Concentration Method for Thermally Labile Pharmaceutical

热不稳定药物的浓缩方法

基本信息

批准号：
6789451
负责人：
John J Bowser
金额：
$ 25.14万
依托单位：
COMPACT MEMBRANE SYSTEMS, INC.
依托单位国家：
美国
项目类别：
财政年份：
2003
资助国家：
美国
起止时间：
2003-08-15 至 2007-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/6789451
关键词：
Concentration Method Thermally Labile Pharmaceutical

项目摘要

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.

描述（由申请人提供）：冷冻干燥通常用于浓缩温度敏感的药物。冷冻干燥成本昂贵并且会导致产品降解。渗透蒸馏 (OD) 是一种更温和且成本更低的浓缩方法，但尚未进行商业开发，因为微孔膜会因浸湿而失效。在第一阶段，紧凑型膜系统（CMS）使用新型膜来浓缩模型酶，与对照相比不会润湿或导致活性损失。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 来浓缩抗生素。 OD-SCFE 方法比传统化学提取方法多回收 27% 的抗生素。我们得到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) 进一步开发用于药品 OD 的膜/模块 b) 与我们的制药合作伙伴合作构建和测试原型系统 c) 获取关键基础数据并进行经济分析 d) 对OD工艺和生物制药产品进行长期稳定性测试。