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MEDICAL SCIENCES
Vira Drachuk, Igor Zamorskii, Olexandra Goroshko, Natalia Fedyuk, Vlad Fedyuk.
Higher State Educational Establishment of Ukraine «Bukovinian State Medical University» DOI: 10.24411/2520-6990-2020-12072 ИССЛЕДОВАНИЕ ВНУТРЕННЕГО РЫНКА ПРЕПАРАТОВ УРСОДЕСОКСИХОЛОВОЙ
КИСЛОТЫ
Вeра Драчук, Игорь Заморский, Александра Горошко, Наталья Федюк, Влад Федюк.
Высшее государственное учебное заведение Украины «Буковинский государственный медицинский университет»
RESEARCH OF THE DOMESTIC MARKET OF URSODESOXYCHOLIC ACID PREPARATIONS
Abstract.
The article highlights the problems of gallstone disease and cholelithiasis as the most common complications of obesity and metabolic syndrome. One of the ways to prevent gallstones in obese patients is the use of ursodeoxycholic acid. The marketing analysis of the range of ursodeoxycholic acid preparations registered on the pharmaceutical market of Ukraine is carried out, and the prospects oftheir further use in medicine are determined. Given the wide range of UDCA use in medical practice, it can be assumed that drugs containing UDCA are the drugs of choice for pathogenetic therapy of liver and biliary tract diseases, and the results of a comprehensive marketing analysis of the domestic market, it should be noted their significant share among other drugs however, promising when prescribing drugs is to assess the ratio of effectiveness/safety and price/quality, which is important for the patient.
Резюме.
В статье освещаются проблемы желчнокаменной болезни и желчнокаменной болезни как наиболее распространенных осложнений ожирения и метаболического синдрома. Одним из способов предотвращения образования камней в желчном пузыре у пациентов с ожирением является использование урсоде-зоксихолевой кислоты. Проведен маркетинговый анализ ассортимента препаратов урсодезоксихолевой кислоты, зарегистрированных на фармацевтическом рынке Украины, и определены перспективы их дальнейшего использования в медицине. Учитывая широкий спектр применения УДХК в медицинской практике, можно предположить, что препараты, содержащие УДХК, являются препаратами выбора для патогенетической терапии заболеваний печени и желчевыводящих путей, и по результатам комплексного маркетингового анализа внутреннего рынка следует отметил их значительную долю среди других лекарств, однако, при назначении лекарств многообещающе оценить соотношение эффективности / безопасности и цены / качества, что важно для пациента.
Key words: ursodeoxycholic acid, hepatoprotector, cholagogue, marketing analysis, range.
Ключевые слова: урсодезоксихолевая кислота, гепатопротектор, желчегонное средство, маркетинговый анализ, ассортимент.
Formulation of the problem. Gallstone disease is a common disease. Among the adult population of Europe, the prevalence of pathology is very high, so gallstones are found in 10-15% of the population. In European countries, the prevalence of gallstone disease is noted in Switzerland (18% - among men and 39.5% - among women) [1], in Ukraine, the prevalence of gallstone disease is 97.5% [2]. Ursodeoxycholic acid (UDCA) has been a leader in the treatment of liver and biliary tract diseases for the past 20 years. Formal indications indicated in the instructions to the drug are
lysis of cholesterol stones in the gallbladder and gastritis caused by bile reflux, as well as symptomatic treatment of primary biliary cirrhosis in the compensation phase [3].
Analysis of recent research and publications. Given the pronounced effect on the biliary system, UDCA is one of the recognized therapeutic agents for the treatment of cholestatic liver disease with intrahepatic cholestasis. This clinical concept covers a wide range of nosologies [4,5]. In almost all of these situations, the leading drug for pharmacotherapy is
and to determine the prospects for their further use in medicine.
Materials and methods of research. The object of the study was the nomenclature of drugs with the active substance ursodeoxycholic acid, which are presented on the pharmaceutical market of Ukraine. Ursodeoxycholic acid preparations were taken into account, which according to the international PBX classification belong to the pharmacological group. Drugs used in diseases of the liver and biliary tract, bile acid preparations (PBX code A05A A02). The study used methods of marketing analysis of the range of drugs and statistical processing of the data.
