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

STTR第一期：利用食物效应设计和开发新型口服药物制剂

• 批准号: 2015053
• 负责人: Oljora Rezhdo
• 金额: $ 22.48万
• 依托单位: MECHASIM INC.
• 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: 2020-12-15 至 2023-02-28
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2015053&HistoricalAwards=false
• 关键词: STTR; Phase; Design; development; novel

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.

该小企业技术转让 (STTR) 第一阶段项目的更广泛影响/商业潜力是开发新型食品口服药物剂型，其可能优于传统片剂，因为它们可以以较低剂量给药，而不会影响治疗效果。目前，片剂形式的制剂需要以高剂量给药才能达到所需的治疗效果，从而推动了口服给药系统的改进。 所提出的剂型可能能够减轻药物标签中的食品限制，特别是有助于具有显着胃肠道毒性的口服药物。患者可以受益于无论食物如何服用药物的灵活性，以简化复杂的药物治疗方案并最终提高依从性。近期的商业重点将是推进包含两种拟议测试药物的通用平台的开发。 该小型企业技术转让 (STTR) 第一阶段项目旨在通过利用食物增强药物吸收的作用来开发生物利用度更高的剂型。由于超过 40% 的上市药物和约 90% 的正在开发的药物都存在溶解度差和相关的生物利用度低的问题，因此所提出的技术将成为药物与食物一起服用时吸收增强的平台。该项目将有效地利用食品成分（例如脂质、蛋白质）来开发市售口服药物的生物利用度更高的剂型。活动包括使用计算建模工具来定量估计特定膳食食品成分在提高药物吸收效率方面的效果。最终，这一过程将为新型食品配方的合理、高效设计提供先验信息，而不是通过试错过程。该奖项反映了 NSF 的法定使命，并通过使用基金会的智力优势和更广泛的评估进行评估，被认为值得支持。影响审查标准。