Lyophilized formulation development with novel excipients derived from cassia roxburghii for a pegylated therapeutic protein

Abstract

The principal of this thesis is newlineThe objective of the present research is to assess the use of a constituent of Cassia Roxburghii as a novel excipient in the development of a lyophilized formulation for a PEGylated therapeutic protein. The identified excipient was 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. Since the identified novel excipient has polymers and saccharides, it was considered suitable for developing a lyophilized formulation for a PEGylated therapeutic protein. newline