Design, Development, and Optimization of Valsartan and Amlodipine Micro Tablets

摘要

In the present study combination product of Amlodipine, 10 mg, and Valsartan 160 mg in the Capsule dosage form is developed through micro tablets technology.The effect of various excipients was studied through the Design of Experiments and optimization of the formulation was conducted to achieve the most suitable formulation.The manufacturing process was a simple direct compression process and can be scaled up to various manufacturing scale.The same formulation can be extended to various combinations of Valsartan and Amlodipine.The developed capsule dosage form had a similar drug release profile as that of the marketed formulations.The formulation with sufficient operational range was selected for comparison of drug release in various dissolution media with various pH along with the marketed formulation.The developed micro tablets with the larger surface area were found to have better results in dissolution studies.