Industrial Research Laboratory, Department of Pharmacy, Birla Institute of Technology and Science, Pilani, Pilani Campus, India.
Industrial Research Laboratory, Department of Pharmacy, Birla Institute of Technology and Science, Pilani, Pilani Campus, India.
Biomed Pharmacother. 2021 Sep;141:111940. doi: 10.1016/j.biopha.2021.111940. Epub 2021 Jul 23.
The intersection of lipid-based nanoparticles and lyotropic liquid crystals has provided a novel type of nanocarrier system known as 'lipid-based lyotropic liquid crystals' or 'liquid crystalline nanoparticles' (LCNPs). The unique advantages and immense popularity of LCNPs can be exploited in a better way if the formulation of LCNPs is done using the approach of quality by design (QbD). QbD is a systematic method that can be utilized in formulation development. When QbD is applied to LCNPs formulation, it will proffer many unique advantages, such as better product and process understanding, the flexibility of process within the design space, implementation of more effective and efficient control strategies, easy transfer from bench to bedside, and more robust product. In this work, the application of QbD in the formulation of LCNPs has been explored. The elements of QbD, viz. quality target product profile, critical quality attributes, critical material attributes, critical process parameters, quality risk management, design of experiments, and control strategy for the development of LCNPs have been explained in-depth with case studies. The present work will help the reader to understand the nitty-gritties in the application of QbD in the formulation of LCNPs, and provide a base for QbD-driven formulation of LCNPs with a regulatory perspective.
基于脂质的纳米粒子和溶致液晶的交叉为新型纳米载体系统提供了一种新的纳米载体系统，称为“基于脂质的溶致液晶”或“液晶纳米粒子”(LCNP)。如果使用质量源于设计(QbD)的方法来制备 LCNP，可以更好地利用 LCNP 的独特优势和广泛的应用。QbD 是一种可用于制剂开发的系统方法。当 QbD 应用于 LCNP 制剂时，它将提供许多独特的优势，例如更好地了解产品和工艺、在设计空间内对工艺的灵活性、实施更有效和高效的控制策略、易于从实验室转移到床边以及更稳健的产品。在这项工作中，探讨了 QbD 在 LCNP 制剂中的应用。深入解释了 QbD 的要素，即质量目标产品概况、关键质量属性、关键材料属性、关键工艺参数、质量风险管理、实验设计和控制策略，以开发 LCNP。本工作将帮助读者了解 QbD 在 LCNP 制剂中的应用细节，并为基于 QbD 的 LCNP 制剂提供监管视角。
