Abstract:
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.
摘要:
本节旨在提供涵盖干粉吸入器(DPI)配方的简明现代技术观点和参考资源。虽然DPI产品目前在销售价值方面是领先的吸入产品,提出了一些令人困惑的观点来说明为什么它们被认为是令人惊讶的,经常令人沮丧,在基础科学层面上知之甚少,从第一原则设计最具挑战性。这个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,成功的DPI产品开发的难度不应低估,最好是由一个协调良好的团队来实现,他们尊重挑战,在设备和配方上并行工作,并对患者所面临的处理环境表示赞赏。一般不同的DPI配方类型,它们已经发展到解决雾化含有粘性药物的细颗粒以创造一致和有效的DPI产品的挑战,被描述。本节回顾了可以产生微米大小的含药物颗粒的颗粒工程方法的范围,以及它们作为基于载体的或无载体的组合物的随后组装。然后在材料的上下文中讨论这种配方的创建,散装,界面和最终的药物递送特性被认为影响制剂性能。一个简短的结论,然后考虑未来的DPI产品选择,特别是在不断发展的吸入器市场中,技术与可负担性的问题。