期刊
EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS
卷 108, 期 -, 页码 235-252出版社
ELSEVIER SCIENCE BV
DOI: 10.1016/j.ejpb.2016.08.001
关键词
Preclinical data; Nanotoxicology; In vivo and in vitro data; SLN/NLC; Biocompatibility; Safety
资金
- Spanish Ministry of Science and Innovation [MAT 2011-26994, MAT 2014-59134R]
- Portuguese Science and Technology Foundation [M-ERA-NET/0004/2015, UID/QUI/50006/2013]
- Ministry of Science and Education (FCT/MEC)
- FEDER
- Portuguese Science and Technology Foundation (Fundacao para a Ciencia e Tecnologia) [BPD/101650/2014]
Solid lipid nanoparticles (SLN) and nanostructured lipid carriers (NLC) were designed as exceptionally safe colloidal carriers for the delivery of poorly soluble drugs. SLN/NLC have the particularity of being composed of excipientsalready approved for use in medicines for human use, which offers a great advantage over any other nanoparticulate system developed from novel materials. Despite this fact, any use of excipients in new route of administration or in new dosage form requires evidence of safety. After 25 years of research on SLN and NLC, enough evidence on their preclinical safety has been published. In the present work, published data on in vitro and in vivo compatibility of SLN/NLC have been surveyed, in order to provide evidence of high biocompatibility distinguished by intended administration route. We also identified critical factors and possible weak points in SLN/NLC formulations, such as the effect of surfactants on the cell viability in vitro, which should be considered for further development. (C) 2016 Elsevier B.V. All rights reserved.
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