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Bioequivalence: Overview

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Pharmaceutical equivalents, by definition, are drug products with the same active ingredient in the same quantities, encapsulated in identical dosage forms, and intended for the same administration routes. These pharmaceutical equivalents are deemed bioequivalent if the bioavailability of the active entity in the drug preparations is similar. Moreover, pharmaceutical equivalents demonstrating bioequivalence are also regarded as therapeutically equivalent. This means that when used as directed,...

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Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...

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Prodrugs are a class of pharmaceutical compounds that undergo a biotransformation process within the body to be converted into a pharmacologically active drug. Prodrugs are designed to improve the therapeutic properties of the parent drug, such as enhancing bioavailability, increasing stability, or reducing toxicity. The concept of prodrugs revolves around modifying the chemical structure of the original drug to make it more effective or convenient for administration.
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An Intestine/Liver Microphysiological System for Drug Pharmacokinetic and Toxicological Assessment

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Development of a New Bioequivalent Omeprazole Product.

Gulzina Kumisbek¹, David Vetchý¹, Arshyn Kadyrbay²

¹Department of Pharmaceutical Technology, Faculty of Pharmacy, Masaryk University, 612 00 Brno, Czech Republic.

Medicina (Kaunas, Lithuania)

|March 28, 2024

Summary

A new generic delayed-release omeprazole formulation was developed using affordable technologies. This bioequivalent generic omeprazole ensures access to quality medication, meeting all stability and bioequivalence criteria.

Keywords:

bioequivalence study dissolution enteric coating industrial development omeprazole pellets stability study

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Area of Science:

Pharmaceutical Technology
Drug Development
Bioequivalence Studies

Background:

Omeprazole, a commonly prescribed enteric-coated medication, is crucial for accessible healthcare.
Kazakhstan prioritizes local pharmaceutical production for affordable, high-quality medicines, mirroring European strategies.
Development of bioequivalent generic drugs is essential for expanding medication access.

Purpose of the Study:

To develop and technologically validate a bioequivalent delayed-release omeprazole formulation.
To ensure the quality, stability, and bioequivalence of the generic omeprazole product.
To support local pharmaceutical manufacturing initiatives in Kazakhstan.

Main Methods:

Laboratory and production-scale testing of various technological parameters for delayed-release omeprazole.
Stability studies conducted under ICH guidelines and Kazakhstan's climate zone II conditions.
Bioequivalence assessment in 24 healthy volunteers comparing generic and reference 40 mg omeprazole formulations.

Main Results:

Successful development and implementation of a generic enteric-form omeprazole capsule manufacturing process.
Formulation demonstrated appropriate dissolution profiles and passed all accelerated (6-month) and long-term (12-month) stability tests.
Bioequivalence study confirmed comparable Cmax and AUC values between the generic and reference omeprazole products.

Conclusions:

A bioequivalent generic delayed-release omeprazole formulation (20 and 40 mg) has been successfully developed.
The formulation utilizes affordable technologies, enhancing local pharmaceutical production capabilities.
This development contributes to ensuring the availability of high-quality, accessible omeprazole in Kazakhstan.