School of Pharmacy and Pharmaceutical Sciences, Trinity College Dublin, Dublin 2, Ireland.
School of Pharmacy and Pharmaceutical Sciences, Trinity College Dublin, Dublin 2, Ireland.
Adv Drug Deliv Rev. 2014 Aug;75:32-52. doi: 10.1016/j.addr.2014.04.005. Epub 2014 Apr 13.
Dry powder inhaler (DPI) products have traditionally comprised a simple formulation of micronised drug mixed with a carrier excipient, typically lactose monohydrate. The presence of the carrier is aimed at overcoming issues of poor flowability and dispersibility, associated with the cohesive nature of small, micronised active pharmaceutical ingredient (API) particles. Both the powder blend and the DPI device must be carefully designed so as to ensure detachment of the micronised drug from the carrier excipient on inhalation. Over the last two decades there has been a significant body of research undertaken on the design of carrier-free formulations for DPI products. Many of these formulations are based on sophisticated particle engineering techniques; a common aim in formulation design of carrier-free products being to reduce the intrinsic cohesion of the particles, while maximising dispersion and delivery from the inhaler. In tandem with the development of alternative formulations has been the development of devices designed to ensure the efficient delivery and dispersion of carrier-free powder on inhalation. In this review we examine approaches to both the powder formulation and inhaler design for carrier-free DPI products.
干粉吸入器(DPI)产品传统上由微粉化药物与载体赋形剂(通常为一水乳糖)的简单配方组成。载体的存在旨在克服与小粒径、微粉化原料药(API)颗粒的内聚性质相关的流动性和分散性差的问题。粉末混合物和 DPI 装置都必须精心设计,以确保在吸入时从载体赋形剂上分离出微粉化药物。在过去的二十年中,人们对 DPI 产品无载体配方的设计进行了大量研究。这些配方中的许多都是基于复杂的颗粒工程技术;无载体产品配方设计的一个共同目标是降低颗粒的固有内聚性,同时最大限度地提高从吸入器中的分散和输送。与替代配方的发展并行的是设计用于确保无载体粉末在吸入时有效输送和分散的装置的发展。在这篇综述中,我们考察了无载体 DPI 产品的粉末配方和吸入器设计方法。