Formulation and In Vitro Evaluation of Release Retardant Diclofenac Sodium Tablets Using Hydrophilic and Waxy Matrices

Abstract

Development of release retardant matrix tablets of diclofenac sodium for 24 h by wet granulation technique using different combinations and ratios of hydroxypropylmethylcellulose (HPMC), sodium carboxymethylcellulose (sodium CMC), sodium alginate and cetostearyl alcohol was carried out. The tablets were evaluated for thickness, diameter, D/H ratio, hardness, weight variation, drug content and in vitro drug release studies. The tablet formulations showed acceptable pharmacotechnical properties and complied with pharmacopoeial specifications for the tested parameters. All the formulations showed extended drug release up to 12 h and the formulation prepared with drug : HPMC in 1:4 ratio using water as granulating agent (F10) extended the drug release up to 24 h with initial burst effect. Upon modification, using ethyl cellulose as granulating agent (F11) extended drug release up to 24 h that followed zero order release kinetics (r2 = 0.9872). Model independent parameters such as t25%, t50%, t90%, DE720 and mean dissolution time (MDT) were also determined