Domestic Pharmaceutical Market Research Articles

The opinion of pharmacists about the pharmaceutical category of herbal medicines. Survey of pharmacy retail employees

Abstract. The category of herbal medicines is represented in the domestic pharmaceutical market in the form of two main groups of pharmacy product assortment – herbal medicinal preparations (HMP) and dietary supplements (DS). They often have similarities in terms of composition, dosage form, and scope of application. Hence, attitude of professional specialists that influence consumer demand and choice, to these groups of pharmacy products is important to be considered. Aim. The purpose of the study is to assess the level of knowledge, prevailing ideas, differences in the perception of HMP and DS among pharmacists working in pharmacy retail. Materials and methods. The survey of pharmacists was conducted using a specially designed questionnaire using the Google forms electronic resource. 162 specialists with at least 1 year of experience in the pharmacy sector participated in the study. The study was conducted on the basis of the “Evalar Pharmacy” pharmacy network, specializing in the sale of herbal medicines. Results. The majority of the surveyed specialists noted urological (54.0%) and neurological diseases (52.1%) as therapeutic areas where herbal medicines have real clinical value. The leading role of retail pharmacists in the choice of products by consumers was noted by 40.1% of respondents. The possibility of replacing HMP with DS in 38.0% of cases is completely denied by them, in 50.0% and 12,0% it is allowed if desired by the patient himself or in any case respectively. 59.3% of specialists point out the difference in the regulatory status of HMP and DS to consumers in their practice. In the majority of cases, they need reliable information about clinical trials on efficacy (73.6%), as well as the quality and safety of products (52.1%). Conclusions. The results of the survey show that pharmaceutical specialists are well aware of the scope, advantages and disadvantages of the phytopreparation category, see differences in HMP and DS, but in their professional activities they are more guided by the opinion of consumers.

МАРКЕТИНГОВЫЙ АНАЛИЗ АССОРТИМЕНТА ОСНОВНЫХ МОНОПРЕПАРАТОВ, ПРИМЕНЯЕМЫХ ДЛЯ ТЕРАПИИ РАССТРОЙСТВ СНА

In recent years, many studies have noted that the number of occurrence of various sleep disorders is increasing among the population, while such problems as self-medication, untimely access to a doctor, the presence of concomitant diseases, the development of acute forms of disorders into chronic ones are highlighted, all this affects the quality and life expectancy of the population and makes it relevant to study pharmacotherapy of drugs for the treatment of these disorders in the field of pharmaceutical care [1-6; 11]. The purpose of the study was to establish a list and conduct a marketing analysis of the assortment of the main groups of monopreparations used for the treatment of sleep disorders presented on the domestic pharmaceutical market for their subsequent use in more extensive comprehensive marketing research in the context of sleep disorder therapy. The materials for the study were data from the State Register of Medicines and regulatory documents reflecting the attitude of objects to accounting and control of their sale on the market. The following methods were used: comparisons, systematization, grouping, statistics, as well as structural and assortment analyses. The article presents the results of a study of the Russian market of monopreparations of this orientation. The systematization of the main monopreparations was carried out, as a result, 7 groups were identified, which include 25 international nonproprietary names of medicines represented by 78 trade names, the proportion of manufactured drugs within each group and relative to the total number of trade names were calculated. The next step was to analyze the conditions for the release of drugs, their inclusion in lists reflecting accounting and control during implementation in accordance with regulatory documentation. In conclusion, it is noted that the obtained ranking data and the corresponding calculations will serve as a basis for further research in the field of the pharmaceutical market of drugs used for sleep disorders.

