Concentration Method for Thermally Labile Pharmaceutical

说明（由申请人提供）：冷冻干燥通常用于浓缩对温度敏感的药物。冷冻干燥是昂贵的，并导致产品降解。渗透蒸馏（OD）是一种更温和、成本更低的浓缩方法，但由于微孔膜因湿化而失效，尚未商业化开发。在第一阶段，紧凑膜系统（CMS）使用新型膜浓缩模型酶，与对照组相比，没有湿化或导致活性损失。我们与一家工业制药公司合作，在超临界流体萃取（SCFE）之前，使用OD浓缩抗生素。OD-SCFE法比传统化学提取法多提取27%的抗生素。我们得到了一家工业制药公司和两家大型膜公司的支持。这些合作关系增强了CMS完成第二阶段和将该技术商业化的能力。在第二阶段，我们将与我们的制药合作伙伴合作开发一种使用OD进行初始脱水和SCFE进行最终浓缩的工艺。我们第二阶段的重点将是：a)进一步开发用于制药产品OD的膜/模块b)与我们的制药合作伙伴合作建立和测试原型系统c)获取关键基础数据并进行经济分析

DESCRIPTION (provided by applicant): Freeze-drying is commonly employed to concentrate temperature-sensitive pharmaceuticals. Freeze-drying is expensive and causes product degradation. Osmotic distillation (OD) is a candidate for gentler and lower-cost concentration but has not been commercially developed because microporous membranes fail due to wet-out. In Phase I, Compact Membrane Systems (CMS) used novel membranes to concentrate a model enzyme without wetting-out or causing activity loss as compared to control. Working with an industrial pharmaceutical company, we used OD to concentrate an antibiotic prior to super critical fluid extraction (SCFE). The OD-SCFE method recovered 27% more antibiotic than the traditional chemical extraction method. We have gained support from an industrial pharmaceutical company and two major membrane companies. These relationships enhance CMS's ability to complete Phase II and commercialize this technology. In Phase II, we will collaborate with our pharmaceutical partner to develop a process using OD for initial dewatering and SCFE for final concentration. Our Phase II focus will be: a) Further developing membrane/module for OD of pharmaceutical products b) Working with our pharmaceutical partner to build and test prototype system c) Obtaining key basic data and performing economic analysis d) Performing long-term stability testing of OD process and biopharmaceutical product.