Pharmaceutical Market Of Ukraine Research Articles

Phytotherapy for respiratory diseases: past and present. Review

Acute and chronic respiratory diseases constitute one of the main reasons of death worldwide. Joining coronavirus infection COVID‑19 worsens the course of diseases of the bronchopulmonary system and other systems and organs, in particular, respiratory, cardiovascular, urinary, gastrointestinal and others. There are a number of drugs of natural origin with multifaceted metabolic and multiorgan action, the use of which associated with minimal risks, mainly due to individual intolerance to particular components. Objective. To analyze the current possibilities of phytotherapy of respiratory diseases, including COVID‑19. Materials and methods. The information search has been performed using sources in print and electronic media, scientific tracking databases with application of methods of the analysis, comparison and generalization. Results. Treatment with herbal remedies was established to have better tolerability and lower frequency of side effects and complications. They are characterized with high biological multifaceted activity and a broad therapeutic index. It is believed that the use of herbal medicine in such cases as an adjunct treatment and maintenance therapy is justified. Monotherapy with drugs from individual medicinal plants is not as effective as their combination. The use of extracts of several medicinal plants is more appropriate for long‑term use, the composition, dose, synergism, compliance, minimal side effects and mild therapeutic effect are important. In the pharmaceutical market of Ukraine there are many domestic and imported herbal remedies used in acute and chronic respiratory diseases. One of them is Bronchilor (Biohels International GmbH, Germany), containing extracts of thyme, Iceland moss, primrose and thorny bamboo. The drug has a local antiseptic effect, it forms a protective film on the the bronchopulmonary receptors, enhances the ciliate epithelial activity, and acts as an expectorant. The publications of Chinese scientists indicate the feasibility of using herbal medicine in the acute period of COVID‑19 infection and postcovid syndrome. Conclusions. Modern multicomponent phytotherapeutic agents play an important role in the complex treatment of acute and chronic respiratory diseases. Further studies are required to investigate the use of phytotherapy, in particular, Bronchilor, as a supportive therapy for postcovid rehabilitation in patients with respiratory system injury.

Overview of the range of medicinal extracts at the pharmaceutical market of Ukraine

Aim. To study the range of medicinal extracts at the pharmaceutical market of Ukraine as of 2020 in order to determine the feasibility of developing a new medicinal product based on them.Materials and methods. The bibliosemantic, analytical, logical research methods were used to analyze the literature sources; the analytical analysis was applied to study the segment of the domestic pharmaceutical market regarding the range of medicinal extracts as of 2020. Thus, their composition, distribution by the aggregate state, forms of production and country of origin, harmonization with the Ph. Eur. were analyzed.Results. It has been determined that the domestic pharmaceutical market has 18 extracts, all of them are liquid. Among all extracts registered in Ukraine the leading place (16 items) belongs to the Ukrainian manufacturers. The nomenclature of imported drugs consists of 1 extract of Vietnamese and 1 of Swiss production. Among the Ukrainian manufacturers, the largest market segment belongs to PJSC “Lubnipharm” ‒ 4 drugs; “Rotokan” is available in 55 and 110 ml bottles, while “Aloe extract”, solution for injection, 1 ml, No. 10, in ampoules is produced by PJSC “Lubnipharm” and CJSC “Darnytsia”; “Eleutherococcus extract”, 50 ml, in a bottle ‒ by LLC “Unipharma” (“Ternopharm”) and agricultural firm “Yan”. There are 19 drugs with extracts at the domestic pharmaceutical market; among them the largest market segment is occupied by drugs in the form of tablets and capsules (7 items), 2 oral solutions, 1 drug in the form of oral drops, 1 syrup and powder for oral solution. Most drugs containing extracts are made by the Ukrainian manufacturers (about 47 %), while manufacturers from Germany, France and Switzerland supply 2 drugs each, Spain, Bulgaria, Slovenia and the Czech Republic ‒ 1 drug each.Conclusions. There are 18 extracts and 19 preparations with extracts at the pharmaceutical market of Ukraine. Most of the drugs in this sample are hypnotics and sedatives (55 %), as well as drugs used in diseases of the liver and biliary tract, they improve digestion and the functional state of the gastrointestinal tract.

