Food and Drug Department, University of Parma, Parco Area delle Scienze 27/A, 43124 Parma, Italy.
ELPEN Pharmaceutical Co. Inc., 95 Marathonos Ave., 19009 Pikermi, Attica, Greece.
Eur J Pharm Sci. 2018 Feb 15;113:64-76. doi: 10.1016/j.ejps.2017.10.042. Epub 2017 Nov 23.
This review aims in discussing the application of the Quality by Design (QbD) approach on the development of the Dry Powders Inhalers (DPIs). It starts with a thorough presentation of the Quality's concept evolution within the pharmaceutical sector and how this slowly adopted set of quality guidelines is now a major scientific and regulatory requirement. DPIs represent a type of delivery system where the system's thinking approach integrating the device, the formulation and the patient represent a major challenge to be met. Within this context this review points out the critical gaps in this optimization exercise and proposes a series of remedies in overcoming the obstacles when the system's parts are viewed alone and not as a whole. Statistical thinking and the corresponding tools are the means for successfully carrying out this purpose. QbD is not just another guideline to simply comply with. It is the ultimate scope of any pharmaceutical development effort, which is to fully understand and then consistently meet the patient's needs during the entire lifecycle of the product. QbD is focusing on delivering quality value to the patients without compromises in product's safety and effectiveness profile.
这篇综述旨在讨论质量源于设计（QbD）方法在干粉吸入器（DPI）开发中的应用。它首先全面介绍了制药行业质量概念的演变，以及这组逐渐被采用的质量指南现在如何成为主要的科学和监管要求。DPI 代表了一种输送系统，其中系统的思维方法将设备、配方和患者整合在一起，这是一个需要克服的重大挑战。在这种情况下，本文指出了在这种优化过程中存在的关键差距，并提出了一系列在单独看待系统各个部分而不是整体时克服障碍的方法。统计思维和相应的工具是成功实现这一目标的手段。QbD 不仅仅是另一个简单遵守的指导方针。它是任何药物开发工作的最终目标，即充分了解并在产品的整个生命周期中始终如一地满足患者的需求。QbD 专注于为患者提供有质量的价值，而不会在产品的安全性和有效性方面做出妥协。
