PDF(Pubmed)
Abstract：
Nanomedicine is an emerging field with continuous growth and differentiation. Liposomal formulations are a major platform in nanomedicine, with more than fifteen FDA-approved liposomal products in the market. However, as is the case for other types of nanoparticle-based delivery systems, liposomal formulations and manufacturing is intrinsically complex and associated with a set of dependent and independent variables, rendering experiential optimization a tedious process in general. Quality by design (QbD) is a powerful approach that can be applied in such complex systems to facilitate product development and ensure reproducible manufacturing processes, which are an essential pre-requisite for efficient and safe therapeutics. Input variables (related to materials, processes and experiment design) and the quality attributes for the final liposomal product should follow a systematic and planned experimental design to identify critical variables and optimal formulations/processes, where these elements are subjected to risk assessment. This review discusses the current practices that employ QbD in developing liposomal-based nano-pharmaceuticals.
摘要：
纳米医学是一个不断成长和分化的新兴领域。脂质体制剂是纳米医学的主要平台，市场上有超过15个FDA批准的脂质体产品。然而,与其他类型的基于纳米颗粒的递送系统一样，脂质体制剂和制造本质上是复杂的，并且与一组因变量和自变量相关，渲染经验优化通常是一个繁琐的过程。质量设计（QbD）是一种强大的方法，可应用于此类复杂的系统中，以促进产品开发并确保可重复的制造过程，这是有效和安全治疗的必要先决条件。输入变量(与材料相关，工艺和实验设计），最终脂质体产品的质量属性应遵循系统和计划的实验设计，以确定关键变量和最佳配方/工艺，这些要素要进行风险评估。这篇综述讨论了目前使用QbD开发基于脂质体的纳米药物的实践。
