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.
Highlights
Nails are a complex structure composed of a nail bed, nail matrix, nail folds, and the outer layer, nail plate
methyl sulphonyl methane (MSM) (10% w/w) and bamboo glycolic extract (Pracofar S.A., Barcelona, Spain), biotin (0.2% w/w) (Siemgluss Iberica S.A., Barcelona, Spain), hydroxypropyl β-cyclodextrin (HP-β-CD) (8.7% w/w), dimethylsilanediol salicylate (0.246% w/w, Exsymol, Monaco), sodium lauryl sulfate (0.87% w/w, BASF, Barcelona, Spain), ethanol 96◦ (34.7%, Alcoholes Oliva, Barcelona, Spain), and purified water were used for the experimental nail lacquer (REG) production
The results indicate that MSM at 0.1 and 1 μM significantly
Summary
Nails are a complex structure composed of a nail bed (the deeper layer), nail matrix, nail folds, and the outer layer, nail plate. The nail plate contains between 80 and 90 layers of dense keratinized (mainly α-keratin) dead cells, with desmosome unions This structure protects the nail bed from external damage. Nails have a low lipid content (around 1%), mainly composed of cholesterol, and the water content is higher than in the stratum corneum at around 10–30% (as a protein solvate) in a normal state [4]. These facts mean nails have different permeability properties from skin, which should be considered in formula development
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