Analytical and Characterization Studies of Organic Chemicals, Drugs and Drug Formulation
Abstract
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. Specific objectives were to design, develop, validate, and apply methods to determine chemical and physical characteristics on bulk drugs and drug products. For the entire contract period, 1 July l997 to 6 January 2004, ll7 samples of bulk drugs and dosage formulations were analyzed for identity and purity or potency; 31 samples were studied for bulk stability, solubility and solution stability. Chiral chromatographic separation methods were developed and validated for five bulk drugs. Extensive dissolution studies in four media were performed on five batches of tablets. A special project was development of methods to isolate anti- malarial agents from rabbit plasma and applying the methods to determine these drugs in 128 samples of rabbit plasma. A second and much more important special project was development of a highly sensitive and specific method to determine squalene in 17 lots of Anthrax Vaccine Adsorbed. As a result of this work, several awards were presented to members of the project team and to SRI International. A third special project was development and production of a formulated drug product for artesunic acid. Two batches of this drug product were produced and sent to the Army for toxicological evaluations. A poster presentation was made at the 2000 Bioscience Review, and one publication appeared in press.
Document Details
- Document Type
- Technical Report
- Publication Date
- Feb 01, 2004
- Accession Number
- ADA421361
Entities
People
- Peter Lim
Organizations
- SRI International