The conference will take place on June 25 in Moscow in a live format. The conference is organized by LLC "CPHA" and the scientific and production journal Drug development & registration.

Organic solvents are widely used in the synthesis of pharmaceutical products and cannot always be completely removed during the manufacturing process. To ensure safety, the end products are tested for the residual content of solvents used in manufacturing processes, how efficiently they are removed or, if they are still present, whether their concentration is within acceptable limits. The results presented in this paper demonstrate that the new TriPlus 500 HS autosampler, combined with the Trace 1310 GC and FID detector, provides the performance needed for the analysis of residual solvents in pharmaceutical products, meeting or exceeding USP <467> method requirements.

Focusing on patient safety and meeting his individual needs is a new trend, resulting in new requirements for drugs and their delivery vehicles. It is obvious that the growing demands on cleanliness can only be met with using ultra-clean packaging throughout the supply chain. Both secondary and primary packaging must be produced in a "clean room" environment to meet all existing standards.

Introduction. Azomethine derivatives of 2-amino-4,5,6,7-tetrahydro-1-benzothiophene-3-carboxamide are acyclic precursors of biologically active compounds derived from 5,6,7,8-tetrahydro-3H-benzoteopheno[2,3-d]pyrimidine-4-one. Examples of these groups of compounds with different pharmacological properties are given in the literature, but their cytostatic effect is mainly described. These data and the preparative availability allow us to judge the prospects for further study and molecular design in a number of azomethine derivatives of 2-amino-4,5,6,7-tetrahydro-1-benzothiophene-3-carboxamide. Optimization of methods for the synthesis and analysis of substances of this series and the identification of structure-activity relationship are of considerable interest for medical chemistry and pharmaceutical science. The resulting leading compounds will allow us to further develop laboratory requirements for the synthesis of an active pharmaceutical substance.
Aim. To make a predict, optimize the synthesis conditions and develop a method for high performance liquid chromatography (HPLC) analysis of pharmacologically active azomethine derivatives of 2-amino-4,5,6,7-tetrahydro-1-benzothiophene-3-carboxamide.
Materials and methods. The prediction of biological activity was carried out through the web resource PASS Online. The synthesis of the target azomethines was carried out by the interaction of aromatic aldehydes with 2-amino-4,5,6,7-tetrahydro-1-benzothiophene-3-carboxamide in an ethanol. The reaction was monitored by thin-layer chromatography (TLC). The determination of related impurities was done by HPLC. The analysis was carried out under the conditions of isocratic elution with a mobile phase of acetonitrile – water (70:30).
Results and discussion. The results of the prediction of the biological activity of the constructed structures suggest the manifestation of cytostatic, antitubercular and anti-inflammatory activity characteristic of all target azomethines. The analysis of the reactivity revealed the influence of substituents of aldehydes contained in the aromatic core on the completeness of the condensation reaction. The spectral characteristics clearly confirmed the structure of the products, and the HPLC results showed the purity of the obtained substances, which is more than 95 %.
Conclusion. As a result of the conducted studies, the structure of promising azomethine derivatives of 2-amino-4,5,6,7-tetrahydro-1-benzothiophene-3-carboxamide was justified and the method of their synthesis and analysis by HPLC was optimized. In the future, the results of the research will allow us to identify the leading compounds with the specified pharmacological properties.

