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Vol 71, No 7 (2022)

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information Competent

Formation and development of the biopharmaceutical doctrine of creating effective medicines

Demina N.B., Bardakov A.I., Krasniuk I.I.

Abstract

The article considers the stages of formation and development of Biopharmacy as a scientific direction in Russia. One of the founders of biopharmacy was Corresponding Member of the Russian Academy of Medical Sciences, Professor A.I. Tentsova. Under her leadership, the All-Union Scientific Research Institute of Pharmacy began studying pharmaceutical factors that affect the effectiveness of drugs, determining bioavailability and bioequivalence, created a pharmacopeialmonograph for the Dissolution test, and began developing new dosage forms based on liposomes, microcapsules, solid dispersions. Biopharmaceutical concepts are now well recognized and they have found their application in pharmaceutical development, quality assessment and drug efficacy. The article provides an overview of modern biopharmaceutical research currently being carried out in universities and scientific organizations of the Russian Federation. The contribution of Russian scientists to the development of areas of biopharmaceutical doctrine is: the creation of dosage forms of the latest generations based on nano- and microcarriers, with prolonged, modified release, targeted action, etc.; study of pharmacokinetics and bioequivalence of drugs; methodology for conducting the Dissolution test, etc. Today, biopharmacy has become part of the educational process of preparing pharmacists, as well as one of the areas of scientific research for highly qualified specialists, which is reflected in the passports of scientific specialties. Biopharmacy, logically combining various pharmaceutical areas in favor of the patient, has become fundamental in the creation of effective and safe medicines.

Farmaciya (Pharmacy). 2022;71(7):5-10
pages 5-10 views

Literature review

Probiotics on the Russian pharmaceutical market

Molokhova E.I., Tarasevich V.N., Lipin D.E.

Abstract

Introduction. Inclusion for the first time in the State Pharmacopoeia of the XIII edition of the general Pharmacopoeia article of the GPM.1.7.1.0008.15 “Probiotics” make the systematization and analysis of modern requirements for this group of drugs relevant. Objective: This is an analysis of the range and technology of probiotics presented on the Russian pharmaceutical market, by composition, indications for use and dosage forms. Material and methods. The study was conducted using the official source of information on the registration of medicines in the Russian Federation, the State Pharmacopoeia of the XIV edition and modern reviews of probiotic preparations presented in the bibliographic list. Results. The main classifications of probiotics are considered by the number of strains; by taxonomic groups of microorganisms; by the degree of interaction of active substances. The characteristic of modern probiotic preparations is given: combined, containing spore-forming bacteria and metabolic products of human normoflora bacteria. When analyzing the State Register of the Russian Federation, it was found that 62.1% of the range of probiotics are produced by domestic manufacturers. The cardinal change in the probiotic market is evidenced by the appearance in the assortment of pharmacies of a large number of biologically active food additives containing, as a rule, multicomponent probiotics in the form of capsules. The current trends in the development of probiotic technologies are highlighted. Conclusion. As a result of the work carried out, it was found that in recent years the range of complex preparations has significantly expanded, such dosage forms as lyophilizate for the preparation of suspension, ointment for topical use, sachets have appeared. Among the oral dosage forms are probiotics of domestic production in capsules. As directions for the development of probiotic technologies, the expansion of the group of sorbed probiotics, the creation of domestic drugs in the form of drops for oral administration, soft dosage forms and sprays for topical use, including for the creation of therapeutic and prophylactic agents in the field of cosmetology, is promising.

Farmaciya (Pharmacy). 2022;71(7):11-17
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Pharmaceutical chemistry and pharmacognosy

Development of a UV spectrophotometric method for quantitative determination of a clopidogrel metabolite suitable for chemical and toxicological analysis

Anosova L.S., Remezova I.P., Agafonov A.M.

