This time the annual scientific and practical conference was held in a live format in Moscow. The conference was organized by Center of Pharmaceutical Analytics and research and production peer-reviewed journal "Drug development & registration". The event took place on June 25 in Moscow in Technopark "KALIBR". The event was dedicated to the life cycle of biotechnological medicines. We discussed certain aspects of the development, research and production of various groups of biotechnological drugs, such as monoclonal antibodies, low molecular weight heparins, insulins, peptide drugs, and others.

Accurate and reproducible quantitation of impurities in pharmaceuticals is an important part of drug development. Impurities must be controlled to levels that will ensure the quality of the product is as good or better than the quality of materials used in preclinical safety studies and clinical trials. International Council for Harmonisation (ICH) Q3A and Q3B guidelines for drug substances and drug products, respectively, provide regulatory expectations for investigation and control of impurities including process-related substances and degradation products. Thresholds for identification and safety qualification of impurities can be based on relative percentages or directly in milligrams of exposure, depending on the nature of drug substances and products1. Therefore, an accurate assessment of impurity levels is needed both to guide development efforts and during the entire lifecycle of the drug.

Purpose of the article: To demonstrate the direct transfer of analytical HPLC methods from an Agilent™ 1260 Infinity system to the UltiMate 3000 platform and the Vanquish platform.

This article demonstrates the benefits of the UltiMate 3000 and Vanquish platforms for direct transfer of HPLC methods, as required by the USP.

• Flexible control of total system volume on Thermo Scientific™ UltiMate™ 3000 systems and Thermo Scientific™ Vanquish™ UHPLC systems simplifies the transfer of analytical HPLC methods.
• The advanced hardware features of the Thermo Scientific™ Vanquish™ LC system allow flexible adjustment of the total system gradient hold volume to facilitate fine tuning during transfer.
• Equivalent chromatographic results are obtained with both systems, but improved system resolution and repeatability are provided by the Thermo Scientific™ Vanquish™ System.
• If detection sensitivity is a critical issue, then Thermo Scientific™ LightPipe™ technology is the optimal solution.

The scientific school "Personnel reserve for the biopharmaceutical and chemical industry" is traditionally held at the Peoples' Friendship University of Russia in order to familiarize potential applicants with the educational programs implemented at the university. Also, the task of the scientific school is to present the results of scientific work and exchange opinions both between outstanding scientists and young scientists - students, undergraduates, graduate students.

The first International Pharmaceutical Exhibition-Forum "TechnoPharm Siberia" 2021 has become one of the largest face-to-face events in the context of the coronavirus pandemic. The Exhibition-Forum took place in the spring of 2021 and brought together more than 30 companies and 700 participants together. The event was attended by regional and federal players, experts from the scientific community and pharmaceutical production, the Deputy Minister of Industry, Trade and Entrepreneurship Development of the Novosibirsk Region Vadim Vitalievich Vasiliev. The organizer of the exhibition-forum is the TechnoPharm company and the director is Ekaterina Vastyanova.

From October 5 to 8, the international scientific congress in the field of biotechnology, virology and biopharmaceuticals OpenBio will take place in the Koltsovo science city of the Novosibirsk region. Traditionally, a scientific conference and a business forum will be held within its framework. The event will be organized in a hybrid format: experts, speakers and guests can participate online.

Introduction. Liver diseases with all the variety of clinical manifestations have common pathogenetic links at the cellular level. The group of hepatoprotective agents is represented by drugs that exhibit versatile mechanisms for protecting liver cells from the effects of damaging factors, the main of which are membrane-stabilizing, antioxidant, regenerative, detoxifying, choleretic and anti-inflammatory effects. The high therapeutic and hepatoprotective effectiveness of modern drugs is largely due to their metabolic effects, as well as their ability to bind free radicals and reactive oxygen species in the cell.

