Volume :
2
Issue :
4
Abstract :
The main objective of this combination therapy is to develop a stable formulation of antihypertensive drugs of Telmisartan and Amlodipine Besylate as an immediate release bilayer tablet and evaluate their pre-compression and post-compression parameters. The FT-IR studies were also conducted and was found to have no interaction between drug and the excipients. The formulation of the developed work was initiated with wet granulation method for Telmisartan and direct compression for Amlodipine Besylate. Microcrystalline cellulose pH102 and mannitol were used as diluents. polyvinyl pyrolidone K30 in isopropyl alcohol was used as the binder. The sodium starch glycolate (SSG) was used as the disintegrant. Magnesium stearate and purified talc were used as lubricants. The prepared granules were compressed by a double-rotary compression machine. Thus, the tablets formulated with higher concentrations of SSG around 16% in F-9 formulation showed satisfactory physical parameters and was found to be stable. Invitro dissolution was carried out using USP dissolution apparatus type 2 (paddle) by using HPLC method. The optimized formulation F-9 had 96.68% of drug release for telmisartan layer and 95.73% drug release for amlodipine layer. The stability studies for optimized batches were carried out at 30 and 60 days and was found to be stable. The results suggest the feasibility of developing bilayer tablets with two drugs Telmisartan and Amlodipine Besylate for the convenience of patients with severe hypertension, especially when monotherapy fails to control the blood pressure.