University of Khartoum

Biowaiver Study on Five Generics of Metformin Hydrochloride Tablets in Sudan

Biowaiver Study on Five Generics of Metformin Hydrochloride Tablets in Sudan

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Title: Biowaiver Study on Five Generics of Metformin Hydrochloride Tablets in Sudan
Author: Ibrahim, Alaa Elmardi Osman
Abstract: Background: Metformin hydrochloride is an oral antihyperglycemic drug in the biguanide class. It is one of only two oral antihyperglycemic drugs in the World Health Organization Model List of Essential Medicine (WHO-MEL) and is now believed to be the most widely prescribed antihyperglycemic drug in the world. Objectives: The aim of this study was to evaluate the pharmaceutical equivalence of four brands of metformin hydrochloride in comparison with the innovator, through the assessment of the physicochemical parameters and dissolution profiles. Furthermore, to assess if brands of metformin hydrochloride tablets under study are eligible for biowaiver. Methods: Two different batches of five different brands of metformin hydrochloride 500 mg tablets available in the Sudanese market have been evaluated and subjected to a number of official tests (from United States Pharmacopeia and British Pharmacopeia) and non official tests. Dissolution under biowaiver was applied for two batches from each brand. The data obtained were compared using similarity factor (f2) and difference factor (f1). Furthermore, for each brand, the first batch was kept at room temperature for six months to study the influence of normal storage conditions on the dissolution behavior of the brands under study. This has been evaluated using the comparison of the dissolution profiles with similarity factor (f2) and difference factor (f1) along with the statistical comparison of the area under the dissolution curve (AUC) and the dissolution efficiency (DE). Results: The physicochemical tests for the first and second batches showed that, all brands A, B, C, D and E had passed the assay, weight variation, hardness, thickness, friability, disintegration time and dissolution tests. Dissolution under biowaiver conditions results showed that all the metformin hydrochloride brands, except brand D, from the two batches had released more than 85% of the labeled amount in pH 6.8 at 15 minutes. All batches, except brands A and D, released more than 85% in pH 4.5 at 15 minutes. However, in pH 1.2 no brand has released more than 20% till the end of the dissolution time. Comparison of the resulted dissolution profiles of the four generics (B, C, D and E) to the innovator drug A had indicated similarity of all generics to the innovator. Results of the dissolution profiles of the first batches after six months of keeping them at room temperature were compared using f2, f1, AUC and DE, the results indicated that the is no significant difference observed in the dissolution behavior. Conclusion: Based on biowaiver protocol, none of the five brands of metformin hydrochloride tested met the requirements of biowaiver. The obtained dissolution profiles of all generics from the two selected batches compared to the dissolution profile of innovator (A) showed that the dissolution profiles of the multisource products were similar to that of the innovator, indicating their pharmaceutical equivalence. No significant difference in dissolution was observed after storing the first selected batches at room temperature for six months.
Description: 118 Pages
URI: http://khartoumspace.uofk.edu/123456789/26661


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