SBIR Phase I: Dense Nanolipid Fluids (DNLFs) for Delivery of Drugs with Poor Bioavailability: Synthesis, Manufacture, and Drug Properties

这项小企业创新研究（SBIR）第一阶段项目的更广泛影响/商业潜力是使用纳米剂量形式的药物分子来照顾患有糖尿病、多发性硬化症（MS）、获得性免疫缺陷综合征（AIDS）和癌症等疾病的患者。制造纳米级的药物有助于药物被吸收并转移到需要的身体部位。制造纳米药物的能力来自于一项发现，即使用双螺杆挤出机可以减小药物的尺寸，双螺杆挤出机通常用于生产散装产品，如塑料管、垃圾袋、零食、谷物和意大利面。在发现双螺杆挤出机之前，药物纳米颗粒的产量非常少，而且价格昂贵。NSF SBIR的第一阶段项目旨在挖掘纳米药物形式的潜力，使其能够经济地制造出来，并将其送到医学研究人员手中。这项小企业创新研究（SBIR）第一阶段项目旨在提供与表面活性剂-脂质-水系统和纳米颗粒药物输送相关的新知识。尽管已经有很多研究集中在使用脂质纳米颗粒增加人体对药物的吸收上，但由于纳米颗粒不能以足够的可重复性、质量或足够的数量生产，使得它们过于昂贵，因此向临床的转化一直受到限制。这个SBIR项目试图通过使用双螺杆挤压来解决这些问题，这是一种通常用于大宗商品生产的工艺，如塑料管、垃圾袋、零食和面食。双螺杆挤出工艺是基于可破裂的表面活性剂-脂质-水中间相在通过挤出机筒的过程中短暂形成的。为了在药物纳米剂型的双螺杆挤出中取得成功，必须创造新的科学知识，将表面活性剂-脂质-水系统的概念从时不变的平衡结构推进到高度时变的动态非平衡过程。该奖项反映了美国国家科学基金会的法定使命，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 Innovation Research (SBIR) Phase I project is to care for patients suffering from diseases including diabetes, multiple Sclerosis (MS), acquired immunodeficiency syndrome (AIDS), and cancer using nano dosage forms of drug molecules. Making drugs nano-sized helps them be absorbed and move to parts of the body where needed. The ability to manufacture nanosized drugs comes from the discovery that drug sizes may be decreased with a twin screw extruder, a type of machine usually used to produce bulk products such as plastic pipes, garbage bags, snack foods, cereal, and pasta. Before the discovery of the twin screw extruder, drug nanoparticles were only made in thimbleful quantities and were prohibitively expensive. This NSF SBIR Phase I project seeks to tap the potential of nano-sized drug forms by allowing them to be made economically and getting them into the hands of medical researchers. This Small Business Innovation Research (SBIR) Phase I project seeks to provide new knowledge related to surfactant-lipid-water systems and drug delivery nanoparticles. Although there has been much research focused on increasing the body’s absorption of drugs using lipid nanoparticles, translation to the clinic has been limited because nanoparticles cannot be produced with sufficient reproducibility, quality, or in sufficient quantities, making them prohibitively expensive. This SBIR project seeks to solve these problems by using twin-screw extrusion, a process typically used for bulk manufacturing of commodity goods such as plastic pipes, garbage bags, snack foods and pasta. The twin screw extruder process is based on the transient formation of rupturable surfactant-lipid-water mesophases during transit through the extruder barrel. To be successful at the twin screw extrusion of drug nano dosage forms, new scientific knowledge must be created to advance conceptualization of surfactant-lipid-water systems from time invariant equilibrium structures to highly time dependent dynamic non-equilibrium processes.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.