The analysis of prolonged-release drugs at the Ukrainian pharmaceutical market

Aim. To analyze the range of prolonged-release dosage forms at the Ukrainian pharmaceutical market focusing on the pharmacotherapeutic groups that are insufficiently saturated with prolonged-release drugs, in particular to determine the proportion of non-steroidal anti-inflammatory drugs (NSAIDs). Materials and methods. The research was conducted in accordance with the data of the State Registry of Medicines of Ukraine and the АТС classification system. The methods of scientific analysis, in particular methods of grouping and comparison, marketing methods of analysis were applied. Results. The study of the assortment of prolonged-release drugs registered at the Ukrainian pharmaceutical market has been performed. The structure of the assortment by manufacturer, dosage forms, the АТС classification system has been analyzed. As a result of the study, it has been found that 202 trade names of prolonged-release drugs are registered in Ukraine. Most of them (196 names, 84 %) are medicines of foreign manufacturers. Prolonged-release drugs registered in Ukraine are mostly presented in the form of tablets and capsules, but tablets (72.77 %) are the largest part. The analysis of distribution of prolonged-release drugs by the ATC classification groups has shown that a significant number of prolonged-release drugs belongs to group N – Nervous system (80 trade names), and group C – Cardiovascular system (44 trade names). The share of group M – Musculoskeletal system, in particular prolonged-release NSAIDs, is insignificant (9 trade names). Conclusions. The marketing research of the prolonged-release drugs conducted allowed us to characterize the structure of the assortment of the Ukrainian market by pharmacotherapeutic groups, manufacturers and dosage forms. As a result of the research, the current assortment of prolonged-release NSAIDs has been determined.

The marketing study of the pharmaceutical market of Ukraine in the segment of antihemorrhagic agents to stop dental bleeding

Aim. To conduct the marketing research of the Ukrainian market in the segment of antihemorrhagic agents used in dentistry.Materials and methods. The study was performed using the structural analysis, logical and graphical methods, marketing analysis methods.Results. The state of the Ukrainian market of drugs of this group has been determined. The market structure has been revealed in the number of names, brands, in forms of production, manufacturers, composition. Despite the sufficient number of registered drugs at the market (26 positions), a rather small arsenal of active substances (4) and dosage forms (3) can be observed. The market is characterized by a limited amount of drugs with a certain pharmacodynamics combining a rapid hemostatic effect, safety in use, the ability to suppress bacterial flora, and without the effect on healthy tissues. However, a positive moment should be noted: by the structure of manufacturer countries the market remains domestic (60 : 40).Conclusions. The Ukrainian pharmaceutical market is characterized by a sufficient assortment of hemostatic agents, but the use of these drugs in dentistry has its limitations. Dental doctors have certain problems with the occurrence of capillary bleeding and require a sufficient amount of effective and fastacting drugs for local application. Therefore, the search and creation of new drugs with a similar action at this stage remains a relevant scientific issue.

Modern concepts on the state of esophagus epithelial barrier at gastroesophageal reflux disease and possibilities of correction with alginates

Gastroesophageal reflux disease (GERD) remains an urgent problem in clinical medicine. The search for ways of effective treatment leads to the need to set new accents in the multifactorial pathogenesis of the disease. According to current trends, special attention is paid to the epithelial barrier of the esophagus. The article presents considerations of the structure of the mucosal epithelial layer, the features of transport routes and intercellular interactions of the esophageal epithelium. Special attention is paid to the phenomenon of the Dilated Intercellular Spaces (DIS) and the syndrome of increased epithelial permeability (SІEP) at GERD. An interpretation of these concepts is given, their role in the implementation of inflammatory processes and the formation of clinical manifestations of the disease, such as heartburn and pain, is revealed. The data on the possible mechanisms of the formation of the DIS and SІEP phenomenon, methods of their diagnosis and aspects that are discussed in the scientific world are presented.
 The possibilities of cytoprotective therapy using alginate preparations have been shown. Among the alginates, available on the pharmaceutical market of Ukraine, the pharmacological line Gaviscon® (LLC Reckitt Benckiser Ukraine, Great Britain) is presented. The results of experimental studies with the use of the latest technologies, and data from randomized clinical trials confirming the alginates’ clinical efficacy, have been outlined.
 The phenomenon of DIS of the esophageal epithelium and SІEP for aggression factors is one of the leading links in GERD pathogenesis, in particular, its non‑erosive form, and to some extent determines the features of the clinical manifestations of the disease. Treatment of GERD with the use of alginates is logically justified, successfully used in clinical practice, and continues to be actively studied. The use of Gaviscon® products is expedient due to their unique mechanism of action to increase the resistance of the esophagus.