Introduction. Thioctic (α-lipoic) acid is an endogenous antioxidant and is used for liver diseases, poisoning with salts of heavy metals, hyperlipidemia, atherosclerotic heart disease, neuropathy, insulin-resistant forms of diabetes mellitus, etc. technologies for producing tableted medicinal preparations of thioctic acid, necessary for the pharmaceutical development of thioctic acid tablets at pharmaceutical industry enterprises.
Text. The review considers the physicochemical properties of the pharmaceutical substance thioctic acid, the features of its pharmaceutical and technological properties, and compatibility with excipients. In the technology of thioctic acid tablets, methods of direct compression and compression with preliminary wet granulation, including those using organic solvents, are used. To increase photostability, thioctic acid tablets are coated. Information on excipients in the composition of core tablets and film coat of thioctic acid tablets registered in Russia is presented. The problems of tabletting thioctic acid are described: sintering of the granulate during the drying process, adhesion of the tabletting mass to the pressing tool and the resulting unevenness of the tablet surface. The ways of optimizing the tabletting process of thioctic acid using various compositions of excipients, improving the flowability of a pharmaceutical substance both during its synthesis and as a result of technological processing, choosing the optimal modes of granulation, drying, pressing are considered.
Conclusion. As a result of the analysis of the literature data, the features of the technology for producing thioctic acid tablets were revealed, which are due to the high content of the pharmaceutical substance in tablets (up to 600 mg), the need to use a minimum amount of excipients (from 27 to 51 %), poor flowability, and low melting point of the pharmaceutical substance. Improvement of compressibility and prevention of adhesion can be achieved by using the pharmaceutical substance thioctic acid of a certain granulometric composition, auxiliary substances of the basic nature and a high content of glidants (up to 6 %). The identified manufacturing features should be taken into account in the pharmaceutical development of thioctic acid tablets.

Introduction. The presence of biologically active substances in the extract from the roots of turmeric extract (Curcuma longa L.) makes it reasonable and makes it possible to predict their effectiveness in pathological conditions caused by oxidative stress and immune disorders arising against its background. Based on data obtained, a pattern was revealed in improving the solubility of the combination of methionine and turmeric extract, which includes auxiliary substances. Dosage form – granules with methionine and liquid turmeric extract, with enteric coat can be used to eliminate the consequences of oxidative and immune disorders, treatment and prevention of systemic diseases caused by oxidative stress.
Aim. Biopharmaceutical and in-process tests of the pharmaceutical composition of granules with methionine and liquid turmeric extract.
Materials and methods. The object of the trials was the multicomponent drug containing methionine and a liquid turmeric extract of the roots. The proposed composition of plant compositions is original, had no analogues and protected by a patent for an invention (RU 268 4111). To assess the pharmaceutical properties, biopharmaceutical trials carried out by the UV-spectrophotometric method using biorelevant medium. The research results statistically processed using Statistica for Windows, version 10.
Results and discussion. Based on the data obtained, a pattern revealed in improving the solubility of the combination of methionine and turmeric extract, in contrast to the multicomponent composition containing only turmeric extract.
Conclusion. The developed multicomponent pharmaceutical composition will expand the register of herbal medicines of domestic production for the prevention and treatment of diseases caused by oxidative stress.

Introduction. Microencapsulation is one of the promising areas for obtaining new dosage forms. The peculiarity of microencapsulated forms is that the substance is protected from the effects of various environmental factors that can cause their destruction (acidity of gastric juice, the effect of food, joint intake of other drugs, diseases of the gastrointestinal tract, etc.). This method is used for various groups of drugs, such as antibiotics, nootropics, vitamins, probiotics, anticonvulsants, enzymes. Particular attention should be paid to antibacterial drugs, since the possibility of microencapsulation solves one of the most important problems in antibiotic therapy – the resistance of microorganisms.
Text. The purpose of the review is to analyze modern research in the field of microencapsulation, to study trends and directions for the creation of microcapsules with high activity and bioavailability and with minimal side effects. The article provides brief information and main conclusions on the development of techniques and selection of conditions for microencapsulation of individual medicinal substances, on the study of polymers of various natures for use as carriers, on the methods of forming double shells of microcapsules, and also investigated the efficiency of microencapsulation of biologically active substances, such as antibacterial preparations, substances of plant and animal origin and preparations from various pharmacological groups. Variants of microencapsulation techniques for specific compounds that are suitable for substances similar in composition and action, as well as methods for creating microcapsules with double shells for compounds insoluble in water, are presented.
Conclusion. The article shows the achievements and prospects of using microencapsulation of medicinal substances and their advantages over standard dosage forms. The active introduction of the developed methods into production will allow the creation of new dosage forms with known medicinal substances that have a prolonged effect, which will reduce the frequency of use of the drug, as well as retain their activity under the influence of negative factors of the internal environment of the body. Also, in the form of microcapsules, the substances are more active in comparison with non-encapsulated substances.

