Bioequivalence

Immediate release

Friability

Innovator

Discrete mathematics

Equivalence (formal languages)

Chromatography

Operating system

Computer science

Bioavailability

Drug

Business

Dissolution

First pass effect

Organic chemistry

Biopharmaceutics Classification System

Blood pressure

Atenolol

Dissolution testing

Mathematics

Entrepreneurship

Internal medicine

Pharmacology

Intellectual property

Medicine

Chemistry

Finance

International Journal of Applied Pharmaceutics

Objective: The therapeutic equivalence of generic brands is a great challenge for manufacturers. This study aimed to evaluate the bioequivalence of four different generic brands of atenolol tablets under biowaiver conditions.&#x0D; Methods: Physiochemical properties of the tablet products namely uniformity of weight, hardness, disintegration, and drug content were assessed. The dissolution profiles of atenolol tablets were conducted in pH 1.2, 4.5, 6.8 and 7.6 buffers using USP dissolution apparatus II. Similarity and difference factors were calculated. Finally, four kinetic models have been offered to describe the release characteristics of atenolol under experiment conditions.&#x0D; Results: All tablets showed accepted physiochemical characters. Dissolution profiles revealed that G2 showed the highest similarity to innovator (f2 91.86) in pH 7.6. Dissolution kinetics of G2 at the same pH could be best described as Higuchi model of release. &#x0D; Conclusion: The study showed that excipients and manufacturing practices play an important role in marketing biowaiver generic products meet the international regulatory bodies criteria.

EQUIVALENCE STUDY OF IMMEDIATE RELEASE TABLETS OF BETA BLOCKER DRUG