干燥模型溶剂的过程开发研究研究
Nicholas H McCarthy1, Norah S Alsaiari1,2, Thomas Brown3
1School of Chemical and Process Engineering, University of Leeds, Leeds LS2 9JT, U.K.
概括
开发了一种新型的Schiff基溶盐,用于研究药品中有机溶剂干燥挑战. 控制的结晶产生了更大的晶体和可扩展的过程,为工业干燥应用提供了一个有前途的模型.
科学领域:
- 化学工程是化学工程的重要组成部分.
- 结晶科学 结晶科学
- 制药制造业 制药制造业 制药制造业
背景情况:
- 干燥有机溶酸盐在缩放和理解方面存在挑战,原因是溶剂去除困难和对晶体属性的控制不佳.
- 这些问题在制药行业中至关重要,要求对活性药物成分 (API) 制定严格的质量标准.
研究的目的:
- 为研究和优化干燥过程,开发一种具有成本效益的希夫基溶盐,是API的代表.
- 建立一个可扩展和高收益的结晶方法,用于模型溶解物.
- 描述工业干燥应用中的溶酸盐的特性及其解溶行为.
主要方法:
- 从o-vanillin和para-aminobenzoic酸合成希夫基,以形成甲醇溶盐.
- 通过播种和控制的试剂添加来优化结晶,以管理超和.
- 使用粉末X射线衍射 (XRD) 进行晶体形态和多态的表征.
- 开发一种定量XRD方法来评估溶剂含量.
主要成果:
- 成功将结晶过程扩大到1L尺度,达到93%的产量和高度.
- 晶体形态的修改,有利于增长而不是核化,导致更大,更高的比例晶体 (8到20).
- 从溶解希夫基逐渐转化为明显的脱溶解多态的观测,可通过XRD量化.
- 鉴定该化合物作为一个有前途的模型溶剂,由于其形态,稳定性和有利的溶解温度.
结论:
- 开发的希夫基溶盐作为一个有效的模型系统,用于研究工业相关的干燥过程.
- 优化的结晶策略克服了产量,度和晶体特性方面的挑战.
- 该化合物的特性使其适合在受控条件下研究溶剂去除和溶解.
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