Nitric oxide topical application apparatus and methods

Inventors

Miller, C. MichaelHill, Gordon K.Pate, A. JohnBell, David A.

Assignees

Noxy Health Products Inc

Publication Number

US-12150953-B2

Publication Date

2024-11-26

Expiration Date

2037-01-25

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Abstract

A topical application of nitric oxide may be provided by two separate containers, each containing an active component media to produce nitric oxide when combined. For example, a nitrite component media may be contained in one dispenser and an acidified component media may be contained in another dispenser. Each dispenser may dispense the respective component media as a foam. The resultant foams are combined to initiate the production of nitric oxide and the mixture of foams is applied topically to treat various skin disorders or wounds.

Core Innovation

The invention provides apparatus and methods for the topical application of nitric oxide using two separate media contained in distinct dispensers. One medium contains a nitrite reactant such as sodium nitrite, and the other contains an acidified reactant such as citric acid or lactic acid. Each medium is dispensed as a foam, and when the two foams are combined, a chemical reaction is initiated that produces nitric oxide. This resultant foam, containing bubbles with nitric oxide, is then applied topically to skin or wounds to facilitate transdermal absorption of nitric oxide.

The problem addressed by the invention arises from the instability of nitric oxide, which complicates the development of consistent, effective topical products for delivering usable nitric oxide to human cells and tissues. Current methods and products often fail to produce nitric oxide efficiently or maintain adequate concentrations for treatment. This invention offers a controlled foam-based delivery system whereby the rate of nitric oxide production can be regulated via component formulation, surfactants, and salt buffers, enabling efficient topical treatment for various maladies.

The invention further details specific formulations of the two component media, including water, appropriate nitrite salts, acids, surfactants, and optional buffering agents. The foam carrier acts as a barrier that retains nitric oxide near the skin to enhance transdermal absorption while reducing exposure to nitrogen dioxide, a pollutant. The invention also includes the use of mechanical or chemical foaming dispensers to deliver the individual media, which when mixed produce a stable foam with high nitric oxide to nitrogen dioxide ratios, optimizing therapeutic efficacy.

Claims Coverage

The patent includes multiple independent claims defining methods for transdermal absorption of nitric oxide and treatment of skin disorders using topical foams formed from two separate media.

topical delivery of nitric oxide via foam mixture

Providing two separate media—first medium containing water and a nitrite reactant, second medium containing water and acidic reactants—dispensing portions from each, mixing to create a foam with nitric oxide-containing bubbles, applying to skin so bubbles burst adjacent to skin, enabling transdermal nitric oxide absorption.

regulation of nitric oxide production with specific formulations

Use of specific formulations for the two media including approximately 100 mL water with 10 g sodium nitrite for the first medium and approximately 100 mL water with multiple acidic reactants (e.g., ascorbic acid, citric acid) for the second medium, including cationic surfactants and optional salt buffers to control reaction rate and ensure nitric oxide production efficacy.

foam structure serving as a barrier to retain nitric oxide near skin

Applying the resultant foam such that a first portion of bubbles is near skin and a second portion is away from skin, acting as a barrier that keeps nitric oxide bubbles close to the skin, facilitating absorption and controlling exposure.

use of specific acidic and nitrite reactants for nitric oxide production

Selecting nitrite reactants from sodium nitrite and potassium nitrite, and acidic reactants from citric acid, lactic acid, salicylic acid, phosphoric acid, ascorbic acid, and hydrochloric acid to drive the reaction for nitric oxide production in topical applications.

application method including retention time and removal

Allowing the applied mixed foam to remain on the treated skin area for at least three minutes, enabling nitric oxide absorption, followed by removal of remaining medium.

The independent claims cover methods combining separate nitrite and acidified media to generate a nitric oxide-containing foam for topical application, with specific formulations, foam structure, reactant selection, and method steps designed to optimize transdermal nitric oxide absorption and skin treatment efficacy.

Stated Advantages

Provides a comparatively efficient way to promote production of nitric oxide usable by human cells and tissues.

Enables controlled reaction rates for nitric oxide production via salt buffer inclusion and media formulation.

Foam carrier acts as a barrier keeping nitric oxide close to skin, enhancing absorption and minimizing nitrogen dioxide exposure.

Simplifies metering and delivery of nitric oxide via separate foaming dispensers for each reactant.

Produces antimicrobial, antifungal, analgesic, anti-inflammatory, wound healing, and cosmetic benefits.

Demonstrates high efficacy in disinfecting skin, shown to reduce bacterial content comparably or better than commercial antibacterial agents.

Documented Applications

Topical treatment of various skin disorders including acne, cuts, scrapes, minor burns, and ingrown hairs.

Wound healing applications, including chronic wounds such as diabetic ulcers, promoting significant healing and recovery.

Antimicrobial and antifungal topical applications for disinfecting skin and breaking up biofilms.

Localized analgesic and anti-inflammatory treatment via nitric oxide absorption.

Cosmetic use to reduce appearance of wrinkles.

Hand cleaning and disinfecting applications demonstrated in comparative bacterial reduction tests.

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