Sapporo Medical Journal

Abstract : Diabetes Mellitus is one of the most common syndrome in the world. Many complications result from Diabetes including sexual impairment which highlyaffects quality of life in men. The aim of this work is to formulate and evaluate oro-dispersible tablets (ODTs) contain 500 mg metformin and 5 mg Tadalafil. A successful, simple, valid method of analysis for simultaneous determination of metformin and tadalafil was developed using HPLC with UV detector. Acetonitrile-phosphate buffer pH 3.5 was used as a mobile phase and a successful separation and quantification wer achieved. Linearity, precision, recovery and robustness were all tested according to the ICH guideline of pharmaceutical analysis. Four formulas were prepared, using three types of disintegrants, cross povidone, sodium starch glycolate and cross-linked alginic and tw types of diluents. The powder mix each formula was tested for flowability and compressibility. Then, tablets were compressed by direct compression method and evaluated according to the USP specifications of Oro-dispersible tablets. Results showed that the evaluation of all formulas showed an effect of type of disintegrant and diluent on wetting and disintegration times, where cross povidone gave the shortest disintegration time (52 ±2 seconds) Also, increase concentration of Avicel resulted in increase in disintegration time (from 46±2 to 52±2 seconds). Dissolution test of F4 in pH 1.2 and 6.8 showed very fast dissolution of both drugs were more than 85%