Text. The purpose of this work is to form an analytical review of the literature on the assortment and concepts of improving the dosage forms of hepatoprotective agents. According to the analysis and systematization of modern publications devoted to the use of hepatoprotectors in the treatment of liver diseases, it is shown that it is necessary to develop new formulations and combinations of biologically active substances with the manifestation of versatile mechanisms of hepatoprotection, as well as to improve the composition and manufacturing technologies of existing traditional therapies. One of the current trends is the use of new substances in the development of traditional and innovative dosage forms. The search for biologically active molecules with antioxidant, antiradical and membrane-stabilizing activity that can be considered as effective hepatoprotectors continues. An integral task of pharmaceutical development is the creation of bioavailable drugs that have a prolonged effect and minimal side effects. A promising direction in pharmaceutical technology is the development of innovative drugs for the directed transport of biologically active molecules to the affected organ.

Conclusion. As a result of the analysis of modern data, priority directions for the development and improvement of existing formulations based on modern approaches to the production of innovative dosage forms are identified. The relevance of improving the dosage forms of hepatoprotectors presented on the pharmaceutical market is shown. Of particular interest is the development of innovative targeted delivery systems with effective and safe hepatoprotectors in various combinations, including those based on cinnamic acid derivatives.

Introduction. The article presents the results of a study of the physicochemical properties of dry extract of olive leaves, standardized by hydroxythyrozol - a biologically active substance that is part of the chemical composition of aerial parts of the olive tree.

Aim. The purpose of the study is to develop tablet Formulations containing dry extract of olive leaves and to standardize by hydroxythyrozol by reversed-phase-HPLC method on the main substancecontent.

Materials and methods. Substance of dry extract of olive leaves, microcrystalline cellulose (Avicel® PH-112), Aerosil® (Aeroperl® 300 Pharma), Ludipress® (Ludipress®), lactose, potato starch, sodium salt of carboxymethyl starch, magnesium stearate, direct pressing, HPLC.

Results and discussion. Studies of the physicochemical properties of dry extract of olive leaves have been carried out. Selected excipients for the study of tablettable masses. Formulations for further tabletting have been developed. A complex of studies of the obtained tablets was carried out according to Russian Pharmacopoeia XIV for compliance with quality indicators.

Conclusion. The biological properties of dry extract of olive leaves are have been studied, indicating the prospect of developing drugs based on it. Formulations of tablets with dry extract of olive leaves have been developed and their quality indicators have been investigated.

Introduction. Due to increase in the frequency of detecting cases of tuberculosis caused by strains of mycobacteria with resistance not only to traditional, but also recently introduced into clinical circulation anti-tuberculosis drugs, it is urgent to search for and develop new drugs that can be effective against multidrug-resistant (MDR-TB) and extensively drug resistant (XDR-TB) strains. One of the most promising classes of such compounds are fluorine derivatives of benzothiazinones, and particularly compound PBTZ169 (INN macozinone). This antibiotic has a high specificity against mycobacteria tuberculosis (M. tuberculosis), inhibiting one of the key enzymes of cell wall synthesis. However, macozinone as an active pharmaceutical ingredient has significant features of physical and chemical properties that hinder the development of oral dosage forms based on it. It is classified as class IV by BCS and is characterized by a very low solubility and lipophilicity, a pronounced dependence of dissolution rate on the pH of the medium, and very low bioavailability when taken orally.

Aim. To substantiate the target profile, critical quality attributes and to develop a prototype of an oral dosage form with modified release of macozinone, allowing to maximize its pharmacological activity.

Materials and methods. Using pharmaceutical substance macozinone hydrochloride and various excipients, experimental tablets with a dosage of 500 mg macozinone were developed. The influence of the composition of the media and the added excipients on the solubility of macozinone in various biorelevant media, the degree of swelling in the liquid and the degree of mucoadhesion of the experimental tablets to the mucus of the pig stomach were evaluated. The HPLC method was used to evaluate the kinetics of the release of the active substance.

