Design and Evaluation of Bilayered Tablets of Amlodipine Besilate with Enalapril Maleate
Journal Title: Indian Journal of Research in Pharmacy and Biotechnology - Year 2018, Vol 6, Issue 3
Abstract
Bilayer tablets of Amlodipine Besilate (Immediate Release) Enalapril Maleate (Sustained Release) were formulated for treatment of hypertension. The main objective of this combination is to encourage the low doses of drug to reduce patients BP, to reduce the dose dependent side effects. Twelve different formulations are prepared with amlodipine as immediate release layer and Enalapril maleate as sustained release layer .In the formulation of immediate release sodium starch glycolate were used as a superdisintegrant and was directly compressed .In sustained release portion cross povidone polymer were used in granulation stage and also extra granularly. Pre-compression studies were performed before compression. All the evaluated parameters of the optimized formula showed the Enalapril Maleate drug release over a period of 12 hours and the amlodipine Besilate shows at 1hour. IR studies revealed that there is no disturbance peaks of pure drugs Amlodipine Besilate and Enalapril Maleate. The stability studies were carried out for the optimized formulation for acceptable results. The kinetic studies for the formulation were formulated .The optimized formulation of bilayer tablet showed good release profile and are within pharmacopoeial limits .The optimized formulation shows Non-Fickian diffusion mechanism and this formulation is subjected to stability studies. It showed acceptable results.
Authors and Affiliations
N. Divya Sri, P. Srinivasa Babu, N. Sravani N. NarasimhaRao
Keywords
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