Abstract

FORMULATION AND CHARACTERIZATION OF TASTE MASKED ORO-DISPERSIBLE TABLETS OF METFORMIN HYDROCHLORIDE

Abstract

Metformin hydrochloride is an oral antidiabetic biguinide agent, used in the management of non-insulin dependant (type-2) diabetes mellitus. The purpose of present work was to mask the taste of metformin hydrochloride and to formulate its patient friendly dosage form. Complexation technique using Indion 234 (Polycyclic potassium with carboxylic functionality), an ion-exchange resin was used to mask the bitter taste and then the taste masked drug was formulated into an orodispersible tablet (ODT). The drug loading onto ion-exchange resin was optimized for mixing time, activation, effect of pH, mode of mixing, ratio of drug: resin and temperature. The resinate was evaluated for taste masking and characterized by X-Ray diffraction study and IR. Using drug-resin complex ODTs were formulated. The developed tablets were evaluated for hardness, friability, drug content, weight variation, content uniformity, friability, water absorption ratio, in vitro and in vivo disintegration time and in vitro drug release. The tablets disintegrated in vitro and in vivo within 20 sec and 25 sec respectively. Drug release from tablet was completed within 3 minutes. The obtained results revealed that metformin HCl has been successfully taste masked and formulated into an ODT as a suitable alternative to the conventional tablets.

Keywords: Metformin hydrochloride, Indion 234, Taste masking, Sodium starch glycolate, Orodispersible tablet.