Abstract

Oro-dispersible tablets (ODTs) are becoming more popular among innovative oral drug delivery systems since they have some extra benefits over existing formulations and can increase patient compliance. In the presence of saliva, ODTs dissolve within a minute in the mouth. It is an appropriate oral dose form for use in pediatric and geriatric patients who have difficulty swallowing. The aim of this study was to formulate and evaluate ODTs containing 500 mg metformin (MTF) and 50 mg vildagliptin (VLD) using the direct compression method. Three formulas were prepared using different types and concentrations of superdisintegrant with a fixed amount of diluents and additives to achieve a target weight of 1,000 mg/tablet. The fourth formula was prepared using cross povidone as a disintegrant but with a different ratio of avicel-mannitol to investigate the effect of avicel concentration on the parameters of the evaluation. The prepared powder of the four formulations showed good flow properties with an angle of repose of 34–37o and a Carr’s index of 11–13.5 with characteristics of free-flowing, according to the results. F1 demonstrated the quickest wetting (20 seconds) and disintegration (22 seconds) times, meeting both USP and EMA requirements. The evaluation of formulas showed the effect of the type of disintegrant and diluent on both wetting and disintegration times. Drug release showed that F1 exhibited a very fast dissolution of both drugs where more than 85% of both drugs were released in less than 10 minutes. As a conclusion, the formulation design of MTF 500 mg – VLD 50 mg was successful as ODTs.