Material provided by CHIMMED company.

Introduction. Cancer is one of the most serious and common diseases with a high level of mortality. Due to this reason the searching of new directions and methods of cancer treatment is becoming more and more important with each passing year. Significant advances in cancer immunotherapy have been reached over the past few decades. Moreover, an inhibition of the interaction between the programmed cell death receptor (PD-1) and its ligand (PD-L1), is sure to be perspective direction of the immuno-oncological therapy development.

Text. PD-1/PD-L1 interaction plays a pivotal role in negative regulation of immune system, that protects host’s cells and tissues from the excessive immune response. However, it is also used by tumor cells to avoid the host's immune system. The discovery of this mechanism led to the development of inhibiting PD-1 or PD-L1 agents that enhance anti-tumor immunity. Meanwhile, anti-PD-L1 agents provide less toxicity in comparison with anti-PD-1 agents. FDA currently approved Atesolizumab, Durvalumab, and Avelumab PD-L1 inhibitors for cancer treatment. These agents demonstrated effective response during the clinical trials, however, they are used for a limited number of oncological diseases. In addition, BMS-936559 is a promising agent that had passed the first stage of the clinical trials. Nevertheless, immunotherapy involving PD-L1 inhibitors is closely related to a vast number of severe side effects including immune-mediated effects caused by the inhibition of PD-L1 ligands located on healthy cells. In these terms, the development of new agents deprived of these disadvantages is the reason for further studies.

Conclusion. Immunotherapy in cancer uncovers new perspectives in treatment of refractory to standard therapies forms of cancer. And the development of new and improvement of existing PD-L1 blocking agents are of great importance in fighting against tumoral diseases.

Introduction. Naltrexone hydrochloride belongs to µ-opioid receptor antagonists and is widely used in the treatment of alcohol and drug addiction at an oral dose of 50 mg/day. It is also a blocker of other receptors – opioid growth factor and Toll-like factor, which is especially evident at doses of 1.5–5 mg/day. This allows it to be used to treat diseases associated with impaired immunity.

Text. To date, there is a significant amount of data indicating the effectiveness of naltrexone hydrochloride administered orally in doses from 1.5 to 5.0 mg per day for the treatment of significant diseases such as AIDS, cancer, autism, multiple sclerosis, etc. However, on the pharmaceutical market still lacks a drug that provides such doses. Due to the fact that oral administration of naltrexone is associated with its first-pass hepatic metabolism and the formation of significant amounts of substances that cause side effects of neuropsychiatric effects and gastrointestinal disorders, as well as the possible effect of naltrexone and its metabolites by other drugs, which in large amounts are used for these diseases, the creation of a parenteral dosage form is relevant.

Conclusion. The review presents current research in the field of low-dose naltrexone application, its mechanisms of action, and considers possible areas of application in medical practice. The disadvantages of oral administration are noted and an alternative route of administration such as intranasal is considered. Approaches to the development of a finished dosage form – nasal spray, are implemented when selecting the optimal content of the active substance and auxiliary components of the drug. The most promising is the creation of a drug based on thermoreversible polymers with a naltrexone hydrochloride content of up to 3,0 %.

Introduction. Buccal drug delivery has a number of advantages over oral administration: ease of application, good blood supply to the buccal mucosa, drug can enter the systemic circulation directly, avoiding the "first pass effect through the liver", and are not exposed to the acidic environment of the gastric juice and the destructive action of digestive enzymes. The use of interpolymer complexes (IPCs) makes it possible not only to ensure adhesion to the mucosal membranes of the oral cavity, but also to achieve a prolonged release of drugs.

Aim. Development of carriers based on interpolymer complexes using Carbopol^® 971 NF (C971) and poly(2-ethyl-2-oxazoline) (POZ) of different molecular weights for buccal delivery of metformin (MF).

Materials and methods. The study of IPC adhesion was carried out using a TA.XTplus texture analyzer (Stable Micro Systems, UK); mucin compacts with a diameter of 13 mm were used as a substrate; these were prepared by compressing porcine gastric mucin powder using a manual hydraulic press for IR spectroscopy (PerkinElmer, USA) at a pressure of 2.45 MPa. The study of the swelling capacity was carried out by placing polymer matrices in an artificial saliva medium, with constant thermostating at a temperature of 37.0 ± 0.5 °C for 5 hours. The study of the release of MF from the matrices based on IPC was carried out using a DFZ II apparatus (Erweka, Germany) according to the Flow Through Cell method (USP IV) with cells for tablets (22.6 mm) and adaptors for ointments, creams and gels in a medium simulating saliva. The concentration of MF in the samples from the dissolution tests was determined with UV-spectrophotometry (Lambda, PerkinElmer, USA) at 232.8 nm.

