Gel with Ectoine improves wound healing on a thermal burn model in rats

Due to the ability to create complexes of water molecules on the surface of the mucous membrane, ectoine is a promising compound for the treatment of burns. Evaluate the reparative activity of Ectoine using the thermal burn model in rats. In male rats (n=30), 2 thermal burns were counteracted under counter-anesthesia, one of which was treated by topical application of the test drugs for 7 days, and the other served as a contro

Interchangeability of Essential Phospholipid Products

A significant share of the hepatoprotectors pharmaceutical market is represented by innovator and generic products containing essential phospholipids. One of the main issues in pharmacotherapy is confirmation of similarity between reference and generic products, which helps to assess their interchangeability. Therefore, it seems relevant to conduct comparative studies examining the products’ formulations (content of active pharmaceutical ingredients and excipients), dosage forms and routes of administration to identify characteristics that can affect interchangeability of essential phospholipid products. The objective of the study was to analyse interchangeability of generic and reference hepatoprotectors containing essential phospholipids. The nomenclature of essential phospholipids (oral (capsules), parenteral (solution for intravenous infusion and lyophilisate for solution for intravenous infusion), and topical (gel for cutaneous use) dosage forms) is given in accordance with the State Register of Medicinal Products, information storage and retrieval systems, and library databases (eLibrary, PubMed, CyberLeninka, ResearchGate).There was a significant difference in the content of phosphatidylcholine (29—93 %) in phospholipid substances produced by different manufacturers; minor differences were found in the quantitative composition of excipients in solutions, and significant differences were observed in the composition and quantities of excipients in capsules, which is most likely attributed to different production methods. The obtained data may be used to optimise pharmaceutical development and assess interchangeability of essential phospholipid products

Effects of bischofite gel on reparative processes in wound healing

The study showed that the best results were obtained with external use of the gel with bischofite. Actovegin has a less significant but pronounced reparative effect on this model. The least satisfactory results were obtained when applying Contractube

Investigação do efeito reparador do gel de ectoína em modelo de queima térmica

Due to the ability to create complexes of water molecules on the surface of the mucous membrane, ectoine is a promising compound for the treatment of burns. In male rats (n=30), 2 thermal burns were counteracted under counter-anesthesia, one of which was treated by topical application of the test drugs for 7 days, and the other served as a control. On the 8th day, skin samples in the area of the burn were taken for morphological examination. Histological sections were then scored by independent experts. The best histological picture of thermally damaged tissues was demonstrated by animals receiving ectoine. A less significant, but pronounced reparative effect was observed in histological samples of the actovegin group. The least significant reparative effect was demonstrated by contractubex. Ectoine improved the histological picture, improved repair and reduced the inflammatory response of the tissues and can be recommended for further preclinical studies as a treatment for burns.Debido a la capacidad de crear complejos de moléculas de agua en la superficie de la membrana mucosa, la ectoina es un compuesto prometedor para el tratamiento de las quemaduras. En ratas macho (n = 30), 2 quemaduras térmicas se contrarrestaron con contraestesia, una de las cuales se trató mediante la aplicación tópica de los fármacos de prueba durante 7 días, y la otra sirvió como control. En el octavo día, se tomaron muestras de piel en el área de la quemadura para un examen morfológico. Las secciones histológicas fueron calificadas por expertos independientes. El mejor cuadro histológico de los tejidos dañados térmicamente fue demostrado por los animales que recibieron ectoína. Se observó un efecto reparador menos significativo, pero pronunciado en muestras histológicas del grupo actovegin. El efecto reparador menos significativo fue demostrado por contractubex. Ectoine mejoró el cuadro histológico, mejoró la reparación y redujo la respuesta inflamatoria de los tejidos y puede recomendarse para estudios preclínicos adicionales como tratamiento para las quemaduras.Devido à capacidade de criar complexos de moléculas de água na superfície da membrana mucosa, a ectoína é um composto promissor para o tratamento de queimaduras. Em ratos machos (n = 30), duas queimaduras térmicas foram combatidas sob anestesia, uma das quais foi tratada por aplicação tópica das drogas de teste por 7 dias, e a outra serviu como controle. No oitavo dia, amostras de pele na área da queimadura foram retiradas para exame morfológico. As secções histológicas foram então classificadas por especialistas independentes. O melhor quadro histológico dos tecidos termicamente lesados foi demonstrado pelos animais que receberam ectoína. Um efeito reparador menos significativo, mas pronunciado, foi observado em amostras histológicas do grupo da actovegina. O efeito reparador menos significativo foi demonstrado pelo contratoubex. Ectoine melhorou o quadro histológico, melhorou o reparo e reduziu a resposta inflamatória dos tecidos e pode ser recomendado para estudos pré-clínicos adicionais como tratamento para queimaduras

