Bioequivalence Study of Antidiabetic Activity Between Two Marketed Formulations of Metformin on Glucocorticoid-Induced Hyperglycemia in Rabbit

Abstract

Objective: Bioequivalence studies are the commonly accepted methods displaying therapeutic equivalence between two products. This study was conducted to evaluate the bioequivalence study of anti-diabetic activity between two formulations of metformin tablets which were marketed in India. Methods:In in vitro study five essential in vitro tests including disintegration, weight variation, hardness, friability and a comparative in vitro dissolution study were performed.Results: For in vivo study adult male rabbits were divided into three groups of two each. The first group is regarded as control group received 3 ml of normal saline daily by using the gastric tube for 15 d and the second and third group received (0.35 mg/Kg B.W. single dosage) of dexamethasone tablets which were powdered, dissolved in 3 ml of normal saline daily for 15 d. After 15 d the blood glucose of second and third group was estimated and after that received formulation X and formulation Y, dissolved in 3 ml of normal saline daily for 15 d at the dose of 0.5 gm/kg body weight orally. After 15 d again blood glucose of second and third group was estimated and compare the results of both the group. This shows the favourable response of metformin against glucocorticoid-induced renal damage and hyperglycemia. Conclusion:Results of this study showed that the extent, rate of absorption and anti-diabetic activity of two different formulations of metformin tablets are bioequivalent to each other.

Virtual Bioequivalence in Pharmaceuticals: Current Status and Future Prospects

“…In the meantime, consideration should be given to how long a drug stays in each area of the GI system, especially for formulations with controlled or extended-release with a significant dissolution crossdomain [52]. Currently, the dissolution environment in vivo is frequently simulated using a single non-bio-relevant (e. g., pH 1.2, 4.5, or 6.8 buffer) or bio-relevant dissolution medium (e. g., simulated gastric or fluid), which is a practical when the majority of the drug is rapidly dissolved in a specific part of the GI tract under a particular pH condition [53,54]. The are different types of approaches, such as Noyes-Whitney modification [55], fitting data to the weibull model, using lumped parameters [56], estimation of particle size [57], direct incorporation [58], and fitting of deff scales [58] already established for incorporating dissolution in PBPK models.…”

Rapid, Method for Determination of Metformin and Canagliflozin in Plasma by Liquid Chromatography-Tandem Mass Spectrometer, Application to Bioequivalence Study

“…When we see at the structures of both, metformin ionizes in positive mode, whereas canagliflozin ionizes in negative mode. Devineni et al reported method individual estimation methods for metformin and canagliflozin [2], Attimara et al reported LC-MS method for the simultaneous determination of metformin and miglitol in human plasma: Application to pharmacokinetic studies [3], Kobuchi et al reported method for canagliflozin by LC-MS/MS [4] and many others have reported either metformin in plasma or canagliflozin in plasma [5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21].…”