxylic acid esters with aliphatic, terpenic, triterpene and sterol alcohols. It also contains vitamins, proteins, sterols and other physiologically active compounds. In the hydrolysis of wool fat, a mixture of sterol alcohols, triterpene alcohols and fatty acid salts are assumed. Valuable among them are sterol alcohols, which constitute up to 29% of the sum of all alcohols. Cholesterol and its derivatives are the raw materials for the synthesis of steroid drugs. Salts of fatty acids are used as an emulsifier in pharmacy and cosmetology. The aim of this paper is to complete the saponification of wool fat and the separation of a mixture of sterol alcohols. We show the patterns of alkaline hydrolysis of wool fat in the liquid phase in the presence of mixtures of various solvents. As a solvent, the ethanol-water, isopropanol-water system in which wool fat is only partially dissolved has been studied. In the wool fat-alcohol-water-NaOH system, a stable emulsion is formed. Ways that prevent the formation of an emulsion are proposed.
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Tomczak, Szymon, Maciej Chmielewski, Jagoda Szkudlarek i Anna Jelińska. "Antiemetic Drugs Compatibility Evaluation with Paediatric Parenteral Nutrition Admixtures". Pharmaceutics 15, nr 8 (15.08.2023): 2143. http://dx.doi.org/10.3390/pharmaceutics15082143.
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Chemotherapy-induced nausea and vomiting are defined as the most common of side effects of treatment and, at the same time, are very difficult to accept for patients’, frequently causing changes in the therapy regimen, significantly reducing its effectiveness. Thus, an antiemetic prophylactic is essential to the provision of such a therapy for the patient. Pharmacotherapy often includes various drugs, including antiemetics, with the administration of such drugs by injection through two separate catheters being the preferred method. However, the co-administration of drugs and parenteral nutrition admixtures (PNAs) requires the consideration of compatibility, stability and potential negative interactions. To meet the purposes of clinical pharmacy, a compatibility test of ondansetron, dexamethasone and hydrocortisone with paediatric PNAs was conducted. PNAs differ in the composition of amino acid source (Primene® or Aminoplasmal Paed® 10%) and the type of injectable lipid emulsion (Lipidem® 200 mg/mL, Clinoleic® 20%, SMOFlipid® 200 mg/mL, Intralipid® 20%). An in vitro evaluation was performed in a static way as a simulated co-administration through a Y-site. The drug PNA ratios were determined based on the extreme infusion rates contained in the characteristics of medicinal products. All calculations were performed for a hypothetical patient aged 7 years weighing 24 kg. As a result of this study, it can be concluded that all tested PNAs showed the required stability in the range of parameters such as pH, osmolality, turbidity, zeta potential, MDD and homogeneity. The co-administration of antiemetic drugs does not adversely affect lipid emulsion stability. This combination was consistently compatible during the evaluation period.
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Shmalko, O. O., i L. A. Bodnar. "The substantiation of the composition and technology of obtaining a microemulsion in laboratory conditions for pediatric use". News of Pharmacy 107, nr 1 (20.03.2024): 34–41. http://dx.doi.org/10.24959/nphj.24.138.