MANAGEMENT OF PATIENTS WITH DYSLIPIDEMIA IN THE PRACTICE OF FAMILY MEDICINE

Dyslipidemia is an important problem for family doctors, as it is a risk factor for the development of atherosclerotic cardiovascular diseases (ACVD). ACVD is the cause of more than 4 million deaths in Europe today. Women in this sad statistic are 2.2 million, and men - 1.8 million. It is expected, that mortality due to cardiovascular diseases in men aged up to 65 years is significantly higher than in women (430 thousand and 193 thousand, respectively).
 The ESC/EAS-2019 (European Society of Cardiology / European Society of Atherosclerosis) updated guidelines on the management of people with dyslipidemia (DLP) provide specific recommendations that can be used by family doctors in Ukraine in their daily preventive and curative work. The ESC/EAS-2019 (European Society of Cardiology / European Society of Atherosclerosis) and the Ukrainian Society of Atherosclerosis (USA) guidelines emphasize that the cornerstone of the prevention and treatment of ACVD is primarily the detection and correction of DLP. The prevalence of DLP in Ukraine is about 20%.
 At the same time, for effective correction of DLP it is important to verify the type of dyslipidemia, isolate genetically determined forms of dyslipidemia (familial hypercholesterolemia), establish cardiovascular risk, select the most effective measures of lifestyle modification and formulate therapeutic goals of prevention / treatment.
 In the treatment of DLP apart from lifestyle modification, the drugs of choice are statins in high-intensity doses. Ezetimibe and PCSK-9 inhibitors can be used in addition to statin therapy in case of its ineffectiveness or side effects. It was found, that resistance to statins and their intolerance is the basis for the use of non-statin hypolipidemic drugs (nutraceuticals), among which the most studied are ω-3 PUFA and phytosterols.
 The ESC / EAS (2019) guidelines state that consumption of ω-3 PUFAs is associated with a lower risk of death from CVD and stroke. It was noted, that the mechanism of reducing TG levels under the influence of ω-3 PUFA may be related to their ability to interact with PPAR (receptors that activate the proliferation of peroxisomes) and reduce the secretion of apoprotein B. Recent clinical studies confirm the need for high doses of highly purified form of ω-3 PUFA for patients with elevated TG levels, despite treatment with statins.
 Another non-statin drug that reduces LDL levels is bempedoic acid. Studies have shown a significant reduction in LDL levels in patients receiving additional bempedoic acid. The effectiveness of bempedoic acid as a monotherapy of DLP is now being studied.
 This review presents new data on the effectiveness of the combination of sugar cane extract policosanol with ω-3 PUFA (docosahexaenoic acid 10%). The drug of this composition "Cardioneurin" is present on the pharmaceutical market of Ukraine. Clinical studies have shown, that in case of resistance or intolerance to statins, especially in high doses, a hybrid strategy of lipid-lowering therapy can be used - a combination of low-intensity doses of statins with a combined nutraceutic "Cardioneurin". This treatment reduces the level of atherogenicity by 22%, which gives grounds for its use in the practice of family doctors.
 Other forms of policosanol (other than sugar cane), such as those derived from beeswax or wheat germ, do not have an adequate evidence base.
 Thus, dyslipidemia is the primary and main factor in the development of ACS, it in most cases occurs long before the emergence of other important risk factors and may even be a prerequisite for their occurrence. Epidemiological evidence suggests, for example, that DLP may in itself be a risk factor for STEMI / NSTEMI and unstable angina.

Ефективність антигістамінних препаратів I покоління при лікуванні алергічних захворювань у дітей

У статті викладені сучасні відомості про клінічне застосування, ефективність та безпеку використання представника першого покоління Н1-антигістамінних препаратів — диметиндена малеату. Подана стисла характеристика препарату, вказані основні показники його фармакокінетики та фармакодинаміки. Акцентовано увагу на основних фармакологічних механізмах клінічних ефектів препарату. Проведено аналіз результатів клінічних досліджень із застосуванням диметиндена малеату при алергічних та інфекційних захворюваннях шкіри у дітей. Надані основні фармакологічні властивості та характеристика препарату Фенокіт, який нещодавно з’явився на фармацевтичному ринку України, обґрунтовані основні показання до призначення препарату.

