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

Eur J Pharm Biopharm. 2016 Nov;108:235-252. doi: 10.1016/j.ejpb.2016.08.001. Epub 2016 Aug 9.


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.

Keywords: Biocompatibility; In vivo and in vitro data; Nanotoxicology; Preclinical data; SLN/NLC; Safety.

MeSH terms

  • Administration, Oral
  • Administration, Topical
  • Animals
  • Antineoplastic Agents / chemistry
  • Cell Line, Tumor
  • Cell Survival
  • Colloids / chemistry
  • Drug Carriers / chemistry*
  • Drug Delivery Systems
  • Excipients
  • Eye / drug effects
  • Humans
  • Infusions, Parenteral
  • Inhibitory Concentration 50
  • Lipids / chemistry*
  • Mice
  • Mucous Membrane / metabolism
  • Mutagens / chemistry
  • Nanoparticles / chemistry*
  • Oxidative Stress
  • Skin / drug effects
  • Surface Properties
  • Surface-Active Agents / chemistry


  • Antineoplastic Agents
  • Colloids
  • Drug Carriers
  • Excipients
  • Lipids
  • Mutagens
  • Surface-Active Agents