STTR Phase I: Design and development of novel oral drug formulations by leveraging the food effect

The broader impact/commercial potential of this Small Business Technology Transfer (STTR) Phase I project is the development of novel food-based oral dosage forms of pharmaceutics potentially superior to traditional tablets as they can be administered at lower doses without compromising therapeutic benefits. Currently tablet form preparations require administration at high doses to achieve desired therapeutic effects, motivating improved oral delivery systems. The proposed dosage forms may have the ability to mitigate food restrictions in drug labels and particularly helping oral drugs with significant gastrointestinal toxicities. Patients could benefit from the flexibility of taking medications irrespective of food to ease complex drug regimens and ultimately improve compliance. The near-term commercial focus will be to advance development toward a general platform with two proposed test drugs. This Small Business Technology Transfer (STTR) Phase I project seeks to develop more bioavailable dosage forms by exploiting the effect of food in enhancing drug absorption. As more than 40% of marketed drugs and about 90% of drugs in development pipelines suffer from poor solubility and associated low bioavailability, the proposed technology will serve as a platform for drugs showing enhanced absorption when taken with food. This project will effectively enable the use of food ingredients (e.g., lipids, proteins) to develop more bioavailable dosage forms of marketed oral drugs. Activities include use of computational modeling tools to quantitatively estimate the effect of specific dietary food ingredients in increasing the efficiency of drug absorption. Ultimately this process will inform rational, efficient design of novel food-based formulations a priori rather than by a trial-and-error process. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.