Transmucosal Intra-Oral Drug Delivery System for THC

描述(由申请人提供)：本研究项目的总体目标是开发一种有效的、热熔融挤压的“跨粘膜基质贴片”(TMP)，作为Delta-9-四氢大麻酚(THC)的输送系统。THC将被合并到一个稳定的生物粘附性药物输送系统中，该系统适用于受试者的口腔黏膜。THC的受控释放通过生物可擦除聚合物基质输送到受试者的体循环中。该项目将通过一项工作计划完成，以实现以下具体目标： 1.制定并生产初步的TMP体系 2.评估初步系统，开发和优化铅配方 3.热熔挤出、模切和包装引线系统配方 4.测试和评价TMP系统的生物黏附性能 5.进行系统稳定性研究，最终确定最优TMP系统 6.在动物模型中测试最终的TMP配方 将THC成功地并入热熔融挤压系统中，作为一种替代的、更有效的输送方法，将对许多慢性病患者产生巨大影响，例如那些感染艾滋病毒或正在接受化疗的患者。这种用于THC的新型药物输送系统还可以缓解那些已知可通过THC改善的病情的患者，如青光眼、偏头痛、风湿性和骨关节炎、与多发性硬化症相关的肌肉功能障碍、酒精和其他化学依赖戒断症状、极端应激、抑郁、哮喘和癫痫发作。

DESCRIPTION (provided by applicant): The overall goal of this research project is to develop an effective, hot-melt extruded "Transmucosal Matrix Patch" (TMP) as a delivery system for Delta-9-Tetrahydrocannabinol (THC). THC will be incorporated into a stable, bioadhesive drug delivery system that is applied to a subject's buccal or labial oral mucosa. The controlled release of THC is delivered to the systemic circulation of the subject via a bio-erodable polymer matrix. This project will be accomplished through a plan of work to achieve the following specific aims: 1. Formulate and produce preliminary TMP systems 2. Evaluate preliminary systems, develop and optimize lead formulations 3. Hot-melt extrude, die-cut and package lead system formulations 4. Test and evaluate bioadhesive properties of TMP systems 5. Conduct stability studies of systems and finalize optimal TMP systems 6. Test final TMP formulations in animal models Successful incorporation of THC into a hot-melt extruded system as an alternate, more efficient method of delivery will have a tremendous impact on many chronically ill patients, such as those infected with the HIV virus or those undergoing chemotherapy. This novel drug delivery system for THC could also provide relief for those patients suffering from conditions known to be ameliorated by THC, such as glaucoma, migraines, rheumatic and osteo-arthritis, muscle dysfunction associated with multiple sclerosis, alcohol and other chemical dependence withdrawal symptoms, extreme stress, depression, asthma and epileptic seizures.