Transmucosal Intra-Oral Drug Delivery System for THC

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 1R41GM067304-01
Agency Tracking Number: GM067304
Amount: $99,986.00
Phase: Phase I
Program: STTR
Awards Year: 2003
Solicitation Year: N/A
Solicitation Topic Code: N/A
Solicitation Number: N/A
Small Business Information
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 (662) 236-2609
Business Contact
Phone: (662) 236-2609
Research Institution
 P.O. BOX 907
 Nonprofit college or university
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.

* Information listed above is at the time of submission. *

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