DEVELOPMENT OF CO-PROCESSED EXCIPIENTS TO IMPROVE GRANULAR CHARACTERISTICS AND DISSOLUTION OF TABLET CONTAINING AN INSOLUBLE DRUG

Dr. T. Mahesh Kumar*, G. Mathan Kumar and J. Manikandan

ABSTRACT

The objective of this research was to develop co-processed excipients having improved granular properties and use it for enhancing the dissolution of BCS class II drug-piroxicam in tablet formulation. Excipients of different combinations were co-processed together by partial granulation method and the obtained granules were analysed for flow and compression properties. FT–IR spectroscopy employed to study the drug-excipients compatibility at 1:1 ratio. Tablets were prepared by directly compressing the blend of developed co-processed excipients with piroxicam drug and analyzed the quality parameters like weight variation, hardness, thickness, friability and disintegration. In vitro drug dissolution performed to study the drug release profile of the prepared formulations. One of the tablet formulation with co-processed excipient which contains combination of microcrystalline cellulose, sodium starch glycolate and surfactant exhibit synergistic effect on enhancement of drug dissolution and was comparable with market available reference product. Results of this study proved the suitability of the developed composition and process to use in formulation development of insoluble drug containing dosage forms.

Keywords: Co-process, excipient, compatibility, synergistic effect, insoluble, dissolution.