CONCENTRATION METHOD FOR THERMALLY LABILE PHARMACEUTICAL

水工艺流程的浓缩在制药工业中是很常见的。当产品活性对室温以上的温度敏感时，采用冷冻干燥等工艺。渗透蒸馏（OD）是一种低成本的浓缩高质量产品的候选方法，但由于被浓缩的溶液渗透微孔膜结构可能导致失败，因此尚未发展用于应用。新多孔/非多孔膜的适用性将被证明用于制药产品的OD。无孔特性将避免上述失效模式。该膜是基于新型聚合物，具有较高的透水性要求。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。初步外径测试表明系统工作良好。第一阶段的目标包括生产合适的无孔膜和多孔膜模块，研究每种膜在浓缩模型溶液中的相对效率，展示它们的相对“湿掉”趋势，或由于工艺流污染膜而失败，并确定表面构象变化和对大分子稳定性的影响。强烈的行业兴趣允许实际的第一阶段试点测试。建议的商业应用：该工艺的开发将对制药公司在不失去活性的情况下浓缩产品的敏捷性和以较低成本这样做的能力产生直接影响。其他可能受益的应用包括果汁和蔬菜汁的浓缩和从液体中去除挥发性成分，例如葡萄酒的脱醇。

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.