Лечение функциональных гастроинтестинальных расстройств у детей раннего возраста

В статье изложены современные сведения об основных патогенетических механизмах развития и клинических проявлениях функциональных гастроинтестинальных расстройств у детей раннего возраста в соответствии с Римскими критериями ІV. Представлены требования к пробиотическим препаратам, которые применяются в современной медицине. Акцентировано внимание на основных характеристиках наиболее изученного пробиотического штамма Lactobacillus rhamnosus (LGG). Проведен анализ результатов клинических исследований с применением LGG с целью лечения и профилактики функциональных и органических заболеваний у детей. Представлены основные фармакологические свойства и характеристика продукта Актив Флора беби, который недавно появился на фармацевтическом рынке Украины, обоснованы и представлены основные показания к назначению продукта.

Особливості фітотерапії цукрового діабету крізь призму коморбідності й профілактики ускладнень (огляд літератури)

Стаття присвячена огляду літератури з фітотерапії хворих на цукровий діабет (ЦД) крізь приз­му коморбідних процесів і профілактики ускладнень. У статті приділено увагу огляду складових частин рослин, що відповідають за гіпоглікемічну дію, таргетним шляхам їх дії, а також основним принципам і патогенетичним механізмам фармакологічної дії фітопрепаратів при ЦД. Наголошено на комплексності антиглікемічної дії, яка обумовлена взаємодією різних речовин. Автори детальніше зупинились на окремих представниках лікарських рослин, які найчастіше використовуються при лікуванні ЦД, таких як чорниця звичайна, галега лікарська, квасоля звичайна, бузина лікарська, аралія висока, кульбаба лікарська, оман високий, льон звичайний, аралія висока, момордика, гімнема звичайна, гуньба сінна, гінкго дволопатеве. Розглянуто основні комплексні препарати, протидіабетичні рослинні збори, дієтичні добавки, які є на фармацевтичному ринку України. Висвітлені основні підходи до застосування лікарських рослинних препаратів та їх роль у лікуванні та довготривалій реабілітації хворих на ЦД. Наголошено на необхідності проведення наукових пошуків зі створення полікомпозитних ліків рослинного походження багатоцільової дії та вдосконалення лікувально-профілактичних заходів за допомогою фітотерапії.

ANALYSIS OF PHARMACEUTICAL WORKERS RECOMMENDATIONS FOR WOUND-HEALING DRUGS IN UKRAINE

ANALYSIS OF PHARMACEUTICAL WORKERS RECOMMENDATIONS FOR WOUND-HEALING DRUGS IN UKRAINE

The marketing study esearch of the range of glucometers on the pharmaceutical market of Ukraine in 2021

Achieving proper glycemic control in patients with diabetes remains a challenge, both in the world and in Ukraine. Self-monitoring of blood glucose with glucometers is recognized as a cost-effective strategy to improve glycemic control.
 The aim of the work was to conduct a marketing study of the range of glucometers and test strips in Ukraine to determine their characteristics, configuration and features of use.
 The objects of the study were the information of the State Register of Medical Equipment and the offers of pharmacies and online stores available to Ukrainian consumers. Used marketing, analytical, graphical, generalizing analysis.
 It is established that in 2021 in Ukraine the range of glucometers is 44 models. Analysis of the device market by country of manufacture showed its import dependence. Most of the market (63.3%) is represented by producers from Asia, the second largest part (27.3%) is represented by European countries and the smallest part is provided by producers from the USA (9.1%). The range consists of 17 types of glucometers, which are encoded automatically, 2 devices – manual and 25 codeless devices. Almost all glucometers available on the market in Ukraine are calibrated by plasma, except for two that are calibrated by whole blood. Measurements with modern glucometers are very fast, mostly 5–6 seconds. Many types of glucometers are equipped with special signals: «warning of hypoglycemia» and «alarm» function (reminder of the need for self-monitoring). A small proportion of glucometers measure other blood parameters (cholesterol, hemoglobin, uric acid and ketones). Appropriate test strips for each meter model and their shelf life have been determined.
 A multifaceted marketing research of glucometers, test strips and finger piercing devices on the Ukrainian market was conducted. The analysis of the market of devices for self-control by the country of the manufacturer showed its import dependence. It is established that the wide range, features of application, additional functions and complete set of glucometers give the chance to patients with a diabetes mellitus to choose the necessary device for self-control which will fully satisfy its needs and requirements. Knowledge of the features of glucometers is an important aspect for pharmacists in providing pharmaceutical services to patients with diabetes.

