Dr. Dayaram Patel Pharmacy College, Bardoli, 394601, Gujarat, India.
Department of Pharmacy, Banasthali Vidyapith, Banasthali Niwai, 304022, India.
Nanomedicine (Lond). 2022 Jul;17(17):1173-1189. doi: 10.2217/nnm-2022-0069. Epub 2022 Sep 30.
Engineered nano-sized liposomes have attained the highest success rate in commercialization among the reported nanomedicines. However, developing industrially acceptable nanoliposomes is still challenging because the process, formulation factors and even their properties may critically influence the desired attributes of the final nanoliposomal product. Implementation of quality-by-design (QbD) in nanoliposomal fabrication has led to revolutionary advancement int better analysis of the interacting factors (drug and lipid ratio, hydration, sonication, etc), which, in turn, leads to better product performance with predefined attributes (entrapment efficiency percentage, drug release time and pattern, vesicles size, polydispersity index, surface charge and surface morphology). This review provides a summary of decade of research and an in-depth analysis of QbD-based nanoliposomes developed to address different cancers. The review aims to provide complete details of QbD-inspired nanoliposomal development from process to application.
在已报道的纳米药物中，工程化的纳米脂质体在商业化方面取得了最高的成功率。然而，开发工业上可接受的纳米脂质体仍然具有挑战性，因为该过程、配方因素甚至它们的性质可能会严重影响最终纳米脂质体产品的预期属性。在纳米脂质体制备中实施质量源于设计（QbD），导致对相互作用因素（药物和脂质的比例、水合作用、超声处理等）的更好分析，从而导致具有预定义属性的更好的产品性能（包封效率百分比、药物释放时间和模式、囊泡大小、多分散指数、表面电荷和表面形态）。这篇综述提供了十年来研究的总结，并对基于 QbD 的纳米脂质体进行了深入分析，这些纳米脂质体的开发旨在解决不同的癌症。综述旨在提供从工艺到应用的 QbD 启发式纳米脂质体开发的完整细节。
