Concentration Method for Thermally Labile Pharmaceutical

热不稳定药物的浓缩方法

• 批准号: 6584708
• 负责人: John J Bowser
• 金额: $ 45.65万
• 依托单位: COMPACT MEMBRANE SYSTEMS, INC.
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-08-15 至 2005-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6584708
• 关键词: Concentration; Method; Thermally; Labile; Pharmaceutical

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.

性状（由申请人提供）：冷冻干燥通常用于浓缩温度敏感性药物。 冷冻干燥是昂贵的，并导致产品降解。渗透蒸馏（OD）是一种温和和低成本的浓缩方法，但由于微孔膜会因润湿而失效，因此尚未进行商业开发。 在第一阶段，紧凑膜系统（CMS）使用新的膜浓缩模型酶没有润湿或导致活性损失相比，控制。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法比传统的化学提取法多回收27%的抗生素。 我们获得了一家工业制药公司和两家主要膜公司的支持。这些关系增强了CMS完成第二阶段并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。我们的第二阶段重点将是：a）进一步开发用于药品OD的膜/组件B）与我们的制药合作伙伴合作构建和测试原型系统c）获得关键基础数据并进行经济分析 d）进行OD工艺和生物制药产品的长期稳定性测试。