SBIR Phase I: Hydrogel tablets as cost-effective oral dosages for solubility enhancement

Veramorph Llc, Norwood MA

Investigators

Abstract

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to improve the efficacy of drug products through a novel tablet. Current formulation technologies have limited compatibility with the estimated 60% of drugs that do not dissolve easily, restricting the number of therapeutic options. This project will develop a more versatile way of delivering therapeutic compounds. This Small Business Innovation Research (SBIR) Phase I project will validate the oral drug delivery performance by hydrogel tablets of poorly soluble drug substances requiring formulation technologies to improve oral absorption. Solubility enhancement by current technologies is limited to a small range of drugs and typically causes poor shelf-life and limited drug loading, critical characteristics of effective oral dosages. A current limitation of hydrogel tablets is that their drug release is limited to a small pH range within the known variability of the human gastrointestinal tract. This project aims to optimize the composition of hydrogel tablets, with objectives inlcuding: 1) Identify cross-linkers capable of immediate drug release over the full range of human pH values, validating compositions using standard analytical chemistry techniques; 2) Characterize each hydrogel’s performance via dissolution studies and accelerated stability studies. By correlating the hydrogel performance with the chemistry and content of cross-linkers, an optimal hydrogel composition for drug release will be determined using two well-established types of polymers as the “backbone” of the hydrogel. 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.