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Effect of Penetration Enhancers on Toenail Delivery of Efinaconazole

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Effect of Penetration Enhancers on Toenail Delivery of Efinaconazole molecules Article Effect of Penetration Enhancers on Toenail Delivery of Efinaconazole from Hydroalcoholic Preparations Jun Soo Park 1,†, Jeong Soo Kim 2,†, Myoung Jin Ho 1, Dong Woo Park 1, Eun A. Kim 1, Yong Seok Choi 1, Sun Woo Jang 2 and Myung Joo Kang 1,* 1 Colledge of Pharmacy, Dankook University, Dongnam-gu, Cheonan 330-714, Chungnam, Korea; [email protected] (J.S.P.); [email protected] (M.J.H.); [email protected] (D.W.P.); [email protected] (E.A.K.); [email protected] (Y.S.C.) 2 Dong-A Pharmaceutical Co. Ltd., Giheung-gu, Yongin 446-905, Gyeonggi, Korea; [email protected] (J.S.K.); [email protected] (S.W.J.) * Correspondence: [email protected]; Tel.: +82-41-550-1446 † These authors contributed equally to this work. Abstract: The incorporation of permeation enhancers in topical preparations has been recognized as a simple and valuable approach to improve the penetration of antifungal agents into toenails. In this study, to improve the toenail delivery of efinaconazole (EFN), a triazole derivative for onychomycosis treatment, topical solutions containing different penetration enhancers were designed, and the permeation profiles were evaluated using bovine hoof models. In an in vitro permeation study in a Franz diffusion cell, hydroalcoholic solutions (HSs) containing lipophilic enhancers, particularly prepared with propylene glycol dicaprylocaprate (Labrafac PG), had 41% higher penetration than the HS base. Moreover, the combination of hydroxypropyl-β-cyclodextrin with Labrafac PG further facilitated the penetration of EFN across the hoof membrane. In addition, this novel topical solution Citation: Park, J.S.; Kim, J.S.; Ho, prepared with both lipophilic and hydrophilic enhancers was physicochemically stable, with no drug M.J.; Park, D.W.; Kim, E.A.; Choi, Y.S.; degradation under ambient conditions (25 ◦C, for 10 months). Therefore, this HS system can be a Jang, S.W.; Kang, M.J. Effect of Penetration Enhancers on Toenail promising tool for enhancing the toenail permeability and therapeutic efficacy of EFN. Delivery of Efinaconazole from Hydroalcoholic Preparations. Keywords: efinaconazole; transungual drug delivery; hydroalcoholic solution; permeation enhancer; Molecules 2021, 26, 1650. https:// bovine hoof; onychomycosis; propylene glycol dicaprylocaprate; hydroxypropyl-β-cyclodextrin doi.org/10.3390/molecules26061650 Academic Editor: Luigi A. Agrofoglio 1. Introduction Received: 17 December 2020 Onychomycosis is one of the most chronic and prevalent nail disorders, caused by Accepted: 9 March 2021 fungal infection. Epidemiological studies suggest about 19% of the global population is Published: 16 March 2021 affected by onychomycosis caused by dermatophytes (Trichophyton rubrum and Trichophyton mentagrophytes), non-dermatophyte molds, and yeasts (Candida albicans)[1,2]. Efinacona- Publisher’s Note: MDPI stays neutral zole (EFN, Figure1), the first topical triazole derivative, is prescribed for the treatment of with regard to jurisdictional claims in toenail onychomycosis. This antifungal agent has been demonstrated to be potent against published maps and institutional affil- Trichophyton rubrum, Trichophyton mentagrophytes, and Candida albicans in toenail by obstruct- iations. ing ergosterol biosynthesis, presumably through sterol 14-demethylase inhibition [3,4]. Topical application of EFN solution (10% w/w) was markedly efficacious than other topical treatments with amorolfine or ciclopirox against mild to moderate subungual onychomy- cosis [5]. Currently, the marketed product of EFN is designed as a hydroalcoholic topical Copyright: © 2021 by the authors. solution (Jublia, Kaken Pharmaceutical Co., Ltd. (Tokyo, Japan)) [6]; ethanol is employed as Licensee MDPI, Basel, Switzerland. a volatile vehicle to dissolve the antifungal agent. In addition, to enhance the skin and/or This article is an open access article nail delivery of EFN, lipophilic enhancers, such as myristyl lactate and diisopropyl adipate, distributed under the terms and are included, along with cyclomethicone as a wetting agent. Upon topical application, the conditions of the Creative Commons organic vehicle is rapidly vaporized, providing high drug concentration onto the nail plate. Attribution (CC BY) license (https:// creativecommons.org/licenses/by/ Subsequently, EFN molecules diffuse through the nail plate with lipophilic permeation 4.0/). enhancers. Molecules 2021, 26, 1650. https://doi.org/10.3390/molecules26061650 https://www.mdpi.com/journal/molecules Molecules 2021, 25, x 2 of 13 rapidly vaporized, providing high drug concentration onto the nail plate. Subsequently, EFN molecules diffuse through the nail plate with lipophilic permeation