Development of Reconstitutable Suspension Containing Aceclofenac Micro particulates

Abstract

A reconstitutable sustained release suspension of micro particulate system of aceclofenac was formulated by solvent evaporation technique. Biocompatible polymers like ethyl cellulose and Eudragit RS-100 were used to prepare microspheres. The formulated microspheres were characterized for particle size, surface morphology, drug-polymer compatibility studies, differential scanning calorimetric analysis, XRD studies, SEM studies, percentage drug entrapment efficiency and in-vitro drug release studies. The prepared microspheres were found to be free flowing and particle size of the microspheres were found to be in the range of 144.93-301.26 µm. SEM studies indicated that the microspheres were spherical in shape. In-vitro drug release studies showed a sustained release of drug over a period of 9 hours. The reconstitutable suspension of aceclofenac microparticulates was prepared using xanthan gum in various concentrations of 1.5, 2.0 and 2.5 % w/v as suspending agents. The suspensions were evaluated for reconstitutability, viscosity, sedimentation rate, percent drug content and in-vitro dissolution studies. The optimized microsphere formulation showed Peppas model to be the most appropriate drug release mechanism. The prepared sustained release suspension is capable of sustaining the drug release over a period of 10 hours. Stability studies showed no significant change in drug content in the optimized formulation after 6 months. The results obtained in this work thus suggest that a microparticulate dosage form of aceclofenac can be successfully designed to provide sustained drug delivery.