COMPARATIVE ASSESSMENT OF QUALITY PARAMETERS OF OMEPRAZOLE PREPARATIONS IN THE PHARMACEUTICAL MARKET
Keywords:
Omeprazole, pharmaceutical market, quality parameters, comparative assessment, pharmacopoeia requirements, dissolution test, drug quality, generic drugs.Abstract
Omeprazole preparations are among the most widely used proton pump inhibitors in the pharmaceutical market. Their production by many manufacturers using different technologies can lead to certain differences in quality parameters. This article discusses the issues of comparative assessment of quality parameters of omeprazole preparations in the pharmaceutical market. In the course of the study, such main pharmaceutical indicators as appearance, dose uniformity, disintegration and dissolution indicators, active substance content, and packaging quality are analyzed. The results of the comparative assessment serve to determine the compliance of the preparations with the requirements of the pharmacopoeia, assess the quality level, and create a scientific basis for selecting the most reliable and effective products. The study is aimed at strengthening pharmaceutical quality control, ensuring therapeutic equivalence of drugs, and increasing patient safety.
References
State Pharmacopoeia of the Republic of Uzbekistan. Volume 1. Tashkent: Uzdavlatnashr, 2018. 720 p.
Ministry of Health of the Republic of Uzbekistan. A set of regulatory documents on quality and safety control of medicines. Tashkent, 2020. 356 p.
Katzung B.G. Basic and Clinical Pharmacology. 14th ed. New York: McGraw-Hill Education, 2018. 1256 p.
United States Pharmacopeia (USP 43) National Formulary (NF 38). Rockville, MD: United States Pharmacopeial Convention, 2020. 6890 p.
British Pharmacopoeia. Vol. I-II. London: The Stationery Office, 2021. 5600 p.
European Pharmacopoeia. 10th ed. Strasbourg: Council of Europe, 2020. 4300 p.
Aulton ME, Taylor KMG. Aulton's Pharmaceutics: The Design and Manufacture of Medicines. 5th ed. Edinburgh: Elsevier, 2018. 896 p.
Ansel H.C., Allen L.W., Popovich N.G. Pharmaceutical Calculations. 15th ed. Philadelphia: Wolters Kluwer, 2021. 784 p.