Introduction. Currently, for the treatment of gastric ulcer, drugs with a combined effect are used. To eliminate possible side effects of the drugs used, the search for new molecules to create more effective and safe histamine H₂ receptors continues. As a possible solution to these problems, we investigated the substance dinitrate of 2-phenyl-9-diethylaminoethylimidazo[1,2-α]benzimidazole (DFDB).
Aim. The aim of this study was to obtain 2-phenyl-9-diethylaminoethylimidazo[1,2-α]benzimidazole dinitrate tablets and develop methods for quality control.
Materials and methods. The object of study was tablets based on the substance DF DB. The physicochemical and technological properties of the tablet dosage form were studied. Pharmaco-technological and physico-chemical indicators were determined according to the methods of the State Pharmacopoeia of the XIV edition. Identification and quantitative determination of DFDB in tablets was performed by HPLC.
Results and discussion. Based on the physico-chemical properties and determination of the main technological indicators of DFDB, an optimal tableting technology has been developed. The optimal composition of tablets has been developed. Identification of tablets is proposed to be carried out using HPLC in comparison with the standard sample of DFDB. Related impurities, according to the data obtained, do not exceed 0.1 %. We found that the tablets do not have an antimicrobial effect. The analyzed tablets correspond to category 3A. The content of DFDB should be from 95 to 105 % of the declared amount in one tablet. During the analysis, we conducted biopharmaceutical and technological studies of the finished dosage form during storage under the conditions of long-term stability testing in polymer cans with screw-on lids. It is shown that the selected composition of excipients and the production technology ensure the stability of the finished dosage form for two years of storage under the observed conditions. To select the tableting technology, the main technological properties of the DFDB substance are analyzed. The choice of excipients and the composition of the film coating was carried out.
Conclusion. The technology is developed and standardization of tablets based on the substance DFDB is proposed.

Introduction. As is known, the selection of optimal conditions for the analysis of extracts from medicinal plant raw materials (MPМ), as well as medicinal herbal preparations and pharmaceutical substances of plant origin, characterized by a complex variable composition of biologically active substances (BAS) by TLC, presents certain difficulties. For the design of mobile phases for the separation of mixtures of BAS of plant origin, in a thin layer of sorbent, the following approaches are used: literary sources; standard mobile phases; spot elution method; the scheme proposed by the firm Camag (Switzerland); model "PRISMA"; variocameras and others. In foreign literature, there are publications on the generalization of the available experimental data on the determination of various natural groups of BAS in objects of plant origin. However, such reviews did not reveal the regularities of the chromatographic behavior of individual BAS in a thin layer, as well as the influence of various factors on the reproducibility of R_f values. The study of the possibility of a theoretical approach to the choice of optimal conditions for chromatography of groups of BAS of different polarity, allowing them to separate, identify and quantify by TLC is a relevant and poorly developed area of chromatography in general.
Aim. The aim of this work was to develop a theoretical approach to the choice of optimal conditions for the chromatographic separation of various groups of BAS of plant origin in a thin layer of sorbent.
Materials and methods. To study the regularities of chromatographic behavior in a thin layer of representatives of the main classes of BAS present in MPМ (amino acids, flavonoids, tannins, simple sugars, ascorbic acid, fat-soluble vitamins), the value of the main factor affecting the parameters of the efficiency of the chromatographic process, the polarity of the eluent, was studied. As objects of research, we used ready-made chopped raw material of nettle leaves, produced by a domestic manufacturer, that meets the requirements of regulatory documents, as well as sea buckthorn fruits collected on the territory of the Voronezh region, according to the rules for harvesting MPМ of various morphological groups in fresh and dried form.
Results and discussion. The regularities of elution and mathematical models describing the chromatographic behavior of plant BAS in a thin layer of sorbent have been established. Based on the totality of the results obtained, from the standpoint of the efficiency of the chromatographic process, the optimal conditions for their TLC analysis were selected and theoretically substantiated. To study the qualitative composition of BAS and to achieve a clear separation of zones on chromatograms, TLC methods were developed and tested on the studied MPМ using simple, frontal or two-dimensional chromatography.
Conclusion. It is shown that the determination and separation in a thin layer of the sorbent of hydrophilic and lipophilic BAS of MPМ in the presence of a joint requires different approaches and techniques. The paper proposes an algorithm for the selection of the mobile phase and methods of chromatography of BAS of medicinal products. The revealed mathematical models describing the chromatographic behavior of BAS will make it possible to select the conditions under which it is possible to determine the individual components of multicomponent mixtures without preliminary separation. The developed methods for the determination of BAS can also be used for standardization and quality assessment of other types of MPМ, phytopreparations and pharmaceutical substances of plant origin.

