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A drug-in-adhesive anti-onychomycotic nail patch: Influence of drug and adhesive nature on drug release, ungual permeation, in vivo residence in human and anti-fungal efficacy

Rizi, K; Xu, K; Begum, T; Faull, J; Bhakta, S; Murdan, S; (2022) A drug-in-adhesive anti-onychomycotic nail patch: Influence of drug and adhesive nature on drug release, ungual permeation, in vivo residence in human and anti-fungal efficacy. International Journal of Pharmaceutics , 614 , Article 121437. 10.1016/j.ijpharm.2021.121437. Green open access

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Abstract

A nail patch is an attractive option for the topical treatment of onychomycosis, although no product is commercially available. We previously identified optimal nail patch formulations for two anti-onychomycotic drugs, based on their properties, as well as those of the other patch components. In this paper, our aim was to further investigate the potential of the patch formulations as topical nail medicines, in particular, whether the drug-in-adhesive patches release drug which then permeates into and through the nail plate and show anti-fungal efficacy, and whether and to what extent they remain adhered to the human nail plate in vivo when tested over 2 week durations. In addition, the influence of the drug (amorolfine HCl, ciclopirox olamine) and PSA (Duro-Tak 2852 or Duro-Tak 202A) on these parameters was determined. We found that both the nature of the drug and of the PSA influenced in vitro drug release. The nature of the drug, but not that of the PSA, influenced ungual drug permeation through human nail clippings, with considerably greater (almost double) permeation for ciclopirox olamine, the smaller and less lipophilic molecule. In vivo residence, tested with 3 out of the 4 patches, excluding the patch where ciclopirox olamine degraded with time, showed greater residence on toenails compared to fingernails reflecting their far lesser exposure to environmental stresses during daily activities. In vivo residence was enhanced when the patch was cut to the shape of the nail, was applied at bedtime, and when a clear colourless nail varnish was applied on top of the patch to ‘seal’ it into place on the nail. Comparison of the patches indicated greater residence of Duro-Tak 202A containing patches over those containing Duro-Tak 2852. Amorolfine HCl in Duro-Tak 202A based patch also showed antifungal efficacy in contrast to Duro-Tak 2852-based patch, and is particularly promising for further development as a potential toenail medicine, remaining almost fully adhered to toenails for at least two weeks.

Type: Article
Title: A drug-in-adhesive anti-onychomycotic nail patch: Influence of drug and adhesive nature on drug release, ungual permeation, in vivo residence in human and anti-fungal efficacy
Open access status: An open access version is available from UCL Discovery
DOI: 10.1016/j.ijpharm.2021.121437
Publisher version: https://doi.org/10.1016/j.ijpharm.2021.121437
Language: English
Additional information: This version is the author accepted manuscript. For information on re-use, please refer to the publisher’s terms and conditions.
Keywords: Nail, ungual, transungual, onychomycosis, fungal, patch, pressure-sensitive adhesive, drug, release, permeation, adhesion, residence, in vivo, anti-fungal, efficacy
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Life Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Life Sciences > UCL School of Pharmacy
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Life Sciences > UCL School of Pharmacy > Pharmaceutics
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > UCL GOS Institute of Child Health
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > UCL GOS Institute of Child Health > Infection, Immunity and Inflammation Dept
URI: https://discovery.ucl.ac.uk/id/eprint/10141899
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