# US 2014/0154193 A1 · Formulation and method for the treatment of fungal nail infections > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2014/0154193 A1 - Document ID: US20140154193A1 - Status: Published application - Kind: A1 - Application number: 13/732,509 - Filed: 2013-01-02 - Published: 2014-06-05 - Earliest claimed: 2006-10-06 - Assignees: Institute of Technology Sligo - Applicants: Institute of Technology Sligo - Inventors: John Reginald Barrett; James Joseph Brennan; Thomas Patrick Patton - Web page: https://patentgrep.com/patent/US20140154193A1 ## CPC - A61K 33/40: Peroxides - A61K 31/7004: Monosaccharides having only carbon, hydrogen and oxygen atoms - A61K 38/443: {acting on CH-OH groups as donors, e.g. glucose oxidase, lactate dehydrogenase (1.1)} - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) ## 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. ## Claims ### Claim 1 A storage-stable antimicrobial formulation for the treatment of fungal nail infections, comprising; glucose oxidase at an activity of at least 10 U per 100 g of the formulation; D-glucose from 20 to 85% by weight based on the weight of the total formulation; additional sugars selected from one or more of sucrose, fructose or maltose from 5 to 70% by weight based on the weight of the total formulation; water from 10 to 20% by weight based on the weight of the total formulation; with a pH from approximately 4 to 8 wherein the formulation provides a two-stage hydrogen peroxide release in which (a) storage-stable endogenously produced hydrogen peroxide is bioavailable within the formulation at a level of at least 10 mg per litre for immediate release; and (b) sustained release of further hydrogen peroxide for at least a twenty-four hour period occurs upon rehydration of the formulation. ### Claim 2 A storage-stable antimicrobial formulation for the treatment of fungal nail infections, wherein the formulation has antifungal and sporocidal effects which penetrate into and through the nail plate. ### Claim 3 (depends on 1) The formulation as claimed in claim 1 for the treatment of fungal nail infections caused by Trichophyton rubrum or Aspergillus niger. ### Claim 4 (depends on 1) The formulation as claimed in claim 1 in a form suitable for topical administration. ### Claim 5 (depends on 1) The formulation as claimed in claim 1 wherein the storage-stable endogenously produced hydrogen peroxide is bioavailable within the system at a level of at least 75 mg per litre for immediate release. ### Claim 6 (depends on 1) The formulation as claimed in claim 1 wherein the level of sustained release hydrogen peroxide produced upon rehydration of the system is at least 10 mg per litre. ### Claim 7 (depends on 1) The formulation as claimed in claim 1 further comprising a buffering agent. ### Claim 8 (depends on 1) The formulation as claimed in claim 1 wherein the additional sugars are present from 10 to 70% by weight based on the weight of the total system. ### Claim 9 (depends on 1) The formulation as claimed in claim 1 wherein the additional sugars are sucrose, fructose and maltose. ### Claim 10 (depends on 1) The formulation as claimed in claim 1 wherein fructose is present from 8 to 50% w/w %, maltose is present from 4 to 15 w/w %, sucrose is present from 0.5 to 3 w/w % and the D-glucose, is present from 10 to 85 w/w %. ### Claim 11 (depends on 1) The formulation as claimed in claim 1 further comprising at least one viscosity modifying ingredient. ### Claim 12 (depends on 1) The formulation as claimed in claim 1 adapted for delivery as part of a tissue, bandage or dressing. ### Claim 13 (depends on 1) A combined therapy for the treatment of fungal nail infections comprising (i) the formulation of claim 1 and (ii) an antimicrobial agent for the treatment of fungal nail infections. ### Claim 14 (depends on 13) The combined therapy according to claim 13 wherein the antimicrobial agents is selected from one or more of Griseofulvin, Ketoconazole, Itraconazole, Terbinafine, Clotrimazole, Amorolfine or Ciclopirox. ### Claim at position 15 15-18. (canceled) ### Claim 19 (depends on 1) The formulation of claim 1 wherein the level of sustained release hydrogen peroxide produced upon rehydration of the system is at least 20 mg per litre. ### Claim 20 (depends on 7) The formulation of claim 7 wherein said buffering agent is selected from carbonic acid-bicarbonate, phosphoric acid and disodium hydrogen phosphate.