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Aim. To substantiate the composition and parameters of the technological process of obtaining a microemulsion with the essential oil of common fennel fruit for pediatric use. Materials and methods. The study objects were experimental samples of an emulsion with fennel essential oil (active pharmaceutical ingredient), acacia, xanthan and guar gums, soy lecithin, PEG-40 hydrogenated castor oil, PEG-100 stearate, glycerin monostearate, polysorbate-80 (emulsifiers) and purified water. Information-search, information-analytical, organoleptic, physicochemical, rheological and pharmacotechnological research methods were used. The rheological parameters were determined on a “Reotest-2” rotary viscometer (Germany) with coaxial cylinders, pH was measured potentiometrically on a pH‒150 MI pH-meter (Khimtest Ukraine+), thermal stability was determined in a SP50 drying cabinet. The microscopic studies of experimental emulsion samples were carried out using a Granum microscope with a Toupcam UCMOS video camera. The statistical processing of the data obtained was performed using Microsoft Excel 2007 spreadsheets. Results and discussion. The composition and technology of obtaining a microemulsion with the essential oil of fennel fruit in the conditions of a pharmacy for pediatric use were experimentally substantiated. The technological process consisted of the following stages: preparatory work, weighing of ingredients, mixing of ingredients, packaging, and registration of the drug for dispensing. The drug was manufactured in aseptic conditions. Standardization of the drug obtained was carried out: description, thermal and colloidal stability, pH value, viscosity, uniformity of the mass of doses extracted from multi-dose containers, mass of the contents of the container. The presence of anethole and terpenoids was proven by TLC method. Conclusions. At the current level of development of the pharmaceutical industry, the improvement of providing consumers with high-quality medicines is implemented by choosing the optimal dosage form, the composition of excipients, rational technology, and the use of modern equipment.
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KLASNER, Georgy Georgievich, i Alexandr Maximovich SPIRIDONOV. "EXPERIMENTAL STUDY OF THE YIELD OF SOY PROTEIN IN THE EXTRACTANT WHILE THE ABRASION-RESISTANT SOYBEANS IN SOAKED FORM". Periódico Tchê Química 17, nr 36 (20.12.2020): 1061–74. http://dx.doi.org/10.52571/ptq.v17.n36.2020.1076_periodico36_pgs_1061_1074.pdf.
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Nowadays, every farmer is faced with the task of providing their livestock with high-quality food that will contribute to their rapid growth and health. It is also common knowledge that large farms have more opportunities to implement their projects and put new technologies and gadgets into operation. The presented device makes it possible to obtain a product of processing soy grain into soy milk, soy cheese "tofu", soy protein base for preparing feed for farm animals and poultry in small farms. This article explains the experimental method for finding the optimal values of the speed of rotation of the movable disk, the temperature of the extractant, the gap between the movable and stationary disks of the shredder, and the ratio of the hydromodule. Optimal values are those that contribute to the maximum protein yield. Experimental factors: ambient temperature from 17°C to 22 °C, barometric pressure from 93325 PA to 96658 PA, relative humidity from 65% to 85%. Protein extraction in an emulsion is based on the physical and chemical properties of the diffusion of dissolved organic compounds, with water as the extractant. As a result, methods have been found for the effective production of protein from soy grains, which can increase the yield of the suspension to 24-28 Gr. This is the most productive way to produce protein for feed modification using this device.
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De la Paz, Nilia, Dania Pérez, Mirna Fernández, Dulce M. Soler, Yanet Rodríguez i Antonio Nogueira. "Physical stability of emulsion and hydrophilic gels with chitosan and chitosan acetate". Journal of Pharmacy & Pharmacognosy Research 5, nr 1 (1.01.2017): 288–300. http://dx.doi.org/10.56499/jppres17.235_5.5.288.
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Context: Chitosan has received great attention because it is a functional, biodegradable, renewable and non-toxic biopolymer with multiple pharmaceutical applications, including stabilizing agent. Aims: To evaluate the physical stability of emulsified bases and hydrophilic gels containing chitosan or chitosan acetate as stabilizing agents. Methods: Stability of shelf-life formulations at room temperature and in refrigeration was evaluated over a period of 60 days and by thermal stress testing and centrifugal destabilization. The organoleptic characteristics, pH, conductivity and flow behavior were evaluated, the latter through the analysis of the rheograms, the determination of rheological parameters (consistency index, apparent viscosity, creep value and flow index), as well as their comparison statistics. The possible correlations between these parameters and the concentration of the biopolymers were also evaluated. Results: The bases elaborated with chitosan or its soluble derivative showed adequate physical stability during the study time. The effect of the storage temperature, as well as the type and concentration of the stabilizing agent used was evidenced. Emulsifier combinations provided less stability. A linear correlation between the rheological parameters and the biopolymer concentration was evidenced. Conclusions: Chitosan and chitosan acetate can be used as emulsifying agents in semi-solid and gelling bases in hydrophilic gels, due to the electrostatic stabilization and the viscosity they contribute to the system in relation to its concentration.