Results and discussion. In a comparative study of the mucoadhesive properties of polymer samples, IPC compacts showed a mucoadhesion capacity comparable to that of poly(2-ethyl-2-oxazoline); at the same time, compacts from physical mixtures (PM) and C971 are inferior in terms of the separation force to IPC samples, however, POZes dissolve in an artificial saliva medium, that is, they are not suitable as dosage forms for buccal delivery. For 5 hours of the experiment to assess the swelling capacity, the IPC matrices did not change significantly, which can ensure their comfortable use as carriers for buccal delivery. When evaluating the release of metformin from polymer matrices (with weight ratio MF/IPC 1: 0.5), the most complete release (more than 90 %) is observed from both IPC matrices compared to matrices of PM and individual polymers.

Conclusion. Polycomplex matrix systems based on C971-POZ (50 kDa) and C971-POZ (500 kDa) are suitable for buccal delivery of metformin.

Introduction. Effective delivery of ophthalmic drugs is challenging. The eye has a number of protective systems and physiological barriers, which is why ophthalmic dosage forms have a low bioavailability, usually not exceeding 5 %. Topical drug administration is relatively easy to use and is most commonly prescribed by physicians for the treatment of ophthalmic diseases, especially the anterior segment of the eye. However, when using traditional delivery systems, a number of problems arise: patients' violation of the drug administration technique, and, as a consequence, a decrease in treatment compliance, restriction of drug delivery to the target eye tissues due to low epithelial permeability and rapid clearance after drug administration. Maintaining a constant therapeutic drug level is another challenge that traditional delivery systems often fail to cope with.

Text. The article discusses the types of ophthalmic delivery systems. Traditional ones are represented by such dosage forms as eye drops, ointments, gels. Modern ophthalmic dosage forms are represented by: eye films, contact lenses and eye implants. The characteristics, advantages and disadvantages of each type of delivery systems and their promising directions of development, as well as modern developments in this area are given.

Conclusion. Currently, most of the scientific research on the development of ophthalmic delivery systems is devoted to obtaining dosage forms capable of maintaining a constant concentration of the drug in the target tissue, providing the transport of active ingredients to them. This is achieved by using modern advances in nanotechnology and polymer chemistry. Receive liquid and soft dosage forms with micro-, nano- and micro-nano-carriers. Polymeric delivery systems such as films, lenses and implants are being actively developed and studied. The development of modern technological approaches opens up new possibilities for the treatment of a wide range of ophthalmic diseases by reducing the side effects often induced by the intrinsic toxicity of molecules, reducing the frequency of the administered dose and maintaining the pharmacological profile of the drug. Thus, the use of modern ophthalmic delivery systems can significantly limit the use of invasive treatments.

Introduction. Usage of aggressive conditions (solvents, high temperature, etc.) in a dosage form manufacturing can lead to a change in the properties of a pharmaceutical substance. Darunavir (D) amorphous and darunavir ethanolate (DE) crystalline both have poor solubility, ability to pseudopolymorphism and are sensitive to high temperatures.

Aim. Study the effect of solvents and drying temperature on the physicochemical properties of D and DE substances

Materials and methods. D (Mylan Laboratories Limited), DE (Mylan Laboratories Limited), D (reference standard) 99,9 % (MSN Pharmachem Private Limited). D and DE weighed quantity was suspended in one of the solvents via magnetic stirrer and was dried via universal oven. Powder X-ray diffraction of dried samples was carried out via automatic powder diffractometer. Using DSC thermal properties of the samples were studied. Crystalline samples were examined using IR spectroscopy. Identification of D and DE was performed by HPLC method.

Results and discussion. This article summarizes study results of the investigation of various solvents and drying temperature influence on the physicochemical properties of D and DE are presented. The impact of solvent type and drying temperatures in physicochemical properties of the APIs was studied by X-ray powder diffraction, differential scanning calorimetry, IR spectroscopy and HPLC methods. It was shown, that solvent type and drying temperatures can result in the presence of crystalline D solvates or amorphous D.