Introduction. Urinary tract infections are a common group of diseases worldwide, affecting more than 150 million people every year. In about 30 % of patients with initial infection, UTI becomes chronic. Herbal medicines, along with synthetic diuretics and antibiotics, are widely used for the prevention and treatment of UTIs, which makes the search and isolation of various substances from plant materials an important task. The present study is devoted to the isolation of compounds belonging to the class of proanthocyanidins from the aerial part of the black crowberry (Empetrum nigrum L.).
Aim. Method development for the isolation of individual dimeric type A proanthocyanidins from the aerial part of Empetrum nigrum and the elucidation of their chemical structure using modern physicochemical methods of analysis.
Materials and methods. Shoots of Empetrum nigrum were collected next to the Saint Petersburg State Chemical-Pharmaceutical University Nursery Garden of Medicinal Plants (Leningrad region, Vsevolozhsky district, Priozerskoe highway, 38 km) in August 2019. Fraction analysis was performed through analytical high-performance liquid chromatography (HPLC) using a Prominence LC-20 (Shimadzu corp., Japan) equipped with a SPD-M20A diode-array detector, as well as by high performance thin layer chromatography (HPTLC) using a CAMAG HPTLC system (Switzerland). The isolation of compounds was carried out by open column chromatography using sorbents with different selectivity, as well as by preparative HPLC using a Smartline system (Knauer, Germany) equipped with a spectrophotometric detector. The structures of the isolated compounds were established by 1D and 2D NMR experiments (Bruker Avance III 400 MHz, Germany), as well as high-resolution mass spectrometry (HR-ESI-MS) (Bruker Micromass Q-TOF, Germany).
Results and discussion. Using the developed methods, from the Empetrum nigrum shoots we managed to isolate and characterised three individual compounds belonging to the class of A-type proanthocyanidins. According to NMR and mass spectrometry data, compound 1 is epicatechin-(2β → O → 5, 4β → 6)-epicatechin, with an extremely rare type of intermonomer bond (2β → O → 5, 4β → 6). Compounds 2 and 3 are epicatechin-(2β → O → 7, 4β → 8)-epicatechin (procyanidin A2) and epicatechin-(2β → O → 7, 4β → 8)-catechin (procyanidin A1), respectively. All individual compounds (1-3) were found and isolated from Empetrum nigrum for the first time.
Conclusion. As a result of the research, three individual compounds (A-type proanthocyanidins) were isolated from the aerial part of Empetrum nigrum. All individual compounds (1-3) were found and isolated from Empetrum nigrum for the first time. Future assessment of the isolated compounds biological activity is presumed.

