Dissolution Profile Evaluation of Eight Brands of Metformin Hydrochloride Tablets Available in Jimma, Southwest Ethiopia

Abstract

Background: Dissolution is the critical quality control parameter and used to predict an in vivo oral bioavailability, and it is used to support bio-waiver. Aim: To evaluate and compare the dissolution profile of eight brands of metformin HCL 500 mg tablets available in Jimma town, Southwest Ethiopia. Methods: The study was conducted in Jimma town, Ethiopia. Eight (seven brands and one comparator) metformin HCL 500 mg tablets were included. The dissolution study was conducted as per United States Pharmacopeia, and the dissolution profile was compared by one-way ANOVA, model-dependent and model-independent approaches. Results: All of the included tablet brands complied with single-point dissolution study specification. Statistical comparisons of the dissolution profile by one-way ANOVA revealed that all brands had similar dissolution profiles (p=0.89). All of the brands had a similarity factor (f 2 ) >50% and the difference factor (f 1 ) <15. The entire brands followed the Weibull curve approach (the highest coefficient of determination and lowest Akaike Information Criteria) for the release of an active pharmaceutical ingredient. Conclusion:All of the brands complied with single point dissolution study and all of them could be used interchangeably with the innovator drug. All brands followed the Weibull method for the release of the drug substance.

Dissolution Test of Patent and Generic Drugs of Metformin Hydrochloride

“…With Setebaid, the difference between batches was less. Umeta et al reported that the necessary amount of drug substance released after 30 minutes as indicated in the USP (> 80% cumulative dissolution) is one of the most important quality control tests that helps to guarantee uniformity and equivalence between different batches (13,17). Only two batches (Dinorax batch 1 and Setebaid batch 2) satisfied the USP criteria for an immediate-release dosage form (Fig.…”

“…the small intestine is the main site of absorption of immediate-release metformin, and little absorption occurs in the stomach and colon (12). Therefore, metformin must have a rapid dissolution rate to increase the contact time of the dissolved drug with the absorption mucosa (13,14). The dissolution test is a physical test that measures the ability of both the pure drug (intrinsic dissolution) and the one contained in a solid pharmaceutical form to dissolve in a given medium under controlled experimental conditions.…”

In vitro Comparative Dissolution Studies of Different Propranolol Generic Tablets Available in Bangladesh

“…show that all test samples are equivalent to the reference brand, with a DE difference of less than 10%30 . From the results of model independent fit factors, all PRP samples can be considered as interchangeable with reference brand.Furthermore, multiple model dependent kinetic models such as zero order, first order, Higuchi, Hixon-Crowell, Korsmeyer-Peppas, and Weibull models were examined by fitting experimental data in this study.…”

Quality of Antimalarial Drugs in East Africa: A Systematic Review

“…And each unit in a batch should have a drug substance within a range around the label claim. 30 Of 158 samples tested for mass uniformity, 1.93% (4/158) of them failed to comply with the test.…”

“…31 The ability of a drug to dissolve is a crucial part of its evaluation, and it is one of the quality control tests for ensuring product uniformity and batch-tobatch equivalence. 30 According to the current review, 226-samples of antimalarial drugs were examined for dissolution. In contrast, 36 (15.93%) antimalarial drugs failed the dissolution test.…”