FORMULATION & DEVELOPMENT OF ORODISPERSIBLE TABLET FOR TREATMENT OF MIGRAINE

Abstract

The aim of the present investigation was to formulate and develop Orodispersible tablets (ODT) for treatment of migraine by using industrially adoptable approaches. Several approaches for formulation of ODT like direct compression, freeze-drying, cotton candy process, molding, spray drying, mass extrusion, and compaction. Among all, direct compression and the phase transition were the most preferred methods from the pharma industries point of view. These methods involve the use of super disintegrants. For direct compression approach; crosspovidone, ac-di-sol were explored as super disintegrants. Each excipient were used alone and in combinations at different concentrations to obtain the desired formulation characteristics like disintegration time below 30 sec along with acceptable tablet parameters like hardness ,friability, etc. The 32 full factorial designs were applied by using design expert to study the effects of formulation variables for the amount of Crosspovidone and pregelatinized starch (Independent variables) on the response factor like hardness and disintegration time (dependent variables). It was found that all the independent parameters’ interaction have positive effect on the Y1 (hardness) and Y2 (Disintegration time). It was observed that as the value of independent variables increases the value of dependent variable increases. The optimized formulation was developed by using direct compression approach and several parameters like formulation characteristics, stability study data, industrial adoptability and the cost of formulation was analyzed .In conclusion, and direct compression approach for formulation of ODT was explored and optimized by appropriate design of experiment.