Results and discussion. In this work, the expediency of creating macozinone-containing gastro-retentive dosage forms with a slow release of the active substance, the delay mechanism of which is provided by swelling and increased adhesion to the gastric mucosa, has been substantiated. Various tablet samples were experimentally tested in which the modification of the release of the active substance and the degree of swelling and mucoadhesion were varied by introducing various excipients into the formulations, including known swelling and bioadhesive matrix agents.

Conclusion. According to the results of the experiments, samples of high-dose (500 mg) swellable and mucoadhesive tablets created by the technology of two-stage granulation with the inclusion of macozinone - hydroxypropyl-beta-cyclodextrin mixtures in the primary granules and introduction of combinations of soluble and insoluble hydrophilic matrix agents into the intergranular space were recognized as the most promising for subsequent pharmacokinetic studies.

Introduction. The creation of new effective antibacterial drugs for the treatment and prevention of purulent-inflammatory diseases is an urgent task of modern pharmacy. Active use in the treatment of purulent infection is found by chemotherapeutic agents from the class of fluoroquinolones, which include ofloxacin.

Aim. Development of a method for the quantitative determination of ofloxacin in the complex preparation "Ofloxazol".

Materials and methods. For the analysis, the substance ofloxacin, titanium-containing gel "Tizol", solutions of ofloxacin on 95 % ethanol, hydrochloric acid 0.01 mol/l, ointment under the conditional name "Ofloxazol" containing 0.5 % of the drug in the gel "Tizol" were used. The study was carried out by near-UV spectrophotometry.

Results and discussion. When studying the absorption spectra, it was found that for the quantitative spectrophotometric analysis of ofloxacin, it is rational to use the wavelength range of 275-320 nm (λ_max = 294 nm). Statistical processing of the analysis results showed that the relative error of quantitative determination does not exceed ±1.66 %. The sensitivity of the determination of ofloxacin is 0.245 mcg/ml at A(min) = 0.02. The developed method is validated. Its specificity, linearity, correctness and precision are confirmed. According to the calibration schedule, the content of ofloxacin in the soft dosage form is determined, it is in the range of 0.0483-0.0562 g, which corresponds to the permissible deviations.

Conclusion. The conducted studies allowed us to develop and propose a method for the quantitative determination of ofloxacin in the ointment "Ofloxazol", obtained on a titanium-containing basis. The method allows you to evaluate the quality of manufacturing the dosage form, including setting the content of the drug with an error that does not exceed the standard deviations.

Introduction. Quinazoline derivatives have a wide range of pharmacological properties, which makes this group quite unique among other classes of heterocyclic compounds. Substance VMA-10-18, which has cerebrovasodilating, antidepressant, anxiolytic and nootropic properties, may become a promising new drug. In this regard, an urgent task is to develop methods for standardizing this substance.

Aim. Development of a method for the quantitation of related impurities of a new biologically active substance VMA-10-18 (Quinazophene) by HPLC with subsequent statistical processing of the results.

Materials and methods. To develop the conditions for chromatographic analysis, was used a highly purified substance 3-[2-(4-methoxyphenylamino)-2-oxoethyl]-quinazolin-4(3H)-one, as well as its related impurities: impurity I (unsubstituted quinazolin-4(3H)-one) and impurity II (4-methoxychloroacetanilide). Test solutions were prepared using volumetric glassware of accuracy class 1. Ethyl alcohol 95 % was used as a solvent. Chromatography was performed using a Dionex UltiMate 3000 system (Dionex, United States) with a spectrophotometric detector. The analysis was carried out at a wavelength of 231 nm. Data collection and processing was carried out using the Chromeleon v.7 system. A mixture of acetonitrile and orthophosphoric acid was used as a mobile phase. The analysis was performed in an isocratic mode. The validation of the developed method was carried out taking into account the requirements of the State Pharmacopeia of Russian Federation XIV edition and the recommendations of the ICH.