Erratum

Introduction. An inadequate diet and living in the northern regions can lead to a lack of vitamin D₃ and the development of diseases, including a decrease in immunity. To compensate for the lack of vitamin D, vitamin drugs are used that contain vitamin D in one of its active forms (usually in the form of cholecalciferol, vitamin D₃).
Aim. To develop and validate HPLC-UV method for the determination of vitamin D₃ in vitamin drugs and to evaluate the content of cholecalciferol in selected drugs anddietary supplements presented in the Russian Federation.
Materials and methods. Determination of vitamin D₃ was carried out by HPLC with UV detection at a wavelength 266 nm. Sample preparation of vitamin drugs was carried out by extraction with methanol (for liquid dosage forms based on aqueous or triglyceride solutions) and extraction with an aqueous-methanol solution (for solid dosage forms based on water-soluble substances with vitamin D₃) in a ratio of 2 to 8 (water-methanol).
Results and discussions. The analysis methodology for the parameter "Vitamin D₃ (cholecalciferol) content" in vitamin dosage forms by HPLC was validated according to the following validation parameters: specificity; accuracy; precision; linearity; range.
Conclusion. The analysis methodology for the parameter "Vitamin D₃ (cholecalciferol) content" in vitamin dosage forms by HPLC was developed. The method was validated according to the following validation parameters: specificity; accuracy; precision; linearity; range. The range of the method was 9,5–38 μg/ml. The method was used to determine vitamin D₃ in vitamin drugs based on water-soluble forms of vitamin D₃, in the form of aqueous solutions and form of fatty acids triglyceridessolutions.

Introduction. Acute toxicity of naltrexone hydrochloride nasal spray during intragastric administration to mice and local irritant effect on rabbits was studied. At all stages of the experiment, observations were made on the General condition of the animals. The state of homeostasis was evaluated using functional, hematological and morphometric methods. According to the results of research, there was no local irritant effect on the eyes of rabbits, as well as no toxic effect of high doses of the drug on animals. Introduction. Naltrexone hydrochloride in doses of 1.5– 5 mg/day has shown its effectiveness in the treatment of a number of diseases. Due to the lack of such a "low-dose" naltrexone registered on the pharmaceutical market, we have developed the composition of the nasal spray naltrexone hydrochloride. One of the stages of our research is to study the safety of the drug being developed. The first step in this direction was to study its acute toxicity and local irritant effect.
Aim. Study of acute toxicity and local irritant effect of naltrexone hydrochloride nasal spray.
Materials and methods. The object of the study was a nasal spray of naltrexone hydrochloride. Acute toxicity studies were performed on outbred adult mice (females). Study of local irritant effect on Soviet chinchilla rabbits (males).
Results and discussion. The study of acute toxicity showed that the drug, at a dose significantly higher than the estimated maximum daily therapeutic dose for humans, did not have a significant toxic effect on the body of laboratory animals. The presence of a local irritant effect in the studied drug was not established in the framework of the experiment.
Conclusion. As part of the experiment, the drug under study did not have a local irritant or toxic effect on the animal body. The results obtained allow us to continue the development and study of the nasal spray naltrexone hydrochloride.

Introduction. The study of pharmacokinetics of medicinal substances and evaluation of their pharmacokinetic parameters is a necessary stage of pharmaceutical development of original medicinal agents, allowing to choose the composition and dosage form of the preparation. This is due to obtaining characteristics of all processes that occur in the body of an animal (human), from the absorption of a drug from the place of administration to its excretion from the body.
Aim. To conduct a study of the pharmacokinetics of the pharmaceutical substance and the complex compounds based on it to confirm the pharmaceutical development of a drug of 1-[2-(2-benzoylphenoxy)ethyl]-6-methyluracil and to justify the optimal composition of the ready dosage form (GLP).
Materials and methods. The study was carried out on male rabbits with a single oral administration of investigated objects in one dose. Plasma concentrations of 1-[2-(2-benzoylphenoxy)ethyl]-6-methyluracil were determined by high performance liquid chromatography (HPLC) with ultraviolet (UV) detection. Pharmacokinetic parameters were calculated by extramodel method of statistical moments.
Results and discussion. Assay 1-[2-(2-benzoylphenoxy)ethyl]-6-methyluracil quantification in rabbit blood plasma by HPLC has been developed and validated in the concentration range 10–720 ng/ml in accordance with modern requirements and satisfies them for all indicators. Assay was applicated to analysis of plasma samples obtained from laboratory animals after a single oral administration of a substance and solid dispersion systems of 1-[2-(2-benzoylphenoxy)ethyl]-6-methyluracil in one dose. The main pharmacokinetic parameters of the studied objects were calculated after obtained plasma concentrations of 1-[2-(2-benzoylphenoxy)ethyl]-6-methyluracil. It was found that the solid dispersion system with Kollidon 17PF has the greatest relative bioavailability from the examined objects; its relative bioavailability to the substance by oral administration was 583 %.
Conclusion. The solid dispersion system method increased the bioavailability of 1-[2-(2-benzoylphenoxy)ethyl]-6-methyluracil. Obtained results confirmed correctness of solid dispersion system selection drug e composition and technology development.

