Stein Stephen W, Sheth Poonam, Hodson P David, Myrdal Paul B
3M Drug Delivery Systems, 3M Center-Building 260-3A-05, St. Paul, Minnesota, 55144, USA,
AAPS PharmSciTech. 2014 Apr;15(2):326-38. doi: 10.1208/s12249-013-0062-y. Epub 2013 Dec 20.
Pressurized metered dose inhalers (MDIs) were first introduced in the 1950s and they are currently widely prescribed as portable systems to treat pulmonary conditions. MDIs consist of a formulation containing dissolved or suspended drug and hardware needed to contain the formulation and enable efficient and consistent dose delivery to the patient. The device hardware includes a canister that is appropriately sized to contain sufficient formulation for the required number of doses, a metering valve capable of delivering a consistent amount of drug with each dose delivered, an actuator mouthpiece that atomizes the formulation and serves as a conduit to deliver the aerosol to the patient, and often an indicating mechanism that provides information to the patient on the number of doses remaining. This review focuses on the current state-of-the-art of MDI hardware and includes discussion of enhancements made to the device's core subsystems. In addition, technologies that aid the correct use of MDIs will be discussed. These include spacers, valved holding chambers, and breath-actuated devices. Many of the improvements discussed in this article increase the ability of MDI systems to meet regulatory specifications. Innovations that enhance the functionality of MDIs continue to be balanced by the fact that a key advantage of MDI systems is their low cost per dose. The expansion of the health care market in developing countries and the increased focus on health care costs in many developed countries will ensure that MDIs remain a cost-effective crucial delivery system for treating pulmonary conditions for many years to come.
压力定量吸入器(MDIs)于20世纪50年代首次推出,目前作为治疗肺部疾病的便携式系统被广泛处方。MDIs由含有溶解或悬浮药物的制剂以及容纳该制剂并能向患者有效且一致地给药所需的硬件组成。该装置硬件包括一个大小合适的药罐,用于容纳足够数量剂量所需的制剂;一个计量阀,每次给药时能够输送一致量的药物;一个雾化制剂并作为将气雾剂输送给患者的管道的促动器吸嘴;以及通常一个向患者提供剩余剂量数量信息的指示机构。本综述聚焦于MDI硬件的当前技术水平,并包括对该装置核心子系统所做改进的讨论。此外,还将讨论有助于正确使用MDIs的技术。这些技术包括储雾罐、带阀储雾器和呼吸驱动装置。本文讨论的许多改进提高了MDI系统满足监管规范的能力。尽管MDI系统的一个关键优势是其每剂量成本低,但增强MDIs功能的创新仍在持续平衡这一优势。发展中国家医疗保健市场的扩大以及许多发达国家对医疗保健成本的日益关注将确保MDIs在未来许多年内仍然是治疗肺部疾病具有成本效益的关键给药系统。