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

NSF I-Corps这项活动的目标是系统地研究技术转型，并建立封装疏水性化合物的聚合物纳米颗粒可规模化生产技术的商业可行性。 聚合物纳米颗粒的最大优点之一是，它们可以以比这些化合物在水溶液中的溶解度高得多的浓度携带疏水性化合物，然而，包封使化合物免于暴露于生理条件，直到它们到达它们的目标。然而，它是具有挑战性的，以产生大规模的聚合物纳米粒子具有良好的控制的物理，化学和药物性质的生物医学应用。所提出的产品是一种连续的、可扩展的方法，用于通过将快速纳米沉淀与干燥过程相结合来生成聚合物纳米颗粒。该研究团队将通过评估产品的可能性、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，并为整个社会带来健康益处。疏水性化合物的低剂量和给药频率以及降低的副作用可以通过增加药物生物利用度来实现。被证明具有体外或离体治疗功效但不可递送或难以施用的药物化合物可被配制并可用于治疗复杂疾病的临床应用。具有可控性质的可重复产生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.