The primary objective of this proposal is to develop a controlled release implantable delivery system for buprenorphine. This implant formulation will be easily administered and will deliver the drug for periods of 3 months to a year. Buprenorphine HCI is under investigation for use in the treatment of patietns with opiate dependency. Currently, no long acting formulations for the treatment of drug dependency are commercially available. An implant product that can deliver drug from periods of 3 months to a year will not only improve the management of patients but it will also reduce the overall cost of this therapy and prevent misuse of the product. The goal of this project is to develop an ethylene-vinyl acetate implant formulation that would deliver buprenorphine HCI at a rate of 1-4 mg/day for a period of 3 months to a year. The formulation will consist of multiple implants to achieve the desired dose. Each implant will to be approximately 2.4 mm in diameter and 2.6 cm in length. The Phase I proposal involves formulation development, formulation optimization, and pharmacokinetic study to determine pharmacokinetic parameters which will serve as critical tools in development of this product and other implant products.
