Powder Technology and Pharmaceutical Development: Particle Size and Particle Adhesion
Powder Technology and Pharmaceutical Development: Particle Size and Particle Adhesion
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粉末技术和药物开发：粒径和颗粒粘附
DOI：
10.14356/kona.2013014
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发表时间：
2013
期刊：
影响因子：
--
通讯作者：
M. Uddin
中科院分区：
文献类型：
--
作者：
F. Etzler;M. Uddin
FDA（美国食品和药物管理局）和 ICH（国际协调会议）都敦促将质量源于设计 (QbD) 纳入药品制造中。许多药品制造工艺的性能和某些药品的性能需要了解粉末特性。根据 QbD 的原则，可以调整工艺以适应粉末特性的变化。反过来，这些调整需要了解粉末特性和制造性能之间的关系。粉末特性和性能之间的这种关系通常没有被很好地理解；因此，没有收集到所需的信息。在本文中，颗粒-颗粒和颗粒-表面相互作用被认为是产品变异性的根源。由于颗粒尺寸效应与颗粒粘附效应交织在一起，因此也考虑了该主题。从下面的讨论可以看出，颗粒的表面化学性质可能因机械处理、结晶溶剂和表面污染而变化。表面化学的变化会影响颗粒间的粘附力，从而可能导致工艺或产品性能的变化。详细讨论了与压片和干粉吸入器相关的颗粒间粘附作用的问题。显然，要全面实施 QbD，需要更深入地了解粉末状态并建立适当的分析工具。需要改进粒度技术、改进粉末取样程序和颗粒表面特性的测量。希望本文能激发人们对这个问题的思考。
Both the FDA (U.S. Food and Drug Administration) and ICH (International Conference on Harmonisation) have urged the incorporation of Quality by Design (QbD) into the manufacture of pharmaceutical products. The performance of many pharmaceutical manufacturing processes and the performance of some pharmaceutical products requires a knowledge of powder properties. Under the principles of QbD it is possible to adjust processes to account for variations in powder properties. These adjustments, in turn , require knowledge of the relation between powder properties and manufacturing performance. This relation between powder properties and performance is often not well understood; thus, the required information is not collected. In this paper, particle-particle and particle-surface interactions are considered to be a source of product variability. As particle size effects are intertwined with particle adhesion effects this topic is also considered. From the discussion below, it can be seen that the surface chemistry of particles can vary due to mechanical treatment, crystallization solvent, and surface contamination. Variations in surface chemistry affect interparticle adhesion and thus may lead to process or product performance changes. Issues concerning the role of interparticle adhesion that are related to tableting and dry powder inhalers are discussed in some detail. It is clear that a deeper understanding of the powder state and the establishment of appropriate analytical tools will be required to fully implement QbD. Improvements in par ticle sizing technologies, improvements powder sampling procedures and measurements of particle surface properties will be required. It is hoped that this paper will stimulate thought on this issue.