FORMULATION DEVELOPMENT OF PIOGLITAZONE TABLETS EMPLOYING A NEW CO-PROCESSED EXCIPIENT

摘要

An efficient platform for the manipulation of excipient functionality is provided by co-processing two or more existing excipients. Co-processing is based on the novel concept of two or more excipients interacting at the sub particle level, the objective of which is to provide a synergy of functionality improvements as well as masking the undesirable properties of individual excipients In the present study a new co-processed excipient consisting of cellulose and ethylcellulose was developed and evaluated for its application in the formulation development of pioglitazone tablets fulfilling the official dissolution rate test specification. Cellulose –EC co-processed excipient was prepared by kneading method and was characterized by determining melting point, solubility, swelling index in water, pH, and micromeritic characters namely particle size, bulk density, tapped density, angle of repose and compressibility index and evaluated for its application as directly compressible vehicle in the formulation of pioglitazone tablets. Cellulose-EC co-processed excipient prepared by kneading method is granular, discrete and free flowing. It is insoluble in water and aqueous fluids of pH 1.2, 4.5 and 7.4. It exhibited slight swelling (24%) in water. Cellulose-EC co-processed excipient has excellent flow properties alone and as blends with the selected drug it exhibited excellent to good flow properties. Pioglitazone tablets prepared by direct compression method employing Cellulose-EC co-processed excipient as DCV were of good quality with regard to drug content, hardness, friability and disintegration time. The tablets formulated disintegrated rapidly within 2 min 40 sec. Pioglitazone tablets prepared gave rapid dissolution of the contained drug and fulfilled the official (IP) dissolution rate test specification prescribed. The formulated tablets also gave rapid and higher dissolution of pioglitazone than the commercial tablets tested. Thus Cellulose-EC co-processed excipient developed in this study was found to be a promising directly compressible vehicle for the preparation of compressed tablets and pioglitazone tablets with rapid disintegration and dissolution characteristics could be developed employing the new co-processed excipient