Results and discussion. The optimal conditions for chromatography of the VMA-10-18 substance and its impurities have been developed. It was found that for a clear separation of the peaks of the substance and impurities among themselves, the mobile phase should contain acetonitrile and orthophosphoric acid in a ratio of 80 : 20. The specificity of the method was determined by chromatography of ethyl alcohol in order to exclude its influence on the analysis results. The linearity and correctness of the method were determined at 7 levels of concentration of impurities of the substance. The correlation coefficient has exceeded 0.99. Also, the free term of the linear dependence equation (a) for both impurities was less than its confidence interval (Δа), which proves the absence of a systematic error of the method. When determining the "Convergence" indicator, the calculated relative standard deviation did not exceed 2 %. When determining the intralaboratory precision, Student's t-test and Fisher's F-test were calculated. Both indicators met the stated requirements.

Conclusion. A method for the quantitative determination of impurities in the VMA-10-18 substance by HPLC has been developed and validated.

Introduction. Liposomal preparations have the following advantages: they protect body cells from the toxic effects of drugs; prolong the action of the drug introduced into the body; protect medicinal substances from degradation; promote the manifestation of targeted specificity due to selective penetration from blood into tissues; change the pharmacokinetics of drugs, increasing their pharmacological effectiveness; allow you to create a water-soluble form of a number of medicinal substances, thereby increasing their bioavailability. The development of liposomal forms of vinpocetine is highly relevant. Currently, when developing the composition of liposomal forms, molecular modeling methods are widely used, which are a convenient method for predicting both the properties of the membranes themselves and aspects of the interaction of membranes with small molecules or proteins.

Aim. The aim of this study is to model the process of liposome assembly from soy lecithin phospholipids in the presence of vinpocetine by the molecular dynamics method; as well as predicting the distribution of vinpocetine between the internal cavity of the liposome, the phospholipid membrane, and the dispersion medium based on the simulation results.

Materials and methods. To simulate the process of liposome formation, the method of coarse-grained molecular dynamics in a Martini 2.2 force field was used using the Gromacs 2016.4 program. The assembly of the simulated system - a solution of soy lecithin phospholipids in water was performed using the Internet service Charmm-GUI-> Inputgenerator-> Martinimaker-> Randombuilder.

Results and discussion. The results of molecular modeling showed that the vinpocetine molecules did not penetrate into the liposome, but were adsorbed on its surface. This is due to the low solubility of vipocetin in the hydrophobic medium of the soy lecithin liposome membrane.

Conclusion. It was shown that the minimum diameter of a liposome formed from purified soy lecithin is 15.3 nm. Vinpocetine does not penetrate into liposomes from purified soy lecithin, but is adsorbed on the outer surface of their membrane. The surface excess in this case, according to the results of modeling coarse-grained molecular dynamics at a temperature of 298 K in an alcohol-water medium, is 1.2 • 10^-7 mol/m².

Introduction. Indolocarbazole derivatives are of increasing scientific interest for practical oncology. A number of N-glycosides, indolo[2,3-a] carbazole under the laboratory code LCS, were synthesized in the laboratory of chemical synthesis of the National Medical Center of Oncology named after N.N. Blokhin. Currently, one of the most promising compounds in this class is LCS-1208, a representative of the arabinoside class of indolo [2,3-a]pyrrolo[3,4-c]carbazole-5,7-dione. According to the mechanism of biological action, LCS-1208 is a protein kinase C inhibitor and is of great interest for the treatment of malignant neoplasms.

Aim. Chemical and pharmaceutical standardization of the pharmaceutical substance LCS-1208.

Materials and methods. Laboratory samples of pharmaceutical substance LCS-1208. Methods of investigation: gravimetry, spectrophotometry, polarimetry, high-performance liquid chromatography (HPLC), high-resolution nuclear magnetic resonance (NMR) spectroscopy and infrared (IR) spectroscopy.