Взаимозаменяемость препаратов на основе эссенциальных фосфолипидов

A significant share of the hepatoprotectors pharmaceutical market is represented by innovator and generic products containing essential phospholipids. One of the main issues in pharmacotherapy is confirmation of similarity between reference and generic products, which helps to assess their interchangeability. Therefore, it seems relevant to conduct comparative studies examining the products’ formulations (content of active pharmaceutical ingredients and excipients), dosage forms and routes of administration to identify characteristics that can affect interchangeability of essential phospholipid products. The objective of the study was to analyse interchangeability of generic and reference hepatoprotectors containing essential phospholipids. The nomenclature of essential phospholipids (oral (capsules), parenteral (solution for intravenous infusion and lyophilisate for solution for intravenous infusion), and topical (gel for cutaneous use) dosage forms) is given in accordance with the State Register of Medicinal Products, information storage and retrieval systems, and library databases (eLibrary, PubMed, CyberLeninka, ResearchGate).There was a significant difference in the content of phosphatidylcholine (29—93 %) in phospholipid substances produced by different manufacturers; minor differences were found in the quantitative composition of excipients in solutions, and significant differences were observed in the composition and quantities of excipients in capsules, which is most likely attributed to different production methods. The obtained data may be used to optimise pharmaceutical development and assess interchangeability of essential phospholipid products.Значительная доля фармацевтического рынка гепатопротекторов представлена референтными и воспроизведенными препаратами, содержащими эссенциальные фосфолипиды (ЭФ). Одним из основных вопросов фармакотерапии является доказательство идентичности референтного и воспроизведенного препаратов для оценки их взаимозаменяемости, поэтому представляется актуальным проведение сравнительных исследований состава препаратов (содержания действующих и вспомогательных веществ), лекарственной формы и способов введения для выявления показателей, влияющих на взаимозаменяемость препаратов на основе ЭФ. Цель работы — анализ взаимозаменяемости воспроизведенных и референтных гепатопротекторов, содержащих ЭФ. В обзоре представлена номенклатура ЭФ (формы для приема внутрь (капсулы), парентерального введения (раствор для внутривенного введения и лиофилизат для приготовления раствора для внутривенного введения) и местного применения (гель для наружного применения)) в соответствии с данными Государственного реестра лекарственных средств, поисково-информационных и библиотечных баз данных (eLibrary, PubMed, CyberLeninka, ResearchGate). Выявлены значительные различия содержания фосфатидилхолина (29—93 %) в субстанциях фосфолипидов различных производителей, установлены несущественные различия в количественном составе вспомогательных веществ в растворах и значительные отличия в составе и количественном содержании вспомогательных веществ в капсулах, что может быть связано с различной технологией производства. Представленные данные могут быть использованы для оптимизации фармацевтической разработки и оценки взаимозаменяемости лекарственных препаратов ЭФ

Взаимозаменяемость лекарственных препаратов флуконазола

Fluconazole – an antifungal agent belonging to the chemical class of triazole derivatives – is represented in the Russian pharmaceutical market by a large number of generic drugs. An important issue of rational pharmacotherapy is the demonstration of the reference and generic drugs’ equivalence with the aim of assessing their interchangeability. Therefore, the aim of this study was to analyse fluconazole drug dosage forms and routes of administration, as well as qualitative and quantitative composition of active substances and excipients in order to identify characteristics that may affect interchangeability. The analysis of the nomenclature and composition of fluconazole drugs was carried out based on the data contained in the National Register of Medicinal Products of the Russian Federation and the Reference Book of Medicines®. It was shown that the current nomenclature of fluconazole drugs includes the following types of products: for parenteral use, internal use, and topical use. The generic fluconazole drugs in the form of capsules differ from the reference Diflucan® in excipients, shelf life, and packaging. The fluconazole substance has a number of specific features, i.e. the presence of polymorphic modifications, their specific characteristics, and the influence of the process parameters and storage on their stability. It was revealed that in many cases the production of fluconazole capsules involved the use of substances purchased from two or more suppliers, which may lead to changes in quality and bioavailability during storage. The obtained data can be used in the future for optimisation of pharmaceutical development and evaluation of interchangeability of fluconazole drugs.В настоящее время препарат флуконазол, противогрибковое средство из группы производных триазола, представлен на российском фармацевтическом рынке большим количеством воспроизведенных препаратов. Важным вопросом рациональной фармакотерапии является доказательство идентичности референтного лекарственного препарата и воспроизведенного, с целью оценки взаимозаменяемости. Исходя из этого, целью работы являлся анализ лекарственных препаратов флуконазола в отношении лекарственных форм и способов введения, а также качественного и количественный состава действующих веществ, вспомогательных веществ для выявления возможных показателей, влияющих на взаимозаменяемость. Анализ номенклатуры и состава лекарственных препаратов флуконазола проведен в соответствии с данными Государственного реестра лекарственных средств Российской Федерации и Справочника лекарств РЛС®. Выявлено, что современная номенклатура лекарственных препаратов флуконазола представлена следующими формами выпуска: для парентерального применения, внутреннего применения, местного применения. Воспроизведенные препараты флуконазола в форме капсул отличаются от референтного препарата Дифлюкан® по составу вспомогательных веществ, по сроку хранения, упаковке. Обращает на себя внимание специфика субстанции флуконазола – наличие полиморфных модификаций, их особенностей, влияния параметров технологического процесса и хранения на их стабильность. Выявлено, что во многих случаях при производстве капсул флуконазола используется субстанция двух или более поставщиков, что может приводить к изменению показателей качества и биодоступности в процессе хранения. Полученные данные в дальнейшем могут быть использованы для оптимизации фармацевтической разработки и оценки взаимозаменяемости лекарственных препаратов флуконазола

