I-CORPS: Scalable Production of Polymeric Nanoparticles Encapsulating Hydrophobic Compounds

NSF I-Corps活动的目标是系统地研究技术过渡，并建立可规模生产包裹疏水化合物的聚合物纳米颗粒的技术的商业可行性。聚合物纳米粒子的最大优点之一是它们可以携带比这些化合物在水溶液中的溶解度高得多的疏水化合物，然而，这种包裹性使这些化合物在到达目标之前不会暴露在生理条件下。然而，制备具有良好控制的物理、化学和药物性质的大规模聚合物纳米颗粒用于生物医学应用是具有挑战性的。建议的产品是一种连续的、可扩展的过程，通过将闪光纳米沉淀法与干燥过程相结合来生成聚合物纳米颗粒。所得到的纳米粒具有高载药量、高药物包封率和良好的粒度分布。团队将通过评估产品可能性、潜在市场、经济和商业模式来达到I-Corps研究的目标。如果成功，具有受控性质的聚合物纳米颗粒的商业规模生产技术将引发生物制药行业的范式转变，实现对整个社会健康益处的潜力。通过提高药物的生物利用度，可以实现低剂量和剂量频率，并减少疏水化合物的副作用。被证明具有体外或体外治疗效果但无法给药或难以给药的药物化合物可以被配制成可用于治疗复杂疾病的临床应用。可重复生产的具有可控性质的纳米颗粒可以作为研究药物药代动力学、功能和疗效的平台。

The goal of this NSF I-Corps activity is to systematically study technology transition and establish the commercial viability of the technology of scalable production of polymeric nanoparticles encapsulating hydrophobic compounds. One of the greatest advantages of polymeric nanoparticles is that they can carry hydrophobic compounds at much higher concentrations than the solubility of these compounds in aqueous solutions and yet, the encapsulation keeps the compounds from being exposed to physiological conditions until they reach their targets. However, it is challenging to generate large-scale polymeric nanoparticles with well-controlled physical, chemical, and pharmaceutical properties for biomedical applications. The product being proposed is a continuous, scalable process for generating polymeric nanoparticles by integrating flash nanoprecipitation with drying processes. The resulting nanoparticles can have high drug loading, high drug encapsulation efficiency, and narrw particle size distribution.The team will reach the goal of this I-Corps study through assessing product possibilities, potential markets, economics and business models. If successful, the technology of commercial scale production of polymeric nanoparticles with controlled properties will initiate a paradigm shift in the biopharmaceutical industry with realized potential for health benefits for society at large. Low dose and dose frequency, and reduced side effects of the hydrophobic compounds can be achieved by increasing drug bioavailability. Drug compounds demonstrated to have in vitro or ex vivo therapeutic efficacy but undeliverable or difficult to administer can be formulated and available for clinical applications of treating complex diseases. Reproducibly generating nanoparticles with controlled propertied can serve as a platform to study drug pharmacokinetics,functionality, and efficacy.