BIOEQUIVALENCE STUDY OF ANTIDIABETIC ACTIVITY BETWEEN TWO MARKETED FORMULATIONS OF METFORMIN ON GLUCOCORTICOID-INDUCED HYPERGLYCEMIA IN RABBIT

Debanga Das; Jashabir Chakraborty; Suvakanta Dash

doi:10.22159/ijcpr.2017v9i4.20762

Authors

Debanga Das Girijananda Chowdhury Institute of Pharmaceutical Science (GIPS), Azara, Guwahati, Assam 781017
Jashabir Chakraborty Girijananda Chowdhury Institute of Pharmaceutical Science (GIPS), Azara, Guwahati, Assam 781017
Suvakanta Dash Girijananda Chowdhury Institute of Pharmaceutical Science (GIPS), Azara, Guwahati, Assam 781017

DOI:

https://doi.org/10.22159/ijcpr.2017v9i4.20762

Keywords:

Bioequivalence, Hyperglycemia, Dexamethasone, Metformin

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.

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