DEVELOPMENT AND IN-VITRO DISSOLUTION STUDIES OF BILAYER TABLET OF METOPROLOL SUCCINATE (SR) AND HYDROCHLOROTHIAZIDE (IR)

Abstract

Bilayer tablets of Hydrochlorothiazide (IR) Metoprolol succinate (SR) were formulated for the management of hypertension. In the formulation of immediate release Micro crystalline cellulose and 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, thickness, hardness, friability, drug content, and in-vitro drug release using USP dissolution apparatus type 2 (paddle) by using HPLC method. It was found that the optimized formulation F-7 showed 17.34%, 33.06%, 55.35%, 97.78% release for Metoprolol succinate in 1, 4, 8, 20 hours respectively. However, Hydrochlorothiazide was released 95.29% at the end of 60 minutes, and DSC studies have done and show no interaction between the drug and polymer. The stability studies were carried out for the reproducibility batches F-8 and F-9 for 60 days and it showed acceptable results. The Bilayer tablet technology can be successfully applied for sustained release of Metoprolol Succinate and immediate-release of Hydrochlorothiazide.