Pharmaceutical Excipient Development from Natural Source

Nature has provided us a wide variety of materials to help, improve and sustain the health of all living things either directly or indirectly. Gums and mucilage’s are widely used natural materials for conventional and novel dosage forms. These natural materials have advantages over synthetic ones since they are chemically inert, nontoxic, less expensive, biodegradable and widely available. They can also be modified in different ways to obtain tailor-made materials for drug delivery systems. The USFDA also encourages innovation in excipients to develop new drugs or improve approved therapeutics and IPEC is helping to drive acceptance of these novel products into the market .The objective of the present research is to assess the use of constituents of Cassia Roxburghii as a novel excipient in the development of suitable pharmaceutical dosage forms. The identified excipients were prepared from the seeds of C. Roxburghii by solvent extraction. The final extracted mucilage was freeze dried to obtain a fine gum powder. The obtained novel excipients were characterized by various physical, phytochemical and structural identifications techniques; the ideal excipient characteristics such as Bulk density, Tapped density, Angle of repose and Carr’s index results were comparable to the reference excipient (selected from IPEC - FDA). Further, the results from FT-IR, MALDI-TOF, MALDI-ESI and DSC confirmed the presence of saccharides as carbohydrates in multiple units and amino acids in variable amounts. It is common practice in the pharmaceutical industry to incorporate amino acids and saccharides into the final drug product formulation to enhance stability.