Integrated Formulation, Testing and Analysis Program for Trans Sodium Crocetinate (TSC)

Abstract

Abstract : The purpose of the research under this contract is to support the transition of the novel drug trans sodium crocetinate (TSC) from pre-clinical to clinical use, especially as to advanced drug formulation, stability testing and chemical characterization and data documentation and analysis tasks required by the U.S. FDA. TSC was invented at the University of Virginia by Professor John Gainer, who has received funding from the Office of Naval Research (ONR) since 1995 to advance the development of TSC for the treatment of hemorrhagic shock. ONR is currently supporting Diffusion Pharmaceuticals LLC, Charlottesville, VA in development of TSC for clinical testing. An important step is the development of a drug product formulation that has the required solubility, stability, pH and osmolality characteristics for use both in humans and in high-dosage animal toxicology tests. As previously reported, manufacture of the basic API (active pharmaceutical ingredient), including five related (analog) molecules, has been completed by CarboGen to Good Manufacturing Practice (GMP) standards. During this quarter, stability tests were conducted by CarboGen (of Switzerland) on the API up through the 9-month time point, and stability tests were conducted on the final, formulated drug product through the 6-month time point by Aptuit of Kansas City. Both the API and the final drug product show good stability in these tests, which suggests that TSC can be safely stored under various conditions, both as a raw drug and as a final, formulated drug product. The improved formulation to support animal toxicology testing shipped in March, 2006.