Conclusion. To obtain the final drug containing as an API amorphous D, which perform better dissolution, one of the enlisted solvents can be used: dichloromethane, chloroform and heptane. In such case the intermediate product drying should be performed at not exceeding the solvent boiling point temperatures. In case of ethanol, methanol, acetone and tetrahydrofuran drying phase can be performed at temperatures, that are higher than melting points of obtained pseudopolymorphs. For the utilization of DE as an API only ethanol usage is efficient and drying temperature should not exceed 73.4 °C.

Introduction. Lemna minor L. (duckweed) refers to the duckweed subfamily (Lemnaceae S. F. Gray) and widely distributed in ponds of Russia. Literature data confirm the possibility of harvesting significant volumes of this raw material in natural habitat and grown in aquaculture. The process of biosynthetic accumulation in duckweed fronds provides a variety of compounds with a wide spectrum of biological activity. Therefore, the use of raw materials Lemna minor L. is promising for the development of drugs and parapharmaceutical products. Thus, it is an urgent task to quantify active components of duckweed and standardize (determination of criteria for identification, quality and safety) plant material.

Aim. Establish macro- and microscopic characteristics of raw materials and develop methods for the quantitative determination of the main groups of biologically active substances (BAS) for standardization of raw duckweed.

Materials and methods. Samples of duckweed was collected in natural habitats of Western Siberia. Macro- and microscopic assay, HPLC, UV-spectrometry were used in research process.

Results and discussion. Were established the criteria for identification of duckweed fronds by studying external (macroscopic) and microscopic features of raw material Lemna minor L. Was developed and validated the procedure of the quantitative determination of phenolcarboxylic acids in raw material Lemna minor L.

Conclusion. The study of external (macroscopic) and microscopic features provided the criteria for identification of the raw material Lemna minor L. The technique for the quantitative analysis of polysaccharides using gravimetry does not need validation, because is a direct method of substance measurement. Was validated quantification method of phenolcarboxylic acids (in terms of chlorogenic acid) by criteria of linearity, repeatability, in-laboratory precision and accuracy. Was established quality criteria for identification and quantitative assay, which can be used in the draft for normative documents for medicinal plant raw material of Lemna minor L. «Duckweed fronds».

Introduction. Among the different groups of drugs, diuretics are one the most popular classes that have been used for treatment of cardiovascular system and kidney diseases. At the same time, synthetic diuretics which are widely used, cause large amounts of side effects, such as violation of electrolyte, acid-base and water balances, carbohydrate and lipid metabolism. Therefore, it is important to search for individual compounds of plant origin – potential pharmaceutical substances for the treatment of urinary tract diseases. In this study individual compounds were isolated from the terrestrial parts of Ononis arvensis L. and Solidago canadensis L. The diuretic activity of the summary extracts of Ononis arvensis and Solidago canadensis has previously been proven.

Aim. Method development for the isolation of individual compounds, using modern physicochemical methods of analysis, from the terrestrial parts of Ononis arvensis and Solidago canadensis and the elucidation of their structure.

Materials and methods. Aerial parts of Ononis arvensis and Solidago canadensis were collected in the Saint Petersburg State Chemical-Pharmaceutical University (SPCPU) Nursery Garden of Medicinal Plants (Leningrad region, Vsevolozhsky district, Priozersk highway, 38 km) in August 2019 and identified by Dr. Goncharov Mikhail of the Saint-Petersburg chemical-pharmaceutical university, Saint-Petersburg, Russia. Fraction analysis were preformed with analytical high-performance liquid chromatography using a LC-20 Prominence (Shimadzu corp., Japan) with a SPD-M20A diode-array detector. Isolation of individual compounds was carried out by preparative high-performance liquid chromatography using a Smartline (Knauer, Germany). The structures of the isolated compounds were elucidated using 1D and 2D NMR experiments (Bruker Avance III 400 MHz) along with HR-ESI-MS (Bruker Micromass Q-TOF).

Results and discussion. Using the developed methods, from the aerial part of the field restharrow (O. arvensis) we managed to isolate and characterised three individual compounds (1-3). Compounds 1 and 2 are isloflavonoids – pseudobaptigenin-7-О-ß-D-glucopyranoside and formononetin-7-О-ß-D-glucopyranoside, respectively. Compound (3) is a flavonoid – kaempferol-3-O-ß-D-glucopyranoside (astragalin). All compounds were isolated for O. arvansis for the first time. Along with this, four individual compounds (4-7) were isolated from the aerial part of the canadian goldenrod (S. canadensis), namely, quercetin-3-O-ß-D-6''-acetylglucopyranoside, isoramnetin-3-О-ß-D-rutinoside (narcissin), quercetin-3-О-rutinoside (rutin) and quercetin, respectively.

