An analysis of the range of propranolol-based drugs in the Russian and global pharmaceutical markets

Introduction. Propranolol is a non-selective β-adrenergic blocker used to treat cardiovascular and other medical conditions in both adults and children. In adults, it is employed for the treatment of arterial hypertension, angina pectoris, arrhythmias, and essential tremor; in children, it is used for treating arrhythmias, pheochromocytoma, thyrotoxicosis, migraine, infantile hemangiomas, as well as symptoms of anxiety and aggressive behavior.

Aim . To conduct an analysis of the range of propranolol drugs in the Russian and global pharmaceutical markets.

Materials and methods. The objects of the research were the state registers of medicines of the Russian Federation (RF), the Republic of Belarus, the Republic of Kazakhstan, the Republic of Armenia, and the Kyrgyz Republic, countries of the Eurasian Economic Union (EAEU), the United States, and the United Kingdom. Research methods: comparative, structural, statistical, logical, marketing, and content analyses.

Results . In the RF, 10 propranolol-based drugs are registered, 9 of which are in the form of tablets for adults in dosages of 10 and 40 mg, included in the List of Vital and Essential Drugs (LVED), and manufactured in the RF; 1 is an oral solution in a dosage of 3.75 mg/ml, intended for children, not included in the LVED, and produced in France. In the Republic of Belarus, 2 propranolol drugs as tablets for adults, in dosages of 10 and 40 mg are registered, manufactured in the Republic of Belarus and Ukraine. In the Republic of Kazakhstan, only a pediatric oral solution with a dosage of 3.75 mg/ml, produced in France, is registered currently. In the Republic of Armenia and the Kyrgyz Republic, only 1 trade name (TN) is registered – tablets for adults 40 mg manufactured in the Republic of Belarus. In the EAEU, 2 propranolol-based drugs are registered: tablets 10 and 40 mg (RF) and an oral solution 3.75 mg/ml (France). In the United Kingdom, 17 TN of propranolol are registered in various dosages and dosage forms (DFs): tablets, fi lm-coated tablets, and extended release capsules. Dosages of solid DFs include 10, 40, 80, 160 mg. Liquid DFs include oral solutions 5 mg/5 ml, 10 mg/5 ml, 40 mg/5 ml, and 50 mg/5 ml. In the United States, 18 TNs of propranolol available in various DFs are registered: tablets (10, 20, 40, 60, 80 mg), extended release capsules (60, 80, 120, 160 mg), oral solutions (3.75 mg/ml, 20 mg/5 ml, and 40 mg/5 ml), and injectable solutions (1 mg/ml).

Conclusion. In the RF, propranolol-based drugs are available in two DFs: tablets (10 and 40 mg) and an oral solution (3.75 mg/ml). A similar situation is observed in EAEU’s countries. In the markets of the USA and the United Kingdom, there is a wide range of propranolol-based drugs, including 7 solid DFs, 1 injectable DF, and 6 liquid DFs, including for children. In the RF, only one pediatric drug (in a single dosage) in the form of oral solution is registered. This drug is imported and is not included in the LVED, which contributes to its high cost and, consequently, low accessibility for the population. The issue of the lack of aff ordable and diverse pediatric propranolol DFs in the RF requires urgent resolution.

1. Rehsia N.S., Dhalla N.S. Mechanisms of the benefi cial eff ects of beta-adrenoceptor antagonists in congestive heart failure. Exp. Clin. Cardiol. 2010;15(4):e86-95. PMID: 21264074. PMCID: PMC3016066.

2. Gillette P., Garson A. Jr., Eterovic E. et al. Oral propranolol treatment in infants and children. J. Pediatr. 1978;92(1):141-144. DOI: 10.1016/s0022-3476(78)80096-1.

3. Forsythe W.I., Gillies D., Sills M.A. Propanolol (‘Inderal’) in the treatment of childhood migraine. Dev. Med. Child Neurol. 1984;26(6):737-741. DOI: 10.1111/j.1469-8749.1984.tb08166.x.

4. Tan X., Guo S., Wang C. Propranolol in the treatment of infantile hemangiomas. Clin. Cosmet. Investig. Dermatol. 2021;14:1155-1163. DOI: 10.2147/CCID.S332625.

5. Szeleszczuk Ł., Frączkowski D. Propranolol versus other selected drugs in the treatment of various types of anxiety or stress, with particular reference to stage fright and post-traumatic stress disorder. Int. J. Mol. Sci. 2022;23(17):10099. DOI: 10.3390/ijms231710099.

6. Srinivasan A.V. Propranolol: A 50-year historical perspective. Ann. Indian Acad. Neurol. 2019;22(1):21-26. DOI: 10.4103/aian.AIAN_201_18.

7. Rubricator of the Clinical Recommendations. Infantile hemangioma. 2023. URL: https://cr.minzdrav.gov.ru/ recomend/769_1 (accessed 18.09.2023).

8. Orange Book. Approved Drug Products with Therapeutic Equivalence Evaluations. URL: https://www.fda.gov/drugs/scripts/cder/ob/index.cfm (accessed 25.09.2023).

9. State Register of Medicines of the Russian Federetion. URL: http://www.grls.rosminzdrav.ru (accessed 28.09.2023).

10. On approving of the List of Vital and Essential Drugs, as well as the Lists of hospital grade medicines and the minimal range of medicines for medical care providing: Order of the RF Government dated by 12.10.2019 No. 2406-р (revised at 09.06.2023). URL: https://www.consultant.ru/document/cons_doc_LAW_335635/ (accessed 28.09.2023).

11. AptekiPlus. URL: https://aptekiplus.ru/ (accessed 11.10.2023).

12. Zdravcity. URL: https://zdravcity.ru/accessed (11.10.2023).

13. eApteka. URL: https://www.eapteka.ru/ (accessed 11.10.2023).

14. Apteka.ru. URL: https://apteka.ru/ (accessed 11.10.2023).

15. Registries of the Center of Expertises and Tests in Healthcare of the Republic of Belarus. URL: https://www.rceth.by/refbank (accessed 25.09.2023).

16. National Center for Expertise of Medicines and Medical Devices. State Registry of Medicines and Medical Devices. URL: http://register.ndda.kz/category/search_prep (accessed 25.09.2023).

17. Unifi ed Information System for Medicines of the Republic of Kyrgyzstan. URL: http://212.112.103.101/reestr (accessed 25.09.2023).

18. Register of Medicines of the Republic of Armenia. URL: http://pharm.cals.am/ (accessed 25.09.2023).

19. Portal of Public Information Resources and Open Data. Unifi ed Register of Registered Medicines of the Eurasian Economic Union. URL: https://portal.eaeunion.org/sites/commonprocesses/ru-ru/Pages/DrugRegistrationDetails.aspx (25.09.2023).

20. MHRA (Medicines and Healthcare products Regulatory Agency). Products. URL: https://products.mhra.gov.uk/ (accessed 25.09.2023).