Results and discussion. The quality assessment of LCS-1208 was carried out according to the indicators adopted in the XIV edition of the State Pharmacopoeia of the Russian Federation for quality control of pharmaceutical substances. LCS-1208 - orange amorphous powder, odorless; soluble in dimethylsulfoxide (DMSO) and dimethylformamide (DMF); very slightly soluble in 95 % ethyl alcohol and practically insoluble in water. The authenticity of the substance is confirmed by NMR and IR spectra, as well as electronic absorption spectra. The values of the specific optical rotation of LCS-1208 (1 % solution in DMF) are placed in the range from +58° to +61°. All the studied samples of the substance were free of inorganic impurities, sulphate ash, heavy metals and contained no more than 1.0 % water, determined by the K. Fischer titration method. The content of possible related impurities in the substance LCS-1208 and the content of the main active substance were determined by HPLC. The studied laboratory series of the pharmaceutical substance LCS-1208 contained no more than 1.0 % of any single and no more than 3 % of the total unidentified impurities. The content of the main active substance was more than 97 %.

Conclusion. As a result of the work carried out, quality criteria and parameters were selected and methods for their determination were developed, which allow to adequately assess the quality and standardness of the pharmaceutical substance LCS-1208.

Introduction. Currently, close attention in the field of pharmacy and medicine is directed to the search for new sources of biologically active substances of various origins, including vegetable. The woody plant Elaeagnus argentea is considered as a promising source. Despite its widespread use in the food industry, folk medicine as an anti-inflammatory, restorative, antimicrobial agent, the chemical composition of this plant has not been sufficiently studied.

Aim. Qualitative and quantitative determination of the main groups of biologically active substances (BAS) in the raw material (leaves) of Elaeagnus argentea growing on the territory of the Astrakhan region for further development of a methodology for standardizing the raw material of this plant.

Materials and methods. The leaves of Elaeagnus argentea were harvested in the spring in the eastern part of the delta of the Astrakhan region (Volga region). Drying of raw materials was carried out in natural conditions. In the study, unified methods were used: to determine the amount of flavonoids and saponins, the spectrophotometric method was used, ascorbic acid - the titrimetric method. For the analysis of flavonoids in the leaves of Elaeagnus argentea, an aqueous-alcoholic solution of 70 % concentration was used as an extractant. The quantitative content of flavonoids was determined in the obtained raw material extract in terms of luteolin-7-glucoside. The amount of saponins in the leaves of Elaeagnus argentea was determined in terms of oleanolic acid. 96 % ethanol was used as an extractant. The quantitative determination of ascorbic acid in the aqueous extract of crushed raw materials was carried out by titrimetry based on the ability to reduce 2,6-dichlorophenolindophenol.

Results and discussion. In the pharmacognostic study of biologically active substances in the leaves of Elaeagnus argentea, the content of ascorbic acid was found to be at least 0.32 %, the amount of flavonoids in terms of luteolin-7-glucoside was at least 1.92 %; saponins - 2.38 %; which indicates the need for a more detailed study of the phytochemical composition of other morphological groups of the plant Elaeagnus argentea growing in the Astrakhan region.

Conclusion. The data obtained during the study can be used to confirm the quality of raw materials (leaves) of Elaeagnus argentea. A more detailed study of leaves for the presence of other groups of biologically active substances will make it possible to use the obtained data for the development of regulatory documents for medicinal plant raw materials «Elaeagnus argentea leaves».

Introduction. The medicine "Flakozid" with hepatoprotective effect has been developed at the VILAR. The drug is presented in dosage form-tablets of 0.1 g for oral drug administration

Aim. To analyze the clinical efficacy and safety of "Flakozid" therapy according to clinical laboratory methods, as well as the motility of the gallbladder and bile ducts in patients with diseases of the hepatobiliary system.