Conclusion. As a result of the research, methods have been developed for the isolation of 7 individual compounds, using modern physicochemical methods of analysis, from the aerial parts of Ononis arvensis and Solidago canadensis, the structures of all the isolated compounds were elucidated. Future assessment of the isolated compounds biological activity is presumed.

Introduction. The species of the genus Hedysarum L. of the Fabaceae family are of significant interest in connection with the accumulation of a group of biologically active substances with antibacterial and antiviral activity against DNA-containing viruses.

Aim. The purpose of the work is to develop a method for the quantitative determination of mangiferin in the aboveground part of species of the genus Hedysarum L., Hedysarum caucasicum M.Bieb., Hedysarum grandiflorum Pall., Hedysarum daghestanicum Rupr. ex. Boiss. collected in the North Caucasus by zonal capillary electrophoresis.

Materials and methods. The objects of the study were species of the genus Hedysarum L., namely Hedysarum caucasicum M.Bieb., Hedysarum grandiflorum Pall., Hedysarum daghestanicum Rupr. ex. Boiss. collected in the North Caucasus. Registration of electronic spectra was carried out on capillary electrophoresis "KAPEL'®-105m" (OJSC "Lumex-marketing", Russia) with quartz capillary L_eff./L_tol. = 50/60 cm, ID = 75 μm. As a standard sample, mangiferin (substance-powder, mangiferin content ≥98 %, Sigma-Aldrich, Lot SLBP4044V) was used.

Results and discussion. As a result of comprehensive pharmacognostic studies of species of the kopecki genus growing in the North Caucasus under natural conditions, as well as under the conditions of introduction on the territory of the Botanical Garden of the Pyatigorsk Medical and Pharmaceutical Institute and the Mountain Botanical Garden of the Dagestan Federal Research Center of the Russian Academy of Sciences, we developed a method for the isolation and quantitative determination of mangiferin by capillary electrophoresis.

Conclusion. Studies show that the use of the zonal capillary electrophoresis method in the analysis of xanthones, including the determination of the quantitative content of mangiferin, is promising. The largest content of mangiferin (0.25 %) is distinguished by Hedysarum caucasicum M.Bieb., which confirms the assumption based on molecular genetic studies, since it is this species that belongs to the Obscura section, as well as the alpine penny used to produce mangiferin. Therefore, it is possible to provide this technique for analysis of mangiferin xanthone glycoside along with spectrophotometry and high performance liquid chromatography.

Introduction. The purpose of the analytical review is to summarize the data of modern scientific literature on the directions and possibilities of using the approaches of metabolomics in the analysis of medicinal plants, plant raw materials and herbal drugs.

Text. Analysis of literature data showed that metabolomic approaches have great potential in the field of quality control of multicomponent phytopreparations and biologically active additives, detection of falsifications of rare and expensive plant materials, chemosystematics of medicinal plants, study of the mechanisms of action and toxicity of medicinal plants, etc.

Conclusion. Metabolic analysis can become an effective analytical platform both for phytochemical research of plant raw materials and for regular activities to control the quality of plant material and phytopreparations.

Introduction. According to the XIV Edition of the Russian Federation State Pharmacopoeia, the quality control of the «Veratrum Lobelianum rhizome and roots» herbal substance is carried out through the determination of the alkaloid sum by means of the titration-based method. There are no selective and sensitive instrumental methods for the quantitative analysis of veratrum aqua active ingredients either. Veratrum aqua is produced from the mentioned above herbal substance. Therefore, the study of veratrum aqua alkaloid composition is relevant, as well as the development of a modern analytical method for individual alkaloid determination that can be implemented in veratrum aqua standardization.

Aim. To develop an approach to the quantitative analysis in Veratrum Aqua standardization.

Materials and methods. Two analytical methods were developed: one for the veratrum alkaloid determination in veratrum aqua samples by means of high performance liquid chromatography coupled with tandem mass-spectrometry (HPLC-MS/MS), another – for jervine, the main veratrum aqua alkaloid, quantitation by means of HPLC with diode-array detector (HPLC-DAD).

Results and discussion. Three main alkaloids, namely jervine, protoveratrine A and protoveratrine B, were identified in veratrum aqua. Jervine was found to be the most abundant one, hence it was chosen for the further development of a more affordable HPLC-DAD method. This method was validated for specificity, linearity, accuracy and precision. Jervine concentrations were measured in seven veratrum aqua samples produced by different manufacturers.

