The Contractor shall serve as a drug formulations resource in support of preclinical pharmacological/toxicological evaluations and clinical trials. In brief, the objectives of this contract are to determine the physical and chemical characteristics of a drug substance to develop the substance into clinically useful formulations. It involves identifying the chemical characteristics of the drug and its compatibility with various solvents, reagents and inactive ingredients, and its stability to environmental conditions (e.g., light, temperature, humidity). The formulation must be compatible with the route of administration intended, the drug's metabolism upon administration and its ability to achieve a clinically effective tissue/target concentration. Patient compliance issues, such as: each of use; frequency and route of administration; and diversion to illegal use must also be considered when formulating a new dosage or a new drug substance. The data and products generated by this contract will be utilized by the NIDA Medications Development Division (MDD) in developing and testing pharmaceutical preparations in the treatment of drug addictions.
