Formulation development and optimization of fast dissolving tablets of aceclofenac using natural superdisintegrant.

Abstract

The current research work involves preparation of fast dissolving tablets of Aceclofenac by direct compression method using different concentrations of Lepidium sativum mucilage as natural superdisintegrant. A two-factor three-level (3(2)) factorial design is being used to optimize the formulation. Nine formulation batches (D1-D9) were prepared accordingly. Two factors as independent variables (X 1-amount of β-cyclodextrin and X 2-amount of Lepidium sativum mucilage) were taken with three levels (+1, 0, -1). The levels of two factors were selected on the basis of preliminary experiments conducted and their effect on three dependent variables (disintegration time, wetting time, and in vitro drug release) was studied along with their % prediction error. All the active blends were evaluated for postcompression parameters (angle of repose, Carr's index, Hausner ratio, etc.) and the tablets were evaluated for postcompression parameters (weight variation, hardness, and friability, wetting time, disintegration time, water absorption ratio, and in vitro drug release studies). The optimum batch was further used for SEM and stability studies. Formulation D5 was selected by the Design-Expert software which exhibited DT (15.5 sec), WT (18.94 sec), and in vitro drug release (100%) within 15 minutes.