The comparative analysis of the economic availability of antihypertensives from the group of beta-blockers in Ukraine

The comparative analysis of the economic availability of antihypertensives from the group of beta-blockers in Ukraine

АНАЛИЗ АССОРТИМЕНТА РАСТВОРИТЕЛЕЙ И РАЗБАВИТЕЛЕЙ ИНЪЕКЦИОННЫХ РАСТВОРОВ ДЛЯ ПЕДИАТРИЧЕСКОЙ ПРАКТИКИ

Introduction. Solvents and diluents for parenteral medicines are widely used in pediatric hospitals and occupy leading positions in terms of the number of packages in purchases. Injectables are prescribed to children in reduced volumes, as compared to adults. In this regard, it is relevant to study the solvents and diluents available for parenteral administration of drugs in terms of packaging types and reduced volumes for use in pediatrics in the domestic pharmaceutical market. Aim of the study is to analyze the available solvents and diluents for parenteral medicines, such as water for injection, isotonic solutions of sodium chloride, Ringer, and Ringer lactate, on the Russian pharmaceutical market and in a multidisciplinary children’s hospital. Material and Methods. Objects of the study were data from the State Register of Medicines of Russia, the requisition slips of Medical Devices and Pharmacy of Tatarstan for medicines shipped from a warehouse to the Republic Clinical Children’s Hospital of the Ministry of Health of the Republic of Tatarstan in 2022, the price lists for medicines of pharmaceutical wholesalers (September 2023), and the data from scientific publications. Results and Discussion. The data obtained indicate that the regional pharmaceutical market has about twice as many options for the supply of medicinal solvents and diluents than in a children’s multidisciplinary hospital, and this allows expanding the range of this group of medicines. It can be assumed that pharmaceutical industrial enterprises do not produce a full range of options for the volume of primary packaging of solvents and diluents registered in the State Register of Medicines. Conclusions. In Russia, reduced volumes (20-30 ml) of 0.9% sodium chloride, 5% glucose, Ringer, and Ringer lactate solutions in vials for intravenous drip administration in pediatric practice are neither registered nor produced. The depth coefficient of the assortment of the studied solvents and diluents for parenteral medicines in relation to the volume of primary packaging in a children’s multidisciplinary hospital is 0.102. This indicates the need for medical organizations to consider the possibilities of the pharmaceutical market when drawing up applications for the supply of medicines.

PROSPECTS FOR STRATEGIC PARTNERSHIP BETWEEN THE EAEU AND BRICS COUNTRIES IN THE PHARMACEUTICAL INDUSTRY

Providing all segments of the population with the necessary medicines is the basis for protecting the health of citizens and creating a high quality of life. The successful development of the pharmaceutical market is based on the principle of international cooperation. One of the largest economic alliances with Russia's participation is the EAEU and BRICS, which act not only as strategic partners, but also as centers of scientific development. The purpose of the study was to determine the effectiveness of Russia's entry into geopolitical alliances from the perspective of the development of the pharmaceutical market. Method or methodology of the work. Collection and analysis of statistical data of the retail audit of the domestic pharmaceutical market and comparison of basic indicators 2022/2023 Results. In the course of the study, it was revealed that it is beneficial for Russia to join international alliances, since the volume of the commercial pharmaceutical market in 2023 increased by 19.8%. In Russia, two leading pharmaceutical companies were formed both in the domestic and foreign markets – Otisipharm and Binnopharm. It was determined that the main group of drugs on the domestic market is represented by generic drugs. Scope of application of the results: results of the study can be used as a confirmation of the need for further cooperation between Russia and major economic alliances – the EAEU and BRICS.

Long-term results of transferring the patient from therapy with glucagon-like peptide-1 receptor agonists in combination with metformin to a dipeptidyl peptidase-4 inhibitor in combination with pioglitazone and inhibitor of type 2 sodium-glucose cotransporter in type 2 diabetes

The pioglitazone belongs to the class of antidiabetic medications and has various pleiotropic effects. The evidence base for this medication, based on the results of randomized clinical trials, demonstrates convincing cardio- and cerebroprotective efficacy of pioglitazone, comparable to innovative glucose-lowering drugs from the classes of GLP-1 agonists and SGLT-2 inhibitors. Currently, in Russia, a fixed combination of pioglitazone and alogliptin is available. However, it should be noted that there has been a recent lack of GLP-1 agonists on the domestic pharmaceutical market, which raises questions about the choice of further tactics for patients who have been taking them until recently.This clinical case presents an example of the transformation of glucose-lowering therapy from a combined treatment regimen with semaglutide and metformin to the combined use of a fixed combination of alogliptin and pioglitazone with empagliflozin. Against the background of therapy change, a stable and pronounced glucose-lowering effect was obtained and confirmed after six months, comparable to GLP-1 receptor agonists without the effect of escape and hypoglycemia. No edema or weight gain was observed, and no other adverse events were detected, which allowed continuing the chosen glucose-lowering therapy. Strategic perspectives of the prescribed therapy were determined — reducing cardio- and cerebrovascular risk and improving the patient’s prognosis.

