Quality by Design in Pulmonary Drug Delivery: A Review on Dry Powder Inhaler Development, Nanotherapy Approaches, and Regulatory Considerations

IF 3.4 4区 医学 Q2 PHARMACOLOGY & PHARMACY
Ashish Dilip Sutar, Rahul Kumar Verma, Rahul Shukla
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Abstract

Dry powder inhalers (DPIs) are state-of-the-art pulmonary drug delivery systems. This article explores the transformative impact of nanotechnology on DPIs, emphasizing the Quality Target Product Profile (QTPP) with a focus on aerodynamic performance and particle characteristics. It navigates global regulatory frameworks, underscoring the need for safety and efficacy standards. Additionally, it highlights the emerging field of nanoparticulate dry powder inhalers, showcasing their potential to enhance targeted drug delivery in respiratory medicine. This concise overview is a valuable resource for researchers, physicians, and pharmaceutical developers, providing insights into the development and commercialization of advanced inhalation systems.

Graphical Abstract

Abstract Image

肺部给药的设计质量:干粉吸入器开发、纳米疗法方法和监管考虑因素综述。
干粉吸入器 (DPI) 是最先进的肺部给药系统。本文探讨了纳米技术对干粉吸入器的变革性影响,强调了质量目标产品简介 (QTPP),重点是空气动力学性能和颗粒特性。文章介绍了全球监管框架,强调了安全和疗效标准的必要性。此外,它还重点介绍了纳米颗粒干粉吸入器这一新兴领域,展示了其在呼吸医学中加强靶向给药的潜力。这本简明扼要的综述是研究人员、医生和药品开发人员的宝贵资源,为先进吸入系统的开发和商业化提供了真知灼见。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
AAPS PharmSciTech
AAPS PharmSciTech 医学-药学
CiteScore
6.80
自引率
3.00%
发文量
264
审稿时长
2.4 months
期刊介绍: AAPS PharmSciTech is a peer-reviewed, online-only journal committed to serving those pharmaceutical scientists and engineers interested in the research, development, and evaluation of pharmaceutical dosage forms and delivery systems, including drugs derived from biotechnology and the manufacturing science pertaining to the commercialization of such dosage forms. Because of its electronic nature, AAPS PharmSciTech aspires to utilize evolving electronic technology to enable faster and diverse mechanisms of information delivery to its readership. Submission of uninvited expert reviews and research articles are welcomed.
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