New Stable, High Flux Membrane for Osmotic Distillation of Labile Pharmaceutical

描述(由申请人提供)：该项目将开发一种用于渗透蒸馏(OD)的新的稳定、高通量的膜，作为从水发酵液中浓缩未经加工的药品的技术。渗透蒸馏(OD)是一种潜在的有用的过程，可以部分或全部从热不稳定的药物化合物中去除水分，而不会使药物化合物暴露在不需要的(高温)温度下。渗透蒸馏要解决的两个主要问题是：1)需要具有非常高的水分传输率的膜，以及2)需要避免潮湿的膜。该计划通过使用非湿润、低表面能、双层微孔聚偏氟乙烯(PVDF)膜来解决这两个问题，该膜具有高的湿出阻力(即稳定性)和极高的水传输率。CMS将开发涉及酶L-乳糖酶脱氢酶脱水的特殊OD应用。对蛋白质活性前后的测试将在宾夕法尼亚州立大学安德鲁·齐德尼教授的指导下在CMS进行。这种酶的加工稳定性是决定CMS OD过程对其他不稳定药物的可行性的一个极好的替代物。这一开发一旦完成，将代表着CMS膜技术的应用，对制药生产具有相当大的意义。

DESCRIPTION (provided by applicant): This program will develop a new stable, high flux membrane for osmotic distillation (OD) as a concentration technique for the unprocessed pharmaceutical products from aqueous fermentation broths. Osmotic distillation (OD) is a potentially useful procedure to partially or totally remove water from thermally labile pharmaceutical compounds without exposing the pharmaceutical compounds to undesirable (high) temperatures. The two main issues to be addressed with osmotic distillation are the need: 1) for a membrane with a very high water transport rate, and 2) for a membrane that avoids wet out. This program addresses both of these issues by using a non-wetting, low surface energy, double-skinned microporous polyvinylidene fluoride (PVDF) membrane that has high wet out resistance (that is, stability) and extraordinarily high water transport. CMS will develop the particular OD application involving dewatering of the enzyme L-lactase dehydrogenase. Tests on the before and after protein activity will be done at CMS under the direction of Professor Andrew Zydney at Penn State University. The processing stability of this enzyme is an excellent surrogate to determine the viability of the CMS OD process toward other labile pharmaceuticals. This development, once completed, will represent an application of CMS membrane technology that has considerable significance to pharmaceutical manufacturing.