This contract is to provide the National Cancer Institute's Division of Cancer Treatment with dosage form development service for about five compounds per year. Studies include: solubility determinations in vehicles suitable for intravenous use, development of stability indicating assays, pH profiles to determine optimum pH for stability, pilot scale freeze drying experiments, compatability studies with container-closure systems, stability studies of drug solutions under simulated use conditions and analyses of these dosage forms. After completion of the development assignment, the contractor will devise and carry out an appropriate manufacturing procedure on production scale. Most projects will require preparation of sterile freeze dried dosage forms in batch sizes of 4000-6000 units per batch. About two batches per year will involve solid oral dosage forms(tablets or capsules). The contractor is responsible for the quality control testing of all formulation components including active ingredients, excipients, container-closure systems as well as the finished products.
