Stable, Biodegradable Sustain-Release Analgesic System. Phase I
Final rept. 15 Mar 96-14 Mar 1997
SAIMOL INTERNATIONAL INC MINNETONKA MN
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The work done in this SBIR Phase 1 was to investigate the feasibility of producing a sustain-release injectable gel formulation for Buprenorphine hydrochloride and Buprenorphine free base using Poly-lactide-co-glycolide polymers with various plasticizers and solvents. Our Phase 1 efforts have shown that we can produce gel formulations for both of these molecules that will give prolonged release of the drug from the gel as shown by in-vitro studies. Our studies have demonstrated that these polymers can prolong the release of buprenorphine for over 30 days. However, for acute pain relief, release over a period of 24 - 72 hours would be desirable. Our data has shown that with the initial studies conducted here, we can get release of buprenorphine over 24 - 144 hours in-vitro. In-vivo rates should be faster than these and we plan to carry out animal studies to show this. The initial studies also shows that there are a lot of variables in this system that need to be studied and optimized to get the best release profile with the right therapeutic levels released which can be carried out in Phase 2.
- Anatomy and Physiology