ABSTRACT:
Present study related to the preparation and evaluation of atorvastatin calcium (ATR) by incorporation of methacrylic acid copolymers such as Eudragit L100, Eudragit EPO, Eudragit RSPO and Eudragit RLPO. ATR is insoluble in aqueous solution of pH 4 and below; it is very slightly soluble in water and slightly soluble at pH 7.4 phosphate buffers. Spherical agglomerates were prepared by quasi-emulsion solvent diffusion system using a three solvent comprising methanol: dichloromethane: water (good solvent, bridging solvent and bad solvent respectively). The effect of speed of rotation and amount of bridging solvent on spherical agglomeration were studied. The agglomerates were subjected to various physicochemical evaluations such as practical yield, drug content, solubility, flowability, packability, compactibility, wettability, crushing strength, scanning electron microscopy, FTIR spectroscopy, differential scanning calorimetry, X-ray powder diffraction studies and dissolution studies. This study, demonstrated that the successful development of directly compressible spherical agglomerates of ATR prepared by incorporation of Eudragit L100 showed improved micromeritic properties, a better solubility and modified drug release profile which could provide a greater amount of drug being made available at lower GI tract for absorption which could potentially increases oral bioavailability.