Commodity analysis of compression products for varicose veins

Compression therapy occupies a key place in the complex treatment and prevention of chronic venous insufficiency of the lower extremities. Today the pharmaceutical market of Ukraine is represented by a wide range of compression products. Popular in Ukraine are manufacturers of compression products from the Baltic region, Ukraine, there are also Russian, but leading in quality are Germany, USA, and Italy. A survey of consumers and pharmacy practitioners has been performed. The results obtained indicate that compression products for varicose veins treatment are inferior to medicinal products in sales. The main motive for buying a compression product is a doctor’s prescription. The most popular compression garments are stockings.

PHARMACEUTICAL INDUSTRY'S IP PROBLEMS AND PERSPECTIVES IN UKRAINE

In the article we are considering the role and the current place of the intellectual property in the pharmaceutical industry in Ukraine. For doing that in the right way the role of IP in the global pharmaceutical industry was considered, within this question was highlighted the main tendency — constantly growing number of patents, and most of them are secondary. And researchers agreed, that the quality of patents for pharmaceuticals nowadays is lower than average, and lower than quality of the patents in other less mature fields. In the same time, pharmaceuticals also a high accounting rate of return worldwide, and in Ukraine as well. Looking on the situation inside the pharmaceutical market in Ukraine, we can claim that it is one of the fastest growing (have the second indicator of growth per year in Europe), and in spite of all challenges Ukrainian economy faces stays one of the most stable and the most promising area. Ukrainian pharma market has a significant export potential, high levels of investment and shows growing presence in foreign markets. All of these characteristics represents the great basis for the industry to grow and develop rapidly and effectively. But, this rapid growth and opportunity of entering European market slowed down by problems when it comes to intellectual property. According to the European Commission annual report on the situation with the protection of intellectual property in third countries, Ukraine is on the list of the biggest copyright infringers. There are legislative gaps in Ukraine in terms of protection of intellectual property rights and producers of original products, no or ineffective legal mechanisms to challenge unfair trademark registration, widespread transit of counterfeit and pirated products to EU markets. Among the industries most affected by copyright infringement, the European Commission's representatives are primarily pharmaceuticals. The only way to move forward and make over the situation is to provide fast changes to the legislation and to the norms of IP regulation. The Cabinet of Ministers of Ukraine approved the Concept of reforming the state system of legal protection of intellectual property in Ukraine, which defines the conceptual foundations of state policy in the field of intellectual property, including pharmaceuticals. This Concept envisages a number of changes in the system of public administration in the field of IP legal protection, that began to be actively implemented at the end of 2019.

CLINICAL AND ECONOMIC ASPECTS OF HORMONOTHERAPY ER (+) HER2 (–) BREAST CANCER (BC): FOCUS ON AROMATASE INHIBITORS (AI)

Aim. Analysis of clinical efficacy of AI for therapy ER (+) HER2 (–) BC, assortment and volume of their consumption in Ukraine in 2017–2020. Materials and methods. Analysis of the assortment and prices and consumption of AI for hormone therapy ER (+) HER2 (–) BC, available on the pharmaceutical market of Ukraine in 2017–2020. Results. A retrospective analysis of the assortment, prices and consumption of AI used for therapy ER (+) HER2 (–) BC, presented on the Ukrainian pharmaceutical market in 2017–2020, was carried out. AI were represented by 3 INNs: anastrozole (L02B G03), letrozole (L02B G04) and exemestane (L02B G06). Market prices in 2017 range from 460.5 to 4163.8; in 2018 – from 486.3 to 1849.0; in 2019 – from 308.7 to 1677.0; and in 2020 – from UAH 449.6 to UAH 2545.3. IA implemented in 2017 – 55,943, in 2018 – 81,284, in 2019 – 126,628, and in 2020 – 160,858.4 thousand packages. Conclusion. There is a clear tendency towards stabilization and even a decrease in prices for AI, if we compare the indicators of 2017 and 2020. There is a clear upward trend in consumption AI are implemented mainly of import production. The price picture for AI has changed somewhat due to the registration of drugs from the letrozole group in 2019-2020, and in 2020 – from the exemestane group.

