This Guide is intended to provide support to both manufacturers and users of co-processed excipients. In addition, it is intended that this Guide should facilitate communication between excipient users and suppliers regarding the safety information required for regulatory filing for a product containing a novel co-processed excipient.
The development of novel excipients with enhanced functionality has been explored using particle engineering by co-processing. The aim of this study was to improve the functionality of tapioca starch (TS) for direct compression by co-processing with gelatin (GEL) and colloidal silicon dioxide (CSD) in optimized proportions.
For the development of this directly compressible excipient no chemical modification was applied. The enhanced functionality enabling a nearly zero order release was achieved by techniques such as physical mixing, high shear mixer granulation and spray drying.