CONCENTRATION METHOD FOR THERMALLY LABILE PHARMACEUTICAL

热不稳定药物的浓缩方法

基本信息

批准号：
6210833
负责人：
John J Bowser
金额：
$ 10.51万
依托单位：
COMPACT MEMBRANE SYSTEMS, INC.
依托单位国家：
美国
项目类别：
财政年份：
2000
资助国家：
美国
起止时间：
2000-09-30 至 2001-09-30
项目状态：
已结题

项目摘要

Concentration of aqueous process streams is common in pharmaceutical industry. When product activity is sensitive to temperatures above room temperature, processes such as freeze drying are employed. Osmotic Distillation (OD) is candidate for lower cost method for concentration of higher quality product, but has not been developed for the application because of potential failure due to penetration of microporous membrane structure by solution to be concentrated. Suitability of new porous/nonporous membrane will be demonstrated for use in OD of pharmaceutical products. The nonporous nature will avoid the failure mode described above. The membrane is based on novel polymer which has high water permeability required. High chemical and thermal resistance of this polymer allows common sterilization methods to be used. Preliminary OD testing has shown system to work well. Objectives of Phase I include producing suitable modules of nonporous and porous membranes, investigating relative efficiency of each in concentrating a model solution, demonstrating their relative tendencies to "wet out", or fail due to fouling of membrane by process streams, and determination of conformational changes to surface and effect on macromolecule stability. Strong industry interest allows actual Phase I pilot testing. PROPOSED COMMERCIAL APPLICATION: Development of this process will have an immediate impact on the agility of Pharmaceutical Companies to concentrate products without losing activity of such, and the ability to do so at a lower cost. Other applications that may benefit include the concentration of fruit and vegetable juices and removal of volatile components from liquids, for example the dealcoholization of wine.

水性工艺流的浓缩在制药工业中很常见。当产品活性对高于室温的温度敏感时，会采用冷冻干燥等工艺。渗透蒸馏 (OD) 是浓缩高质量产品的低成本方法的候选方法，但尚未开发用于该应用，因为待浓缩的溶液渗透微孔膜结构可能导致故障。将证明新型多孔/无孔膜在药品 OD 中的适用性。无孔性质将避免上述故障模式。该膜基于具有高透水性要求的新型聚合物。这种聚合物的高耐化学性和耐热性允许使用常见的灭菌方法。初步 OD 测试表明系统运行良好。第一阶段的目标包括生产合适的无孔和多孔膜模块，研究每种膜在浓缩模型溶液中的相对效率，证明它们“浸湿”的相对倾向，或由于工艺流污染膜而失败，以及确定构象表面变化及其对大分子稳定性的影响。强烈的行业兴趣使得实际的第一阶段试点测试成为可能。拟议的商业应用：该工艺的开发将对制药公司在不损失活性的情况下浓缩产品的敏捷性以及以较低成本实现这一目标的能力产生直接影响。其他可能受益的应用包括浓缩果汁和蔬菜汁以及去除液体中的挥发性成分，例如葡萄酒的脱醇。