Analysis of the list of medicines for arterial hypertension therapy during pregnancy

Preserving the pregnant women health is one of the most important task in the health care system. In 2020, more than 21,000 cases of hypertensive disorders were diagnosed during pregnancy in Ukraine. Arterial hypertension during pregnancy is the main risk factor for negative consequences for the child and mother. During pregnancy, antihypertensive therapy reduces the risk of morbidity or premature birth, as well as adverse effects to the fetus/newborn.
 The purpose of the study was to analyze the list of registered antihypertensive medicines under the INN, which are presented on the domestic pharmaceutical market, and to analyze their socio-economic availability.
 Research materials and methods. Analysis of antihypertensive medicines in accordance with national recommendations for the arterial hypertension treatment during pregnancy in Ukraine; analysis of the State Register of Medicinal Products of Ukraine, the National List of Essential Medicines, the State Formulary of Medicines (15 issue). Data from the information resource «Tabletki.ua» were used to determine the pharmaceuticals prices. Methods – information search, analysis, generalization, marketing research, «minimization of cost» method, calculation of socio-economic affordability ratios – the liquidity ratio Cliq, the ratio of adequacy solvency Ca.s.
 The results of the analysis of antihypertensive medicines that are registered and have indications during pregnancy showed that the following medicines with INNs are available on the pharmaceutical market: methyldopa, nifedipine, metoprolol tartrate, esmolol, nicardipine, uradipyl, but the following INNs labetalol, hydralazine, acebutolol, mepindolol, oxprenolol are missing. It was established that the list of antihypertensive medicines used during pregnancy is represented by 33 trade names of various medicinal forms from 10 countries of the world, the specific weight of which is 69% of medicines of foreign production. There is an insufficient amount of methyldopa medicines on the domestic pharmaceutical market, as there is only one name of a foreign manufacturer.
 It was determined by the «cost minimization» method that the costs for one month of treatment when using nifedipine of a domestic manufacturer compared to a drug of a foreign manufacturer are lower by 90%. For metoprolol of the domestic manufacturer, the costs are 73% lower than for the imported drug.
 The socio-economic availability of medicines was determined using the price liquidity ratio and the solvency adequacy ratio, which indicated relatively adequate price competition and the high availability of most antihypertensive medicines for the population of Ukraine.

Competition protection and social orientation in the pharmaceutical market: Regional aspects

In the article the processes connected with the development of the domestic pharmaceutical market and the formation of biopharmaceutical and medical clusters, as well as the nuclear educational cluster in the Kaluga Oblast are studied. The results of the conducted scientific work allowed to formulate a number of features characterizing the modern pharmaceutical market: positive dynamics of development, state support of the competitive environment, reliance on innovative projection of digital technologies and the triple helix model, clearly expressed social function of providing the population with medicines. Proven long-term development prospects and effective results of the implementation of cluster policy, carried out within the framework of domestic and international trends, leading countries and companies of the world, integrating technological innovation (bioengineering, biotechnology, biomedicine). In recent years, the provisions of the Strategy for the Development of the Pharmaceutical Industry of the Russian Federation for the period up to 2030 have been actively implemented. Kaluga Oblast is purposefully improving its activities on the formation of modern cluster policy, the priority direction of which is the development of the cluster of innovative pharmaceuticals, biomedicine, bioengineering and biotechnology. The creative orientation of nuclear and radiological scientists in their scientific research was not limited to narrow specialization, but made a breakthrough in pharmacology, medicine and biology. And innovative knowledge is brought to the stage of commercialization, objectively giving a new projection to the conditions of formation of the pharmaceutical market, which acquires features of constructive competition, creating socially oriented mechanisms of cost management, which leads to lower prices of medicines.

