LONG ACTING NALTREXONE BIODEGRADABLE INJECTABLE GEL

描述（由申请人提供）：本项目的总体目标是 开发一种新的方法来治疗药物滥用， 获得专利的可生物降解的可注射凝胶制剂， 释放纳洛酮。这些新的可生物降解的get配方， 治疗浓度的纳洛酮至少4周， 单次皮下注射，从而产生一种产品， 当前口服治疗模式的主要缺点，即， 代谢不良和患者依从性差。因此， 这项研究如下： (1)开发和评价新型注射凝胶的体外药物释放速率 注射了纳洛酮。 本研究的第一步是制备载药凝胶制剂， 改变制剂因素并确定纳洛酮的体外释放速率 从凝胶配方中。 (2)确定凝胶的生物降解性、生物相容性以及 纳洛酮的恒定血药浓度可以在体内维持， 单次皮下注射。 载药凝胶的生物降解性和生物相容性及持续时间 维持恒定的血浆浓度的纳洛酮释放两个 将在大鼠中检查优化的载药凝胶形成， 单次皮下注射凝胶。 拟定商业应用： 一种非肠道给药的麻醉剂拮抗剂制剂在治疗阿片类药物依赖性中是重要的，该制剂是可生物降解的，并且在单次注射后可以在2-4周的时间内以受控的速率释放药物。 这种药物递送系统的潜在商业意义不仅在阿片类药物滥用治疗领域中，而且在治疗酗酒方面都是重要的，酗酒是当今社会中一个更大的和经济上毁灭性的问题。该系统的美国专利申请正在审批中，预计不久将获得批准。因此，我们相信，已发布的专利以及I期和II期研究产生的数据将有助于我们将该技术商业化并制造出可行的产品。

DESCRIPTION (provided by applicant): The overall goal of this project is to develop a novel approach for the treatment of drug abuse using unique and patented biodegradable injectable gel formulations which can control the release of naltrexone. These novel biodegradable get formulations wit maintain therapeutic concentrations of naltrexone for at least 4 weeks, following a single subcutaneous injection, thereby creating a product that will overcome the major disadvantages of current mode of oral therapy, i.e. significant first pass metabolism and poor patient compliance. Therefore, the specific aims of this study are as follows: (1) Develop and Evaluate In Vitro Drug Release Rates from Novel Injectable Gels Loaded with Naltrexone. The first step in this study is to prepare drug-loaded gel formulations with varying formulation factors and ascertain in vitro release rates of naltrexone from the gel formulations. (2) Ascertain Biodegradability, Biocompatibility of the Gels and How Long Constant Plasma Concentrations of Naltrexone can be Maintained in Vivo after a Single Subcutaneous Injection. Biodegradability and biocompatibility of the drug-loaded gels and the duration of maintaining constant plasma concentration of naltrexone released from two optimized drug-loaded gel formations will be examined in rats following a single subcutaneous injection of the gels. PROPOSED COMMERCIAL APPLICATION: A parenterally administered formulation of a narcotic antagonist that is biodegradable and can release the drug at a controlled rate over a 2-4 week period following a single injection would be important in the treatment of opiate dependence. The potential commercial implications of such drug delivery system will be significant not only in the field of opiate abuse treatment, but also in the treatment of alcoholism, a much larger and economically devastating problem in our society today. A U.S. patent application for this system is pending and is expected to be granted shortly. Therefore, we believe that an issued patent and data generated from both Phase I and phase II studies will help us commercialize the technology and make a viable product.