IN VITRO BIOEQUIVALENCE STUDY OF “MEXIBAT” TABLETS BY DISSOLUTION TEST

Abstract

“Mexibat” tablets the product of Georgian pharmaceutical company “Inovas”, the generic analogue of the Russian original product “Mexidol” is appeared on Georgian pharmaceutical market. The generic “Mexibat” 125 mg tablets have the high solubility and permeability and under BCS classification, with high probability, could be considered as the first class product. The WHO and FDA consider that first class products do not required in vivo bioequivalence study to prove the similarity  with original product. Respectively, in vitro dissolution test is the way to study bioequivalence of generic product versus original.  Study of in vitro equivalence of test product was conducted under “Dissolution Test” in respect of manufacturer ND, WHO and FDA guidelines. The “Dissolution Test” of both products – test and original were done by four methods. Method #1 – pH1.2, Method #2 – pH 4.5, Method #3 – pH-6.8, Method #4 – pH-2.0. The  last method was conducted under manufacturer’s ND demands (0.01 M HCl (pH 2.0)). The in vitro study of bioequivalence of two test and original products: Mexibat and Mexidol 125 mg tablets in different pH ambiance showed that, there is no reliable difference between them. On the basis of received in vitro dissolution test data, could be considered, that product of research “Mexibat” is bioequivalent to original product – “Mexidol”.