NOVEL INHALATION SYSTEM FOR DELIVERING VAPOR-STATE DRUGS

Delta-9-tetrahydrocannibinol (THC) is approved for AIDS-related anorexia, chemotherapy-related nausea and vomiting, and clinical evidence supports efficacy of THC in pain, even suggesting an opioid sparing strategy with equivalent analgesia. Current THC formulations have significant disadvantages, including imprecise dosing, variable absorption, poor bioavailability, slow onset of action, and toxic components and legal issues if smoked. Medical experts agree that a rapid-onset, reliable and safe delivery system for THC represents an unmet patient need. MDC proposes its hand-held inhaler to meet this need. The inhaler is the first to deliver vapor-state drug without excipients. The inhaled, reproducible dose will be absorbed from the lung rapidly with high bioavailability, providing effective blood levels, and rapid-onset of action. Utilizing an in vitro test apparatus, MDC demonstrate feasibility by generating ultrafine particles of optimal size and distribution, without degradation, for vapor-state inhalation delivery. In Phase I we propose developing a benchtop prototype device and conducting in-vitro verification. Phase I AIMS include: 1) designing, constructing and testing a benchtop prototype producing acceptable, ultrafine particle sizes and PSD, 2) producing doses reproducibly without degradation, and 3) analyzing economical scale-down for hand-help operation. The ultimate goal is clinical evaluation of efficacy and safety leading to an NDA and regulatory approval. PROPOSED COMMERCIAL APPLICATION: The commercial market potential for the MDC Inhalation Delivery of THC alone includes, among others, millions of cancer patients and thousands of AIDS patients who would benefit from improved management of pain, cachexia, nausea, and other symptoms using inhaled analgesia medications (as prescribed by their doctors) in the United States and other countries.