Comparative characteristics and evaluation of the quality of cosmetic creams and ointments

The purpose of the study is to study the quality and comparative characteristics of cosmetic creams and ointments based on physical and chemical studies and determination of fat-soluble vitamins.Цель исследования – исследование качества и сравнительная характеристика косметических кремов и мазей на основе проведенных физико-химических исследований и определении жирорастворимых витаминов

Elaboration of the bischofite eye drops using the biopharmaceutical criteria

Our research is of theoretical and practical importance and aims at the development of ophthalmological dosage form comprising mineral component (bischofite). It is mineral complex consisting of 96% magnesium chloride with macro- and microelements. Having carried out complex physicochemical and biopharmaceutical researches in vitro, we developed composition and technology of 10% bischofite solution in the form of eye drops. After is one of the perspective tools in technological researches. After using of the analytic hierarchy process by T. Saaty the optimal eye drops composition was selected according to all chosen criteria for this pharmaceutical form

PLANT RAW MATERIAL EXTRACTS AS COMPONENTS OF COSMETIC PRODUCTS AND FORMULATIONS FOR TOPICAL ADMINISTRATION: THE PRODUCT RANGE, THE PRODUCTION CHARACTERISTICS (REVIEW)

In contemporary pharmaceutical practice extracts are used as a separate cosmetic product and as an intermediate for external medicinal forms (ointments, gels, liniments) and cosmetic forms. Their range is highly diverse.The aim is an overview of the scientific and technical information concerning plant  raw materials extracts using in the external drug and cosmetic products.Methods. To describe the range of extracts proposed for external use the analysis of the proposals of Russian and foreign producers submitted their official websites and online trading platforms was used. The specificity of extraction of biologically active substances of plant extracting agents: water, ethyl alcohol, glycols, vegetable oils, carbon dioxide used to obtain extracts was described on the basis of available scientific literature (eLIBRARY, PubMed, Cyberleninca, Google Books). Results. Examples of external drugs and cosmetic products based on plant raw materials extracts from a range of pharmaceutical organizations are given. It was found that from the extracting solvent used the range is presented by hydrophilic, such as glycol (propylene glycol, glycerin), water, alcoholic extracts; lipophilic (oil, CO2-extracts), and two-phase (caprylic/caprate triglyceride/water extracts). The main features of the extracting solvent used for this category of extracts: the specifics of the use in cosmetics (the skin specific effect), in particular selectivity to groups of biologically active plant substances, microbiological purity, are noted. Results of research data on the study of the prospects for the use of cosmetic ingredients – silicones, caprylic/ capric triglyceride, isopropyl myristate both solvents. The extraction techniques: classical (maceration, percolation) and intensified (electro-plasma dynamic extraction, vacuum extraction circulation, CO2 supercritical extraction) used in industry to produce cosmetic extracts are described.Conclusion: in this way, the range of extracts for use in exterior cosmetics is very diverse and is characterized by the use of different solvents, performing the function of the components in cosmetics, and extraction methods

Разработка состава глазных капель бишофита с использованием биофармацевтических критериев

Our research is of theoretical and practical importance and aims at the development of ophthalmological dosage form comprising mineral component (bischofite). It is mineral complex consisting of 96% magnesium chloride with macro- and microelements. Having carried out complex physicochemical and biopharmaceutical researches in vitro, we developed composition and technology of 10% bischofite solution in the form of eye drops. After is one of the perspective tools in technological researches. After using of the analytic hierarchy process by T. Saaty the optimal eye drops composition was selected according to all chosen criteria for this pharmaceutical form.Основной целью проводимых исследований являлась разработка состава и технологии пролонгированной жидкой лекарственной формы бишофита (природный минеральный комплекс, состоящий на 96% из магния хлорида с включением макро- и микроэлементов) для применения в офтальмологии. На основании комплексных физико-химических и биофармацевтических исследований in vitro разработаны состав и технология 10%-го раствора бишофита в форме глазных капель. По результатам иерархического анализа Т. Саати отобрана оптимальная композиция глазных капель с учетом всех выбранных критериев для данной лекарственной формы