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

该小企业技术转让（STTR）I期项目的更广泛影响/商业潜力是开发可能上级传统片剂的新型食品口服剂型，因为它们可以以较低剂量给药而不会影响治疗益处。目前，片剂形式的制剂需要以高剂量给药以实现所需的治疗效果，从而促使改进的口服递送系统。 拟议的剂型可能有能力减轻药物标签中的食物限制，特别是帮助具有显著胃肠道毒性的口服药物。患者可以从不考虑食物的灵活服药中受益，以简化复杂的药物方案并最终提高依从性。近期的商业重点将是推进开发一个具有两种拟议测试药物的通用平台。 这个小企业技术转让（STTR）第一阶段项目旨在通过利用食物在促进药物吸收方面的作用来开发更多的生物利用度剂型。由于超过40%的上市药物和约90%的开发管道中的药物存在溶解度差和相关的生物利用度低的问题，拟议的技术将作为药物与食物一起服用时吸收增强的平台。该项目将有效地使食品成分的使用（例如，脂质、蛋白质）以开发更多的市售口服药物的生物可利用剂型。活动包括使用计算建模工具来定量估计特定膳食食物成分在提高药物吸收效率方面的作用。最终，这一过程将为合理、有效地设计新颖的食品配方提供信息，而不是通过反复试验的过程。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 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.