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

描述（由申请人提供）：本项目将开发一种新的稳定、高通量膜，用于渗透蒸馏（OD），作为水发酵液中未加工药品的浓缩技术。渗透蒸馏（OD）是一种潜在的有用方法，可以从热不稳定的药物化合物中部分或全部去除水，而无需将药物化合物暴露在不需要的（高）温度下。渗透蒸馏需要解决的两个主要问题是：1)需要具有非常高的水传输速率的膜，2)需要避免湿出的膜。该方案通过使用非润湿、低表面能、双皮微孔聚偏氟乙烯（PVDF）膜来解决这两个问题，该膜具有高抗湿性（即稳定性）和极高的水输运性。CMS将开发涉及l -乳糖酶脱氢酶脱水的特殊OD应用。在宾夕法尼亚州立大学Andrew Zydney教授的指导下，在CMS进行前后蛋白质活性的测试。该酶的加工稳定性是确定CMS OD工艺对其他不稳定药物的可行性的一个很好的替代指标。这一发展一旦完成，将代表CMS膜技术的应用，对制药制造具有相当重要的意义。

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.