title: Preclinical safety of solid lipid nanoparticles and nanostructured lipid carriers: Current evidence from in vitro and in vivo evaluation.
abstract: 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.
authors: Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Coimbra, Azinhaga de Santa Comba, 3000-548 Coimbra, Portugal.
authors: Slavomira
authors: S
authors: Doktorovová
authors: Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Coimbra, Azinhaga de Santa Comba, 3000-548 Coimbra, Portugal.
authors: Andjelka B
authors: AB
authors: Kovačević
authors: Department of Physical Chemistry, Faculty of Pharmacy, University of Barcelona, Av. Joan XXIII s/n, 08028 Barcelona, Spain; Institute of Nanoscience and Nanotechnology, University of Barcelona, Av. Joan XXIII s/n, 08028 Barcelona, Spain.
authors: Maria L
authors: ML
authors: Garcia
authors: Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Coimbra, Azinhaga de Santa Comba, 3000-548 Coimbra, Portugal; REQUIMTE/LAQV, Group of Pharmaceutical Technology, Faculty of Pharmacy, University of Coimbra, Coimbra, Portugal. Electronic address: ebsouto@ff.uc.pt.
authors: Eliana B
authors: EB
authors: Souto
mesh_terms: D000284:Administration, Oral; D000287:Administration, Topical; D000818:Animals; D000970:Antineoplastic Agents / Q000737:chemistry; D045744:Cell Line, Tumor; D002470:Cell Survival; D003102:Colloids / Q000737:chemistry; D004337:Drug Carriers / Q000737:chemistry*; D016503:Drug Delivery Systems; D005079:Excipients; D005123:Eye / Q000187:drug effects; D006801:Humans; D007263:Infusions, Parenteral; D020128:Inhibitory Concentration 50; D008055:Lipids / Q000737:chemistry*; D051379:Mice; D009092:Mucous Membrane / Q000378:metabolism; D009153:Mutagens / Q000737:chemistry; D053758:Nanoparticles / Q000737:chemistry*; D018384:Oxidative Stress; D012867:Skin / Q000187:drug effects; D013499:Surface Properties; D013501:Surface-Active Agents / Q000737:chemistry
chemical_list: D000970:Antineoplastic Agents; D003102:Colloids; D004337:Drug Carriers; D005079:Excipients; D008055:Lipids; D009153:Mutagens; D013501:Surface-Active Agents
keywords: Biocompatibility; In vivo and in vitro data; Nanotoxicology; Preclinical data; SLN/NLC; Safety