AllExcel Inc., 1 Controls Drive, Shelton, Connecticut, 06484, USA.
PureTech Health, 6 Tide Street, Boston, Massachusetts, 02110, USA.
Pharm Res. 2019 Sep 3;36(11):153. doi: 10.1007/s11095-019-2692-6.
The purpose of this review is to discuss the challenges associated with the development of nanoparticle-based quality drug products in adhering to the principles of quality by design (QbD) and defining appropriate quality parameters towards successful product development. With the advent of nanotechnology into the pharmaceutical field, the novel field of nanomedicine was born. Due to their unique properties in terms of size, conformation and targeted delivery, nanomedicines are able to overcome many drawbacks of conventional medicine. As nano-sized formulations have made their way into more and more therapies, it has became clear that these very unique properties create hurdles for nanomedicines in successfully traversing the regulatory pathways and there is a need to develop nanomedicines in a more controlled and consistent fashion. The elements of a QbD methodology explained in this review enable the development of nano-based formulations in a way that maximizes the possibility of success. The identification of critical quality attributes (CQA) of the drug product and its intermediates are discussed in detail with a focus on nanomaterial-based formulations. In conclusion, QbD and the identification and specification of CQAs at its core are critical to the design, development and growth of nanomaterials in pharmaceuticals.
本文旨在讨论在遵循质量源于设计（QbD）原则和定义适当的质量参数方面，开发基于纳米粒子的优质药物产品所面临的挑战，以实现成功的产品开发。随着纳米技术进入制药领域，诞生了新的纳米医学领域。由于纳米药物在大小、构象和靶向传递方面具有独特的性质，因此能够克服传统药物的许多缺点。随着纳米大小的制剂越来越多地应用于各种疗法，很明显，这些非常独特的性质给纳米药物在成功通过监管途径方面带来了障碍，因此需要以更可控和一致的方式开发纳米药物。本文中解释的 QbD 方法的要素能够以最大限度提高成功可能性的方式开发基于纳米的制剂。本文详细讨论了药物产品及其中间体的关键质量属性（CQA）的确定，并重点关注基于纳米材料的制剂。总之，QbD 以及其核心的 CQA 的识别和规范对于药物中的纳米材料的设计、开发和应用至关重要。
