Pharmacy Discipline, Faculty of Science and Technology, Queensland University of Technology (QUT), Brisbane, QLD 4000, Australia.
Med Eng Phys. 2012 May;34(4):409-27. doi: 10.1016/j.medengphy.2011.12.025. Epub 2012 Jan 23.
Pulmonary drug delivery is the focus of much research and development because of its great potential to produce maximum therapeutic benefit. Among the available options the dry powder inhaler (DPI) is the preferred device for the treatment of an increasingly diverse number of diseases. However, as drug delivery from a DPI involves a complicated set of physical processes and the integration of drug formulations, device design and patient usage, the engineering development of this medical technology is proving to be a great challenge. Currently there is large range of devices that are either available on the market or under development, however, none exhibit superior clinical efficacy. A major concern is the inter- and intra-patient variability of the drug dosage delivered to the deep lungs. The extent of variability depends on the drug formulation, the device design and the patient's inhalation profile. This article reviews recent advances in DPI technology and presents the key factors which motivate and constrain the successful engineering of a universal, patient-independent DPI that is capable of efficient, reliable and repeatable drug delivery. A strong emphasis is placed on the physical processes of drug powder aerosolisation, deagglomeration, and dispersion and on the engineering of formulations and inhalers that can optimise these processes.
肺部药物输送是许多研究和开发的重点,因为它具有产生最大治疗效益的巨大潜力。在现有的各种选择中,干粉吸入器(DPI)是治疗日益多样化疾病的首选设备。然而,由于从 DPI 输送药物涉及一系列复杂的物理过程以及药物制剂、设备设计和患者使用的整合,因此这项医疗技术的工程开发被证明是一项巨大的挑战。目前,市场上或正在开发的设备种类繁多,但没有一种设备表现出卓越的临床疗效。一个主要关注点是输送到肺部深处的药物剂量在患者之间和患者内部的可变性。可变性的程度取决于药物制剂、设备设计和患者的吸入方式。本文综述了 DPI 技术的最新进展,并提出了推动和限制成功开发通用、患者独立的 DPI 的关键因素,该 DPI 能够实现高效、可靠和可重复的药物输送。本文重点关注药物粉末气溶胶化、解聚和分散的物理过程,以及能够优化这些过程的制剂和吸入器的工程设计。