Abstract
The objective of this research activity was to formulate and evaluate Raloxifene Hydrochloride (RLX HCl) tablets (BCS class II drug) with enhanced aqueous solubility thereby achieving a formulation with improved dissolution characteristics. Tablets were prepared by incorporating excipients such as disintegrant, solubilizer, wetting agent and evaluated for various pre compression and post compression parameters. Also assay and in-vitro dissolution studies were performed. Formula RLX HCl 27 containing disintegrant Ac-di-sol® (15 mg-intragranular and 5 mg- extragranular) and solubilizer Dimethyl Sulfoxide (DMSO- 10 mg) was selected as the best optimised formula. Optimised formula was scaled up and stability studies were carried out according to the stability protocol. The results indicated that the formulation was stable and had improved dissolution profile as compared to marketed tablet.
Department of Quality Assurance, Gahlot Institute of Pharmacy, Koparkhairane, Navi Mumbai-400709, Maharashtra, India