Development of liposomal and microemulsion formulations for transdermal delivery of clonazepam: effect of randomly methylated β-cyclodextrin

Int J Pharm. 2014 Nov 20;475(1-2):306-14. doi: 10.1016/j.ijpharm.2014.08.066. Epub 2014 Sep 4.

Abstract

Transdermal administration of clonazepam, a poorly water-soluble benzodiazepine, is an interesting strategy for overcoming the drawbacks of its oral administration. With this aim, two nano-carrier formulations, based on ultra-deformable liposomes and microemulsions, have been developed to favour clonazepam transdermal delivery. Considering the solubilizing power of methyl-βcyclodextrin (Me-βCD) toward clonazepam and its potential positive influence on transdermal drug delivery, the effect of its addition to these formulations was investigated. Artificial lipophilic membranes simulating the skin allowed a rapid evaluation of the drug permeation properties from the systems, compared with those from an aqueous drug suspension, with or without Me-βCD. The best formulations were further characterized by permeation through excised rabbit ear skin. All the formulations increased drug permeability, ranging from 2-fold (liposomes without Me-βCD), up to over 4-fold (microemulsions containing Me-βCD). The different formulations allowed for pointing out different possible permeation enhancing mechanisms of Me-βCD: increase in drug solubility and thermodynamic activity in the vehicle, when added to the drug aqueous suspension; interactions with the vesicle bilayer, in case of liposomal formulations; interactions with the skin membrane lipids, as evidenced in experiments with excised rabbit ear for microemulsions containing Me-βCD, that were then selected for further in vivo studies.

Keywords: Clonazepam; Liposomes; Microemulsions; Permeation enhancers; Randomly methylated β-cyclodextrin; Transdermal delivery.

MeSH terms

  • Administration, Cutaneous
  • Animals
  • Chemistry, Pharmaceutical / methods
  • Clonazepam / administration & dosage
  • Clonazepam / chemistry*
  • Drug Carriers / chemistry
  • Emulsions / administration & dosage
  • Emulsions / chemistry*
  • Liposomes / administration & dosage
  • Liposomes / chemistry*
  • Membrane Lipids / metabolism
  • Permeability
  • Rabbits
  • Skin / metabolism
  • Skin Absorption
  • Solubility
  • beta-Cyclodextrins / administration & dosage
  • beta-Cyclodextrins / chemistry*

Substances

  • Drug Carriers
  • Emulsions
  • Liposomes
  • Membrane Lipids
  • beta-Cyclodextrins
  • methyl-beta-cyclodextrin
  • Clonazepam