A Pharmaceutical Study on Quality Surveillance of Six Empagliflozin (10 mg) Tablet Generics in Pakistan
Abstract
Sodium glucose co-transporters are a novel and potent class of anti-diabetic drugs. One of the members of this newest class of drugs is empagliflozin. It is considered as a favorable option for controlling type II diabetes mellitus. The objective of the current study is based on the quality surveillance of different empagliflozin brands in Pakistan. Six different empagliflozin counterparts (Emp-A to Emp-F) were collected and assessed for various pharmacopeial and non-pharmacopeial tests. The findings indicated good-quality features. In vitro kinetics was also evaluated by applying various dissolution models using DD-Solver software. All the six selected brands of empagliflozin generics satisfied the compendial requirement. Moreover, the percentage content obtained was within specifications (95%-105%). The applied method was validated. The released kinetic model was found to be the Korsmeyer-Peppas as the best fit at pH 6.8. The statistical evaluation (ANOVA) of the dissolution test exhibited no significant difference in the release pattern of empagliflozin substitutes (p > 1.00, 95% C.I.). This in vitro comparative approach will highlight the significant prospect and its interchangeability. Among all, Emp-A was found superior on the basis of pharmaceutical properties, while this study concluded that all empagliflozin brands available in the commercial market exhibited similar release profiles and is safe to use.
Keywords: marketed brands, quality surveillance, empagliflozin.
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