РАЗРАБОТКА СОСТАВА И ОПРЕДЕЛЕНИЕ ПОКАЗАТЕЛЕЙ КАЧЕСТВА СИРОПОВ С ИЗВЛЕЧЕНИЯМИ ИЗ СЫРЬЯ ФАРМАКОПЕЙНЫХ РАСТЕНИЙ СЕМЕЙСТВА ROSACEAE

The largest number of plant species included in the State Pharmacopoeia of the Russian Federation belong to the Rosaceae family. However, the number of phytopreparations based on this plant raw material in the domestic pharmaceutical market is not so diverse. Taking into account the growing popularity of the medicinal form of syrups, the authors conducted a study aimed at developing the composition and technology for producing syrups with rhizomes and roots of Sanguisorba (Sanguisorbae officinalis rhizomata et radices), rhizomes of Potentilla (Potentillae erectae rhizomata), leaves of wild strawberries (Fragariae vescae folia), fruits of aronia (dry) (Aroniae melanocarpae sicco fructus), rowan fruits (Sorbi aucupariae fructus), rosehip fruits (Rosae fructus), cherry fruits (Padi avii fructus). Syrups were obtained using a technology using liquid extracts in the composition, which were obtained in accordance with the requirements of the OFS.1.4.1.0021.15 Extracts. For all the syrups obtained, quality indicators were determined: density, pH, refractive index, microbiological frequency. To determine the quantitative content of biologically active substances in the developed syrups, the authors used the principle of end-to-end standardization, involving the use of the same quality control methods used in the standardization of the initial medicinal plant raw materials. The total content of tannins was determined for syrups with rhizomes and roots of medicinal hemophlebus, rhizomes of lapchatka, cherry fruits, the total content of anthocyanins was determined for the syrup of aronia fruits, the total content of anthocyanins was determined for the syrups of rowan and rosehip fruits, the content of ascorbic acid was determined and for strawberry leaf syrup the total content of flavonoids in terms of rutin. According to the results of the conducted studies, the norms of the content of active substances in the studied forms were recommended.

The study of the range and sales volume of capillary stabilizing medicines presented at the domestic pharmaceutical market

The study of the range and sales volume of capillary stabilizing medicines presented at the domestic pharmaceutical market

Abdominal pain syndrome in patients with irritable bowel syndrome: features of selection of therapy

Irritable bowel syndrome (IBS) is an important social problem, since it is often diagnosed in people of young working age, significantly affects the quality of life of patients and causes economic damage to society. IBS is a chronic functional bowel disease, the main manifestation of which is pain combined with changes in bowel movements, frequency and character of stool. The mechanism of formation of abdominal pain syndrome is due to a disruption in the interaction along the brain-gut axis, which leads to changes in the regulation of intestinal motor function and the development of visceral hypersensitivity (VH). Abdominal pain as a manifestation of IBS is primarily associated with spasm of intestinal smooth muscles. The first-line drugs for pain relief are antispasmodics, which reduce the tone and contractility of intestinal smooth muscles, effectively coping with abdominal pain. The domestic pharmaceutical market is represented by different groups of muscle relaxants, among which calcium channel blockers are of particular relevance for patients with IBS. Representative of the latter is the drug Otilonium bromide, which is widely used throughout the world, is effective and safe, well tolerated and superior to placebo in reducing symptoms and preventing relapse of pain in patients with IBS. The effectiveness of otilonium bromide is due to a triple mechanism of action: blockade of calcium channels (relief of spasm), antagonism of tachykinone NK2 receptors (effect on HHV) and inhibition of acetylcholine muscarinic receptors (M3-ChR) (reduction of intestinal secretion). This article presents a short review of the literature on the causes and mechanism of development of pain in IBS, as well as the possibilities of its relief, primarily with the use of smooth muscle relaxants, namely otilonium bromide.

