Controlled Release Drug Delivery for Treatment

Naltrexone, a narcotic antagonist, can be an effective drug in the treatment of opiate addiction. However, one obstacle in achieving success with drug treatment regimes is lack of patient compliance. In work dealing with the treatment of narcotic addiction our team previously developed for NIH/NIDA a biodegradable controlled release delivery system of implantable beads made from a polylactic- co-glycolic acid (PLGA) polymer. In preliminary clinical studies, a single dose of naltrexone, given in these implantable beads, mitigated the opiate effects of morphine challenges for up to one month. These beads were of immediate utility in evaluating the concept of using an implant in treatment regimes for drug abuse. We have developed proprietary non-solvent technologies for the formulation of PLGA/drug controlled release systems which maintain the advantages of earlier solvent-based drug delivery systems. This program aims to further develop one of these non-solvent controlled release systems with the goal of a single-dose PLGA/naltrexone treatment for use in a one-month treatment regimen specific for the management of drug abuse. Because our formulation has no residual solvent, the system shows greater reproducibility and will find more ready acceptance by the FDA when planning clinical trials and final product development.