Process Understanding - For Scale-Up and Manufacture of Active Ingredients
Process Understanding - For Scale-Up and Manufacture of Active Ingredients
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工艺理解 - 用于活性成分的放大和生产
DOI：
10.1002/9783527637140.ch7
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发表时间：
2011
期刊：
影响因子：
--
通讯作者：
Cronin L
中科院分区：
文献类型：
--
作者：
Cronin L
为先进材料和药物应用而开发的分子化合物的出现，需要采用更先进的方法来控制和表征固态特性；实现这一目标的一个关键途径是了解这些化合物的结晶。晶体和固体形式的制造是一种普遍的应用——超过80%的医药产品和60%以上的精细和特种化工产品都是以晶体形式制造的，例如药品、农用化学品、脂肪和油、食品和糖果、颜料和油墨、消费品、材料和金属。这导致人们对结晶过程、新形式的发现、多晶型现象的控制、特定递送模式的形态设计、配方和放大、以批量或流动模式优化结晶过程的兴趣和重要性显着增加。此外，人们普遍认识到，结晶过程从根本上来说是固态材料生产的核心，并将对涂层，特别是外延生长层做出越来越大的贡献。在理解结晶过程中需要解决的问题包括物理形态发现和筛选、用于表征合成产品的颗粒技术分析方法，并由微观和宏观过程的建模和理论支持。更详细地说，为了确定下面介绍的讨论范围，每一个都提出了一系列技术和科学挑战，必须解决这些挑战，以便充分了解适合生产选定固体材料形式的特定结晶过程。
The emergence of molecular-based compounds being developed for applications as advanced materials and pharmaceuticals necessitates an ever more advanced approach to the control and characterization of solid-state properties; one key route to accomplish this goal is by understanding the crystallization of these compounds. Crystalline and solid-form manufacturing is a universal application–more than 80% of pharmaceutical products and 60% of fine and specialty chemical products are made in crystalline form, for example, pharmaceuticals, agrochemicals, fats and oils, foods and confectionary, pigments and inks, consumer products, materials, and metals. This has led to a dramatically increased interest and prominence in crystallization processes, in the discovery of new forms, control of polymorphism, design of morphology for particular modes of delivery, and for formulation and scale-up, in optimizing the crystallization process in batch or flow modes. Further, there has been a general realization that the crystallization process is core to the production of solid-state materials, at a fundamental level, and is set to make an increasing contribution to coatings, especially epitaxially grown layers. Among the issues that require to be addressed in understanding the crystallization process include physical form discovery and screening, particle technology analytical methods for characterizing the synthesized products, backed up by modeling and theory of both microscopic and macroscopic processes. In more detail, and to set the scope for the discussions introduced below, each of these raise a range of technical and scientific challenges that must be addressed to inform a full understanding of particular crystallization processes geared at the production of selected solid material forms.