Farmaciya (Pharmacy)

The principles of the quality management system in the of fixed dose combinations pharmaceutical development by the active film coating technology: film coating technology as a method for fixed dose combinations tablets producing, which involves coating a solid dosage unit using a solution or suspension containing a pharmaceutical substance. The target profile formulation and a strategy for identifying critical quality attributes summarized. Thus, the active coating technology used to obtain a combination of different release profiles of active substances in one tablet: immediate release from the coat followed by prolonged release from the tablet core. An analysis of the data showed, that the quality target product profile of fix dose tablets is based on general data in accordance with the EAEU Pharmacopoeia, the State Pharmacopoeia of the RF and other regulatory documents. Thus, the target profile contains a combination of two release methods: immediate and prolonged. In the pharmaceutical development of fixed dose combinations tablets by using active film coating technology, the indicators “Assay”, “Dissolution”, “Impurities”, and “Water” are used as critical quality attributes. They affect the composition and/or parameters of the technological process and tested at all stages of pharmaceutical development. For tablets produced using active film coating, uniformity of dosage should be considered as a critical quality attributes characterized by high risk, since the formulation and technological factors determining uniformity of dosage of a pharmaceutical substance in an active film coating differ from tablets obtained by pressing.

Introduction. Plants of the genus Reynoutria are used in the traditional medicine of various countries, and in Asian countries, they are sources of pharmacopoeial types of medicinal plant raw materials and are used for the production of various medicines. In the European part of Russia, particularly in Moscow and the Moscow region, the most common species of the genus Reynoutria is Bohemian knotweed (Reynoutria × bohemica Chrtek et Chrtkova). It belongs to the Polygonaceae family and is a perennial herbaceous plant, a hybrid between Reynoutria sachalinensis (F.Schmidt) Nakai and Reynoutria japonica Houtt.

Objective: to study the composition of biologically active substances (BAS) in the leaves of Bohemian knotweed and their transfer into infusion and decoction to select a rational dosage form.

Material and methods. he research object was the leaves of Bohemian knotweed harvested in the Botanical Garden of the Sechenov First Moscow State Medical University (Sechenov University) in September 2024 and in June 2023. The methods and procedures of pharmacognostic analysis from the State Pharmacopoeia of the Russian Federation, XV edition, were used in the study.

Results. The quantitative content of various BAS groups in the 2023 and 2024 samples was studied. The content of water-extractable substances was 28.58±0.27 and 23.04±0.56%, respectively. The content of tannins, calculated as tannin, was 3.75±0.14 and 4.95±0.22%, respectively. The total flavonoid content, calculated as rutin and determined spectrophotometrically after reaction with aluminum chloride, was 1.16±0.04 and 1.52±0.07%, respectively. The ascorbic acid content was 0.040±0.001 and 0.20±0.01%, and the sum of free amino acids was 0.40±0.01 and 0.41±0.01%, respectively. The amino acid composition was studied by capillary electrophoresis; 7 essential amino acids were identified, among others. The compositions of the infusion and decoction were also studied and compared.

Conclusion. The leaves of Bohemian knotweed contain significant amounts of tannins, flavonoids, polysaccharides, ascorbic acid and amino acids, which transfer into the infusion and decoction in sufficient quantities. Based on the comparison of the quantitative characteristics of the infusion and decoction, it was concluded that preparing a decoction from Bohemian knotweed leaves is advisable.

Introduction. Recently, the country has been implementing a large-scale set of measures aimed at improving the quality of life of children, preserving and strengthening their health. Within the framework of the state program of the Russian Federation "Development of Healthcare", measures have been planned to modernize the children's healthcare system, including improving the quality and accessibility of medical care for children, including their medical care. The accumulated experience of using various medicines in pediatric practice indicates that their pharmacological and pharmaceutical characteristics do not always correspond to the real needs of children's healthcare. Thus, the organization of pharmacy manufacturing of personalized extemporeal medicines for children is a promising and relevant direction in the domestic pharmacy.

Purpose of the study was to analyze the use of extemporeal drugs in pediatric practice and to provide scientific and practical justification for the development of their manufacture in pharmacies of medical organizations based on the doctrine of personalized medicine.

Material and methods. The theoretical and methodological basis of the research was made up of legislative and regulatory legal acts in the field of drug circulation, drug supply and pharmaceutical activities; scientific papers on technology and quality control of extemporeal medicinal products, as well as other scientific, methodological and reference literature on the subject under consideration. Latent-semantic and structural-logical methods, the method of expert assessments and content analysis were used in the research.