Research results and their discussion.
According to the literature, the range of positive effects of UDCA in various diseases is very wide, which leads to its widespread use in medical practice. The effect of drugs in the treatment of gallstones [6], chronic hepatitis (including B and C) [7], primary biliary cirrhosis [8], cholestasis [9], gallbladder cholesterol [10], primary sclerosing cholangitis and autoimmune hepatitis, biliary dyskinesia, duodenogastric reflux, for the prevention of oncological diseases of the colon [11], as well as the effect of the drug on the immune status of the body [12]. As can be seen from the above data. This range of uses encourages the expansion of the range of drugs in the pharmaceutical market.
According to the results of the marketing research, it was established that 25 names of ursodeoxycholic acid drugs were registered on the pharmaceutical market of Ukraine (Table 1).
Table 1
Medicines registered in Ukraine, which include ursodeoxycholic acid
№n/n Name / dosage form The composition of the active substances Producer
1. URSODESOXYCHOLIC ACID powder (substance) in double plastic bags for pharmaceutical use ursodeoxycholic acid not less than 99.0% and not more than 101.0%, in terms of dry matter Sichuan Seli Pharmaceutical Co., Ltd., China
2. URSODEOXYCHOLIC ACID powder (substance) in double plastic bags in cardboard drums for pharmaceutical use ursodeoxycholic acid from 99.0% to 101.0% (in terms of dry matter) Sichuan Seli Pharmaceutical Co., Ltd., China
3. URSODESOXYCHOLIC ACID MICRONIZED crystalline powder (substance) in double plastic bags for pharmaceutical use ursodeoxycholic acid not less than 99.0% and not more than 101.0%, in terms of dry matter Diapharma Francis S.R.L., Italy
4. URSODEOXYCHOLIC ACID powder (substance) in double plastic bags for the production of non-sterile dosage forms ursodeoxycholic acid not less than 99.0% and not more than 101.0% in terms of anhydrous substance ISE SPA, Italy
5. URSONOST capsules of 150 mg of 10 capsules in a blister; 2 or 5 blisters in a cardboard box 1 capsule contains 150 mg of ursodeoxycholic acid Francia Pharma-ciutici Industria Pharmaco Biologica S.R.L., Italy
6. URSONOST capsules of 300 mg of 10 capsules in a blister; 2 or 5 blisters in a cardboard box 1 capsule contains 300 mg of ursodeoxycholic acid Francia Pharma-ciutici Industria Pharmaco Biologica S.R.L., Italy
UDCA, which is reflected in most clinical guidelines and recommendations. UDCA is often used in the pharmacotherapy of various clinical conditions (acute and chronic hepatitis of various etiologies, cholestasis) (Ilchenko OI), studied the effectiveness of drugs in the treatment of patients with polyposis and polyposis-reticular forms of gallbladder cholesterol (Maev IV), joint use of statins and ursodeoxycholic acid (ursosan) is justified as hypolipidemic therapy and therapy aimed at improving liver function (Korneeva ON, Drapkina OM).
Selection of previously unsolved parts of the overall problem. According to forecasts, the global epidemic of obesity and metabolic syndrome will further increase the incidence of housing. The issue of prevention of obesity and metabolic syndrome, as well as cholelithiasis as the most common development of complications is relevant not only for Ukrainian medicine. Numerous searches for methods of prevention of housing and communal services are being carried out at the present stage, however, information on the relationship between dietary recommendations and prevention of gallstones is numerous, although contradictory. One of the ways to prevent gallstones in obese patients is the use of UDCA. Therefore, it is important to conduct a marketing analysis of the range of drugs ursodeoxycholic acid, which are registered in the pharmaceutical market.
