Omeprazole 20 mg capsules
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Omeprazole 20 mg Capsules: A Comprehensive Review of Bioequivalence Studies
Introduction to Omeprazole 20 mg Capsules
Omeprazole is a widely used proton-pump inhibitor (PPI) that reduces stomach acid production, making it effective for treating various acid-related gastrointestinal disorders. This article synthesizes findings from multiple studies on the bioequivalence of different formulations of omeprazole 20 mg capsules.
Bioequivalence in Different Populations
Algerian Volunteers
A study conducted on 18 healthy Algerian volunteers compared the bioavailability of two brands of omeprazole 20 mg gastro-resistant capsules. The reference product was MOPRAL (AstraZeneca). The study found that while the area under the curve (AUC) values were within the bioequivalence range of 80%-125%, the maximum concentration (Cmax) did not meet this criterion, indicating that the two formulations were not bioequivalent in fasting conditions.
Mexican Volunteers
In a study involving 34 healthy Mexican volunteers, two oral formulations of omeprazole 20 mg capsules were compared: Inhibitron (test) and LosecA (reference). The results showed that both formulations met the bioequivalence criteria for AUC and Cmax, with no significant adverse events reported, indicating that the formulations were bioequivalent.
Bangladeshi Volunteers
A study on 24 healthy Bangladeshi male subjects compared Xeldrin®20 (test) and Losec®20 (reference). The pharmacokinetic parameters, including AUC and Cmax, were within the FDA's bioequivalence range of 80%-125%, suggesting that the two formulations were bioequivalent.
Korean Volunteers
A study involving 24 healthy Korean male volunteers compared Hutex omeprazole (test) and Yuhan Losec (reference). The pharmacokinetic parameters, including AUC and Cmax, were within the bioequivalence range, indicating that both formulations were bioequivalent in fasting conditions.
Formulation Comparisons
Enteric-Coated Tablets vs. Capsules
A study on 40 duodenal ulcer patients compared the bioavailability and intragastric pH profile of omeprazole 20 mg enteric-coated tablets and capsules. The results indicated that the tablet formulation had a higher AUC and Cmax compared to the capsule, but both formulations were considered biodynamically equivalent in terms of their effects on intragastric pH.
Simplified Omeprazole Suspension (SOS) vs. Capsules
A study on seven healthy volunteers compared the pharmacokinetics of omeprazole delayed-release capsules and a simplified omeprazole suspension (SOS). The SOS formulation showed faster absorption and a shorter time to reach maximum concentration (tmax) compared to the capsule, but the overall AUC was lower for SOS.
MUPS Tablets vs. Encapsulated Tablets
A study on 38 healthy male Caucasian subjects compared omeprazole MUPS 20 mg tablets and their encapsulated form. The pharmacokinetic parameters, including AUC and Cmax, were within the bioequivalence range, indicating that encapsulation did not affect the extent and rate of absorption.
Conclusion
The bioequivalence of omeprazole 20 mg capsules varies depending on the formulation and population studied. While some formulations meet the bioequivalence criteria set by regulatory authorities, others do not, particularly in terms of Cmax. These findings highlight the importance of conducting thorough bioequivalence studies to ensure the efficacy and safety of different omeprazole formulations across various populations.
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