School of Engineering, Faculty of Science, Engineering and Built Environment, Deakin University, Waurn Ponds, VIC, Australia.
Monash Institute of Pharmaceutical Sciences, Monash University, 381 Royal Parade, Parkville, Victoria 3052, Australia.
J Aerosol Med Pulm Drug Deliv. 2024 Apr;37(2):90-99. doi: 10.1089/jamp.2024.29109.davm.
This section aims to provide a concise and contemporary technical perspective and reference resource covering dry powder inhaler (DPI) formulations. While DPI products are currently the leading inhaled products in terms of sales value, a number of confounding perspectives are presented to illustrate why they are considered surprisingly, and often frustratingly, poorly understood on a fundamental scientific level, and most challenging to design from first principles. At the core of this issue is the immense complexity of fine cohesive powder systems. This review emphasizes that the difficulty of successful DPI product development should not be underestimated and is best achieved with a well-coordinated team who respect the challenges and who work in parallel on device and formulation and with an appreciation of the handling environment faced by the patient. The general different DPI formulation types, which have evolved to address the challenges of aerosolizing fine cohesive drug-containing particles to create consistent and effective DPI products, are described. This section reviews the range of particle engineering processes that may produce micron-sized drug-containing particles and their subsequent assembly as either carrier-based or carrier-free compositions. The creation of such formulations is then discussed in the context of the material, bulk, interfacial and ultimately drug-delivery properties that are considered to affect formulation performance. A brief conclusion then considers the future DPI product choices, notably the issue of technology versus affordability in the evolving inhaler market.
这一节旨在提供一个简洁的和现代的技术观点和参考资源，涵盖干粉吸入器（DPI）制剂。虽然 DPI 产品目前在销售价值方面是领先的吸入产品，但提出了一些令人困惑的观点来说明为什么它们在基础科学层面上被认为出人意料，而且常常令人沮丧地理解得很差，并且从第一原理设计最具挑战性。问题的核心是精细粘性粉末系统的巨大复杂性。这篇综述强调，成功开发 DPI 产品的难度不应被低估，最好由一个协调良好的团队来实现，该团队尊重挑战，并在设备和配方方面并行工作，并了解患者面临的处理环境。描述了为解决将细的粘性含药颗粒气溶胶化以创建一致和有效的 DPI 产品的挑战而发展起来的一般不同的 DPI 制剂类型。这一节回顾了可能产生微米级含药颗粒的各种颗粒工程工艺，以及随后作为载体或无载体组成的颗粒组装。然后根据影响制剂性能的材料、堆积、界面和最终药物传递特性来讨论此类制剂的制备。最后简要考虑未来的 DPI 产品选择，特别是在不断发展的吸入器市场中技术与可负担性之间的问题。