Overview of antidepressants on the pharmaceutical market of Ukraine and dynamics of their consumption during 2015-2019

Among persistent health and disability disorders in Ukraine, the third place among men and the second among women are neuropsychiatric disorders, in the pharmacotherapy of which antidepressants are widely used.
 The aim of the work was to study the range and outpatient and hospital consumption of antidepressants in Ukraine.
 The analysis of the range and volume of antidepressant consumption was conducted in the outpatient market during 2015–2019 and in the hospital market during 2016–2019, according to the analytical company «Proxima Research»/«Morion». Consumption was calculated according to the ATC/DDD methodology. DDD/1 000 inhabitants per day (DID, DDD per 1 000 inhabitants per day) was used as a unit of measurement.
 The results of the study showed that in the pharmaceutical market of Ukraine during 2015–2019, 94–101 tons of antidepressants were used on an outpatient basis, including 29–36 tons of domestic production and 65 tons of foreign manufacturers. In 2016–2019, the hospital used a smaller number of antidepressants TH – 78–79 TH, including 27–29 TH of domestic production and 52–49 TH – imported. The number of trade names of antidepressants in outpatient consumption is 16–22% higher than the number of trade names in hospital consumption, which may be due to lower government procurement of drugs in this group. It was found that outpatient consumption of antidepressants in the period 2015–2019 increased 2.22 times – from 1.08 DID in 2015 to 2.40 DID in 2019. Consumption in hospitals was much lower and ranged from 0.20 DID in 2016. Up to 0.19 DID in 2019 (With a peak of 0.24 DID in 2017). The increase in the use of outpatient antidepressants was gradual, without abrupt changes. Most INN antidepressants, with the exception of N06AX20 Various drugs and the herb St. John's wort N06AX25, have been included in modern medical and technological documents: the State State form of drugs (8–11 issues) and the List of domestic and foreign drugs that can be purchased by health facilities, which are fully or partially funded from the state and local budgets (2015–2017), which indicates their proven clinical efficacy and safety.

Retrospective analysis of the pharmaceutical market of cardiological drugs in Ukraine for 2016–2020

In Ukraine, cardiovascular disease is the leading cause of death and is the highest cause of death among all countries. Nationwide, cardiovascular disease’s mortality has increased by almost 8% over the past 29 years.
 The aim of the work was to analyze the domestic pharmaceutical market of cardiac drugs (code of anatomical-therapeutic chemical classification (hereinafter – ATС) – C01, and C01 E separately) for the 2016–2020 in terms of pharmacotherapeutic groups, manufacturers, dosage forms and others.
 The object of the study was the data of the State Expert Center of the Ministry of Health of Ukraine, the proposals of distributors received from the «Morion» platform for 2016–2020. The research was carried out using modern methods of analysis, systematization and generalization, mathematical and statistical calculations.
 According to the database of the State Expert Center of the Ministry of Health in Ukraine, 256 cardiac drugs by dosage forms have been registered. Analysis of the group of cardiac drugs by ATС classification, allowed to establish a significant dominance of group C01 E – Other cardiac drugs – from 66% to 68% over the years of the study. According to the results of the analysis, a positive trend has been established – the dominance of domestically produced drugs in the group of cardiac drugs in the pharmaceutical market of Ukraine during 2016–2020. The general list of manufacturers presenting cardiac drugs in Ukraine consists of 66–68 companies, where the share of domestic companies was 53–55% during the study period. There is a steady trend towards a slight predominance of solid dosage forms (54–56% during the study period).
 In summary, it should be noted that the analysis of the domestic wholesale market of cardiac drugs showed a significant wide of the group’s assortment, the significant dominance of the group «Other cardiac drugs» in the overall structure, showed a positive trend of domestic cardiac drugs; among dosage forms, solid and liquid dosage forms have been presented evenly.

