Development of a New Bioequivalent Omeprazole Product

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216224%3A14160%2F24%3A00136988" target="_blank" >RIV/00216224:14160/24:00136988 - isvavai.cz</a>

Result on the web

<a href="https://www.mdpi.com/1648-9144/60/3/427" target="_blank" >https://www.mdpi.com/1648-9144/60/3/427</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.3390/medicina60030427" target="_blank" >10.3390/medicina60030427</a>

Result language

angličtina

Original language name

Development of a New Bioequivalent Omeprazole Product

Original language description

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.

Czech name

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Czech description

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Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

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OECD FORD branch

30218 - General and internal medicine

Project

—

Continuities

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Publication year

2024

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

Medicina-Lithuania

ISSN

1010-660X

e-ISSN

1648-9144

Volume of the periodical

60

Issue of the periodical within the volume

3

Country of publishing house

CH - SWITZERLAND

Number of pages

15

Pages from-to

1-15

UT code for WoS article

001192517300001

EID of the result in the Scopus database

2-s2.0-85188883574