Formulation and Evaluation of Indinavir Sulfate Capsules by novel technology using QbD approach

The formulation the drug release up to 45 minutes. The formulation prepared with lactose monohydrates Crospovidone and magnesium stearates.G granulation procedure was the chosen technology for the preparation of Indinavir Sulfate capsule. Based on the preliminary studies, different formulation trials (F1-F7) were carried out with different concentrations of Disintegrants, diluents. From the various formulations it was decided that the formulation batch of F7 was finalized as the optimized formula.. Formulation F7 showed satisfactory results with various physicochemical evaluation parameters like Disintegration time, Dissolution profile, Assay when matched with that of the marketed product. The stability studies at all conditions, indicates that the formulated capsules were found to be stable. Hence, it is finally concluded that, Indinavir Sulfate capsules are pharmaceutically comparable, low cost, quality improved and stable formulation. This study has potential commercial and industrial applications after establishing the real-time stability, safety and efficacy.