CONCENTRATION METHOD FOR THERMALLY LABILE PHARMACEUTICAL

含水工艺流的浓缩在制药工业中是常见的。当产品活性对高于室温的温度敏感时，可采用冷冻干燥等工艺。渗透蒸馏（OD）是用于浓缩更高质量产品的较低成本方法的候选方法，但由于待浓缩溶液渗透微孔膜结构而导致的潜在故障，尚未开发用于应用。将证明新多孔/无孔膜用于药品OD的适用性。无孔特性将避免上述失效模式。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，研究各自在浓缩模型溶液中的相对效率，证明它们相对倾向于“浸湿”，或由于工艺流污染膜而失效，并确定表面的构象变化和对大分子稳定性的影响。业界的强烈兴趣使实际的第一阶段试点测试成为可能。拟定商业应用：这一过程的发展将对制药公司的敏捷性产生直接影响，使其能够在不失去活性的情况下浓缩产品，并以较低的成本实现这一目标。其他可能受益的应用包括水果和蔬菜汁的浓缩以及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.