Article Id:JPRS-DRP-0000864 Title:Effect of manufacturing conditions on physico-chemical characteristics and drug release profiles of aceclofenac sodium microbeads Category:Drug Release Profiles Section:Research Article
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The present study reports the optimization of sustained release microbeads of aceclofenac sodium were prepared by ionotropic gelation technique, using different variables such as drug-polymer ratios, concentration of cross-linking agent, cross-linking time. The effects of these processing variables were evaluated on physicochemical properties and drug release potential of microbeads. .The shape and surface characteristics were determined by scanning electron microscopy (SEM). While increasing in the concentration of sodium alginate dispersion increased sphericity, size distribution, flow properties, mean particle size, swelling ratio and drug entrapment efficiency. While increasing cross-linking time was significantly decreases the mean particle size. The mean particle sizes of microbeads were found to be in the range 596.45±1.04 to 880.10±0.13μm. The drug entrapment efficiency was obtained in the range of 63.24-98.90%w/v. No significant drug-polymer interactions were observed in FT-IR studies. In-vitro drug release profile of aceclofenac sodium from microbeads was examined in simulated gastric fluid pH1.2 for initial 2h, mixed phosphate buffer pH 6.8 up to 6h and simulated intestinal pH 7.2 at end of 24h. The release of drug from the microbeads was pH dependent, showed negligible drug release in pH1.2. Under neutral conditions the beads will swell and the drug release depend on swelling and erosion process resulting optimum level of drug released in a sustained manner and exhibited zero-order kinetics. Aceclofenac sodium microbeads prepared by ionotropic gelation method using natural polysaccharide like sodium alginate showed a satisfactory sustained release profile and minimizing dose related side effects. The entire process is feasible in an industrial scale and demands pilot study.
*Department of Pharmaceutics, T.V.M.College of Pharmacy, Bellary Karnataka, India 1Department of Pharmaceutics, J.S.S. College of Pharmacy, Mysore, Karnataka, India. 2Department of Pharmaceutical Chemistry, S.C.S.College of Pharmacy, Harapanahalli, Karnataka, India.
*Corresponding author. K.M.Manjanna Department of Pharmaceutics, T.V.M.College of Pharmacy, Bellary Karnataka, India
Received on: 25-07-2009; Revised on: 21-08- 2009; Accepted on:12-10-2009