Design, development and optimization of Amlodipine Besylate tablets

By Margaret Chandira, A. Pasupathi, P. Elamathi, Debjit Bhowmik, Chiranjib, Pankaj, B. Jayakar, K. P. Sampath Kumar


The objective of the present study was to develop a tablet formulation of amlodipine besylate calcium channel blocker for better management of hypertension and also suitable in the treatment diabetic hypertension patients, In the present study amlodipine besylate 10 mg tablets have been formulated and developed using direct compression techniques, to provide a safe, highly effective method for treating severe hypertension while reducing undesirable adverse effects. Preformulation parameters were studied for the formulated batches. Amlodipine besylate had maximum solubility in PH3 and thus most suitable medium for amlodipine besylate dissolution studies .the dissolution profile of the formulated formulation was compared with the marketed preparation. The results indicated improved dissolution profile of formulation no. F10 take 30 minutes for complete drug release. To develop 10 mg tablet dosage form for amlodipine besylate using market sample as a reference product strategy with reduced average weight compared to innovator product. To provide the patient with the most conventional mode of administration, there was need to develop of Amlodipine besylate tablet.


Key Words : Tablet, dissolution, direct compression, hypertension, disintegration time.


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