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. 2020 Aug 4;12(8):730.
doi: 10.3390/pharmaceutics12080730.

Transungual Delivery, Anti-Inflammatory Activity, and In Vivo Assessment of a Cyclodextrin Polypseudorotaxanes Nail Lacquer

Francisco Fernández-Campos  1 , Francesc Navarro  1 , Adrian Corrales  1 , Jordi Picas  1 , Eloy Pena  1 , Jordi González  1 , Francisco J Otero-Espinar  2   3
Affiliations

Transungual Delivery, Anti-Inflammatory Activity, and In Vivo Assessment of a Cyclodextrin Polypseudorotaxanes Nail Lacquer

Francisco Fernández-Campos et al. Pharmaceutics. .

Abstract

A new cyclodextrin polypseudorotaxanes nail lacquer (Regenail®) containing biotin, methyl sulphonyl methane (MSM), and dimethylsilanediol salicylate was developed and evaluated in vitro and in vivo. The product was developed to improve nail status and diminish signs of pathological nail alterations. A reference product (Betalfatrus®) was used for comparative purposes. An in vitro permeation experiment in hooves showed high MSM and biotin absorption. The content of sulfur and silicon in hooves was also found to be higher compared with the reference product. MSM was tested in human keratinocytes, exhibiting a good cytotoxicity profile and anti-inflammatory activity by the reduction in IL-8 and TNF-α under LPS stimuli. A clinical study was performed to check product safety and efficacy against nail brittleness and alterations such as Beau's lines and onychorrhexis. A reduction in both alterations and in surface roughness without alteration of nail structure was observed, with a good level of patient acceptance and satisfaction.

Keywords: active penetration; biotin; cyclodextrins; methylsulfonylmethane; nail lacquers.

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Conflict of interest statement

This study was supported by Reig Jofre, Barcelona Spain. F.N., E.P., A.C., J.P., J.G., and F.F.-C. are employees of Reig Jofre. The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript, or in the decision to publish the results. The authors are not involved in any commercial or marketing activities of the developed product.

Figures

Figure 1
Figure 1
Biotin (upper panel) and methyl sulphonyl methane (MSM) (lower panel) content of Regenail® (REG) in stability studies under different climate conditions.
Figure 2
Figure 2
MSM (upper panel) and biotin (lower panel) release over time from REG nail lacquer.
Figure 3
Figure 3
Permeation profiles of MSM through the bovine hoof plate as a model of human nail permeation.
Figure 4
Figure 4
Permeation of biotin across the bovine hoof plate.
Figure 5
Figure 5
HaCaT cell viability by MTT after proliferation under different concentrations of MSM. (*) shows statistical differences at a significance level of α = 0.10. (***) shows statistical differences at a significance level of α = 0.05.
Figure 6
Figure 6
Effect of MSM on gene expression of TNF-α and IL-8 of LPS activated human keratinocytes (HaCaT line). (***) show statistical differences at a significance level of α = 0.05.
Figure 7
Figure 7
Percentage of volunteers whose nail onychorrhexis and Beau’s lines improved after 28 days of treatment versus the baseline (%).
Figure 8
Figure 8
Nail images after the application of Betalfatrus and Regenail.
Figure 9
Figure 9
Subject assessment of the efficacy (by % of satisfied volunteers) of Regenail and Betalfatrus.
See this image and copyright information in PMC

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