Nitric oxide releasing nail coating compositions, nitric oxide releasing nail coatings, and methods of using the same

a technology of nitric oxide and nail coating, which is applied in the direction of dental surgery, pedicure, dental tools, etc., can solve the problems of drug penetration to the nail bed, high potential systemic adverse effects,

Inactive Publication Date: 2018-07-19
NAVAN INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0012]In addition, provided according to some embodiments of the invention are methods of treating a fungal infection of the nail and / or a nail condition comprising contacting a nail and / or skin surrounding the nail with a NO-releasing nail coating composition (e.g., a NO-releasing nail lacquer, paste, and / or ointment) according to an embodiment of the invention. The NO-releasing nail coating composition may not stain and / or discolor the nail and / or skin surrounding the nail.

Problems solved by technology

Oral therapies often involve a long treatment period due to low bioavailability of the drug at the sight of action, as well as a high potential for systemic adverse effects.
However, some drawbacks of many antifungal topical formulations include that drug penetration to the nail bed may be inhibited due to significant lag times in nail penetration, the inherent complex structure of the nail and the short time period in which the formulation remains on the nail.

Method used

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  • Nitric oxide releasing nail coating compositions, nitric oxide releasing nail coatings, and methods of using the same
  • Nitric oxide releasing nail coating compositions, nitric oxide releasing nail coatings, and methods of using the same
  • Nitric oxide releasing nail coating compositions, nitric oxide releasing nail coatings, and methods of using the same

Examples

Experimental program
Comparison scheme
Effect test

example 1

ail Lacquer

[0138]Vehicle nail lacquer solutions were initially prepared to evaluate the film-forming potential, upon solvent evaporation, of formulations comprised of a single polymer. Additional nail lacquer vehicles were prepared to evaluate formulations containing combinations of a strong film-forming polymer and a hydrophilic polymer. While not wishing to be bound to any particular theory, the intention of the binary polymer formulations is that the hydrophilic polymer will form channels within a robust, protective film allowing moisture penetration without disrupting or dissolving the film.

[0139]The vehicle nail lacquers were prepared by first mixing weighed amounts of the solvents and emollient in a 250-mL glass beaker. The weighed amount of polymer was then dissolved in the mixture using an IKA T-18 Homogenizer at a low-to-medium speed setting. The resulting solution was transferred to a 20-mL glass vial, and the visual appearance of the solution was recorded as provided in T...

example 2

ide Releasing Nail Lacquer

[0141]A diazeniumdiolate-functionalized co-condensed silica (Nitricil™) was prepared according to known methods and milled Nitricil™ is a NO-releasing co-condensed silica, from Novan, Inc. and may be provided with one or more different release profiles and / or functional groups, such as, but not limited to, diazeniumdiolate-functionalized co-condensed silica. Nitricil™ was analyzed for nitric oxide (NO) content, moisture content, and the particle size distribution of pre-milled and milled Nitricil™ was determined prior to initiation of the formulation development. The results from the analyses are summarized in Table 3.

TABLE 3Diazeniumdiolate-functionalized Co-Condensed Silica PropertiesParticle SizeParticle SizeMoistureDistribution -Distribution -NO ContentContentPre-MilledMilledResult4.57 μmol / mg6.1% w / wD10: 18.90 μmD10: 1.25 μm(13.71% w / w)D50: 442.38 μmD50: 4.34 μmD90: 843.41 μmD90: 10.59 μm

[0142]The initial development of the Nitricil™ Nail Lacquer was b...

example 3

l Vehicle Nail Lacquers

[0144]Additional example vehicle nail lacquers are provided in Formulas 1-5 below. A NO-releasing compound (e.g., a diazeniumdiolate-functionalized co-condensed silica) may be added to an example vehicle nail lacquer in an amount of about 0.1% to about 70% by weight of the lacquer composition.

Formula 1

[0145]

Ingredient% / WeightFunctionIsopropyl Alcohol65-85SolventNitrocellulose 1-12Film FormerAdipic Acid / Neopentyl 1-12Film FormerGlycol / TrimelliticAnhydride CopolymerTrimethyl Pentanyl1-6PlasticizerDiisobutyrateTriphenyl Phosphate1-6PlasticizerStearalkonium Hectorite1-2Thickening AgentBenzophenone-10.1AntioxidantTitanium DioxideQuantity sufficientColorant

Formula 2

[0146]

Ingredient% / WeightFunctionPNVA1-3 Film FormerIsopropyl Alcohol30-80 SolventPropylene Glycol1-10SolventGlycerine1-10Solvent

Formula 3

[0147]

Ingredient% / WeightFunctionGantrez S-971-10Film FormerIsopropyl Alcohol30-80 SolventPropylene Glycol1-10SolventGlycerin1-10Solvent

Formula 4

[0148]

Ingredient% / WeightF...

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PUM

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Abstract

The present invention relates to nitric oxide (NO)-releasing nail coating compositions, NO-releasing coatings, and methods of using the same, for example, to treat fungal infections of a nail. Provided according to embodiments of the invention are nitric oxide (NO)-releasing nail coating compositions and / or coatings. In some embodiments, a NO-releasing nail coating composition and / or coating may be in the form of a film. In some embodiments, a NO-releasing nail coating may be formed from a NO-releasing nail coating composition. In some embodiments, a NO-releasing nail coating composition may be in the form of a nail lacquer, a paste, a cream, a gel, and / or an ointment.

Description

RELATED APPLICATION INFORMATION[0001]This application is a continuation-in-part of International Application No. PCT / US2015 / 040319, filed Jul. 14, 2015, which claims the benefit of U.S. Provisional Patent Application Ser. No. 62 / 024,200, filed Jul. 14, 2014, the disclosure of each of which is incorporated herein by reference in its entirety.FIELD OF THE INVENTION[0002]The present invention relates to nail coating compositions and / or coatings that may release nitric oxide. The present invention also relates to methods of using nail coating compositions and / or coatings, including methods of using nitric oxide-releasing nail coating compositions and / or coatings to treat fungal infections of the nail and / or nail conditions.BACKGROUND[0003]The current treatment modes for fungal infections of the nail typically include oral therapy, topical therapy, or a combination of the two. Oral therapies often involve a long treatment period due to low bioavailability of the drug at the sight of acti...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61Q3/02A61K31/695A61K47/38A61K47/32A61K47/10A61P31/10A61K9/70A61K8/25A61K8/73A61K8/81
CPCA61Q3/02A61K31/695A61K47/38A61K47/32A61K47/10A61P31/10A61K9/7015A61K8/25A61K8/731A61K8/8182A61K2800/884A61K2800/22A61K9/0014A61K9/06A61K8/19A61K2800/88A61K33/00A61C3/02
Inventor DOXEY, RYANZHANG, YONG
Owner NAVAN INC
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