首页> 外文会议>Proceedings of the 31st annual conference of the North American Thermal Analysis Society(NATAS) >The Complementary Role of Calorimetry, Thermal Gravimetry and Variable Environmental Conditions X-ray Diffraction in Pharmaceutical Sciences
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The Complementary Role of Calorimetry, Thermal Gravimetry and Variable Environmental Conditions X-ray Diffraction in Pharmaceutical Sciences

机译:热量测定法,热重分析法和可变环境条件X射线衍射在药物科学中的补充作用

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The obvious application for calorimetry and TG is to monitor and characterize phaserntransformations. It is in this capacity that calorimetry finds its great application inrnpharmaceutical sciences. There are several stages in drug development, taking on average 8-rn12 years, which call for a precise knowledge of a potential phase transition occurring in eitherrndrug substance or a drug product. The thermal techniques themselves often come short inrndelivering sufficient information or experimental discriminating power to satisfy the need ofrnregulatory requirements or process control. In these cases thermal techniques play a guidingrnrole to predefine experimental conditions to apply other techniques like x-ray diffraction, IRrnor Raman spectroscopy applied at various environmental conditions. Often DVS needs to bernused to specify the environmental conditions more.rnIn this talk we will identify several areas in drug development process, which call forrnuse of thermal techniques. We will also demonstrate how thermal techniques can guide andrnsupplement, IR, Raman and DVS and x-ray diffraction, the most definitive technique tornestablish a presence of a polymorph or a solvate. We will discuss significance of therninformation generated by thermal techniques alone and in combination with other techniquesrnto the drug development process.
机译:量热法和TG的明显应用是监视和表征相变。量热法正是以此身份在制药科学中找到了重要的应用。药物开发有多个阶段,平均需要8-12年,这需要对药物物质或药物产品中可能发生的潜在相变有确切的了解。热技术本身往往不足以提供足够的信息或实验区分能力,以满足监管要求或过程控制的需要。在这些情况下,热技术扮演着指导角色,可以预定义实验条件,以应用其他技术,例如在各种环境条件下应用的X射线衍射,IRrnor拉曼光谱。通常,需要调动DVS来详细说明环境条件。在本次演讲中,我们将确定药物开发过程中的几个领域,这些领域要求废止热技术。我们还将演示热技术如何引导和补充,IR,拉曼和DVS和X射线衍射,这是最确定的技术,可以确定存在多晶型物或溶剂化物。我们将讨论单独通过热学技术以及与其他技术结合产生的热信息对药物开发过程的意义。

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