Marketing analysis and positioning of diuretic medicines at the pharmaceutical market of Ukraine

Aim. To perform the marketing analysis of the domestic pharmaceutical market in the segment of diuretic medicines and study the directions of their positioning. Materials and methods. The research materials are data from the State Register of Medicines of Ukraine and the Electronic Medicines Compendium. To achieve the goal, the methods of logical and meaningful problem formation, desk market research, comparative analysis, content analysis of scientific and practically oriented medical and pharmaceutical publications were used. Results and discussion. The article presents the results of the marketing analysis of the domestic pharmaceutical market of diuretic medicines of group C03 “Diuretics” registered at the pharmaceutical market of Ukraine as of July 1, 2023. It has been determined that the range of diuretic medicines includes 124 trade names analyzed by INN, the number of trade names, by production, dosage form, price range, availability in the assortment of pharmacies. The analysis of the market of the group of medicines studied by producing countries, form of release and conditions of dispensing from pharmacies has been performed, as well as positioning has been carried by the peculiarities of the use of diuretics by such consumer segments as children, women during pregnancy and lactation. The INNs of medicines, which content are not offered by domestic manufacturers, have been identified, and therefore they can be considered promising for updating the product range. Conclusions. The results of the marketing analysis of the diuretic market and development of positioning directions are the basis for the search and development of new effective domestic medicines for the treatment and prevention of renal failure, neurological and cardiac diseases and other diseases in the pharmacotherapy of which diuretics are used.

The methodology of the development of original medicines based on the medicinal plant raw material for the treatment of inflammatory bowel diseases

According to the Ministry of Health of Ukraine, the number of patients with IBD in Ukraine is approximately 30,000 people per 100,000 population, half of which have a medium or severe degree of damage.
 Over the past 5 years, there has been a trend towards an increase in the number of severe cases and treatment-resistant forms of chronic intestinal diseases of an inflammatory nature, which often requires surgical intervention or causes the development of complications, which, in turn, can lead to invalidation of patients and, as a result, causes significant economic costs, related to their care, treatment and rehabilitation. The most common are Crohn’s disease and ulcerative colitis.
 The prevalence of ulcerative colitis (UC) in the population ranges from 21 to 268 cases per 100,000 people. The social significance of UC lies in the fact that the incidence is predominant among young people. Thus, statistical data show that the peak incidence of UC occurs at the age of 20–30 years. In the absence of appropriate therapy, the course of UC is recurrent and remitting.
 In the process of work, the methods of analysis of electronic and paper sources of information were used, on providing the domestic pharmaceutical market with drugs for the treatment of IBD, their directions and mechanism of action, the possibility of using in the therapy of diseases with herbal medicines containing BAS, that affect various links of the pathogenetic process, the possibility of combining it with synthetic API in order to increase the effectiveness of treatment.
 The algorithm of the methodology consists of three blocks: information and search, research and biological. Each block, which ends with obtaining an intermediate result, ensures the setting of the task for the next stage of the research.

МАРКЕТИНГОВЫЕ ИССЛЕДОВАНИЯ ФАРМАЦЕВТИЧЕСКОГО РЫНКА ПРОТИВОГРИБКОВЫХ ПРЕПАРАТОВ

The purpose of the study is to analyze the range of antifungal medicines using the information 
 provided in the State Register of Medicines for 2023. Materials and methods. The data were obtained during 
 the content analysis of the State Register of Medicines and processed using comparative and graphical analysis 
 according to the following characteristics: manufacturers, chemical structure, international nonproprietary 
 names, type of action, dosage forms. Results. Antifungal drugs account for 0.45 % of all medicines (204 out 
 of 44600) and they are represented by 40 active substances; the share of the domestic pharmaceutical market 
 today is almost 55 %; systemic drugs account for 37 % of the total number of antimycotics. Analysis of the 
 information provided in the State Register of Medicines showed that in the period from January 2022 to May 
 2023, there is a decrease in the share of antifungal drugs of foreign production and the number of producing 
 countries; there is a tendency to increase the drugs of systemic action. Conclusion. Thus, the results indicate 
 the need for further research of the pharmaceutical market of antifungal drugs in order to expand their nomen clature and form an optimal assortment in the context of import substitution

ANALYZING THE SELECTION OF PARACETAMOL PREPARATIONS AVAILABLE IN THE UKRAINIAN PHARMACEUTICAL MARKET

The article presents the results of a comprehensive marketing analysis of the structure of the domestic pharmaceutical market of the assortment of drugs with the active ingredient paracetamol by producing countries and the variety of dosage forms. Taking