Materials and methods. The results of clinical studies of "Flakozid" (0.1 g tablets) were analyzed in 99 patients with chronic active hepatitis, chronic stone-free cholecystitis and fatty liver dystrophy, conducted in 2 clinical institutions: Perm State Medical University. Academician E. A. Wagner of the Ministry of Health of Russia and the Central Research Institute of Gastroenterology. "Flakozid" was prescribed against the background of a therapeutic diet (Table No. 5) of 0.1-0.2 g 3 times a day after meals for 32 days and repeated courses (3-5) for 6-12 months. Analysis of the efficacy and safety of "Flakozid" was carried out on the basis of the results of clinical and laboratory studies: general and biochemical blood analysis, general urinalysis, electrocardiogram. To study the motility of the gallbladder and biliary tract, the method of multifractional duodenal probing was used to determine the functional state of the sphincter apparatus of the gallbladder and biliary tract. In cystic and hepatic bile, its biochemical composition was determined. All patients underwent X-ray examination of the gastrointestinal tract, liver scanning and hepatography with iodine-131-bengal-roz.

Results and discussion. In chronic active hepatitis, chronic stone-free cholecystitis and fatty liver dystrophy the use of "Flakozid" orally in daily doses of 0.3-0.6 g for 25-45 days led to an improvement in the General condition of patients, a decrease in pain in the right hypochondrium, a decrease in dyspeptic disorders, and an improvement in appetite. According to cholecystography, the indicators of concentration and contractility of the gallbladder improved. In terms of the severity of the therapeutic effect, "Flakozid" was not inferior to silibor and carsil, and in some indicators (improvement of the motility of the gallbladder and biliary tract) significantly exceeded them.

Conclusions. Treatment of "Flakozid" improved functional state of the liver, reducing the syndrome of cytolysis and cholestasis. "Flakozid" is recommended in clinical practice in the complex treatment of diseases of the hepatobiliary system, such as chronic active hepatitis, chronic stone-free cholecystitis and fatty liver dystrophy.

Introduction. Lappaconitine is an alkaloid, contained into Aconitum leucostomum Vorosh. roots and herbs. The alkaloid is indicated to arrhythmia. The lappaconitine drugs are metabolized into eight pharmacologically active substances, but N-desacetyllappaconitine is the most effective. Drugs based on a lappaconitine has narrow therapeutic range and many kinds of side effects. Pharmacokinetics of lappaconitine should be more studied for safety medical use of lappaconitine drugs.

Aim. The aim of this study is to develop method for the quantitative determination of lappaconitine and its active metabolite N-desacetyllappaconitine in human plasma and blood by high performance liquid chromatography and tandem mass spectrometry (HPLC-MS/MS).

Materials and methods. Determination of lappaconitine and N-desacetyllappaconitine in plasma and blood was carried out by HPLC-MS/MS. The samples were processed by acetonitrile protein precipitation.

Results and discussion. This method was validated by next parameters: selectivity, matrix effect, calibration curve, accuracy, precision, spike recovery, lower limit of quantification, carry-over effect and stability.

Conclusion. The method of the quantitative determination of lappaconitine and N-desacetyllappaconitine in human plasma and blood was developed and validated by HPLC-MS/MS. The analytical range of the was 0.50-50.00 ng/ml for lappaconitine and 0.50-100.00 ng/ml for N-desacetyllappaconitine in biological matrix. Method could be applied to determination of lappaconitine and N-desacetyllappaconitine for PK studies.

Introduction. This publication describes the design and implementation sequence of technological procedures for labeling immunobiological medicinal products produced by the FGHI RusRAPI "Microbe" of the Rospotrebnadzor. In light of meeting the requirements of the Federal Act "On the Circulation of Pharmaceutical Products", the materials of this study are undoubtedly relevant.