The purpose of the study is to conduct a marketing analysis of the range of ursodeoxycholic acid drugs that are registered in the pharmaceutical market of Ukraine,
MEDICAL SCIENCES / <<€©LL©(MyM~J0y®MaL>>#2(II72),2©2©
7. URSODEX film-coated tablets, 150 mg 10 tablets in a blister; 1 or 5 blisters in a cardboard package 1 tablet contains ursodeoxycholic acid 150 mg San Pharmaceutical Industries Limited, India
8. URSODEX film-coated tablets, 300 mg 10 tablets in a blister; 1 or 5 blisters in a cardboard package 1 tablet contains ursodeoxycholic acid 300 mg San Pharmaceutical Industries Limited, India
9. URSODEOXYCHOLIC ACID powder (substance) in double plastic bags for the production of non-sterile dosage forms ursodeoxycholic acid from 99.0% to 101.0% Biocon Limited, India
10. URSODEOXYCHOLIC ACID powder (substance) in two-layer plastic bags for pharmaceutical use ursodeoxycholic acid not less than 99.0% and not more than 101.0% in terms of dry matter Dewung Bio Inc., Korea
11. GRINTEROL® solid capsules of 250 mg of 10 capsules in the nearest part; 5 or 10 blisters in a cardboard pack 1 hard capsule contains 250 mg of ursodeoxycholic acid JSC "Grindeks", Latvia
12. URSOSAN® capsules of 250 mg of 10 capsules in a blister; 1 or 5, or 10 blisters in a cardboard box 1 capsule contains 250 mg of ursodeoxycholic acid PRO.MED.CS Prague AS, Czech Republic
13. URSOSAN® FORTE film-coated tablets, 500 mg 10 tablets in a blister, 1 or 2, or 3, or 5, or 6, or 9, or 10 blisters in a cardboard box 1 film-coated tablet contains 500 mg of ursodeoxycholic acid PRO.MED.CS Prague AS, Czech Republic
14. URSOFALK oral suspension, 250 mg / 5 ml 250 ml in a glass bottle, 1 bottle with 1 measuring cup 5 ml of suspension (one measuring cup) contain ursodeoxycholic acid 250 mg Dr. Falk Pharma GmbH, Germany
15. URSOFALK capsules of 250 mg of 10 capsules in a blister; 1 blister in a cardboard box, 25 capsules in a blister; 2 or 4 blisters in a cardboard box 1 capsule contains 250 mg of ursodeoxycholic acid Dr. Falk Pharma GmbH, Germany
16. URSOFALK film-coated tablets, 500 mg 25 tablets in a blister, 1, 2 or 4 blisters in a cardboard box 1 film-coated tablet contains 500 mg of ursodeoxycholic acid Dr. Falk Pharma GmbH, Germany
17. URSOLIV capsules of250 mg of 10 capsules in a blister; 5 blisters in a box 1 capsule contains ursodeoxycholic acid 250 mg Mega Livesci-ences Public Company Limited, Thailand
18. HOLUDEXAN hard capsules, 300 mg, 10 capsules in a blister, 2 or 5, or 6, or 10 blisters in a cardboard box 1 capsule contains ur-sodeoxycholic acid 300 mg WORLD MEDICINE ILACH SAN. WE TIDE. A.Sh., Turkey
19. URSOMAX capsules of 250 mg, 10 capsules in a blister, 1 or 5, or 10 blisters in a pack of cardboard 1 capsule contains ursodeoxycholic acid (in terms of 100% dry matter) 250 mg LLC "PHARMEX GROUP", Ukraine
20. URSOMAX capsules of 250 mg in bulk: № 1000: 1000 capsules in double plastic bags in plastic containers; in bulk: № 13500: 13500 capsules in double plastic bags in plastic containers 1 capsule contains ur-sodeoxycholic acid (in terms of 100% dry matter) 250 mg LLC "PHARMEX GROUP", Ukraine
21. URSOHOL® capsules of 250 mg, 10 capsules in a contour honeycomb package, 5 or 10 contour honeycomb packages in a pack 1 capsule contains ursodeoxycholic acid 250 mg "Pharmaceutical firm" Darnitsa", Ukraine
22. UKRLIV® tablets of 250 mg, 10 tablets in a blister; 3 or 10 blisters in a cardboard package 1 tablet contains 250 mg of ursodeoxycholic acid LLC "KUSUM PHARM" Ukraine
23. UKRLIV® 500 mg tablets of 10 tablets in a blister; 3 or 10 blisters in a cardboard package 1 tablet contains ursodeoxycholic acid 500 mg LLC "KUSUM PHARM" Ukraine
