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.
| Cao, Yichen; Marra, Michelle; Anderson, Bradley D (2004) Predictive relationships for the effects of triglyceride ester concentration and water uptake on solubility and partitioning of small molecules into lipid vehicles. J Pharm Sci 93:2768-79 |
| Xiang, Tian-Xiang; Niemi, Riku; Bummer, Paul et al. (2003) Epimer interconversion, isomerization, and hydrolysis of tetrahydrouridine: implications for cytidine deaminase inhibition. J Pharm Sci 92:2027-39 |
| Xiang, Tian-Xiang; Anderson, Bradley D (2002) Stable supersaturated aqueous solutions of silatecan 7-t-butyldimethylsilyl-10-hydroxycamptothecin via chemical conversion in the presence of a chemically modified beta-cyclodextrin. Pharm Res 19:1215-22 |
