ASSESSMENT OF PHARMACEUTICAL EQUIVALENCE AND IN VIRTO RELEASE OF SOME PROPRANOLOL HCL TABLET 40MG MARKETED IN SUDAN UNDER BIOWAIVER CONDITIONS

Hajer M. Ahmed, Mohammed E. Adam, Fatehalrahman F. Magbool*

ABSTRACT

In this research bioequivalence study was carried out on three brands of Propranolol HCL tablet 40mg marketed in Sudan. by estimation content%, hardness, disintegration time and the content uniformity of Propranolol HCL tablets and to establish biowavier criteria and requirement by study the dissolution of Propranolol HCL tablets of the innovator d and test products (brand A) and (brand B) in media of pH 1.2, 4.5 and 6.8, First the pharmaceutical equivalence of the three brands using official methods. Second the biowaiver studies were carried according to WHO guidelines. The results of the study of the three brands revealed that the three brands complied with the requirement of the official tests of content%, hardness, disintegration time and the content uniformity. The two sample drugs are bioequivalent to innovator drug as they qualify the WHO criteria for biowaiver (both the sample drugs and innovator are very rapidly dissolving i.e. the amount of released is ≥ 85% of labeled amount in 15 min.) and so there is no need to carry out in vivo bioequivalence studies.

Keywords:

Propranolol HCL, Bioequivalence, Content uniformaty, Official method.

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