Анализ ассортимента прямых пероральных антикоагулянтов на отечественном фармацевтическом рынке

Анализ ассортимента прямых пероральных антикоагулянтов на отечественном фармацевтическом рынке

The substantiation of market opportunities for domestic manufacturers in the segment of anti-inflammatory and anti-rheummatic medicines

Goal is an analysis of the assortment of anti-inflammatory and anti-rheumatic medicines presented on the pharmaceutical market of Ukraine, and substantiation of market opportunities for domestic manufacturers. Materials and methods. The research materials are data from the State Register of Medicines of Ukraine and the online directory of medicines Compendium, publications of scientific and practically-oriented medical and pharmaceutical publications. The methods of office marketing research, comparative analysis, logical summarization of results, and the graphic method were used for achieving the goal. Results of the research. During the study, the structure of the assortment of anti-inflammatory and anti-rheumatic medicines and the characteristic trends for the registration of new medicines on the domestic pharmaceutical market were determined. It has been established that in 2022, 463 trade names will be registered on the domestic pharmaceutical market. The assortment of anti-inflammatory and anti-rheumatic medicines was analyzed by active substance, release form, producing countries, and the possibility of use in pediatrics. Prospective directions for updating the product assortment of anti-inflammatory and anti-rheumatic medicines of domestic production have been determined. Conclusions. According to the results of the study, it was found that the group of anti-inflammatory and anti-rheumatic medicines is represented by a wide assortment, however, the market is characterized by import dependence, which has a negative impact on the medical supply of certain categories of consumers. Prospective segments on the market of anti-inflammatory and anti-rheumatic medicines for domestic manufacturers have been established.

Pharmaceutical development for transdermal dosage forms of nifedipine: justification of the choice and specificity of the action

Background. Present day in medicine can be assessed as an active period of the fight against cardiovascular diseases. This group of diseases cannot be considered obsolete in any way, and even taking into account the emerging new pathology – coronavirus infection – cardiovascular diseases have consolidated their dominant position. Among the drugs used for appropriate pharmacotherapy, stands out nifedipine (1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-3,5-pyridindicarboxylic acid dimethyl ether) – a drug that can inhibit the flow of calcium into the cardiomyocytes of vascular smooth muscle cells. The drug has been on the domestic pharmaceutical market for quite a long time, but it is still in demand. However, nifedipine has quite pronounced side effects, including those associated with its oral administration – nausea caused by irritation of the gastrointestinal tract, rarely gum hyperplasia. And at the same time, the main modern dosage form of nifedipine is tablets. Therefore, expanding the range of its dosage forms is an urgent issue. Moreover, well-chosen dosage forms reduce the side effect of the drug. This is especially true for extended versions. So pharmaceutical development in relation to the creation of original dosage forms of nifedipine is quite appropriate.Aim. Determination of the possibility of absorption of nifedipine from the proposed dosage forms – transdermal patch and transdermal gel.Materials and methods. To determine nifedipine in rat blood plasma samples, high-performance liquid chromatography was used (chromatograph “Millichrome A-02” (Institute of Chromatography “EcoNova”, LLC, Russia).Results. Chromatograms of blood plasma samples of all animals on whose skin a transdermal gel or patch was applied revealed a peak coinciding in retention time with the peak of the standard sample of nifedipine.Conclusion. The possibility of penetration of nifedipine from the patch and transdermal gel through intact animal skin has been confirmed.

Drugs for the treatment of ulcerative colitis on the pharmaceutical market of Ukraine

