US Army Medical Research and Materiel Command Technology Available for Licensing Therapeutic Treatment and Prevention of Infections with Bioactive Materials Encapsulated within a Biodegradable-Biocompatible Polymeric Matrix Features and advantages: • Optimal drug release due to capped status and blend ratio of terminal carboxyl ends within PLGA • Biodegradable, antibiotic-releasing microspheres more effective than standard therapy in eliminating osteomyelitis • Encapsulated hepatitis B antigen is as immunogenic as the conventional vaccine • GI administered CFA/II pilus vaccine, stabilized within microspheres, elicited protective immunity in vivo This invention is a process to prepare sustained release, burst-free, biodegradable microspheres that deliver pharmaceuticals, antigens, and bioactive agents. The blend ratio of end-capped to uncapped (free carboxyl ends) of the poly(lactide/glycolide) [PLGA] copolymer was found key to the exquisite control and duration of release achieved. Antibiotics (ampicillin, cefazolin), vaccine antigens (hepatitis B and CFA/II pilus vaccine), and a representative polypeptide (histatin) were encapsulated.  After sustained in vitro drug release was obtained for each formulation, they were evaluated for efficacy in vivo. A single dose application of antibiotic microspheres was as effective as a 14 day standard course of systemic antibiotic in preventing soft tissue infections, and the single dose encapsulated drug was more effective than standard therapy in eliminating osteomyelitis. Intraduodenal administration of encapsulated E. coli CFA/II pilus vaccine was safe and immunogenic in eliciting protective immunity. Encapsulated hepatitis B antigen produced an immunity equivalent to conventional Heptavax B vaccine in mice. These studies confirm the power of sustained drug delivery in achieving diverse and heightened biological effects in the delivery of pharmaceuticals, vaccine antigens, and bioactive agents in vivo. Advantages accrued from developing this technology include reduced drug toxicity, stabilization of labile agent in vivo, conservation of precious agent, single dose therapy, targeted drug delivery, and ease of use. Patent Status Patent No.: 6,844,010 Date Issued: January 18, 2005 Available from: www.uspto.gov Docket No.: WRAIR 01-06 Point of Contact Dr. Paul C. Mele Director, Office of Research and Technology Applications USAMRMC, MCMR-ZA-J 504 Scott St., Ft. Detrick, MD 21702-5012 E-mail: usamrmcorta@amedd.army.mil Voice: 301-619-6664/2065/7219 Fax: 301-619-5034 KEYWORDS: pharmaceuticals; sustained release; drug delivery; vaccines Licensing Opportunities • Patent licenses are available to companies with commercial interests