Design and characterization of the material attributes of a co-processed excipient developed for direct compression tableting

Abstract

The objective of the study was to characterize the material attributes of a co-processed excipient and determine its suitability for tableting applications. A single composite excipient named SGS consisting of tapioca starch (TS), gelatin (GEL) and colloidal silicon dioxide (CSD) was developed by co-processing using the method of co-fusion and its solid-state, powder and mechanical properties evaluated. Particle morphology revealed spherical shaped particles of SGS with slightly rough surfaces. PXRD was characterized by a halo diffraction pattern consistent with amorphous materials. FT-IR studies demonstrated drug-excipient compatibility. Flow properties of SGS improved in relation to its physical mixture (SGS-PM) and the mechanical properties of SGS was enhanced as a result of co-processing. The outcome of the study demonstrates the suitability of SGS as a tableting excipient.