The aim of the research was to investigate the rheological behaviour of hydroxyethyl cellulose gels, which are used in the development of the composition and technology of the medicine with anti-inflammatory activity. The objects of research were hydroxyethyl cellulose gels in the concentration of 1.0%; 1.5%; 2.0%; 2.5% and 3.0%. Investigation of the rheological behavior of HEC gels (structural and mechanical properties) was performed using the Rheolab QC rheometer from Anton Paar (Austria) using the C-CC27 / SS Coaxial Cylinder System. The obtained results showed that excipients influence on the rheological behaviour in the following way: propylene glycol and polyethylene oxide 400 reduce rheoparameters, while PEG 40 hydrogenated castor oil increases these parameters. The further study of the rheological properties in comparison with medicines “Troxerutin” and “Thiotriazolinum” showed that the developed gel fully corresponds to technological and consumer requirements.
One of the important issues in the pharmaceutical development of a semisolid preparation for dermal use is the scientific and experimental justification for choosing the base-carrier of active substances. The aim of this study was to experimentally substantiate the choice of rational combination of excipients in the development of a semisolid dosage form with a probiotic component for use in dermatology. Materials and methods. Hydrophilic gelling agents were used as excipients in the study: Sepiplus 400, Aristoflex AVC, Carbopol 934, hydroxyethylcellulose HEC, sodium alginate. Physical and chemical, pharmaco-technological and microbiological methods were used to select the optimal basis. Colloidal stability was determined using a laboratory centrifuge at a speed of 6000 rpm for 5 min, an electronic thermometer and a water bath laboratory. Thermostability was determined in the thermostat at (40±2) °C for 24 hours. Investigation of the rheological properties of the samples was performed using a Rheolab QC (Anton Paar, Austria) rheoviscometer using a system of coaxial cylinders C-CC27/SS. The kinetics of water absorption of the samples were studied by dialysis through a semipermeable Cuprophan membrane, Type 150 pm at a temperature of (34±2) °C. The number of viable lactobacilli cells was determined by surface seeding on Petri dishes with dense MRS medium. Research results. The results of the study of the number of viable lactobacilli cells showed that the lowest number of viable cells was in sample based on HEC. Tests for thermostability and colloidal stability showed that for sample No. 5 based on sodium alginate, stratification was observed in the experiment, which indicates its instability. These samples were excluded. Samples on Sepiplus 400 and Aristoflex AVC on a set of rheological features have advantages both consumer and technological; and sample on t Aristoflex AVC has the best indicators of osmotic activity and the viability of cells in the dynamics for this study. Conclusions. As a result of physical and chemical (organoleptic, colloidal and thermostability), pharmaco-technological (osmotic and structural and mechanical properties) and microbiological studies (number of viable lactobacilli cells) studies it was found that further work should be carried out with a sample based on gelling agent Aristoflex AVC, which has the most optimal performance in this development for a semisolid dosage form with a probiotic component for use in dermatology
Национальный фармацевтический университет, г. Харьков, Украина A-концепция и дизайн исследования; B-сбор данных; C-анализ и интерпретация данных; D-написание статьи; E-редактирование статьи; F-окончательное утверждение статьи Цель работы-учитывая широкий ассортимент карбомеров, технологий их изготовления, систем растворителей для синтеза, расхождений в наименовании и нормативном регулировании, возникает необходимость в систематизации этой группы вспомогательных веществ для фармацевтической и косметической промышленности. Материалы и методы. В качестве материалов использовали данные официальных сайтов МЗ Украины, FDA и Lubrizol; фармакопеи США (USP/NF), Европы (Ph. Eur) и Японии (JPE); научные публикации. Использовали методы информационного поиска, систематизации теоретического и практического материала. Результаты. В результате изучения официальной нормативной документации установлено, что фармакопея США (USP/NF) содержит монографии под названием «Carbomer Copolymer», «Carbomer Interpolymer» и «Carbomer Homopolymer», которые классифицируются на типы А, В, С, для полимеров, синтезированных без использования бензола, и монографии «Carbomer 934», «Carbomer 934Р», «Carbomer 940», «Carbomer 941», «Carbomer 1342» для полимеров, синтезированных с использованием бензола. Фармакопея Европы (Ph. Eur) содержит монографию «Carbomers» общего характера, требованиям которой отвечают только полимеры «Carbomer Homopolymer» по USP/NF, синтезированные без использования бензола. Фармакопея Японии (JPE) содержит монографию «Carboxyvinyl Polymer», которая включает карбомеры, синтезированные как с использованием бензола, так и без. При использовании карбомеров в фармацевтической разработке лекарственных средств в регистрационных материалах следует предоставлять результаты дополнительных исследований о соответствии качества фармакопейным показателям.
Every year there is an increase in the number of cases of hypersensitivity to bites from various insects. A local allergic reaction to bites occurs within a few minutes and is accompanied by acute pain at the site of the bite, severe itching, hyperemia, the appearance of papules, tissue edema, and sometimes a small-point rash around. Considering the small number of drugs for local therapy of allergic manifestations and the unidirectional nature of their action, it is urgent to develop a drug containing the antihistamine dimethindene maleate and dexpanthenol, which plays the role of an anti-inflammatory, reparative and dermatoprotective substance. The aim. The aim of the study is to substantiate the delivery system of dimethindene maleate and dexpanthenol based on biopharmaceutical and rheometric research methods. Materials and methods. To determine the component composition of the active ingredient delivery system, the type of dimetindene maleate administration was substantiated by studying its solubility. As a delivery system for active pharmaceutical ingredients, hydrogels were considered, which were made using high-molecular compounds of various origins: a natural substance – xanthan gum, a semi-synthetic substance – gyroxypropyl methylcellulose, and a synthetic substance – carbomer. The rate of release of dimethindene maleate from hydrogels was estimated by studying the kinetics of release through a semipermeable membrane. The assessment of the viscoelastic properties of hydrogels was carried out by performing an oscillatory rheometry test, which makes it possible to quantitatively determine the viscous and elastic components, as well as to characterize the bioadhesive properties. Results. Based on the results of studying the solubility of dimethindene maleate in hydrophilic non-aqueous solvents, it was determined that propylene glycol is optimal for ensuring the introduction of a substance into hydrogel bases as a solution. As a result of studying the kinetics of the release of dimethindene maleate from hydrogels, it was found that the use of carbomer as a delivery system provides the release of 28.33 % of dimethindene maleate, xanthan gum – 25 %, hydroxypropyl methylcellulose – 7.33 %. When studying the viscoelastic properties by determining the values of the storage modulus G', the loss modulus G" and the damping (attenuation) factor tg δ, it was found that the carbomer-based hydrogel is a viscoelastic solid, the xanthan gum and hydroxypropyl methylcellulose-based hydrogels are a viscoelastic liquid. Bioadhesion on the surface of the skin during use has the advantage of carbomer hydrogel. Conclusions. Based on the combination of biopharmaceutical and rheometric methods for substantiating the composition of the delivery system for dimetindene maleate and dexpanthenol, it is rational to use carbomer for further pharmacological and microbiological studies
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