Formulation and evaluation of diclofenac sodium S.R. tablets using Linum

The main accusative of the present work was to develop sustained release matrix tablets of Diclofenac sodium for maintaining therapeutic blood or tissue levels of the drug for extended period of time with minimized local or systemic adverse effects. In the present study, Polysaccharide mucilage derived from the seeds, Linum usitatissimum (family Linaceae) was investigated as sustained release matrix forming material in tablet formulations. Mucilage extracted from seeds was subjected to physicochemical characterization. Matrix tablets were prepared by wet granulation technique using isopropyl alcohol as a granulating agent in different drug: polymer ratios. Compressed tablets were evaluated for uniformity of weight, content of active ingredient, friability, hardness, thickness and in vitro dissolution using paddle method. All the formulations showed compliance with pharmacopoeial standards. Tablets prepared with Hydroxypropyl methylcellulose (HPMC 50cps) and Xanthan gum as matrix forming material for the comparative study. With increasing the percentage of natural polymer, release rate decreased, though drug release pattern was mainly dependent on the type of polymer and follows zero order kinetics. The dissolution study proved that the Linum usitatissimum seeds mucilage can be used as a matrix forming material for making once daily Sustained release matrix tablets of Diclofenac sodium. The optimized formulation of flaxseed mucilage based matrix tablets (LF3) was subjected to stability studies as per ICH guidelines for three months at 45°C temperature with RH 75±5%, and showed stability with respect to release patter