University of Khartoum

Biowaiver study of different brands of Immidiate_Release Propranolol tablets marketed in Sudan

Biowaiver study of different brands of Immidiate_Release Propranolol tablets marketed in Sudan

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Title: Biowaiver study of different brands of Immidiate_Release Propranolol tablets marketed in Sudan
Author: Alamin, Mervat Alhaj Abdallah
Abstract: Background Nowadays, the use of generic drug products is increased to minimize the healthcare cost. With increased availability and use of generic drug products, healthcare professionals are encountered with a large number of multisource products from which they have to select therapeutically equivalent products. In recent years the necessity to provide a scientific basis for biowaivers for individual substances has met considerable interest. Objectives To compare the quality of 3 brands of Propranolol Hydrochloride tablets locally marketed in Sudan. Methods The method of biowaiver was followed according to USP2013 and WHO guidelines. The mentioned methods were validated according to USP guidelines regarding the API under study in different formulations & different pHs (Hydrochloric acid buffer pH 1.2, Acetate buffer pH 4.5 and Phosphate buffer pH 6.8). The study covered use of twelve tablets of each sample (innovator & generics). The samples were analyzed using UV/VIS using spectrophotometer atλmax 290nm. Results The method established was found to be selective, precise and linear in the three specified dissolution media. The percentage released of the active ingredient of the innovator (Inderal) and generics (Cimadral & Emforal) in the three specified media showed that more than 85% of active ingredient of the innovator (Inderal) & generics (Cimadral & Emforal) were released in 15 minutes. Conclusion The results of the dissolution profiles of the innovator (Inderal) and generics (Cimadral&Emforal) in all three specified dissolution media showed that the two products are identical and similar to the innovator without need for additional in vivo bioequivalence study. There was no need to calculate the similarity factor (f2) for these drugs as they were found to dissolve more than 85% of the labeled amount within 15 minutes.
URI: http://khartoumspace.uofk.edu/123456789/27446


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