Development of a New Bioequivalent Omeprazole Product

J 2024

Development of a New Bioequivalent Omeprazole Product

KUMISBEK, Gulzina, David VETCHÝ a Arshyn KADYRBAY

Základní údaje

Originální název

Development of a New Bioequivalent Omeprazole Product

Autoři

KUMISBEK, Gulzina (398 Kazachstán, domácí), David VETCHÝ (203 Česká republika, domácí) a Arshyn KADYRBAY (398 Kazachstán)

Vydání

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

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30218 General and internal medicine

Stát vydavatele

Švýcarsko

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Impakt faktor

Impact factor: 2.600 v roce 2022

Organizační jednotka

Farmaceutická fakulta

DOI

http://dx.doi.org/10.3390/medicina60030427

UT WoS

001192517300001

Klíčová slova anglicky

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

Štítky

rivok, ÚFT

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 2. 9. 2024 07:54, Mgr. Daniela Černá

Anotace

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.

Citovat

KUMISBEK, Gulzina, David VETCHÝ a Arshyn KADYRBAY. Development of a New Bioequivalent Omeprazole Product. Medicina-Lithuania. Basel: MDPI, 2024, roč. 60, č. 3, s. 1-15. ISSN 1010-660X. Dostupné z: https://dx.doi.org/10.3390/medicina60030427.

@article{2427817,
   author = {Kumisbek, Gulzina and Vetchý, David and Kadyrbay, Arshyn},
   article_location = {Basel},
   article_number = {3},
   doi = {http://dx.doi.org/10.3390/medicina60030427},
   keywords = {omeprazole; bioequivalence study; stability study; enteric coating; pellets; dissolution; industrial development},
   language = {eng},
   issn = {1010-660X},
   journal = {Medicina-Lithuania},
   title = {Development of a New Bioequivalent Omeprazole Product},
   url = {https://www.mdpi.com/1648-9144/60/3/427},
   volume = {60},
   year = {2024}
}

TY  - JOUR
ID  - 2427817
AU  - Kumisbek, Gulzina - Vetchý, David - Kadyrbay, Arshyn
PY  - 2024
TI  - Development of a New Bioequivalent Omeprazole Product
JF  - Medicina-Lithuania
VL  - 60
IS  - 3
SP  - 1-15
EP  - 1-15
PB  - MDPI
SN  - 1010660X
KW  - omeprazole
KW  - bioequivalence study
KW  - stability study
KW  - enteric coating
KW  - pellets
KW  - dissolution
KW  - industrial development
UR  - https://www.mdpi.com/1648-9144/60/3/427
N2  - 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.
ER  -

KUMISBEK, Gulzina, David VETCHÝ a Arshyn KADYRBAY. Development of a New Bioequivalent Omeprazole Product. \textit{Medicina-Lithuania}. Basel: MDPI, 2024, roč.~60, č.~3, s.~1-15. ISSN~1010-660X. Dostupné z: https://dx.doi.org/10.3390/medicina60030427.

Podrobný výpis o publikaci