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

小型企业创新研究(SBIR)第一阶段项目的更广泛影响/商业潜力是使用纳米剂型药物分子护理患有糖尿病、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。制造纳米尺寸的药物有助于它们被吸收，并转移到身体需要的部位。制造纳米药物的能力来自于双螺杆挤出机可以减小药物尺寸的发现，这种机器通常用于生产塑料管、垃圾袋、休闲食品、谷类食品和意大利面等大宗产品。在发现双螺杆挤出机之前，药物纳米粒的产量很小，而且价格高得令人望而却步。NSF SBIR第一阶段项目旨在通过以经济的方式制造纳米药物形式并将其送到医学研究人员手中来挖掘纳米药物形式的潜力。这个小型企业创新研究(SBIR)第一阶段项目寻求提供与表面活性剂-脂质-水系统和药物输送纳米颗粒相关的新知识。尽管已经有很多研究集中于使用脂质纳米粒来增加人体对药物的吸收，但由于纳米粒不能生产出足够的重复性、质量或足够的数量，使得它们的价格高得令人望而却步，因此转移到临床上的研究一直受到限制。这个SBIR项目寻求通过使用双螺杆挤出来解决这些问题，这种工艺通常用于批量生产日用品，如塑料管、垃圾袋、休闲食品和意大利面。双螺杆挤出机工艺是基于可破裂的表面活性剂-脂肪-水中间相在通过挤出机机筒时的瞬时形成。为了在药物纳米剂型的双螺杆挤出方面取得成功，必须创造新的科学知识，将表面活性剂-脂质-水体系的概念化从时间不变的平衡结构推进到高度依赖时间的动态非平衡过程。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势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.