Abstract:
In the present study, an attempt was made to prepare immediate-release enteric-coated pellets of a NSAID class of drug, a poorly soluble nonsteroidal anti-inflammatory drug that has a gastro-intestinal intolerance as its serious side effect. Formulation of enteric-coated pellets with improved solubility of drug could address both of these problems. To achieve these goals, pellets were prepared by extrusion–spheronization method using pelletizing agents that can contribute to the faster disintegration and thereby improve the solubility of the drug. Different disintegrants like β-cyclodextrin, cross carmellose sodium, sodium starch glycolate, Prosolve, crospovidone were tried in order to further improve disintegration time. The pellets were characterized for drug content, particle size distribution, flow properties, infrared spectroscopy, surface morphology, disintegration rate, and dissolution profile. The Formulation was Coated with an enteric-coated polymer which does not dissolve at gastric pH but dissolves at intestinal pH, releasing the drug immediately in dissolution medium. The improvement was substantial when it was compared with solubility of pure drug under the same conditions. Here in this review article these topics are discussed briefly.