Novel Pharmaceutical Solvent - Water Separation System

新型药物溶剂-水分离系统

• 批准号: 6880635
• 负责人: Stuart Nemser
• 金额: $ 13.56万
• 依托单位: COMPACT MEMBRANE SYSTEMS, INC.
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-04-01 至 2006-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6880635
• 关键词: biotherapeutic agent; chemical hydration; cost effectiveness; membrane model; membrane reconstitution /synthesis; organic chemicals; solvent extraction; thermostability; water

DESCRIPTION (provided by applicant): There are numerous needs in the pharmaceutical industry to recover high purity solvents. In many cases these solvents are contaminated with water. While the simplest and lowest cost method of separation is distillation, unfortunately in many cases these solvents form difficult to separate azeotropes with water. Examples include ethanol-water, IPA-water, acetone-water and THF-water. While entrainers can help break azeotropes, they are undesirable additives for solvents used in high purity pharmaceutical applications. Therefore there continues to be an ongoing need for identifying simple low cost systems which can separate many pharmaceutical solvents from water. Compact Membrane Systems (CMS) has identified novel membrane routes using novel membrane materials which may provide a unique platform for low cost separation of these organic solvent-water systems. In Phase I CMS will demonstrate the feasibility of this low cost separation first on pharmaceutical solvent-water systems and then working with a small pharmaceutical services company to demonstrate on actual Pharmaceuticals. Objectives are to show CMS process has broad utility and costs at least 20% lower than existing processes. CMS has strong industrial membrane partners. These partners will be valuable in both Phase I and subsequent commercial activity. We will use these relationships and existing commercial products we have collectively developed (with these industrial partners) for our initial testing. Having access to these commercial products will enhance our ability to be successful in Phase I and II as well as get products/systems commercially installed shortly after the completion of this program.

描述（由申请人提供）：制药工业中存在大量回收高纯度溶剂的需求。在许多情况下，这些溶剂被水污染。虽然最简单和成本最低的分离方法是蒸馏，但不幸的是，在许多情况下，这些溶剂难以与水分离共沸物。实例包括乙醇-水、IPA-水、丙酮-水和THF-水。虽然增塑剂可以帮助破坏反相液晶，但它们对于高纯度药物应用中使用的溶剂来说是不期望的添加剂。因此，仍然需要确定可以从水中分离许多药物溶剂的简单低成本系统。紧凑膜系统（CMS）已经确定了使用新型膜材料的新型膜路线，其可以为这些有机溶剂-水系统的低成本分离提供独特的平台。在第一阶段，CMS将首先在制药溶剂-水系统上证明这种低成本分离的可行性，然后与一家小型制药服务公司合作，在实际制药中进行证明。目标是表明CMS工艺具有广泛的实用性，成本至少比现有工艺低20%。CMS拥有强大的工业膜合作伙伴。这些合作伙伴将在第一阶段和随后的商业活动中发挥重要作用。我们将利用这些关系和我们共同开发的现有商业产品（与这些工业合作伙伴）进行初步测试。获得这些商业产品将增强我们在第一阶段和第二阶段取得成功的能力，并在该计划完成后不久将产品/系统投入商业安装。