CicloTech®, a new platform to improve trans-ungual drug release

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Paraquasil research TEAM and USC collaborators that have participated in CicloTech® development. Photograph by Maria Otero Anguiano

CicloTech® is a nail lacquer platform based on thermosensitive hydrogels elaborated with mixtures of soluble pseudopolyrotaxans of poloxamers and beta-cyclodextrin derivatives combined with trans-ungual penetration enhancers. This platform is an advanced and patented trans-ungual release technology, a result of public-private collaborative innovation between the REIG JOFRE team and Paraquasil research group led by Francisco Javier Otero Espinar, from the Department of Pharmacology, Pharmacy and Pharmaceutical Technology, and member of the iMATUS (Institute of Materials) and IDIS (Institute of Heaths Research) of the University of Santiago de Compostela.

The more frequent nail pathologies are onychomycosis and nail psoriasis or alterations such as brittle nails, onychorrhexis, and beau lines among others. Crossing the nail plate and achieving sufficient concentrations of active ingredients throughout the nail plate is the main challenge to be solved in topical nail treatment.

The new CicloTech® technology (https://www.youtube.com/watch?v=e-jQEgSrGEk) incorporates beta-cyclodextrins/poloxamer soluble pseudopolyrotaxane as agents that form a hydrated layer on the nail surface, improving nail hydration and the penetration of the active ingredients. The incorporation of soluble beta-cyclodextrins derivatives promotes the solubility of the active ingredients in the vehicle obtaining high concentrations of the drugs on the nail surface and reducing the resistance of the aqueous layer formed by the hydrated protein structures. Additionally, the beta-cyclodextrin derivatives, in combination with nail penetration enhancers such as sodium lauryl sulfate or n-acetyl-cysteine, can interact with keratins, the main components of the nail plate, modifying the nail microstructure and improving the diffusion and penetration of active agents. In consequence, CicloTech® nail lacquers improve the activity of active agents increasing the healing of pathologies such as onychomycosis or nail psoriasis and increasing and facilitating faster healthy nail growth.

Based in this technology in April 2022 REIG JOFRE pharmaceutical company has commercialized the first CicloTech® product, Regenail®, manufactured at the Barcelona plant, is initially launched in Spain through its specialized network of medical representatives, although it is also planned to be marketed through the company’s subsidiaries mainly in Europe and in the rest of the international markets through its network of business partners. Regenail® is a nail regeneration product composed of hydroxypropyl-beta-cyclodextrin, poloxamer P407, sodium dodecyl sulphate, methyl sulfonyl methane, dimethylsilanediol salicylate and biotin (important role in keratins synthesis). The clinical study developed to check product safety and efficacy against nail brittleness and alterations such as Beau’s lines and onychorrhexis has demonstrated better effectivity in the reduction in both alterations and surface roughness without alteration of nail structure that reference lacquer-based in hydroxypropyl chitosan and horsetail extracts, with a high level of patient acceptance and satisfaction. (Pharmaceutics 2020, 12, 730; https://doi.org/10.3390/pharmaceutics12080730)

Two new products for onychomycosis treatment based on CicloTech® are scheduled to be launched in September 2022: DexUlac® and Nailbris®.

DexUlac® and Nailbris® are two nail lacquers containing ciclopirox base and ciclopirox olamine, respectively that have demonstrated an improved level of antifungal drug permeation in the nail. Cosmetic clinical studies and Phase III clinical trial (https://www.clinicaltrialsregister.eu/ctr-search/trial/2016-003784-19/ES) have shown great effectiveness in the treatment of onychomycosis and a high level of patient’s acceptation.

Relevant documents:

Pharmaceutics 2020, 12, 730; https://doi.org/10.3390/pharmaceutics12080730

Pharmaceutics 2020, 12(3), 231; https://doi.org/10.3390/pharmaceutics12030231 

Pharmaceutics 2018, 10(4), 273; https://doi.org/10.3390/pharmaceutics10040273

Pharmaceutics 2018, 10(3), 156; https://doi.org/10.3390/pharmaceutics10030156 

Eu J Pharm Sci 2018 117, 270-278 https://doi.org/10.1016/j.ejps.2018.02.028

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