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Accelerating development of suspension pressurized metered dose inhaler formulations: innovative techniques to evaluate particle stability

机译:加速悬浮液加压计量吸入器配方的开发:评估颗粒稳定性的创新技术

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摘要

This thesis presents several innovative techniques to rapidly evaluate particle stability in suspension-based pressurized metered dose inhalers (pMDIs). ududChapter 1 reviews techniques available to evaluate particle stability in pMDIs, discussing categories such as particle properties, suspension quality, polymorphism, and long term stability. Emerging techniques such as Liquid Colloidal Probe Microscopy (CPM), Nano X-ray Computer Tomography (NanoXCT), and Pressurized Isothermal Microcalorimetry possess the potential for accelerating pMDI formulation and are developed through the work embodied within this thesis. ududChapters 2, 3, and 4 discuss the improvement and application of liquid CPM to evaluate nano-scale interactions between particles of various porosities in a model propellant. Particle porosity/morphology was found to have a significant effect on these interactions; however, direct measurement of internal particle architecture can be challenging. Thus, in chapter 5, a novel technique using NanoXCT was developed to visualize and quantify the internal porosity of inhalable sized particles with a resolution of 50 nm. It is necessary to control morphology through various manufacturing processes such as freeze and spray drying, since these processes can affect particle physical stability in propellant; thus, in chapter 6 an innovative technique using isothermal microcalorimetry was developed to directly evaluate particle stability in actual pMDI formulations. The versatility of the technique is further demonstrated in Chapter 7, through the evaluation of various other pMDI particle parameters such as amorphicity, excipient compatibility, and moisture ingress.
机译:本文提出了几种创新技术来快速评估基于悬浮液的加压计量吸入器(pMDI)中的颗粒稳定性。 ud ud第1章回顾了可用于评估pMDI中颗粒稳定性的技术,并讨论了诸如颗粒性质,悬浮质量,多态性和长期稳定性等类别。液体胶体探针显微镜(CPM),纳米X射线计算机断层扫描(NanoXCT)和加压等温微量热法等新兴技术具有加速pMDI配方的潜力,并且是通过本文中的工作开发的。 ud ud第2、3和4章讨论了液体CPM的改进和应用,以评估模型推进剂中各种孔隙度的粒子之间的纳米级相互作用。发现颗粒孔隙度/形貌对这些相互作用有显着影响。然而,直接测量内部粒子结构可能是一个挑战。因此,在第5章中,开发了一种使用NanoXCT的新技术来可视化和量化分辨率为50 nm的可吸入尺寸颗粒的内部孔隙率。必须通过各种制造工艺(例如冷冻和喷雾干燥)控制形态,因为这些工艺会影响推进剂中的颗粒物理稳定性;因此,在第6章中,开发了一种使用等温微量热法的创新技术,可以直接评估实际pMDI配方中的颗粒稳定性。通过评估各种其他pMDI颗粒参数(如非晶性,赋形剂相容性和水分进入),在第7章中进一步证明了该技术的多功能性。

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    DSa Dexter;

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  • 年度 2015
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