Introduction. Gestobutanoil is a synthetic pregnane steroid with gestagenic activity. Gestobutanoil has two pharmacologically active metabolites (AMOL and megestrol acetate). This implies the need for a detailed study of the kinetics of metabolites. It is rational to combine the study of the pharmacokinetics of gestobutanoil and its metabolites (AMOL and megestrol acetate). The simultaneous determination of several analytes in the rats’ serum can be carried out using chromatography-mass-spectrometry.
Aim. Development of an analytical method for the simultaneous determination of gestobutanoil and two its metabolites in a biomatrix (rat serum).
Materials and methods. The following methods were used to determine gestobutanoyl and two its metabolites in a biological matrix: GC-MS, HPLCESI-MS, HPLC-ESI-MS with derivatization, HPLC-APCI-MS.
Results and discussion. When working with GC-MS, the chromatographic peaks of gestobutanoyl, AMOL, and megestrol acetate were strongly blurred and superimposed on each other, which is apparently due to the thermolability of the substances. The GC-MS method was abandoned in favor of HPLC. Analytes were separated by HPLC gradient elution on a C18 column. ESI ionization did not give typical protonated ions of gestobutanoyl and AMOL, and the intense signals of their cationized ions and fragment ions, which were observed in the spectra of AMOL and gestobutanoyl, could not ensure the reproducibility of the spectra, since the conditions of their formation are not suitable for routine analysis. Derivatization of analytes to form oximes and substituted hydrazones did not give the expected reaction products for HPLC-ESI-MS. APCI made it possible to remove intense cationized ions from the spectra of gestobutanoyl and AMOL and to increase the reliability of the method. The HPLCAPCI-MS technique was reproduced on model rat blood serum.
Conclusion. An HPLC-MS method was developed for the simultaneous determination of gestobutanoyl, megestrol acetate, and AMOL. The technique was tested on a model rat blood serum containing all three analytes.

Introduction. Tranexamic acid is one of the most common drugs used to stop bleeding after trauma, in surgery and gynecology. The most common analytical method for the determination of this compound is reversed-phase high-performance liquid chromatography (HPLC). However, this compound belongs to the group of so-called poorly retained compounds due to its chemical structure. It is necessary to develop an analytical method that will allow the determination of tranexamic acid in human blood plasma with the least time, resource costs and without the use of specialized columns.
Aim. The aim of this study is to develop a method for tranexamic acid in human plasma by high performance liquid chromatography with tandem mass-spectrometry (HPLC-MS/MS) for pharmacokinetic studies.
Materials and methods. Determination of tranexamic acid 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 effect and stability.
Conclusion. The method of the determination of tranexamic acid in human plasma was developed and validated by HPLC-MS/MS. The linearity in plasma sample was achieved in the concentration range of 100.00–15000.00 ng/ml. Method could be applied to tranexamic acid determination in plasma for pharmacokinetics and bioequivalence studies.