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Ibrahim, Sani, Misni Misran i Yin Teo. "Synthesis and physicochemical characterization of methacrylic acid modified Arabic gum microgel as potential drug carrier". Journal of the Serbian Chemical Society, nr 00 (2022): 15. http://dx.doi.org/10.2298/jsc210909015d.
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Carbohydrate polymers microgels are non-toxic and biocompatible which can be readily used in applications such as drug delivery, medicine, and pharmacy. This work synthesized Arabic gum (AG) microgel and methacrylic acid modified Arabic gum microgel (AGMAA) via water in oil emulsion polymerization technique using Tween 20 as surfactant and hexane as the solvent. The microgels were characterized using various physicochemical analysis such as Fourier Transform Infrared spectroscopy, thermal stability using Differential Scanning Calorimetry, diffraction pattern analysis using X-Ray Diffraction, morphology observation using Field Emission Scanning Electron Microscope and zetasizer was used to analyze the size and zeta potential. The rate of deformation was higher in AG microgel compared to the AGMAA microgel. The particle size and zeta potential of AGMAA microgel were found larger and more negative than AG microgel, respectively. The microgels particle size and zeta potentials were found dependent on the amount of methacrylic acid as the modifying agents. The microgels were encapsulated with doxorubicin through the swelling method and the in-vitro release was studied in medium with pH 4.2 and 7.4. The results suggest the potentials of these microgels for drugs delivery.
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Kozlowska, Justyna, Weronika Prus-Walendziak, Natalia Stachowiak, Anna Bajek, Lukasz Kazmierski i Bartosz Tylkowski. "Modification of Collagen/Gelatin/Hydroxyethyl Cellulose-Based Materials by Addition of Herbal Extract-Loaded Microspheres Made from Gellan Gum and Xanthan Gum". Materials 13, nr 16 (8.08.2020): 3507. http://dx.doi.org/10.3390/ma13163507.
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Because consumers are nowadays focused on their health and appearance, natural ingredients and their novel delivery systems are one of the most developing fields of pharmacy, medicine, and cosmetics. The main goal of this study was to design, prepare, and characterize composite materials obtained by incorporation of microspheres into the porous polymer materials consisting of collagen, gelatin, and hydroxyethyl cellulose. Microspheres, based on gellan gum and xanthan gum with encapsulated Calendula officinalis flower extract, were produced by two methods: extrusion and emulsification. The release profile of the extract from both types of microspheres was compared. Then, obtained microparticles were incorporated into polymeric materials with a porous structure. This modification had an influence on porosity, density, swelling properties, mechanical properties, and stability of materials. Besides, in vitro tests were performed using mouse fibroblasts. Cell viability was assessed with the MTT (3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide) assay. The obtained materials, especially with microspheres prepared by emulsion method, can be potentially helpful when designing cosmetic forms because they were made from safely for skin ingredients used in this industry and the herbal extract was successfully encapsulated into microparticles.
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Ningsih, Indah Yulia, Dewi Dianasari i Mochammad Amrun Hidayat. "Morphology and physicochemical properties of starch extracted from Indonesian ginger". Pharmacy Education 23, nr 2 (15.05.2023): 47–52. http://dx.doi.org/10.46542/pe.2023.232.4752.
