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.
| Repka, Michael A; ElSohly, Mahmoud A; Munjal, Manish et al. (2006) Temperature stability and bioadhesive properties of delta9-tetrahydrocannabinol incorporated hydroxypropylcellulose polymer matrix systems. Drug Dev Ind Pharm 32:21-32 |
| Munjal, Manish; Stodghill, Steven P; Elsohly, Mahmoud A et al. (2006) Polymeric systems for amorphous Delta 9-tetrahydrocannabinol produced by a hot-melt method. Part I: chemical and thermal stability during processing. J Pharm Sci 95:1841-53 |
| Munjal, Manish; ElSohly, Mahmoud A; Repka, Michael A (2006) Chemical stabilization of a Delta9-tetrahydrocannabinol prodrug in polymeric matrix systems produced by a hot-melt method: role of microenvironment pH. AAPS PharmSciTech 7:71 |
| Munjal, Manish; Elsohly, Mahmoud A; Repka, Michael A (2006) Polymeric systems for amorphous Delta9-tetrahydrocannabinol produced by a hot-melt method. Part II: Effect of oxidation mechanisms and chemical interactions on stability. J Pharm Sci 95:2473-85 |
