CRYSTALLIZATION OF THERAPEUTIC MATERIALS

高质量、纯净的晶体在各种工业领域具有重要价值。 和研究应用。结晶是一种常用的方法。 生物技术和制药行业的提纯技术。更多 高度有序的晶体通常会产生更高纯度的 产品。较大的晶体还可以在包装和 处理操作，并可能对控制释放药物具有优势 传送媒体。本提案的目标是证明 使用液化气体、压缩气体、 或皮质液(其性质介于气体和 液体)是一种通常用于形成大的、高纯度的技术 天然抗癌药物等治疗材料制成的晶体 试剂和大分子，如胰岛素。在反溶剂技术中， 感兴趣的材料首先被溶解在合适的有机溶剂中。 压缩/液化气体，例如二氧化碳，其中的化合物 感兴趣的是难于溶解的，然后慢慢加入带来 结晶。该程序也可用于获得大单次 用于X射线结构分析以确定分子的晶体 构象。 建议的商业应用： 拟议中的工艺可以使制药和生物技术行业受益。 通过以更少的残留产生更高的治疗产品纯度 溶剂污染。该技术可用于获得所需的 在药物制造中的颗粒大小，也可能被证明在以下方面有用 微球等控释制剂。

High quality, pure crystals are of great value for a variety of industrial and research applications. Crystallization is frequently used as a method of purification in the biotechnology and pharmaceutical industries. More highly ordered crystals will typically results in a more highly purified product. Larger crystals can also impart advantages in packaging and handling operations, and may have advantages for controlled release drug delivery media. The objective of the present proposal is to demonstrate that anti solvent crystallization using liquefied gases, compressed gases, or cortical fluids (which have properties intermediate to gases and liquids) is a generally useful technique for forming large, high purity crystals from therapeutic materials such as natural product anti-cancer agents and macromolecules such as insulin. In the anti solvent technique, the material of interest is first dissolved in a suitable organic solvent. The compressed/liquified gas, e.g., carbon dioxide, in which the compound of interest is poorly soluble, is then slowly added to bring about crystallization. The program may also be useful in obtaining large single crystals for X-ray structural analyses to determine molecular conformations. Proposed commercial applications: The proposed process can benefit the pharmaceutical and biotech industries by yielding improved purity of therapeutic products with less residual solvent contamination. The technique can be useful in obtaining a desired particle size in drug manufacture, and may also prove useful in terms of controlled release formulations such as microspheres.