Abstract

Introduction. In Russia, more than 50% of all diseases and a fifth of all cases of disability are due to coronary heart disease and stroke. According to the recommendations of the Russian Society of Cardiology (RKO) and the European Society of Cardiology, antiplatelet therapy with clopidogrel is included in the standards of treatment of patients with COVID-19. Clopidogrel is a prodrug, with the help of esterases, hydrolysis occurs with the formation of the main (inactive) circulating metabolite - a derivative of carboxylic acid, which accounts for 85% of all metabolites of this drug. According to the information given in the scientific literature over the past 10 years, clopidogrel is of interest from the point of view of chemical and toxicological studies, since this drug very often becomes the "drug of choice" for suicide purposes. Objective: to develop and validate a technique for the quantitative determination of the main metabolite of clopidogrel -clopidogrel carboxylic acid using an affordable and widely implemented chemical-toxicological analysis method of UV spectrophotometry. Material and methods. Objects of research - Clopidogrel carboxylic acid (SLA) substance-powder. The light absorption of solutions in the UV spectrum was measured with the SF-46 spectrophotometer (JSC LOMO, Russia), the spectral measurement range was from 200 to 350 nm. A standard solution of clopidogrel carboxylic acid in 0.1 M hydrochloric acid solution (100 mcg/ml) was used. Results. The optimal wavelength for the quantitative determination of the main metabolite of clopidogrel - clopidogrel carboxylic acid is 278 nm. The calibration graph for the UV spectrophotometric method was described by the equation: A=0.004128C - 0.008667; linearity was observed within the concentrations of clopidogrel carboxylic acid 20.0-200 mcg/ml; LOD and LOQ were, respectively, 1.655 mcg and 5.015 mcg in the sample. Conclusion. The developed method of quantitative determination of the main metabolite of clopidogrel - clopidogrel carboxylic acid using UV spectrophotometric method meets the requirements for methods recommended for use in forensic toxicology, which is confirmed by validation characteristics.

Farmaciya (Pharmacy). 2022;71(7):18-24
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Technology of medicines

Theoretical and practical development of the composition of intranasal dosage forms with the active component of ginko biloba extract

Kovtun E.V., Stepanova E.F., Pogrebnyak L.V., Glizhova T.K., Pogrebnyak A.V., Bokov D.O.

Abstract

Introduction. The successful use of herbal remedies for the treatment and prevention of a number of diseases is beyond doubt, which is primarily due to their high biological activity. A pronounced action of a complex of substances is noted, in comparison with the action of an individual substance. Nootropics are no exception, the market of which is dynamically growing. That is why the choice of objects of plant origin, which have an effect on cerebral circulation, on the state of blood vessels, seems promising to us. Models based on Ginkgo biloba extract fit into this problem, but careful choice of dosage form is required. Nasal dosage forms have a number of advantages, the main ones are high bioavailability, the possibility of systemic action of medicinal substances and the speed of its development, active absorption of a number of medicinal substances can occur in the nasal cavity, which are cleaved in the gastrointestinal tract, and their maximum concentration in the blood is reached quickly. Objective. The aim of our work is technological studies of the intranasal dosage form - drops, including the theoretical and experimental selection of a group of excipients, as well as their interaction with the active complex of Ginkgo biloba. Material and methods. When creating an intranasal dosage form based on a phytocomposition, various research methods were used: technological, biopharmaceutical, physical, physicochemical, microbiological. In addition, the semi-empirical method of PM7 molecular orbitals was used. Results. Theoretical and experimental studies on the choice of excipients for intranasal dosage form have been carried out. Conclusion. The conducted studies prove the feasibility of developing a technology for a dosage form - drops in the form of an emulsion with active components of Ginkgo biloba.

Farmaciya (Pharmacy). 2022;71(7):25-31
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Development of a domestic standard sample of vitamin D based on comparative studies of its stability

Susyev E.B., Stepanova E.F., Noskova V.D.