Introduction. The objective necessity of the appearance of this code of laws for the pharmaceu-tical industry is shown. The proofs of the readiness of all branches of pharmacy to develop the text of the Pharmacopoeia, taking into account modern international requirements for scientific and practical activities in the development, manufacture and production of medicines, are presented.
Text. The work presents the history of the creation of the VII edition of the State Pharmacopoeia of the USSR. The sequence of steps for the formation of the Pharmacopoeia Commission, the stages of its activities for the preparation of the updated text of the Pharmacopoeia is described, a detailed analysis of the prepared text is given in comparison with the current Pharmacopoeia of the VI edition (1910). Various points of view of experts on the content of the main text are cited, which served as the basis for the new document. The role of domestic scien-tists-pharmacists in the development and publication of the VII edition of the State Pharmacopoeia of the USSR is evaluated.
Conclusion. The role of the Pharmacopoeia Commission in the timely development of the text of the new edition of the State Pharmacopoeia is emphasized. The fact of its wide discussion among experts and the novelty of the approach, which gave a powerful impetus to the development of the entire industry, are noted.

Introduction. Different approaches are used for transfer of impurities determination methods. In most cases, comparative testing of samples or partial validation of methods is performed. At the same time, a number of issues important for practice are still relevant.
Text. The features of methods validation and comparative testing of samples during the transfer of impurities determination methods are considered. Potential acceptance criteria – requirements to the permissible difference between results of transmitting and receiving laboratories – are given. The calculation formulas of the TOST test are considered, and the critical condition for the comparative testing of samples is given. The key points that should be taken into account when transferring the methods are discussed.
Conclusion. The data and recommendations are presented, which are important for increasing the reliability of the transfer of the impurities determination methods.

Introduction. In the process of pharmaceutical development of a medicinal product, it is necessary to substantiate the composition of the medicinal product; develop a technology for a finished dosage form (including a primary packaging system); create documentation for various stages of product development; validate analytical methods and technological processes. Information obtained in the course of experimental research and development of a medicinal product is included in the registration dossier. Documenting a pharmaceutical development allows you to systematize knowledge about monitoring technological processes, product quality indicators, and present the integrity of the data obtained.
Aim. Creation of documentation for pharmaceutical development within the pharmaceutical quality system of the enterprise.
Materials and methods. In the course of the research, the following methods were used: content analysis; system analysis; systems approach.
Results and discussion. On the pharmaceutical development of two-component suppositories within the FGC, based on the knowledge gained about the process and the product and taking into account the risk analysis, we have created documents that were adapted to the enterprise's document flow to optimize the documentation process at the subsequent stages of the drug's life cycle. For optimal documentation of the first stage of drug development, a list of documents is proposed, including: Report on the pharmaceutical development of two-component suppositories; specifications for raw materials and materials, intermediate products, finished products; standard operating procedures during the pharmaceutical development phase; Guidelines for monitoring processes and product quality; Instructions for corrective and preventive actions (CAPA), change management, management review; report on the analysis of the effectiveness of the quality assurance system in the pharmaceutical development of two-component suppositories. The proposed set of documents makes it possible to form a single base of knowledge and results obtained at this stage, to systematize and structure them.
Conclusion. In the course of the pharmaceutical development of two-component suppositories, knowledge has been generated about the process of creating a product of proper quality. A set of documents has been developed, consisting of reports, specifications, standard operating procedures, instructions, for an enterprise planning to produce two-component suppositories. Pharmaceutical development documentation is adapted to the enterprise document flow to optimize the documenting process at the subsequent stages of the drug product life cycle.

Introduction. One of the main business objectives of Russian pharmaceutical companies is export development. To obtain marketing authorization in countries with a good potential for business it is of greater importance to be competent in drugs registration procedure.
Aim. The purpose of this study is to overview general aspects of registration procedure for generic drugs in Georgia for potential launching on pharmaceutical market.
Materials and methods. For research purposes we have utilized data obtained from research articles, official websites, regulatory documents for drug registration procedure in both Russian Federation and Republic of Georgia, and documents of registration dossier. Also for this research we have applied benchmarking study, generalized and classified obtained information.
Results and discussion. The similarities and differences of drug registration procedure have been determined, e.g. timelines, dossier format, and legal frameworks in both Russian Federation and Republic of Georgia. Also we have emphasized a list of features that could be benefiting for drug registration in Georgia.
Conclusion. A review of the state regulation procedure in the field of drug circulation in the Republic of Georgia allows us to conclude that there are favorable conditions for state registration of drugs from a Russian manufacturer.