Aspects of the industrial manufacture of concentrates for haemodialysis

The import dependence of the pharmaceutical market of Ukraine on concentrates for hemodialysis determines the relevance of their manufacture. Elaboration of the transfer of drug development to industrial manufacture and, accordingly, the development of industrial technology of liquid acid concentrates for hemodialysis involves scaling the process, organization of production control, establishing critical points of the production and determining cleanliness classes for concentrates and risks, including ecological ones.
 The aim of the work is to develop approaches to the development of technology for industrial manufacture of acid concentrates for hemodialysis, identification of risks in the technological process and quality control, as well as analysis of major ecological risks and development of methods for their reduction.
 The object of the study was the regulatory and technical documentation regarding the requirements for hemodialysis concentrates, characterization of the hazard profile of acid concentrates as a source of pharmaceutical wastes and generalization of the information about them in the manufacture of acid concentrates. We used the results of our own experimental research on the development of concentrates. The system-survey method of research and content analysis were used in the analysis.
 On the basis of researches, it was to work up the approaches to the development of technology of industrial manufacture of acid concentrates. Requirements of various normative and technical documents for water for the manufacture were generalized, classes of cleanliness of industrial premises for the preparation of containers, preparation, filtering, and packing of solutions are offered. The scheme of pharmaceutical wastes of acid concentrates, which are formed during pharmaceutical development, industrial manufacture, and medical administration, is presented. The profile of their unsafety is given. Potential and real ecological risks in the manufacture of acid concentrates for hemodialysis and ways to minimize them are presented. The proposed stages of risk management for pharmaceutical waste during the manufacture of acid concentrates of hemodialysis include: determining the hazard profile of acid concentrates for the environment; identification of risks, as well as replenishment of knowledge about the hazard profile; planning and implementation of risk minimization measures as well as evaluation of the effectiveness of these risk reduction measures. Methods for eliminating the safety of pharmaceutical wastes of acid hemodialysis concentrates (dilution with water or electrolysis to obtain by-products) have been developed.

THE EVERGREENING STUDY OF UKRAINIAN PHARMACEUTICAL MARKET

The article presents the results of the research on the part of «evergreening patents» in the pharmaceutical market of Ukraine focusing on the daft laws registered in the Ukrainian Parliament (Verkhovna Rada) of Ukraine. The authors analyse the criteria of patent abuse as obstacles to access to treatment, and analyse the novel initiatives aimed at overcoming such abuse. In particular, it concerns thepatentability's criteria of inventions on pharmaceutical products, the possibility to oppose the applications on inventions by a person whose rights or interests are violated by a patent application and prohibition of patenting substances as the utility models.At the level of the national legislation patent reform was initiated by the Parliament of Ukraine on the first reading by the draft Law of Ukraine «On Amendments to Certain Legislative Acts of Ukraine (on Patent Law Reform)» as of October 10, 2019.For the national experts, drafting the mentioned Law, the necessity to provide evergreening research in the field of health care was obvious from the 2014. In 2014 year, the National Academy of Law Sciences of Ukraine in close cooperation with NGO 100 % of Life started the global research — Harmonization of Human Rights and Intellectual Property Rights in the Field of Medicine and Pharmacy. We have to stress that only the evergreening patent research in the pharmaceutical market of Ukraine took near three years. The Research reflects that the gaps of the Ukrainian patent system which causes the possibility to grant evergreening patents have the straight impact on access to vital treatment. The methodology of the research is based on the Guidelines on Examination of the Patent Application in the field of Medicine and Pharmaceuticals based on the recommendations of the WHO and Guidelines for the Examination of Patent Applications Relating to Pharmaceuticals of the UNDP.Thus, the subject of the research is 132 patents covering vital medicines in the field of HIV, hepatitis C, tuberculosis, oncology, rheumatoid arthritis and others. The basis for the research is the followings: the patented single-source medicines, the part of which in the centralized procurements exceeded $ 100,000 in 2017 and the medicines that part of which in hospital and pharmacy procurements exceeded 50 million hryvnia (UAH) in 2017. The research also includes the patented medicines which are or which were not available because of the patent status.

Study of Development problems dynamics of Ukrainian market of stomach ulcer treatment drugs

