Formulation and evaluation of bilayer tablets of amlodipine besilateand metprolol succinate

[摘要] Bilayer tablets of Amlodipine besilate (IR) Metoprolol succinate (SR) were formulated for the management of hypertension. In the formulation of immediate release sodium starch glycolate and pregelatinised starch were used as super disintegrant and was directly compressed. For sustained release portion HPMC polymers were used in granulation stage and also extragranularly. Preformulation studies were performed prior to compression. The compressed bilayer tablets were evaluated for weight variation, dimension, hardness, friability, drug content, disintegration time and invitro drug release using USP dissolution apparatus type 2 (paddle). It was found that the optimized formulation showed 9.96%, 35.56%, 52.12%, 90.46% release for Metoprolol succinate in 1, 4, 8, 20 hours respectively.However, Amlodipine besilate released 98.28% at the end of 30 minutes.The IR spectrum and DSC studies revealed that there is no disturbance in the principal peaks of pure drugs Metoprolol succinate and Amlodipine besilate. This further confirms the integrity of pure drugs and no incompatibility of them with excipients. The stability studies were carried out for the optimized batch for three months and it showed acceptable results. The kinetic studies of the formulations revealed that diffusion is the predominant mechanism of drug and release follows first order kinetics.

[学科分类] 药理学