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

这项NSF I-Corps活动的目标是系统地研究技术转型，并建立可扩展生产聚合纳米颗粒封装疏水化合物技术的商业可行性。高分子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浓度的疏水化合物，然而，封装使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、化学和药物性能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。提出的产品是一个连续的、可扩展的过程，通过将纳米闪蒸沉淀与干燥过程相结合，产生聚合物纳米颗粒。所制备的纳米颗粒具有载药量高、包封效率高、粒径分布窄等特点。该团队将通过评估产品可能性、潜在市场、经济和商业模式来实现I-Corps研究的目标。如果成功，具有可控特性的聚合物纳米颗粒的商业规模生产技术将启动生物制药工业的范式转变，并实现对整个社会的健康益处的潜力。疏水化合物的低剂量、低剂量频率和低副作用可通过提高药物生物利用度来实现。经证明具有体外或离体治疗功效但无法递送或难以给药的药物化合物可以配制并可用于治疗复杂疾病的临床应用。可重复性地生成具有可控性能的纳米颗粒可以作为研究药物药代动力学、功能和功效的平台。

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.