Conclusion. The highest jervine concentration among the examined samples was found to be 170 µg/ml, the lowest – 136 µg/ml. It is proposed to implement the following quantitative content parameter in veratrum aqua standardization: «Quantitative test. Jervine content should be not lessthan 136 µg/ml». This parameter is to be determined by HPLC-DAD.

Introduction. Due to the growth of laboratory-confirmed cases of pertussis among adolescents and adults, the spread of latent form of disease and the identification of asymptomatic carriage of the pathogen, the need arose to create a new vaccine against B. pertussis. On the basis of N. F. Gamaleya Federal Research Center for Epidemiology & Microbiology, a pertussis vaccine, containing attenuated B. pertussus bacteria, was developed. The article presents data on a clinical trial of the first phase of the pertussis vaccine “GumGVK, live intranasal vaccine for the prevention of pertussis” in healthy volunteers. Based on the results of the study, data shows the safety and tolerability of the first intranasal vaccine using on humans.

Aim. To Study the safety and tolerability of the vaccine "GamGVK, live vaccine for intranasal use for the prevention of whooping cough»

Materials and methods. Volunteers who expressed a desire to participate in the study were informed about its goals and objectives, conditions and requirements for participants, including the criteria for their inclusion/exclusion from the study. After signing the informed consent, the volunteers were screened for their compliance with the inclusion criteria. Screening studies and safety assessment of the drug were performed on the basis of anamnesis, subjective complaints, assessment of vital signs, ECG, peak flowmetry, results of laboratory tests of urine and blood, enzyme immunoassay of blood serum, analysis of nasopharyngeal aspirates for the presence of pertussis pathogen DNA, results of physical examination.

Results and discussion. The study involved 36 "healthy" volunteers aged 18–40 years. The average age of the volunteers was 26.2 ± 5.5 years. Not reliably identified AES associated with the use of GumGVK. None of the used doses of the drug led to the formation of local and General allergic reactions to intranasal administration of GumGVK.

Conclusions. The drug GumGVK is safe for nasal use, has good tolerance.

Introduction. Currently, physicochemical methods of quantification are actively used to determine the content of drugs in biological fluids. High-performance liquid chromatography with various detection methods is particularly widespread. One of the most difficult practical tasks is the chromatographic separation of so-called poorly retained compounds – drug substances poorly retained on the chromatographic column. Valganciclovir and Ganciclovir are among such substances.

Aim. The aim of this study is to develop a method for valganciclovir and ganciclovir in human plasma by high performance liquid chromatography with tandem mass-spectrometry (HPLC-MS/MS) for pharmacokinetic studies.

Materials and methods. Determination of valganciclovir and ganciclovir in plasma 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, recovery, lower limit of quantification, carry-over and stability.

Conclusion. The method of the determination of valganciclovir and ganciclovir in human plasma was developed and validated by HPLC-MS/MS. The linearity in plasma sample was achieved in the concentration range of 5.00–1000.00 ng/ml for valganciclovir and 50.00–10000.00 ng/ml for ganciclovir. Method could be applied to valganciclovir and ganciclovir determination in plasma for PK and BE studies.

Introduction. The publication discusses the state and problems of personnel retraining in the implementation of the pharmaceutical quality system at pharmaceutical enter-prises of the Eurasian Union (EU) countries.

Aim. The aim of the study is to comprehensively study the state and problems of retraining of personnel in the implementation of the pharmaceutical quality system at the enterprises of the production of medicines in the EU countries, and the development, based on its results, of scientifically grounded recommendations for the development of appropriate personnel retraining systems.

Materials and methods. The research methodology is based on a comprehensive analysis of scientific literature of foreign and domestic authors on pharmaceutical quality systems and good manufacturing practices, risk management in pharmaceutical industries and personnel in the implementation of FQS, aspects of personnel training and retraining.

Results and discussion. It has been proven that retraining of personnel is an important factor in promoting the introduction of FQS in pharmaceutical industries. On the example of the companies Akrikhin JSC and OZON Pharmaceuticals, aspects of advanced technologies for the development of retraining systems for production personnel in the implementation of FQS are considered. Based on the synthesis of theory and practice, practical recommendations have been prepared for the implementation and development of targeted integrated systems for retraining personnel in the context of comprehensive assistance in the implementation of FQS in pharmaceutical industries at enterprises in the countries of the Eurasian Union.