Text. The paper presents a step-by-step sequence of introducing technological procedures for labeling and interaction with the system for monitoring the movement of pharmaceutical products (MMPP) into the production process of medicines. At the preparatory stage, the following main issues were addressed: verification of the identity of information about medicinal products in the State Register of Medicines and in the automatic identification system "UNISCAN/GS1 RUS"; determination of the method and possibility of applying the identification means onto the secondary packaging; amendments to the pharma-copoeial monographs of the enterprise for each type of drug. Stage 2 [development of requirements for the system of labeling, serialization, verification and aggregation (LSVAS)] included the following activities: development of a functional model of the labeling process in the FGHI RusRAPI "Microbe" and determination of the responsible for the implementation of this scheme units; determination of the method of secondary packaging (manual or automatic), as well as the required degree of aggregation and the required automation of the process, based on the analysis of the functional model and the technological process of labeling; analysis of the experience of introducing drug labeling systems; analysis of the existing IT-structure of the FGHI RusRAPI "Microbe"; monitoring of the market of hardware and software manufacturers; development of technical requirements for the created system of marking, serialization, verification and aggregation. Stage 3 (implementation of the labeling, serialization, verification and aggregation system at the production sites) included the following activities: equipment supply and commissioning; equipment qualification (IQ/OQ); training of the personnel; amendments to regulatory documents. In the materials devoted to the implementation of the final stage, the issues of validation of technological procedures for drug labeling and interaction with the system of labeling, serialization, verification and aggregation are considered.

Conclusion. The works performed made it possible to produce medicines in accordance with the requirements of the Federal Act "On the Circulation of Pharmaceutical Products" and the Decree of the Government of the Russian Federation dated December 14, 2018 № 1556 "On Approval of the Regulation on the System for Monitoring the Movement of Drugs for Medical Use". The material presented may be of interest to manufacturers who produce medicines in small amounts.

Introduction. The stage of wet granulation is often used in the technology of solids. The method of wet granulation in a mixer-granulator with high shear force can be regarded as the most complicated method of its implementation from the engineering and technological point of view. The mixer-granulator has two mixers located in mutually perpendicular planes. Using an impeller, dry components are mixed, and the chopper, turning on when spraying a humidifier, ensures the formation of granules. By setting different chopper rotational speed, granules of different sizes can be obtained. This granulator has the following advantages: it provides a high product yield (≥ 99 %), takes up small workspaces, and the closed design ensures environmental protection.

Aim. The aim of the research is to scale the granulation process, on the example of the solids production technology, using the wet granulation stage - in a mixer-granulator with high shear force.

Materials and methods. Dry extract «N» and auxiliary substances were used as a pharmaceutical substance: lactose monohydrate, microcrystalline cellulose (MCC) (MICROCEL® MC-102), potato starch, povidone (Plasdone™ K-29/32), calcium stearate. Granulate under scaling conditions was produced in a mixer-granulator with high shear force. Technological properties of dry extract «N» and granulate were determined by the methods described in National pharmacopeia XIV.

Results and discussion. On the basis of experimental studies, it was found that the resulting granulate, both when obtained under laboratory conditions and under scaling conditions, has good flowability, and also has a homogeneous fractional composition. The presence of a grinder in the mixer-granulator made it possible to obtain a more uniform fractional composition of the granulate. A 10-fold increase in loading did not affect the composition of the granulate. When scaling the pelletizing process, a risk analysis was carried out, factors influencing the technological process were identified and structured. It turned out that the most important stages are mixing and the actual granulation. To obtain a homogeneous mixture, additional equipment was used - a mixer.

Conclusion. As a result of scaling up the granulation process, the parameters of wet granulation in the mixer-granulator (optimal loading, impeller and grinder rotation frequency), technological properties of the resulting granulate, and risks affecting the technological process were selected. were evaluated and a causal diagram (Ishikawa diagram) was drawn.

Introduction. The article discusses significant changes in the procedure for pharmaceutical inspection of drug manufacturers for compliance with the requirements of the rules of good manufacturing practice (GMP) of the Eurasian Economic Union (EAEU), related to restrictions due to the COVID-19 pandemic.

Text. The article presents the main international guidelines describing the remote conduct of pharmaceutical inspections, which is the basis for further updating the relevant procedures in the law of the EAEU. An overview of the foreign practice of pharmaceutical inspection during the pandemic is given. In addition, the changes in the Russian regulatory approaches to control and supervision in the Russian legislation are presented.

