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

SBIR 第一阶段：水凝胶片作为具有成本效益的口服剂量，可增强溶解度

• 批准号: 2015028
• 负责人: Paul Godfrin
• 金额: $ 22.5万
• 依托单位: Veramorph LLC
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-08-01 至 2022-03-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2015028&HistoricalAwards=false
• 关键词: SBIR; Phase; Hydrogel; tablets; cost

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.

这个小企业创新研究（SBIR）第一阶段项目的更广泛的影响/商业潜力是通过一种新的片剂来提高药物产品的功效。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输送治疗性化合物的方法。这个小企业创新研究（SBIR）一期项目将验证水凝胶片的口服给药性能，这些难溶性药物需要配方技术来改善口服吸收。目前技术提高溶解度仅限于一小部分药物，通常会导致保质期差和药物负荷有限，这是有效口服剂量的关键特征。目前水凝胶片的一个限制是，它们的药物释放被限制在一个小的pH范围内，在已知的人类胃肠道变异性。本项目旨在优化水凝胶片的组成，其目标包括：1)鉴定能够在整个人体pH值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成分；2)通过溶解研究和加速稳定性研究来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，将确定一种用于药物释放的最佳水凝胶组成，使用两种公认的聚合物作为水凝胶的“骨架”。该奖项反映了美国国家科学基金会的法定使命，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。