Abstract

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 degrees C, 37 degrees C and 25 degrees 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 conditions"""""""", for e.g., compatibility with intravenous fluids, packaging components

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
Division of Cancer Treatment (NCI)
Type
Research and Development Contracts (N01)
Project #
N01CM077017-005
Application #
6336064
Study Section
Project Start
1997-06-30
Project End
2002-06-29
Budget Start
2000-06-30
Budget End
2001-06-29
Support Year
Fiscal Year
2000
Total Cost
$252,687
Indirect Cost

  Institution

Name
University of Kansas Lawrence
Department
Pharmacology
Type
Schools of Pharmacy
DUNS #
072933393
City
Lawrence
State
KS
Country
United States
Zip Code
66045