The prevalence of diseases of the digestive organs at the current stage of human development is extremely high, and their universally increasing incidence rate is estimated as an epidemic. In Ukraine, mortality from diseases of the digestive organs ranks fourth in the population mortality structure (after diseases of the circulatory system, neoplasms, and accidents). Among all diseases of digestive organs in the modern world, inflammatory bowel diseases are one of the most serious and unsolved problems in modern gastroenterology and coloproctology. In terms of morbidity, non-specific ulcerative colitis (UC) and Crohn's disease (CD) are inferior to other gastroenterological diseases, although in terms of the severity of the course, the frequency of complications and mortality, they occupy one of the leading places in the structure of diseases of the gastrointestinal tract. Therefore, the goal of our work was the marketing analysis of drugs for the treatment of non-specific ulcerative colitis containing mesalazine as an active component. Obtaining data on the demand on the pharmaceutical market for medicinal products with mesalazine, determining trends in the use of dosage forms with this substance will allow predicting approaches to the development of a domestic effective medicinal product containing mesalazine. The objects of the study were medicinal products of local and systemic action, containing mesalazine in their composition. To achieve the goal, generally accepted research methods were used, which contributed to the objective assessment of the analysis of the pharmaceutical market.
 The analysis of the assortment of medicines with mesalazine presented on the domestic pharmaceutical market was carried out according to the data of the classification system of the ATС, the State Formulary of Medicines, the State Register of Medicines of Ukraine. The presence on the pharmaceutical market of Ukraine of drugs of the group A07E Intestinal antiinflammatory agents indicates that the leader in terms of assortment offers is drugs with mesalazine (5-ASA). As of February 2023, Ukraine has registration certificates for 19 medicinal products of five brands with the active ingredient mesalazine. According to the received data, no medicinal product of domestic production containing mesalazine has been registered on the pharmaceutical market of Ukraine. Several types of dosage forms with mesalazine are available on the pharmaceutical market of Ukraine (coated tablets, long-acting granules, suppositories, and rectal suspension). It should be noted the absence of combined medicines with mesalazine. Also, there is no such medicinal form as enteric-dissolving hard gelatin capsules on the pharmaceutical market of Ukraine.
 Taking into account the obtained data, approaches to the introduction into production of a domestic medicinal product for the treatment of non-specific ulcerative colitis containing mesalazine and medicinal plant raw materials are in demand for pharmaceutical development.

АКТУАЛЬНЫЕ ВОПРОСЫ ОЦЕНКИ КАЧЕСТВА ПОЛИКОМПОНЕНТНОГО ГЕЛЯ РЕПАРАТИВНОГО ДЕЙСТВИЯ

The domestic pharmaceutical market still lacks reparative drugs, which determines research on their creation as an urgent theoretical and applied task. In this regard, the expediency of developing the composition and technology for obtaining a polycomponent gel with a predictable positive effect on wound healing processes based on dermal biopolymers and a complex of biologically active substances of corn columns with stigmas is substantiated. The complex of technological studies carried out made it possible to establish the optimal composition and technology for obtaining a polycomponent gel. At the next necessary stage of pharmaceutical development, it was necessary to solve the issues of assessing the quality of the proposed composition of the polycomponent gel. The purpose of this study was to determine the criteria and methods for monitoring the quality indicators of a multicomponent reparative gel. The object of the study was experimental samples of a multicomponent gel obtained by introducing a thick extract of corn columns with stigmas into a collagen base. The quality of the polycomponent gel was assessed in accordance with the requirements of GPM.1.4.1.0008.15 "Ointments" of the State Pharmacopoeia IV edition according to the following criteria: "Description", pH, "Microbiological purity", authenticity and quantitative content of active substances. The indicator "Description" was evaluated organoleptically. The determination of the pH of the gel was carried out potentiometrically using a pH meter (Mettler Toledo, USA) according to GPM.1.2.1.0004.15 "Ionometry" directly in the gel sample. Microbiological purity was studied by the agar plate method in accordance with GPM.1.2.4.0002.15. The presence and quantitative determination of flavonoids in the developed gel was determined spectrophotometrically on a UV-1800 SHIMADZU spectrophotometer, Japan. As a result of the studies carried out, the criteria for the quality of a multicomponent gel of reparative action were studied and proposed. According to the "Description" indicator, the polycomponent gel is a homogeneous mass of light brown color with a pleasant fruity odor without impurities. It has been established that the polycomponent gel is characterized by a slightly alkaline pH value, which creates optimal conditions for the healing phase of the wound process. It is shown that the use of the method of differential spectrophotometry makes it possible to carry out a statistically significant qualitative and quantitative assessment of the content of flavonoids in the composition of a polycomponent gel.