DEVELOPMENT OF A VAGINAL DRUG DELIVERY SYSTEM

Umd, Inc., Cincinnati OH

Investigators

Abstract

The treatment of uterine pain during menses (dysmenorrhea), a disorder that seriously afflicts 5 million women in the U.S., with prostaglandin synthetase inhibitors (PSIs), has not been optimal because of systemic side effects. Using a rabbit model, we have developed a vaginal drug delivery system that takes advantage of the unique vaginal-to-uterine circulation to achieve therapeutic concentrations of PSIs in the uterine musculature without high concentrations in the systemic circulation. This patented delivery system consists of a drug reservoir/carrier assembly that can be incorporated into a tampon-containing platform or a vaginal ring and is designed to carry the PS through the vaginal mucosa into uterine circulation during menstruation. This innovative approach will provide effective relief during menses to women who still experience disabling dysmenorrhea, miss work, or are hampered in their daily activities. In addition, this drug delivery platform can be modified for delivery of other compounds to treat preterm labor and endometriosis. Phase I studies in rabbits will 1) evaluate two NSAIDs for vaginal absorption, 2) test the optimal drug reservoir system and 3) establish suitable uterine drug delivery rates using the rabbit model. We plan to proceed onto human studies for Phase II using this drug delivery platform. PROPOSED COMMERCIAL APPLICATIONS: UMD will develop a vaginal drug delivery system that can release therapeutic concentrations of prostaglandin synthetase inhibitors (PSIs) in the uterine muscle without the systemic side-effects of dysmenorrhea treatment. This vaginal delivery system can also be modified for delivery of other compounds for the treatment of preterm labor and endometriosis.