DEVELOPMENT AND CHARACTERIZATION OF CONTROLLED RELEASE SPHERICAL AGGLOMERATES BY USING THE QUASI-EMULSION SOLVENT DIFFUSION METHOD

Anuradha A. Ranpise*, Pratiksha M. Kadam, Shilpa P. Chaudhari, Atul A. Phatak

Aspirin is moisture sensitive drug and having poor flowability and compressibility, it is necessary to increase the flowability and compressibility of Aspirin. Spherical crystallization of aspirin was done by quasi-emulsion solvent diffusion method (QESD). 32 factorial design were used to study the effect of agitation speed and amount of polymer in development of spherical agglomerates. Agglomerates were evaluated for micromeritics properties, drug release, scanning electron microscopy, differential scanning calorimetry, Karl Fischer titration, infrared spectroscopy, X-ray diffraction. Flowability and compressibility properties of agglomerates were good enough to adopt direct compression technology. In vitro drug release of optimized formulation shows 98% .X-ray diffraction and thermal analysis reveal the conversion of crystalline drug to amorphous. FTIR of agglomerates does not shown any extra peaks as compared to pure drug. Controlled release aspirin agglomerates were prepared successfully by QESD method. The method was simple, inexpensive and reproducible.