Conclusion. The key role of systematic and high-quality retraining of personnel in the context of comprehensive assistance to the implementation of FQS in pharmaceutical and biopharmaceutical industries at enterprises in the EU countries was confirmed. Despite the numerous problems and contradictions that determine the low level of development of the relevant personnel retraining systems, meanwhile, when implementing a set of optimization measures, such systems can successfully function and provide the desired effect, as evidenced by the studied best practices in promoting the implementation of FQS at certain leading enterprises of the pharmaceutical industry. The recommendations presented by the authors based on the results of the study are comprehensively focused on practical implementation in order to steadily improve the theory and practice of retraining of pharmaceutical production personnel in the context of FQS implementation.

Introduction. The publication is devoted to the topical organizational and personnel issues of the implementation of the pharmaceutical quality system (PQS). The relevance of the study is due to the high importance of quality assurance in the development, production and release of drugs into circulation.

Aim. The aim: to develop guidelines for organizational and personnel assistance in the implementation of pharmaceutical quality systems at enterprises of the Eurasian Union (EAEU) for the production of medicines (drugs) through the toolkit for engaging production personnel in the development of PQS.

Materials and methods. Personnel engagement was assessed based on the engagement index; the benchmarking method was used when studying the impact of the engagement of production personnel on the economic indicators of corporate development (indicators of engagement and related economic indicators of “Akrikhin”, “Ozon” were compared with a panel of similar indicators for 12 pharmaceutical enterprises of the EAEU).

Results and discussion. The important role of ensuring an increase in the engagement of production personnel in the development of PQS as a tool for sustainable provision of the effectiveness of the implementation of PQS and standards of good manufacturing practice (GMP) at drug production enterprises is stated. Taking into account the experience of forming quality circles in classical Japanese management, an innovative toolkit for managing the engagement of production personnel is proposed, based on the formation of employee communities, coordination and management of their engagement and development through the corporate portal of a pharmaceutical enterprise, as well as membership in closed clubs of ‘quality leaders’.

Conclusion. Management of communities (small groups) of production workers is considered as a tool for improving the organizational and personnel support for the implementation and improvement of PQS / GMP at the EAEU pharmaceutical manufacturers. Through the communities, it is proposed to simultaneously manage the engagement, loyalty and job satisfaction of production personnel; community members, through the exchange of best manufacturing practices, ideas and opinions on the development of PQS and the improvement of nuclear quality assurance practices, will stimulate themselves and other production workers to consistently ensure the quality of manufactured drugs. The expected result is a steady increase in the quality of manufactured drugs, adherence of production personnel to the quality philosophy, creation of conditions for the growth of labour productivity of production personnel of pharmaceutical enterprises.

Introduction. The trends in the modern pharmaceutical industry demonstrate the need for proper documentation of all stages of the life cycle of a medicinal product to ensure its quality and eliminate risks to patients. Therefore, documenting pharmaceutical development, as the first stage of this cycle, is relevant. It will allow regulating technological processes, product quality indicators, as well as ensuring the integrity of the data received. It is advisable to document the pharmaceutical development taking into account the requirements established at the enterprise where the industrial production of this drug is planned.

Aim. Development of documentation for pharmaceutical development within the pharmaceutical quality system of the enterprise. One of the objectives of the study was to analyze the document flow of the pharmaceutical quality system of the enterprise planning the production of suppositories for the proper development of documentation for the pharmaceutical development of a medicinal product in this dosage form.

Materials and methods. During the research the following methods were used: content analysis; system analysis; sociological (survey method); SWOT analysis technology; systems approach.

Results and discussion. In order to get acquainted with modern trends related to pharmaceutical development and pharmaceutical quality system, at the first stage, an analysis of the ICH (International Council on Harmonization) guidance document Quality Implementation Working Group on Q8, Q9 and Q10 Questions & Answers was carried out. An important preparatory stage for the optimal documentation of a pharmaceutical development was the study of the document flow of the pharmaceutical quality system of an enterprise planning to produce two-component suppositories. For this purpose, in the course of the research, a questionnaire was developed containing questions related to the functioning of the quality system, documentation processes and production. The analysis of the received responses made it possible to obtain information on documenting the pharmaceutical development of medicinal products, as well as to identify the main trends associated with this process within the pharmaceutical quality system.

Conclusion. The documentation of the pharmaceutical quality system of the enterprise planning the production of suppositories has been analyzed. The strengths and weaknesses of the documentation are identified, a number of proposals for improving the documentation system are highlighted. Based on the results obtained, proposals will be developed for the optimal documentation of pharmaceutical development and a set of documents for an enterprise planning to produce two-component suppositories will be formed.