J 2024

Development of a New Bioequivalent Omeprazole Product

KUMISBEK, Gulzina, David VETCHÝ and Arshyn KADYRBAY

Basic information

Original name

Development of a New Bioequivalent Omeprazole Product

Authors

KUMISBEK, Gulzina (398 Kazakhstan, belonging to the institution), David VETCHÝ (203 Czech Republic, belonging to the institution) and Arshyn KADYRBAY (398 Kazakhstan)

Edition

Medicina-Lithuania, Basel, MDPI, 2024, 1010-660X

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30218 General and internal medicine

Country of publisher

Switzerland

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

Impact factor

Impact factor: 2.600 in 2022

Organization unit

Faculty of Pharmacy

DOI

UT WoS

001192517300001

Keywords in English

omeprazole; bioequivalence study; stability study; enteric coating; pellets; dissolution; industrial development

Tags

Tags

International impact, Reviewed
Změněno: 2/9/2024 07:54, Mgr. Daniela Černá

Abstract

V originále

Background and Objectives: The enteric form of omeprazole is one of the most commonly prescribed medications. Similarly to Europe, Kazakhstan relies on the localization of pharmaceutical drug production as one of its primary strategies to ensure that its population has access to affordable and good-quality medicines. This study comprehensively describes the technologically available development of bioequivalent delayed-release omeprazole. Materials and Methods: Various regimes and technological parameters were tested on laboratory- and production-scale equipment to establish a technical process where a functional and gastro-protective layer is essential. According to the ICH guidance on stability testing and Kazakhstan local rules, stability studies were conducted under conditions appropriate for climate zone II. The comparison of the rate and extent of absorption with subsequent assessment of the bioequivalence of the generic and reference drugs after a single dose of each drug at a dose of 40 mg was performed. Results: The quantitative and qualitative composition and technology of producing a new generic enteric form of omeprazole in capsules were developed and implemented at the manufacturing site of solid forms. Dissolution profiles in media with pH 1.2 and 6.8 were proven. During the accelerated six-month and long-term twelve-month studies, the developed formulation in both packaging materials at each control point passed the average weight and mass uniformity test, dissolution test, acid-resistance stage test, buffer stage test, impurity assay, and microbiological purity test and met all the specification criteria. A bioequivalence study in 24 healthy volunteers compared against the innovative drug showed the bioequivalency of the new generic system. The obtained values from the test and reference products were 1321 +/- 249.0 ng/mL and 1274 +/- 233 ng/mL for Cmax, 4521 +/- 841 ng center dot h /mL and 4371 +/- 695 ng center dot h /mL for AUC0-t, and 4636 +/- 814 ng center dot h /mL and 4502 +/- 640 ng center dot h /mL for AUC0-infinity. Conclusions: Using affordable technologies, a bioequivalent generic delayed-release formulation of 20 and 40 mg omeprazole has been developed.