Customized Nanofiltration Membranes for Enhancing Pharmaceutical Manufacturing

描述(申请人提供)：本申请的总体重点是开发纳滤膜，以回收药物制造过程中产生的废溶剂，允许溶剂重复使用，从而消除浪费。这也是对NIH RFP PA-09-100题为“能源效率和可再生能源系统技术研究与开发”的响应。通过使用压力驱动纳滤与热驱动分离(如蒸馏)回收制药废溶剂，我们还可以直接响应NIH的RFP节能流程。制药工业中的化学合成通常是在溶剂中进行的，会产生大量的废溶剂。药物成分的提取和提纯以及制药设备(如反应器)的清洁也会产生溶剂流出物。制药工业中有许多涉及这些有机溶剂处理的需求。它们包括：i)生产用于有机合成的高纯度溶剂；ii)回收废弃的有机溶剂，以减少产生的有毒废物量。目前的应用是为了从生产原料药物质产生的废有机溶剂中去除污染物。在外加压力梯度的驱动下，纳滤分离允许溶剂选择性地透过膜，保留溶质和非选择性溶剂。药品生产过程中产生的废溶剂大多含有低分子化合物或溶质，如废催化剂和分子量小于1000g/mol的副产物。废溶剂中常含有不易分离的共沸混合溶剂。 与公众健康相关：该项目将开发一种膜产品和工艺，以去除反应溶剂和反应物中的溶解氧和水，以及未反应的化学品、废催化剂和废有机溶剂的副产品。这一发展对降低与药品制造相关的生产成本具有相当大的意义。

DESCRIPTION (provided by applicant): The overall focus of this application is to develop nanofiltration membranes to recover the spent solvents generated from drug manufacturing processes allowing the solvents to be reused resulting in elimination of waste. This is also responsive to NIH RFP PA-09-100 entitled "Energy Efficiency and Renewable Energy System Technology Research & Development". By using a pressure-driven nanofiltration versus a thermal-driven separation such as distillation for recovery of pharmaceutical spent solvents, we also are directly responsive to this NIH's RFP for energy efficient processes. Chemical syntheses in the pharmaceutical industry are often carried out in solvents and generate large amount of spent solvents. Extraction and purification of pharmaceutical ingredients and cleaning of the drug manufacturing equipment such as reactors also generate solvent effluents. There are numerous needs in the pharmaceutical industry that involve the treatment of these organic solvents. They include: i) production of high purity solvents for organic synthesis ii) recovery of spent organic solvents to reduce the amount of toxic waste produced. The current application is addressed to remove contaminants from spent organic solvents generated from the production of bulk pharmaceutical substances. Nanofiltration separation, driven by the applied pressure gradient, allows solvents to permeate selectively through the membrane retaining the solutes and non-selective solvents. Most of the waste solvents produced in the drug manufacturing processes contain low molecular compounds or solutes such as spent catalysts and by-products with molecular weight less than 1000 g/mol. The spent solvents often contain azeotropic solvent mixtures that can not be separated easily. PUBLIC HEALTH RELEVANCE: This project will develop a membrane product and process to remove dissolved oxygen and water from reaction solvents and reactants as well as unreacted chemicals, spent catalysts and byproducts from spent organic solvents. This development has considerable significance to reduce production costs related to pharmaceutical manufacturing.