Monday, 25 August 2014

Formulation and Evaluation of Sustained Release Matrix Tablets of Diltiazem Hydrochloride

Formulation and Evaluation of Sustained Release Matrix Tablets of Diltiazem Hydrochloride: The purpose of present investigation was to develop sustained release matrix tablet of highly water soluble drug diltiazem hydrochloride by wet granulation method by using different hydrophilic (HPMC K4M, HPMC K1M, HPMC K100 M, Na CMC, Na alginate) and different hydrophobic (Eudragit RSPO, Eudragit RLPO, Eudragit RS-100, Eudragit RL-100, Ethyl cellulose) polymers. A 32 full factorial design was applied. The concentration of HPMC K15M in mg (X1) and concentration of Eudragit RSPO in mg (X2) were selected as independent variables. The %CDR at the end of 3 hrs (Q3) and %CDR at the end of 12 hrs (Q12) were selected as dependent variables. The prepared tablets were evaluated for hardness, friability, drug content, In vitro drug release. FT-IR, DSC and physical compatibility study were conducted for drug, and drug excipient mixture for interactions if any. The results indicated that concentration of HPMC K15M (X1) and concentration of Eudragit RSPO (X2) significantly affected the %CDR at the end of 3 hrs (Q3) and %CDR at the end of 12 hrs (Q12). Regression analysis and numerical optimization were performed to identify the best formulation. Formulation F11 prepared with HPMC K15M (70 mg) & Eudragit RSPO (10 mg) was found to be the best formulation with % CDR 20.32% and 96.59% at the end of 3 hrs and 12 hrs respectively. Optimized batch F11 showed similarity factor f2 value 69.14.