Screening of Formulation for the Preparation of Valsartan Capsules and the Evaluation of Their Dissolubility

OBJECTIVE To develop generic valsartan capsules with Novartis' Dioan(80 mg) as a reference. METHODS Formulation of valsartan capsules was evaluated by comparison of in vitro dissolution profiles between generic drug and Dioan. Valsartan from different suppliers were evaluated and the application of solubilizer was optimized for consistent dissolution profile. RESULTS The similarity factor f₂ was calculated to compare dissolution profile of generic drug and Dioan in different mediums. The in vitro drug release behaviors of generic drug and Dioan were similar. CONCLUSION The final formula and manufacturing process of generic valsartan capsules are feasible. The similarity in in vitro dissolution between generic drug and Dioan provides a high confidence in achieving equivalence in in vivo studies.