UNIVERSAL STABILIZATION TECHNOLOGIES, INC. — Department of Health and Human Services SBIR Phase I: Each day, 380 children die from measles virus mostly in developing countries because of th

Description

Each day, 380 children die from measles virus mostly in developing countries because of the high cost and limited access to vaccines. To address this challenge, a vaccine for measles that is inexpensive, easy to administer, and can be maintained without refrigeration should be developed. Our ultimate Phase I goal is to demonstrate feasibility of developing rapid orally disintegrating tables (ODTs) containing dry thermostable measles vaccine for sublingual delivery. A technological innovation that makes this project possible is our patented "Preservation by Vaporization" technology. In preliminary experiments, stable measles vaccines have been produced in high yield and stability for 12 months at 37 degrees C. Objectives are: 1) Evaluate the effects of ODT formulations on physico-chemical tablet characteristics, 2) Evaluate the effects of ODT forumulations on the activity of dry preserved measles vaccine embedded in the ODTs, 3) Select an optimal ODT production process that satisfies our target ODT specifications. Produce ODTs containing dry preserved measles vaccine using the optimized formulation and demonstrate stability of the vaccine in this formulation adn stability of physico-chemical tablet characteristics after at least one month of storage at 25 +/- 2 degrees C adn 37 +/-2 degrees C, and <1 log titer loss after 6 months of storage at 37+/-2 degrees C.