Results. As a result of the analysis of the experience of leading medical organizations in St. Petersburg that provide assistance to children with various pathologies, it has been established that, based on the doctrinal provisions of personalized medicine, the use of extemporeal drugs for children makes it possible to individualize the dosage of active substances and select the optimal composition of excipients, to increase the effectiveness of pharmacotherapy. However, the implementation of this approach faces a number of obstacles, despite which significant prospects for the development of pharmaceutical drug manufacturing in the context of advanced technologies and innovations in regulatory regulation are opening up in modern conditions. Thus, individual dosing of the active (active) substances in medicines, the selection of specialized physical therapy makes it possible to minimize side effects, reduce the number of hospitalizations, which in turn reduces the overall cost of medical care and treatment.

Conclusion. The establishment of the manufacture of extemporeal drugs used in pediatric practice is an important aspect of personalized medicine. The individual manufacture of children's dosage forms requires high professional competence, strict adherence to drug manufacturing technology and consideration of individual patient characteristics. Such an integrated approach will ensure the effectiveness of the implemented pharmacotherapy, reduce the risk of side effects and increase the safety of treatment. At the same time, it is necessary to pay attention not only to the social and medical aspects of patient-oriented therapy, but also to the economic performance of medical organizations.

Introduction. The loading efficiency is a necessary element for assessing the quantitative content of a drug in any nanocarrier and can be expressed by two criteria – the lipid/drug ratio and the inclusion efficiency (IE). IE is the percentage of encapsulated drug in relation to the amount of drug taken to produce liposomes.

Aim. Evaluation of the effect of formulation factors on the efficiency of loading a pharmaceutical substance with hydrophobic properties into liposomes.

Material and methods. The materials of dissertations and research reports on the development of liposomal dosage forms (LDFs) of original domestic substances of various chemical classes were used for the study: borchlorin (A.N. Nesmeyanov Institute of Organoelement Compounds of the Russian Academy of Sciences), thiosens (Research Institute of Organic Semi-Products and Dyes), LHS-1208, LHS-1269, cyfetrilin and compound X (FSBI «N.N. Blokhin National Medical Research Center of Oncology» of the Ministry of Health of the Russian Federation). Statistical, spectrophotometric, and experimental methods for assessing lipophilicity.

Results. Since the hydrophobic drug is incorporated directly into the bilayer, the efficiency of its loading is primarily determined by the amount of phospholipids (PL): with an increase in the concentration of PL, an increase in the IE of the loaded drug is observed. When comparing the PL/drug ratio, at which the maximum IE value of hydrophobic drugs is reached, with their molecular weight, a strong relationship between these variables (correlation coefficient 0.969) was revealed, which can be expressed by a linear equation. It has been shown that the greater the degree of unsaturation of the fatty acid residues that make up the PL and the length of the hydrocarbon chain, the higher the level of loading of the hydrophobic substance into liposomes. The effectiveness of drug loading is also influenced by the presence of cholesterol and pegylated phospholipid, but no general linear relationship has been established between the content of these lipids and the IE of the studied drugs.

Conclusion. The influence of the factors of the formulation of LDFs hydrophobic substances on the efficiency of their loading into phospholipid vesicles has been evaluated, which can serve as a theoretical basis for the development of liposomal drug compositions characterized by low solubility in water.

Introduction. This study presents the results of an analysis of state regulation mechanisms for dietary supplements, as well as the risks of counterfeit, falsified, and substandard products on the national market.

The aim of this study was to assess current trends and development priorities in state regulation of the Russian dietary supplement market.

Material and methods. Judicial practice was monitored using the cross-platform legal reference system "Consultant Plus" at the level of decisions of the highest courts for the period from January 1, 2016, to December 31, 2023, using an advanced search for the keyword "dietary supplements." Regulatory acts governing the circulation of dietary supplements on the Russian market also served as research materials.

Results. The results of the assessment of judicial practice regarding dietary supplements revealed instances of the presence of prohibited substances in supplements (57.89%), discrepancies in the declared dosage of biologically active substances (31.58%), and discrepancies in the microbiological safety profile of the final product (10.53%). Priorities for the development of legal regulation for this product category include expanding the range of safety requirements for dietary supplement quality parameters and establishing an effective system of government oversight using a risk-based approach at individual stages of the life cycle across all distribution channels, including online sales.

Conclusion. Given the heterogeneity of dietary supplements across a number of parameters, primarily end-use, government regulation mechanisms require a balanced and well-founded approach within each individual product category.