Formulation and method for the treatment of fungal nail infections

Inactive Publication Date: 2010-04-22
INST OF TECH SLIGO
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0053]Many other treatments require penetration enhancers, however, for the above reasons the formulation of the invention does not require the use of a penetration enhancer.
[0054]Thus, the sustained release combined with the hydroscopic nature of the formulation, ensures that the formulation provides a very efficient transport mechanism for hydrogen peroxide from the formulation to the site of infection in the nail bed and/or in the nail plate.
[0055]There are other advantages associated with the formulation.
[0056]For example, catalase is secreted by fungi as a defence mechanism. Thus, when hydrogen peroxide is applied to a fungal nail infection, catalase is secreted which results in the breakdown of hydrogen peroxide, reducing the efficacy. We have found that by ensuring the pH of the formulation is low, ideally from 4 to 8, ideally 4 to 6, this provides a less than optimum environment for catalase activity and overcomes one of the infecting fungi defence mechanisms. Thus, the low pH of the formulation prevents the degradation of hydrogen peroxide applied to the site of fungal nail infection.
[0057]Accordingly, we have found that the formulation of the invention is a very effective fungal nail infection treatment. Ideally

Problems solved by technology

However, treatments such as antibiotics have disadvantages because of the emergence of antibiotic resistance.
Furthermore, high levels of hydrogen peroxide have a toxic and irritant effect.
In addition, hydrogen peroxide in solution is typically unstable and it is difficult to provide a sustained delivery system for this material.
Infection is initially a disease of the hyponychium, resulting in hyperkeratosis of the distal nail bed.
Ultimately the underside of the nail is involved which results in thickening of the nail.
The nail may become friable and crumbles away.
Sometimes the fungus proliferates in the space between the nail plate and nail bed (known as a dermatophytoma) and is often the cause of treatment failure.
The infection may worsen, spread to other uninfected locations (other nails or to the surrounding skin) or infect other people.
Infections of the fingernails may be cosmetically unacceptable.
Infections of the toenail can greatly affect the

Method used

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  • Formulation and method for the treatment of fungal nail infections
  • Formulation and method for the treatment of fungal nail infections
  • Formulation and method for the treatment of fungal nail infections

Examples

Experimental program
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Example

Example 1

Characterisation of Antimicrobial Activities in Manuka Honey—Absence of Endogenous Hydrogen Peroxide

[0208]Using the Spectrophotometric bioassay described, antimicrobial activity of commercially available Manuka honey is determined, using several samples to ensure consistency.

[0209]Results shown in FIG. 1a demonstrate that Manuka honey provides a first tier of microbial inhibition activity at dilutions 50% to approximately 6.25% and a second tier of microbial inhibition activity at dilutions 3.125% to approximately 0.195%

[0210]This two tier effect is shown to be produced by separate mechanisms. Initial microbial inhibition on low honey dilution (50%-6.25%) results from a combination of low pH and growth limiting Aw (Available Water) and a very minor role by hydrogen peroxide, which is only produced de-novo upon dilution and after a considerable period of time has elapsed. There is no detectable endogenous hydrogen peroxide present in diluted or undiluted Manuka honey, as sho...

Example

Example 2

A Prototype Antimicrobial Endogenous and Sustained Release Hydrogen Peroxide Generating System

[0215]A prototype formulation containing 31+ / −5 g glucose: 35+ / −5 g fructose: 7+ / −2 g maltose: 1.5+ / −1 g sucrose is made by mixing the ingredients, making the mixture up to a final volume of 100 ml in distilled deionized (DI) water; the mixture is sterilized by autoclaving. Glucose oxidase at 0.05% by weight, which is a similar concentration to that contained in Manuka honey, is added.

[0216]FIG. 2 shows the results of an antimicrobial assay on S. aureus using this prototype formulation. The prototype formulation of this example demonstrated a greater activity compared to Manuka honey. It is probable that the critical role played by the glucose oxidase enzymatic pathway in the antibacterial effect is enhanced once free from impurities and reaction limiting compounds (such as catalase) present in honey. This prototype demonstrates very effective bactericidal activity.

Example 2.1

A Gel...

Example

Example 3

Single Component Antimicrobial System, Having an Endogenous Hydrogen Peroxide Reservoir and Sustained Release

[0224]A formulation for a single component antimicrobial system (hereafter referred to as ‘Antimicrobial System’ or A3IS or A3IS is made in accordance with Table 3.

TABLE 3IngredientPercentage by weightPurified water13.5 adjusted to make 100%Fructose Powder35% + / − 5Glucose Powder38% + / − 5Maltose Powder10% + / − 5Sucrose Powder1.5% + / − 1Glucose Oxidase Powder0.5% enzyme (5600 U / g) pre-dissolved in1.5% of purified waterTOTAL100%

[0225]The pH of A3IS is set at pH 5.5. This low pH is within the glucose oxidase range of activity (pH 4.0-7.0 optimum pH of 5.5). If needed, a buffer can be added to obtain the desired pH, as illustrated in Table 4. The buffer is pre-dissolved in purified water and replaces part of the purified water from the formulation above.

TABLE 4Optional Buffering Ingredientsfor pH 5.5Percentage by weightCitric Acid / Sodium Citrate0.918% pre-dissolved in 2% of...

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Abstract

The present invention relates to a formulation and method for the treatment of fungal nail infections, such as those caused by Trichophyton rubrum and/or Aspergillus niger. The formulation of the invention comprises glucose oxidase, D-glucose and hydrogen peroxide in an aqueous solution. Advantageously, the formulation of the invention provides a two-stage hydrogen peroxide release for the treatment of the fungal nail infections.

Description

FIELD OF THE INVENTION[0001]The present invention relates to a formulation and method for the treatment of fungal nail infections. Ideally, the fungal nail infections are caused by Trichophyton rubrum and / or Aspergillus niger. BACKGROUND TO THE INVENTION[0002]Well-known antimicrobial compositions include conventional treatments such as antiseptics and antibiotics. Other treatments include silver-containing gels, compounds containing heavy metals and solutions of hydrogen peroxide and natural and synthetic pharmaceutically active substances. However, treatments such as antibiotics have disadvantages because of the emergence of antibiotic resistance. Furthermore, high levels of hydrogen peroxide have a toxic and irritant effect. In addition, hydrogen peroxide in solution is typically unstable and it is difficult to provide a sustained delivery system for this material. Additionally, there are a number of naturally occurring antimicrobial systems known which rely on the ability of cert...

Claims

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Application Information

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IPC IPC(8): A61K8/66A61K38/44A61Q3/00
CPCA61K38/443A61K31/7004A61K33/40A61K2300/00
Inventor BARRETT, JOHN REGINALDBRENNAN, JAMES JOSEPHPATTON, THOMAS PATRICK
Owner INST OF TECH SLIGO
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