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Manufacturing and device options for the delivery of biotherapeutics

机译:生物治疗药物的制造和设备选择

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摘要

Biotherapeutic aerosol formulations are an intense area of interest for systemic and local drug delivery. This article provides a short overview of typical factors required specifically for biotherapeutic aerosol formulation design, the processing options open for consideration, and the issue of inhalation device selection. Focusing on spray drying, four case studies are used to highlight the relevant issues, describing investigations into: (1) the mechanical stresses occurring in bacteriophage formulations during spray-dryer atomization; (2) modeling of the spray-dryer process and droplet drying kinetics, to assist process design and predictions of formulation stability; (3) a predictive approach to the design and processing of a five-component dry powder aerosol formulation; and (4) the survival of bacteriophages after pressurized metered dose inhaler atomization.
机译:生物治疗性气雾剂制剂是全身和局部药物递送的重要关注领域。本文简要概述了生物治疗性气雾剂配方设计所需的典型因素,开放的处理选项供考虑,以及吸入装置的选择问题。以喷雾干燥为重点,通过四个案例研究突出了相关问题,描述了以下方面的研究:(1)喷雾干燥器雾化过程中噬菌体制剂中产生的机械应力; (2)喷雾干燥过程和液滴干燥动力学的建模,以协助过程设计和配方稳定性的预测; (3)五组分干粉气雾剂设计和加工的预测方法; (4)加压定量吸入器雾化后噬菌体的存活率。

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