期刊
INTERNATIONAL JOURNAL OF PHARMACEUTICS
卷 598, 期 -, 页码 -出版社
ELSEVIER
DOI: 10.1016/j.ijpharm.2021.120335
关键词
Bupivacaine; Liposome; QbD; Particle size; Morphology; Encapsulation efficiency
资金
- Science and Technology Project of Guangdong Province [201802010047]
- Innovation and Entrepreneurship Team special Fund project of Guangdong Province [2014ZT05Y018]
- Biomedical Innovation Institution of Hong Kong & Guangdong Pharmaceutical University
This study extends QbD principles to liposomal products with a hydrophilic API, demonstrating the feasibility and advantages of the concept for multivesicular liposome-based systems. The preparation process significantly affects the particle size and drug encapsulation efficiency of liposomes, with material attributes and processing parameters playing key roles. Risk assessment was used to monitor factors affecting encapsulation rate and particle size.
This study extends QbD principles to liposomal products containing a hydrophilic active pharmaceutical ingredient (API). The feasibility and advantages of the QbD concept for multivesicular liposome-based systems were demonstrated. We selected the local anesthetic drug bupivacaine as a model compound. Desired properties for three critical attributes of multivesicular liposome drug products, namely, the particle size, morphology, and drug encapsulation efficiency, were defined and evaluated. The liposome preparation process significantly affected both the liposome particle size and drug encapsulation efficiency. In this study, the effects of material attributes and processing parameters during the preparation of liposomes were studied in detail using a microscope and particle size analyzer. We used risk assessment to monitor several factors that substantially affect the encapsulation rate and particle size.
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