Analytical and Characterization Studies of Organic Chemicals, Drugs, and Drug Formulation
Abstract
Although the overall purpose of this contract was to perform chemical/physical analyses on bulk pharmaceutical substances and formulated drug products of interest to the USAMRMC Drug Development Program for parasitic and infectious diseases, chemical and biological defense, etc, by far the majority of time and effort expended during the current contract was devoted to design, development, and cGMP manufacture of an artesunic acid parenteral dosage form. Over 5,000 units of the two-component drug were released to the Army for clinical use. As a part of the cGMP manufacture, a program of stability studies was maintained over the entire contract period to ensure the continued integrity of the drug in its clinical use. To obtain genetox information on our drug, three major genetox assays were performed, and the reports were submitted to our COR. Attributes and faults of our product have been identified, and attempts have been made to correct these faults, in order to produce an improved drug. Associated with this effort were 108 reports, 7 certificates of analyses, one poster presentation, and one patent. Considerable time and effort were also spent on analysis and solutions stability studies on MMB-4, a promising nerve gas antidote of interest to the Army. Results from these studies merit the Army?s continuing interest in developing MMB-4 into a drug product. Associated with the MMB-4 activities, four poster presentations and one paper were submitted for publication. In addition to the above activities, the core project team continued to serve all areas of the Army by performing chemical analyses when required, and reports on these analyses were submitted to the COR. Additionally, one paper based on work performed on the previous contract was published.
Document Details
- Document Type
- Technical Report
- Publication Date
- Mar 01, 2009
- Accession Number
- ADA497533
Entities
People
- Peter Lim
Organizations
- SRI International