The National Cancer Institute is undertaking a drug development effort to evaluate new agents in the treatment of acquired immune deficiency syndrome (AIDS). These compounds will be evaluated intravenously and orally. A number of compounds are presumed to exhibit inadequate solubility and/or stability in vehicles commonly used for intravenous injection and will require longer range, more innovative studies to yield a pharmaceutically acceptable formulation. A work load of 3-4 compounds per year is anticipated. The contractor will be provided a) compounds to be studied b) solubility and stability targets and 3) available analytical chemistry data on the compound. The contractor's studies are to be directed to resolving the specific solubility and/or stability problem culminating in an acceptable dosage form prepared on pilot scale, 50-150 units. These dosage forms will be used to assess biological activity, for confirmatory analysis, and assessment of stability under simulated use conditions in a variety of concentrations and pharmaceutically acceptable vehicles. The product and data generated will subsequently be provided to the dosage form production contractor for subsequent preparation of the product on manufacturing scale.
| Anderson, B D; Chiang, C Y (1990) Physicochemical properties of carbovir, a potential anti-HIV agent. J Pharm Sci 79:787-90 |