Abstract

Introduction. The current level of development of the pharmaceutical industry and all its areas, as well as the introduction of evidence-based medicine dictate the improvement and updating of analytical support for scientific research of production cycles. Thus, the analysis of organic compounds today requires the use of physico-chemical methods: including the transition from traditional titration to complex instrument variants using substances of 100% purity - a standard - standard, thanks to which it is possible to ensure the unity of measurements and traceability of the results obtained. Increasing requirements for the purity and individuality of target products have globalized the role of standardization in the creation and production of medicines, as well as intermediate components used in related fields with pharmacy. Material and methods. As the main research models, various types of standard sample materials (imported, Reference Material and own production) are considered in conditions of various storage options: long-term research, meetdom of “Accelerated aging” and stress research. Results. Based on the conducted research and the obtained statistical data, it is proved that the existing material of domestic production, some objects of foreign production, as well as a control sample of an imported standard sample of vitamin D, are stable. The performed studies are able to provide validation of vitamin D production and the unity of measurements related to the production of vitamins in various fields of domestic industry and agriculture Conclusion. Foreign Reference Material models and a substance of domestic production can equally claim to be used in a standard sample with subsequent approval of its type, and accordingly are applicable as a standard sample for pharmaceutical analysis.

Farmaciya (Pharmacy). 2022;71(7):32-39
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Organization and economy

Russian experience of scientometric research in pharmacy

Sokolova E.V., Guryanov P.S.

Abstract

Introduction. In the conditions of blocking the access of Russian scientists to Western systems of scientometrics and publication in foreign publications, it is difficult to analyze the effectiveness of the Russian pharmaceutical science. Objective: in order to improve the Russian system of analysis and coverage of the innovation process in pharmacy, the historical experience of pharmaceutical science in Russia from 1922 to the present was studied. Materials and methods. Used logical and analytical-synthetic research methods. The publications for 60 years of the leading scientific journal on pharmaceutical sciences in the USSR and Russia - "Pharmacy", abstract collections of scientific articles on pharmacy and sections of scientific journals with abstracts of articles on pharmacy, dissertations on pharmaceutical scientometrics were studied. Results. We identified the stages of development of pharmaceutical scientometrics in the USSR and Russia, the main research organizations, institutes, scientists specialized in this topic, identified trends and ideas of domestic work. The analysis of dissertations was carried out, in which original methods of scientometrics were proposed, models of science were developed, comparisons were made with the level of Western science, forecasts were made for 30 years. Conclusion. It is concluded that Russian developments can be a tool for import substitution of Western systems of scientometrics: the concept of the information field of pharmacy, a set of qualitative and quantitative indicators for evaluating scientific research, and a model for the functioning of pharmaceutical science. At the same time, it is necessary to institutionalize the analysis of the development and planning of pharmaceutical science, as it was in the USSR, where this work was carried out by the All-Union Scientific Research Institute of Pharmacy.

Farmaciya (Pharmacy). 2022;71(7):40-48
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Pharmacology: Experiment and clinic

Clinical Profile of a patient with vitamin D deficiency in the blood

Boldyreva Y.V., Lebedev I.A., Hajiumarova E.A.

Abstract

Introduction. The present work is devoted to the analysis of parameters (social and laboratory data) that allowed us to create a clinical profile of a patient with vitamin D deficiency. It is known that vitamin D is involved not only in the regulation of phosphorus-calcium metabolism, but also has extra-bone effects. However, violations of these processes do not always have specific manifestations that make the doctor and the patient think about vitamin D deficiency. The study found that 64% of patients had vitamin D deficiency in their blood. Considering the above, a doctor of any specialty should remember about the "erased" clinic of vitamin D deficiency and have a certain alertness when diagnosing this condition. Objective: to evaluate the social and laboratory data available in the medical record by compiling a clinical profile of a patient who is being observed in one of the clinics in Tyumen. Material and methods. The work was carried out on the basis of a multidisciplinary clinic of the Tyumen State Medical University in the period 2019-2020. The study included 231 medical records. The D3 content in the blood was determined by laboratory immunological method of quantitative determination of the D3 level in vitro. The ELISA method was used. The results were calculated based on a standard calibration curve. Results. In the course of the study, it was possible to make a clinical profile of the patient depending on the content of vitamin D in the blood. Conclusion. When managing a patient with a particular pathology, determining the level of vitamin D in the blood plays an important role. Since this, among other things, will allow you to approach the treatment and examination of the patient individually.

Farmaciya (Pharmacy). 2022;71(7):49-56
pages 49-56 views

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