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Background: Starch of ginger (Zingiber officinale) is potentially developed as a pharmaceutical excipient of dosage forms. In Indonesia, there are three varieties of ginger, namely Z. officinale var. Roscoe, Z. officinale var. Amarum, and Z. officinale var. Rubrum. Objective: To characterise the morphology and physicochemical properties of starches from the three ginger varieties. Method: The morphology of ginger starch was characterised using a light microscope and Scanning Electron Microscope (SEM). Physicochemical properties were determined using several methods from previous studies. Result: Starch granules of three ginger varieties were elliptical and showed an eccentric hilum with lamella. Starch of Z. officinale var. Amarum (SZA) had enormous size and led the highest swelling power, solubility, density, emulsion capacity, and moisture content. Starch of Z. officinale var. Roscoe (SZRo) had a more acidic pH (6.44 ± 0.02) without foaming capacity. SZA and SZRo had higher browning temperatures, lower gelatinised temperatures, and water absorption. Starch of Z. officinale var. Rubrum (SZRu) exhibited the highest charring temperature (279.00 ± 1.00 °C). Particle size distribution of all starches showed that more than 98% of particles had less than 179 µm in size. Conclusion: Ginger starch can be potentially developed as an excipient of pharmaceutical dosage forms in an optimum formula.
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Moinard-Checot, D., Y. Chevalier, S. Briançon, H. Fessi i S. Guinebretière. "Nanoparticles for Drug Delivery: Review of the Formulation and Process Difficulties Illustrated by the Emulsion-Diffusion Process". Journal of Nanoscience and Nanotechnology 6, nr 9 (1.09.2006): 2664–81. http://dx.doi.org/10.1166/jnn.2006.479.
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The elaboration of nanoparticles aqueous suspensions aimed at the drug delivery and related process development appear as difficult tasks, due to specificities related to the nanometric size. Such small sizes are required for specific applications in pharmacy. The switch of micrometric to nanometric field represents an actual challenge and cannot be considered as a simple scaling-down of chemical engineers. Ideas and concepts developed first in nanosciences have been adapted to the pharmaceutical application in drug delivery. In spite of drastic constraints due to pharmaceutical application, some parameters allow the control. A brief and not exhaustive review of the state-of-the-art on polymer particles used in the drug delivery field is presented. Attention was more particularly paid on preparation processes and their constraints by describing advantages and drawbacks of each process. The adaptation to the pharmaceutical field, the difficulties and pitfalls which are shared, with most research works in nanoscience, are illustrated thanks to our own results on nanocapsules obtained by "emulsion-diffusion" process presented as a case-study. Thanks to these results, we illustrate the peculiar features and difficulties encountered regarding nanocapsules preparation and characterization. Indeed, such a process allows to prepare nanocapsules of few hundreds nanometers diameter having an oil core surrounded by a polymeric membrane. The characterization of such soft particles colloidal suspensions is often difficult and involves heavy investigation techniques in order to highlight physical mechanisms leading to the nanocapsule properties. This is a key step regarding the final properties as a drug delivery system.
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Öztürk, A. Alper, Nur İlge Çinar i Evrim Yenilmez. "Development of nano-sized ketoprofen lysine incorporated Eudragit® S100 nanomedicine by double emulsion solvent evaporation and in vitro characterization". Journal of Pharmacy & Pharmacognosy Research 7, nr 1 (1.01.2019): 47–58. http://dx.doi.org/10.56499/jppres18.447_7.1.47.
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Context: Pain has a very important effect on the biological, psychological, sociological and economic situation of a patient. Nanoparticles (NPs) are being extensively investigated as drug delivery systems worldwide for pharmaceutical applications. Aims: To design and compare the release characteristics of sustained-release formulations of ketoprofen lysine (KL) NPs. Methods: KL-Eudragit® S100 NPs were produced by double emulsion solvent evaporation method. The physicochemical characteristics of NPs were studied. Results: Particle size of NPs prepared was in the range of 99 and 141 nm. Encapsulation efficiency (%) was obtained (76%) for NP formulations prepared. Weibull models were determined to be the most appropriate kinetic models for NP containing KL. KL-loaded NPs demonstrated nanostructural character and NPs showed extended release of KL. Conclusions: NPs developed were found to be stable and representing a promising system for sustained delivery of KL.
