Mohammad Naushad Alam, Amgad A. Awad El-Gied, Mohamed Rahamathulla*, Mohammed Fathey, Mahmoud Abd El Fattah Shaker.
Department of Pharmaceutics, College of Pharmacy, King Khalid University, PO Box 960, Abha, Kingdom of Saudi Arabia.
SHORT COMMUNICATION
Volume 2017, Issue 2017, Article ID 114, Page 01-05.
*Author for correspondence
E-mail: [email protected]
ABSTRACT
The main objective of the present study was to evaluate between four different brands of Glibenclamide which are commercially available in the Saudi Arabian market in comparison with innovator products (Daonil tablets). All the marketed brands were evaluated for quality control test such as thickness, diameter, hardness, weight variation, friability, disintegration and in vitro dissolution test. The results revealed that the thickness and diameter of all marketed brands were within 2.75 mm and 2.76 mm respectively. The friability was less than 1% and passes the content uniformity test. All marketed tablets were disintegrated within 5-12 min. The percentage content of different brands of Glibenclamide tablets showed within the monograph specifications. The in vitro drug release of innovator and all the four generic brands of GLB were carried out in phosphate buffer pH 6.8. All the marketed brands show more than 95 % of drug release for 2 hrs. Among all brands Innovator, Daonil and Glibil tablet brand show 99% and 98% drug release respectively. The In vitro drug release result shows insignificant differences in dissolution behavior were observed between the innovator and four different generic brands.
Keywords: Glibenclamide Tablets, Dissolution test, Quality Control, in-vitro release.
The main objective of the present study was to evaluate between four different brands of Glibenclamide which are commercially available in the Saudi Arabian market in comparison with innovator products (Daonil tablets). All the marketed brands were evaluated for quality control test such as thickness, diameter, hardness, weight variation, friability, disintegration and in vitro dissolution test. The results revealed that the thickness and diameter of all marketed brands were within 2.75 mm and 2.76 mm respectively. The friability was less than 1% and passes the content uniformity test. All marketed tablets were disintegrated within 5-12 min. The percentage content of different brands of Glibenclamide tablets showed within the monograph specifications. The in vitro drug release of innovator and all the four generic brands of GLB were carried out in phosphate buffer pH 6.8. All the marketed brands show more than 95 % of drug release for 2 hrs. Among all brands Innovator, Daonil and Glibil tablet brand show 99% and 98% drug release respectively. The In vitro drug release result shows insignificant differences in dissolution behavior were observed between the innovator and four different generic brands.
Keywords: Glibenclamide Tablets, Dissolution test, Quality Control, in-vitro release.
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