D9-THC for Marijuana Addiction

点击翻译按钮获取中文摘要

DESCRIPTION (provided by applicant): ?9-tetrahydrocannabinol (?9-THC) has been shown to alleviate marijuana withdrawal symptoms and thus has potential for treating cannabinoid dependence. However, the bioavailability of ?9-THC administered orally is poor and variable. In addition, it also requires drug administration several times a day. Formulations to improve bioavailability and/or to reduce dosing frequency would be expected to improve the therapeutic effectiveness of ?9-THC. In Phase I, our technical objectives are to develop improved oral and/or depot formulations of ?9-THC based on biopharmaceutical rationale, and select a formulation that is stable with acceptable in vitro controlled release characteristics. ?9-THC is very hydrophobic and oxygen-sensitive, both factors that are challenges in making formulations that are orally bioavailable and stable. Utilizing proprietary SuperFluids(tm) technologies, we propose to encapsulate ?9-THC in biodegradable polymer nanospheres that will allow transport to the stomach, improve its stability and enhance bioavailability. In Phase II, we will carry out pharmacological, toxicological and pharmacokinetic evaluations of the developed formulation(s). We will also provide a GMP scale-up of a stable dosage form with acceptable in vitro and in vivo bioavailability in animal models and/or in humans. Narrative: The developed controlled release, oral formulation of ?9-THC will be commercialized for treating marijuana dependence and withdrawal symptoms, cancer pain, nausea associated with cancer chemotherapy and AIDS cachexia or wasting.