Continue the development of biodegradable drug delivery based on poly(e-caprolactone) and its copolymers. The work will include the following: obtain an IND to evaluate the current device for 30 days in up to ten women including conducting any additional toxicological studies that may be requested by the FDA; optimize polymer composition and choice of dispersing vehicle; survey potential manufacturing techniques for scaling-up production; and conduct metabolism and distribution studies on the optimal polymer and vehicle.
| Woodward, S C; Brewer, P S; Moatamed, F et al. (1985) The intracellular degradation of poly(epsilon-caprolactone). J Biomed Mater Res 19:437-44 |
