The primary objective of this effort is to develop pharmaceutically acceptable parenteral dosage forms of new compounds with potential utility for the treatment of cancer and the acquired immune deficiency syndrome (AIDS). As indicated, these compounds frequently do not inherently possess adequate aqueous solubility and/or stability for intravenous injection. For many years, the program has supported a contract effort to specifically resolve difficulties presented by these compounds. The complexity of the formulation development is expected to vary and difficult assignments may require substantial development work. The contractors will be expected to carry out solubility determinations, evaluate approaches to improve water solubility, study the effects of pH, heat, oxygen, etc., on stability, prepare dosage forms on a pilot scale, and evaluate the delivery of the drug under simulated use conditions (after reconstitution and in intravenous fluids). The target of these investigations is pharmaceutical dosage formulation that we can transfer to a manufacturing contractor for scale-up to a batch size for clinical evaluation.