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Katsai, O. G., V. V. Prokhorov, G. S. Grigorieva i Yu M. Krasnopolsky. "Development and validation of the method for determination of encapsulation efficiency of cytochrome c in liposomes". Farmatsevtychnyi zhurnal, nr 5 (14.08.2018): 69–75. http://dx.doi.org/10.32352/0367-3057.5.16.05.
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A strategic pathway in creating high-potent medical products is with targeted therapeutic systems that are based on nanoparticles of various structure. Such particles are capable of providing a targeted effect and an increase in bioavailability of the medical products. A special place among modern targeted drug delivery systems is held by liposomal nanoparticles which have apparent advantages over nanoparticles of an another type The problem number one for pharmacy lies in developing specific methods of control of nanosize drug delivery systems.
This research is dedicated to the development and validation of a technique for determining encapsulation efficiency of cytochrome C in liposomes.
The subject of research comprised the obtained liposomal form of cytochrome C, placebo emulsion, and cytochrome C solution. The research was conducted in compliance with the ICH and FDA requirements and recommendations in relation to the development of HPLC methods of control of liposomal preparations.
A method has been developed to enable the determination of encapsulation efficiency of cytochrome C in liposomal preparations and to allow for identifying the composition of liposomal nanoparticles of cytochrome C. This HPLC method has been validated in terms of specificity, limit of detection, and robustness in compliance with the recommended criteria. The technique may find its application in quality control of liposomal form of cytochrome C and in control points manufacturing process.
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Visco, Denise M., Laura H. Hendrix, Lucille Sun, Iris Tam, Marian Macsai i Andrea A. Gibson. "Matching-adjusted indirect comparison of phase 3 clinical trial outcomes: OC-01 (varenicline solution) nasal spray and cyclosporine a 0.05% ophthalmic emulsion for the treatment of dry eye disease". Journal of Managed Care & Specialty Pharmacy 28, nr 8 (sierpień 2022): 892–902. http://dx.doi.org/10.18553/jmcp.2022.22005.
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SALES, J. B. R., E. J. A. OLIVEIRA, D. M. A. F. NAVARRO, L. B. AMORIM i S. S. F. B. RODRIGUES. "POPULATION STUDY OF THE AEDES AEGYPTI MOSQUITO AND MEASURES OF INTERVENTION IN THE FIELD WITH USE OF ESSENTIAL OIL OF CROTON RHAMNIFOLIOIDES WITH DETERRENT EFFECT". Periódico Tchê Química 16, nr 32 (20.08.2019): 1017–28. http://dx.doi.org/10.52571/ptq.v16.n32.2019.1034_periodico32_pgs_1017_1028.pdf.
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The control of the mosquito from larvicides has been the most used form in the prevention of diseases, however, populations of Aedes spp. have become resistant to these compounds, requiring more efficient and less aggressive forms of control to the environment. The objective of this work was to carry out a mosquito population study and to test the efficiency in Croton rhamnifolioides essential oil field as an oviposition deterrent in 30 traps installed in the Várzea-Recife cemetery. The traps were randomly divided into two groups, using 15 test traps containing essential oil and another 15 for control. The essential oil was obtained by hydrodistillation with a content varying from 0.58% to 1.4% (w/w) and its chemical constituents identified by gas chromatography coupled with mass spectrometry, presenting 1,8-cineol (16.57% ) and (E) -Caryophyllene (11.32%) as major constituents. The test of deterrence was repeated 25 times over a period of 12 months. The oil was used at a concentration of 100 μg · mL-1. The detergency response to oviposition was evaluated by counting and comparing the number of eggs placed in each set of traps. As results, 110,157 eggs were collected, presenting an infestation index of 99.8%. Of the 2,964 larvae analyzed, 96% were A. aegypti and only 4% A. albopictus. The oviposition delayed effect was observed in 17 (68%) of the 25 analyzed cycles, with ovitraps with oil showing a quantity of eggs 39% smaller than the number found in the control ovitrampas. The T-student test showed significant difference between test and control ovitrampas (p 0.002). It was concluded that the Várzea cemetery had a high rate of infestation of Aedes spp. and that the essential oil emulsion tested had deterrent power, despite the adverse conditions encountered in the field and the volatility of essential oil. It is recommended, however, additional studies aiming at enhancing its deterrent oviposition power in the field.
