Transmucosal Intra-Oral Drug Delivery System for THC

THC 经粘膜口腔内给药系统

• 批准号: 6583516
• 负责人: MAHMOUD A ELSOHLY
• 金额: $ 10万
• 依托单位: ELSOHLY LABORATORIES, INC.
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-09-01 至 2004-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6583516
• 关键词: biodegradable product; blood chemistry; cannabinoids; cell adhesion; dosage forms; drug delivery systems; gas chromatography mass spectrometry; high performance liquid chromatography; laboratory rabbit; mathematical model; oral mucosa; pharmacokinetics; polymers; technology /technique development

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.

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挤出“大麻素基质贴剂”（TMP），作为Delta-9-四氢大麻酚（THC）的递送系统。将THC掺入稳定的生物粘附性药物递送系统中，该系统应用于受试者的颊或唇口腔粘膜。THC的受控释放通过生物可侵蚀的聚合物基质递送至受试者的体循环。该项目将通过一项工作计划来完成，以实现以下具体目标： 1.制定和生产初步TMP系统 2.评估初步系统，开发和优化铅配方 3.热熔挤出、模切和封装引线系统配方 4.测试和评估TMP系统的生物粘附性能 5.进行系统的稳定性研究并最终确定最佳TMP系统 6.在动物模型中测试最终TMP制剂 成功地将THC掺入热熔挤出系统作为替代的、更有效的递送方法，将对许多慢性病患者产生巨大影响，例如感染HIV病毒的患者或正在接受化疗的患者。这种用于THC的新型药物递送系统还可以为患有已知由THC改善的病症的那些患者提供缓解，所述病症例如青光眼、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、极端压力、抑郁症、哮喘和癫痫发作。