24. UKRLIV® oral suspension, 250 mg / 5 ml of 200 ml in a vial; 1 bottle together with a measuring spoon in a cardboard package; 30 ml in a bottle; 1 bottle together with a measuring spoon in a cardboard package 5 ml of suspension contain ursodeoxycholic acid 250 mg LLC "KUSUM PHARM" Ukraine
25. UKRLIV® oral suspension, 250 mg / 5 ml, 200 ml in a vial; 1 bottle together with a measuring spoon in a cardboard package; 30 ml in a bottle; 1 bottle together with a measuring spoon in a cardboard package; 40 ml in a jar; 1 jar in a cardboard package with a measuring spoon 5 ml of suspension contain ursodeoxycholic acid 250 mg LLC "KUSUM PHARM" Ukraine
Analysis of the market structure of with domestic drugs and 72% (18 items) - by means of ursodeoxycholic acid drugs by producer countries imported production (Fig. 1). showed that consumers by 28% (7 items) are provided
ursodeoxycholic acid drugs by country of origin
Among the drugs of foreign production, the the same share belongs to drugs from India and leading place is occupied by drugs made in Italy (16%), Germany - 12% respectively (Fig. 2).
■ Ital
■ Ind
■ Gei
■ Cz(
■ Ch:
■ Tui
■ Ko:
■ Lat
Fig. 2. The structure of the domestic market offoreign-made drugs containing ursodeoxycholic acid by anuntry
of origin
Pharmaceutical market research in terms of the belongs to capsules (40%), the same share is occupied contribution of different dosage forms showed that by tablets and powders (24%) and 12 % occupy the ursodeoxycholic acid drugs are presented in 4 different suspension. dosage forms (Fig. 3), among which the largest share
Fig. 3. Pharmaceutical market research of different dosage forms ursodeoxycholic acid
Suspension Powders Tablets Capsuls
12%
24% 24%
40%
0%
10%
20%
30%
40%
50%
The immunomodulatory effect of UDCA is due to the suppression of the expression of HL A 1 antigens on the membranes of hepatocytes and HL A 2 on cholangiocytes, the normalization of the cell-specific immune response of lymphocytes [13]. UDCA delays the progression of fibrosis in patients with primary biliary cirrhosis, cystic fibrosis and alcoholic steatohepatitis (antifibrotic effect). In addition, UDCA slows down the processes of premature aging and death of hepatocytes, cholangiocytes (antiapoptotic effect), reduces the level of lipid peroxidation, activates the glutathione system, enhancing antioxidant protection (antioxidant effect) [14]. Due to its high hydrophilicity, UDCA is a virtually non-toxic compound. It is metabolized in the liver, binds to glycine and taurine and excreted from the liver into the bile; in the intestine it is broken down and hydroxylated into lithocholic acid [15].
Given the wide range of UDCA use in medical practice, it can be considered that drugs containing UDCA are the drugs of choice for pathogenetic therapy of liver and biliary tract diseases, and according to the results of a comprehensive marketing analysis of the domestic market, it should be noted their significant share among other drugs however, when prescribing drugs, it is important to evaluate the ratio of efficacy / safety and price / quality, which is important for the patient.
Conclusions. Ursodeoxycholic acid preparations are represented by a wide range of dosage forms, which will allow their use in a number of diseases and prevention of gallstones in obese patients.
Prospects for further research. Further pharmacoeconomic analysis of the use of ursodeoxycholic acid, as well as information work among medical and pharmaceutical professionals on this range of drugs.
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