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Gyan, Emmanuel, Arnaud Pigneux, Mathilde Hunault-Berger, Pierre Peterlin, Martin Carre, Jacques-Olivier Bay, Caroline Bonmati i in. "Adjunction of a Fish Oil Emulsion to Cytarabine and Daunorubicin Induction Chemotherapy in High-Risk AML. the Famyly Pilot Study from the French Innovative Leukemia Organization (FILO)". Blood 136, Supplement 1 (5.11.2020): 34. http://dx.doi.org/10.1182/blood-2020-137210.
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Background. Acute myeloid leukemia (AML) with unfavorable cytogenetics remains a therapeutic challenge. We previously established that ex vivo exposure of AML blasts to eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA) or fish oil emulsion (FO) induces Nrf2 pathway activation, metabolic switch and cell death (Picou et al., Pharmacol Res 2018;136:45-55). Objectives. The FILO group launched a pilot clinical study to evaluate the feasibility, safety and efficacy of the adjunction of a commercial FO emulsion (OMEGAVEN) to 3+7 in untreated AML with unfavorable cytogenetics. Patients and methods. The FAMYLY trial was a multicenter single-arm phase II study. Eligible patients had a diagnosis of untreated AML with unfavorable cytogenetics, 18 years old or above. For patients with WBC < 30 G/L, FO was administered at 2 mL/kg/d IV 2 days before 3+7 induction chemotherapy (daunorubicin 60 mg/m² days 1-3 and cytarabine 200 mg/m²/d as a continuous infusion days 1-7), until day 7 of induction. For patients with WBC >= 30 G/L, FO and 3+7 were started concomitantly, and FO was administered until day 9. The primary objective was complete response (CR) on the BM aspirate at the end of induction. Data from 75 patients with adverse cytogenetics and treated with daunorubicin and cytarabine in LAM2001 study (Lioure et al., Blood 2012) was used as a historical control. Serial blood samples were collected before treatment, and on days 1 and 3 after start of treatment, to evaluate the expression of NRF-2 target genes and antioxidant enzymes by RT-qPCR. Results. Thirty patients were included. The median age was 54 years (range: 30-64 years), and only 3 patients were hyperleukocytic. FO administration raised the plasma levels of EPA and DHA (p<0.05). The Cmax of daunorubicin was 92.2 µg/L (Q1; Q3: 44.8; 105.1), and the AUCꚙ 414.9 ng.h, representing a mean clearance Cl=358.5 mL/h and a half-life T1/2=3.5h. The cytarabine clearance was highly variable with a mean of 1.628 L/h. A historical comparison to the LAM2001 trial found no unexpected toxicity. The CR rate was 76%, similar to the daunorubicin arm of the previous study in patients with unfavorable cytogenetics (72%). No survival improvement was observed in a historical comparison. RT-qPCR analysis of NRF-2 target genes and antioxidant enzymes (particularly HMOX1 and NQO1) in sequential blood samples did not show a significant in vivo response. Conclusions. Altogether, FO emulsion adjunction to 3+7 is feasible and safe. Although CR rate improvement was not shown in this cohort of high-risk patients, further research aiming at finding the sufficient dose to trigger an NRF-2 response in vivo should be considered. ClinicalTrials.gov identifier: NCT01999413. Disclosures No relevant conflicts of interest to declare. OffLabel Disclosure: OMEGAVEN (fish oil emulsion) in Acute Myeloid Leukemia