Abstract

PREPARATION AND EVALUATION OF STARCH - PEG 1500 CO-PROCESSED EXCIPIENT AS A NEW DIRECTLY COMPRESSIBLE VEHICLE IN TABLET FORMULATIONS

B. Lakshmi Satya and K. P. R. Chowdary*

ABSTRACT

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. The objective of the present study is to prepare and characterize starch - polyethylene glycol 1500 (Starch-PEG) co-processed excipient and to evaluate its application as directly compressible vehicle in tablet formulations. Starch-PEG co-processed excipient was prepared by gelatinizing potato starch in the presence of PEG 1500 and drying the resulting mass 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 tablet formulations. Starch-PEG co-processed excipient prepared was found to be granular, discrete and free flowing. It is insoluble in water and aqueous fluids of pH 1.2, 4.5 and 7.4. It exhibited high swelling (445%) in water. Starch-PEG co-processed excipient has excellent flow properties alone and as blends with selected drugs it exhibited excellent to good flow properties. Tablets of (i) aceclofenac and (ii) ibuprofen prepared by direct compression method employing Starch-PEG co-processed excipient as DCV were of good quality with regard to drug content, hardness, friability and disintegration time. All the tablets formulated employing Starch-PEG co-processed excipient disintegrated rapidly within 15 seconds. With both the two drugs, the tablets prepared gave rapid dissolution of the contained drug. Dissolution was complete with in 15-20 min in all the cases and fulfilled the official (I.P 2010) dissolution rate test specification prescribed in each case. Thus Starch-PEG co-processed excipient developed in this study was found to be a promising directly compressible vehicle for the preparation of compressed tablets with fast dissolution characteristics.

Keywords: Co- processed Excipient, Starch- Polyethylene glycol 1500 Co- processed Excipient, Directly compressible vehicle, Aceclofenac, Ibuprofen, Direct Compression.