enhancers. Molecules 2021, 26, 1650 2 of 12 Figure 1. Chemical structure of efinaconazole. Figure 1. Chemical structure of efinaconazole. In designing topical preparations of antifungal agents, especially for toenail treatment, In designing topical preparations of antifungal agents, especially for toenail endowing satisfactory penetration into the relevant layer, including the nail plate, is treatment, endowing satisfactory penetration into the relevant layer, including the nail one of the pivotal factors influencing therapeutic efficacy [7–9]. The nail plate is a thin plate, is one of the pivotal factors influencing therapeutic efficacy [7–9]. The nail plate is (0.25–1.00 mm), hard, and convex-shaped structure, which is principally made of fibrous aproteins, thin (0.25–1.00 approximately mm), hard, 80–90 and layers convex-shaped of keratinized structure, cells, andwhich keratin is principally filaments made [10,11 of]. fibrousThese components proteins, approximatel are tightly junctionedy 80–90 layers via aof disulfide keratinized link cells, which and is responsible keratin filaments for the [10,11].toughness These and components barrier function are tightly of nails. junctioned Most antifungal via a disulfide agents arelink lipophilic which is andresponsible possess forhigh the affinity toughness for keratinized and barrier tissues,function including of nails. Most the toenail, antifungal which agents can haveare lipophilic a deleterious and possesseffect on high drug affinity absorption, for impedingkeratinized drug tissues penetration, including to deeper the toenail, layers ofwhich the nail can plate have [12 a]. deleteriousAlthough EFNeffect has on adrug relatively absorption, lower impeding binding drug affinity penetrat to keratinizedion to deeper tissue layers compared of the nailto several plate [12]. lipophilic Although antifungal EFN has agents a relatively [5], topical lower preparationbinding affinity possessing to keratinized an enhanced tissue comparedpenetration to profileseveral is lipophilic still required antifungal to improve agents the[5], therapeutictopical preparation efficacy ofpossessing the triazole an enhancedderivative penetration in patients withprofile onychomycosis. is still required Actually, to improve the increased the therapeutic topical delivery efficacy ofof EFN the triazolemarkedly derivative accelerated in the patients structural with recovery onychomycosis. of keratin layer Actually, in a guinea the pigincreased onychomycosis topical deliverymodel [13 of]. EFN markedly accelerated the structural recovery of keratin layer in a guinea pig onychomycosisTo enhance the model ungual [13]. delivery of antifungal agents, different strategies have been utilized,To enhance such as the chemical ungual modification delivery of ofantifungal antifungal agents, agents, different employment strategies of penetration have been utilized,enhancers, such nanocarrier-based as chemical modification delivery, andof antifungal mechanical agents, or physical employment approaches, of penetration including enhancers,iontophoresis, nanocarrier-based photodynamic therapy,delivery, and and lasers mechanical [11,14,15]. Theor incorporationphysical approaches, of perme- includingation enhancers iontophoresis, in topical photodynamic preparations, therap such asy, and lacquer, lasers cream, [11,14,15]. or hydrogel, The incorporation have been ofwidely permeation explored enhancers to increase in drug topical penetration preparations, into the such toenail, as lacquer, as a simple cream, and effectiveor hydrogel, tech- havenique been [8,13 widely]. Saner explored et al. (2014) to increase reported drug that penetration topical treatment into the with toenail, lipophilic as a simple excipients and effectiveprincipally technique altered the[8,13]. microstructure Saner et al. of the(20 nail14) platereported through that physicaltopical interactiontreatment with with lipophilicthe lipid componentsexcipients principally of the plate, altered promoting the microstructure drug penetration of [the16]. nail On theplate other through hand, physicalhydrophilic interaction enhancers, with such the aslipid polyethylene components glycols, of the pantothenicplate, promoting acid, hydroxypropyl-drug penetrationβ- [16].cyclodextrin On the other (HP- hand,β-CD) hydrophilic or sodium laurylenhancers, sulfate such (SLS) as polyethylene has been shown glycols, to increase pantothenic drug acid,penetration hydroxypropyl- across theβ nail-cyclodextrin plate by improving (HP-β-CD) the or hydration sodium lauryl level of sulfate the nail (SLS) plate, has forming been showna porous to increase microchannel, drug penetration or by decreasing across thethe contactnail plate angle by improving between topical the hydration solution level and ofthe the surface nail plate, or nail forming plaque [a17 porous–20]. As microc the
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