Stable Biodegradable Polymers for Delivery of Both Polar and Non-Polar Drugs. Phase I

Abstract

Public reporting burden for this collection of information a eatimated to average 1 hour per reponse, Including the time for revlewlrl fnstructions. aereing existing data sources, gathering and maintaining the data needed, and ompleting n reviewing the collection of information. The objective of this project is to develop improved dose forms for the delivery of pain management agents. Given a military scenario where rapid deployment of Special Operations Forces demands effective medical resources, the need for therapeutic pain management tools is obvious. Pain relief is critical in maintaining the ability of the field soldier to defend and protect himself particularly in cases where mobilization is not imminent. Our development work on a pain management system, of which a hydromorphone(}M)/poly(lactide-co-glycolide) (PLGA) delivery system is a part, addresses battlefield treatment with respect to personnel maintenance. A long-acting HMI/PLGA implant, easily implanted via a loaded trocar, could provide systemic relief from pain at the time of injury. Phase I work included in vitro and in vivo (mice) testing of four II/PLGA matrices, HM at 25% and 50% loading in each of two PLGA's (85:15 and 50:50). In vitro release data and mouse tail flick data permitted selection of a system for further development -a 50:50 PLGA containing 25% HIM. Data support its use as a 10-day pain management system for combat casualty care.