This article presents the analysis results of Ukrainian pharmaceutical market segment of stomach ulcer treatment drugs. It was determined that, judging by the quantitative indexes, Ukrainian market of anti-ulcer medication is an actively developing structure that maintains the stability of its development qualitative characteristics nonetheless. For example, during two years (01 June 2016 – 01 June 2018) the quantities of medicinal products and companies that represent these products in Ukraine have both grown: from 396 to 448 names (13.13%) and from 90 companies (25 of them Ukrainian) to 98 (28, correspondingly). On the background of quantity growth of Ukrainian-made drugs from 84 (2016) to 92 (2018), the specified market segment has shown significant dependency on import. For example, the proportion (%) of foreign production drugs has grown from 78.79% (2016) to 79.46% (2018). KRKA is an uncontested leader by the quantity of marketed medicinal products (2016 – 28 products, 2018 – 32 products). The products of Takeda Pharmaceutical Company Limited are presented in the second place (22 and 23 products, corresponding to the years under study). The products of Dr. Reddy's Laboratories take the third place (20 and 21 products, corresponding to the years under study). The said pharmaceutical market segment has kept its monopolistic pattern of distribution as judged by the manufacturing companies whose products are presented in Ukraine, and by international non-proprietary names of products and their pharmacotherapeutic groups. For example, just 8 foreign manufacturing companies were responsible for 40.17% (2016) and 31.92% (2018) of imported assortment of anti-ulcer drugs, and 7 domestic companies were responsible for 64.29% (2016) and 61.54% (2018) of domestic assortment of these drugs. In 2016 75.76% and in 2018 – 71.65% of the whole assortment of anti-ulcer drugs were presented by the drugs from the following groups: A02B-Drugs for peptic ulcer and gastro-oesophageal reflux disease (Gord), A02BC Proton pump inhibitors (55.30% and 50.22%, corresponding to the years under study). Five drugs (A02BC02-Pantoprazole, A02BC01-Omeprazole, A02BC05-Esomeprazole, A02BC03-Lansoprazole, A02BD Combinations for eradication of Helicobacter pylori) presented more than a half of marketed assortment of anti-ulcer products (2016 – 56.57%, and 2018 – 55.14%). Tableted dosage forms (2016 – 58.33%, and 2018 – 55.80%) and drugs of synthetic origin (2016 – 76.26%, and 2018 – 78.13%) have kept their leading positions on the market. Authors have discovered that during 2015-2018 the average retail prices of anti-ulcer drugs have shown the trend of systematic growth. The highest growth of average retail prices was observed for A02BX13-Alginic acid ( avg.=1.37), and the lowest ‒ for A02BC06-Dexlansoprazole ( avg.=1.04). The given above characteristics of the market segment that was studied allow us to state the need to develop and establish the national program of import substitution for the assortment of anti-ulcer drugs in Ukraine.

Analysis of the current state and prospects for the development of sedatives in the modern Ukrainian pharmaceutical market

Modern research has shown that cognitive impairments are directly related to behavioral disorders and psychopathological syndromes. Nootropic drugs used for pharmacotherapy of cognitive impairments demonstrate low clinical efficiency for the treatment of psychoemotional disorders. In this case, it is advisable to correct such states by prescribing sedatives that have an integrated effect on etiological factors, pathogenetic links and symptomatic manifestations of the disease.
 The aim of the research was to carry out a comprehensive assortment analysis of sedative drugs within the pharmaceutical market of Ukraine.
 Materials and methods. Studies were carried out through generally accepted statistical and marketing studies (State Register of Medicines of Ukraine, September, 2020). Our research focused on the information on the structure of the market of sedatives registered in Ukraine. Graphical and logical methods were used in the course of the study.
 Results. The results of the study have shown that the products manufactured in the Ukrainian pharmaceutical enterprises take 71.50 % of this segment; whereas sedatives produced in Germany – 7.50 %; in Poland – 3.56 %; in Italy, Slovenia, France – 1.50 % for each respectively; in Austria, Malta, Great Britain – 1.02 % for each respectively. The preparations of this group are represented in solid (tablets, coated tablets, capsules, granules, herbs in packs and filter bags) and liquid (tinctures, drops, liquid extracts, elixirs, syrups, oral solutions) dosage forms. Among the studied medicines, solid dosage forms predominate; their share makes 62.7 % of the assortment, and the highest percentage rate is held by tablets (45.5 %). The largest market share of liquid medicinal forms is made by tinctures, in particular 18.9 %. The lowest percentage rates are observed in such medicinal forms as liquid extracts, drops, elixirs, syrups and oral solutions (15.5 % in general). Analysis of the state of the Ukrainian pharmaceutical market of sedatives shows that synthetic drugs account for 24.55 % of the market (tablets – 92.7 %), natural (plant) medicines – 75.45 % (solid dosage forms – 89.6 %).
 Conclusions. Marketing studies were carried out on the modern market of sedative medicines in Ukraine. It has been established that the quantitative and qualitative diversity of the current assortment is presented by the imported drugs and domestic producers. Analysis of the state of the Ukrainian pharmaceutical market of sedatives was performed. Sedative preparations of natural (plant) origin have been found to be predominant and occupy 2/3 of the total range of sedatives registered in Ukraine as of September, 2020. Synthetic sedative drugs are mainly combined. Monodrugs of plant origin make up the majority of assorted items. Development of drugs aimed at providing complex pharmacotherapeutical correction of cognitive and psychoemotional disorders and based on such peptides as vasopressin, is one of the most significant and relevant problems in modern neurology and is of great scientific and practical value.