Conclusion. These data give an idea that, with considering the above, there is a need for further convergence of the requirements, the practice of conducting pharmaceutical inspections for compliance with the requirements of GMP Rules in order to harmonize the norms between Russian regulatory documents, the norms of the EAEU law and international standards. This requires the development of a dialogue with the participation of stakeholders.

Introduction. The publication is devoted to the role of laboratory research in ensuring the quality of domestic medicines and is a review and analysis of regulatory documents and current publications on this topic.

Text. A number of different types of laboratories are involved in Drug life cycle and ensuring their effectiveness and safety. Today there are a large number of regulations governing laboratory research. Common to all types of laboratories and regulatory documents is the need to organize an effective quality management system (QMS) for the drug life cycle laboratories. The aim of this review is to analyze approaches to regulating the quality of laboratory research of domestic drugs and to consider the most effective QMS model, which is fundamental for all types of laboratories in the life cycle of drugs.

Conclusion. The laboratory research quality system serves as a basic tool for achieving the ultimate goal - the clinical value of drugs and is designed to ensure that risks for patients are minimized. At the same time, each stage of the drug life cycle provides a solution to a specific problem on the way to this goal, which must be taken into account when building a QMS in each type of laboratory. The range of regulatory documents and external assessment systems (accreditation, certification, inspection control, etc.) in the field of domestic laboratory research is quite diverse. In this regard, it is advisable for the laboratory to build a harmonious QMS based on priorities in accordance with the goals and objectives. The most effective method for building such a system is an integrated management system model.

Introduction. Currently, herbal medicines are becoming increasingly popular. In this regard, of particular interest are medicinal herbal preparations based on rosehip fruits, which have a tonic, choleretic and wound healing effect due to the presence of ascorbic acid, flavonoids and carotenoids. According to the State Pharmacopoeia of the Russian Federation (SP RF) of the XIV edition, the determination of the main groups of biologically active substances (BAS) by thin-layer chromatography (TLC) is carried out only by the presence of ascorbic acid, while the sensitivity of the method does not allow it to be detected in rosehip fruits of low-vitamin species.

Aim. Aim is the development of new approaches to control quality and standardization of Rosehip fruits with using of modern pharmacognostic analysis methods.

Materials and methods. Prepared in Samara Region, the Republic of Mari El Rosehip fruits samples in 2020 and commercial samples from various manufacturers. TLC, UV/Vis-spectroscopy and high-performance liquid chromatography (HPLC) methods were used for determination the main BAS groups.

Results and discussion. The introduction of flavonoids as one of the definitioned groups of BAS in rosehip fruits along with ascorbic acid was justified. A technique for the identification of ascorbic acid by UV/Vis-spectroscopy (wavelength 264 ± 2 nm) was developed and shown the determination possibility of this substance by HPLC.

Conclusion. So phytochemical study results the expediency of the using of modern approaches to quality control and standardization of rosehip fruits, consisting in the qualitative determination of ascorbic acid by UV/Vis-spectroscopy and HPLC, as well as rutin by TLC, was justified.

Introduction. Silver nanoparticles have unique physicochemical properties and can be used for the diagnosis and treatment of various kinds of infections, oncological diseases, as well as drug delivery. The review presents an analysis of scientific literature on the use of silver nanoparticles for biomedical purposes.

Text. The review discusses the perspectives of the silver nanoparticles use in the treatment of oncological diseases as a carrier of drugs, as well as the direct manifestation of their cytotoxic effect on cancer cells. Also, there is considered the use of silver nanoparticles for imparting or enhancing the antibacterial effects of dressings and dental materials. The mechanism of action of silver nanoparticles against viruses is considered. This research presents the use of composite materials containing silver nanoparticles for biomedical purposes.

Conclusion. On the basis of the literature data analysis, carried out by the authors, there are shown possibilities of the nanotechnology achievements for the application in medicine.