Preclinical safety of solid lipid nanoparticles and nanostructured lipid carriers: Current evidence from in vitro and in vivo evaluation

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• 作者：Slavomira Doktorovová ; ^a ; ¹ ; Andjelka B. Kovačević^a ; ¹ ; Maria L. Garcia^b ; ^c ; Eliana B. Souto^a ; ^d ; ^{ebsouto@ff.uc.pt" class="auth_mail" title="E-mail the corresponding author}
• 关键词：IC50 ; the half maximal inhibitory concentration ; ACP ; acid phosphatase ; ALP ; alkaline phosphatase ; ALT ; alanine transaminase syn. alanine aminotransferase syn. serum glutamic ; pyruvic transaminase ; AST ; aspartate aminotransferase syn. aspartate transaminase ; syn. glutamic-aspartic transaminase ; syn. glutamic-oxaloacetic transaminase ; syn. serum glutamic ; oxaloacetic transaminase ; COM ; Compritol® ; 888 ATO (glycerol dibehenate) ; CP ; Cutina® ; CP (cetyl palmitate) ; CTAB ; cetyltrimethylammonium
• 刊名：European Journal of Pharmaceutics and Biopharmaceutics
• 出版年：2016
• 出版时间：November 2016
• 年：2016
• 卷：108
• 期：Complete
• 页码：235-252
• 全文大小：1094 K

文摘

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.