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Abstract

Grant Number:	1R41GM067304-01
PI Name:	ELSOHLY, MAHMOUD A.
PI Email:	elimae@watervalley.net
PI Title:	PRESIDENT
Project Title:	Transmucosal Intra-Oral Drug Delivery System for THC

Abstract: 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.

Thesaurus Terms:
biodegradable product, cannabinoid, dosage forms, drug delivery system, oral mucosa, technology /technique development
cell adhesion, pharmacokinetics, polymer
blood chemistry, gas chromatography mass spectrometry, high performance liquid chromatography, laboratory rabbit, mathematical model

Institution:	ELSOHLY LABORATORIES, INC.
	5 INDUSTRIAL PARK DR
	OXFORD, MS 38655
Fiscal Year:	2003
Department:
Project Start:	01-SEP-2003
Project End:	30-JUN-2004
ICD:	NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES
IRG:	ZRG1

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