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

这一小型企业创新研究（SBIR）I期项目的更广泛影响/商业潜力是通过一种新型片剂提高药品的疗效。 目前的制剂技术与估计60%不易溶解的药物的相容性有限，限制了治疗选择的数量。该项目将开发一种更通用的方法来提供治疗化合物。该小型企业创新研究（SBIR）I期项目将通过水凝胶片剂验证难溶性药物的口服药物递送性能，这些药物需要处方技术来改善口服吸收。目前技术的溶解度增强仅限于小范围的药物，并且通常导致保质期差和载药量有限，这是有效口服剂量的关键特征。水凝胶片剂的当前限制是它们的药物释放限于人胃肠道的已知可变性内的小pH范围。该项目旨在优化水凝胶片剂的组成，其目标包括：1）鉴定能够在人体pH值的整个范围内立即释放药物的交联剂，使用标准分析化学技术验证组成; 2）通过溶解研究和加速稳定性研究表征每种水凝胶的性能。通过将水凝胶的性能与交联剂的化学性质和含量相关联，将使用两种公认的聚合物作为水凝胶的“骨架”，确定用于药物释放的最佳水凝胶组合物。该奖项反映了NSF的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

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.