Overview of Contract Objectives and Efforts are as follows: 1. Determination of the solubility profile of the supplied bulk drug substance in various physiologically acceptable aqueous vehicles and organic solvents. 2. Development of novel approaches for intravenous delivery of drugs exhibiting inadequate solubility and/or stability in aqueous solution. 3. Development of suitable stability indicating assays to monitor the integrity of the parent compound during formulation studies. Also, study stability of the prototype formulation under accelerated stability conditions at 50 degree C, 37 degree C and 25 degree C. 4. Perform preformulation studies including determination of pKa and partition coefficient. 5. Prepare pilot scale batches of the prototype formulation(s) for preclinical evaluation. 6. Study experimental dosage forms under simulated """"""""end user condiitons"""""""", for e.g., compatibility with intravenous fluids, packaging components.

Agency
National Institute of Health (NIH)
Institute
Division of Cancer Treatment (NCI)
Type
Research and Development Contracts (N01)
Project #
N01CM077108-000
Application #
2616739
Study Section
Project Start
1997-06-30
Project End
2002-06-29
Budget Start
1997-06-30
Budget End
1998-06-29
Support Year
Fiscal Year
1997
Total Cost
Indirect Cost
Name
University of Utah
Department
Pharmacology
Type
Schools of Pharmacy
DUNS #
City
Salt Lake City
State
UT
Country
United States
Zip Code
84112