Physiologically balanced, ionized, acidic solution and methodology for use in wound healing

• US 7,393,522 B2
• Filed: 09/03/2003
• Issued: 07/01/2008
• Est. Priority Date: 01/12/2000
• Status: Expired due to Term

• Current Assignee: NovaBay Pharmaceuticals, Inc.
• Original Assignee: NovaBay Pharmaceuticals, Inc.
• Inventors: Bassiri, Mansour, Wang, Lu, Najafi, Ramin, Yang, Jane
• Primary Examiner(s): Kwon; Brian
• Application Number:
  US10/655,493
• Publication Number:
  US 20040137078A1
• Time in Patent Office: 1,763 Days
• Field of Search: 424/78.04, 424/78.06, 424/78.07, 424/613, 424/661, 424/78.05
• US Class Current: 424/78.04
• CPC Class Codes: A01N 2300/00 Combinations or mixtures of active ingredients covered by classes A01N27/00 - A01N65/48 with other active or formulation relevant ingredients, e.g. specific carrier materials or surfactants, covered by classes A01N25/00 - A01N65/48
• CPC Class Codes: A01N 59/00 Biocides, pest repellants or attractants, or plant growth regulators containing elements or inorganic compounds
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/74 Synthetic polymeric materials
• CPC Class Codes: A61K 33/14 Alkali metal chlorides; Alkaline earth metal chlorides
• CPC Class Codes: A61K 33/24 Heavy metals; Compounds thereof
• CPC Class Codes: A61K 33/30 Zinc; Compounds thereof
• CPC Class Codes: A61K 33/40 Peroxides
• CPC Class Codes: A61K 9/0048 Eye, e.g. artificial tears
• CPC Class Codes: A61L 2/0035 Gamma radiation
• CPC Class Codes: A61L 2/0088 Liquid substances
• CPC Class Codes: A61P 17/02 for treating wounds, ulcers, burns, scars, keloids, or the like
• CPC Class Codes: C01B 11/04 Hypochlorous acid
• CPC Class Codes: C02F 1/4618 for producing "ionised" acidic or basic water
• CPC Class Codes: C02F 2001/46185 only anodic or acidic water, e.g. for oxidizing or sterilizing
• CPC Class Codes: C02F 2103/026 Treating water for medical or cosmetic purposes
• CPC Class Codes: C02F 2201/46115 Electrolytic cell with membranes or diaphragms
• CPC Class Codes: C02F 2201/4618 Supplying or removing reactants or electrolyte
• CPC Class Codes: C02F 2209/04 Oxidation reduction potential [ORP]
• CPC Class Codes: C02F 2209/06 pH
• CPC Class Codes: C02F 2303/04 : Disinfection

Abstract

Described herein is a physiologically-balanced, acidic solution. Typically the solution is prepared by a chemical reactions or by the electrolysis of a solution comprising a mixture of an inorganic salt to form a physiologically balanced solution. This invention also relates to methods for use of the solutions, including a specialized bandage which may be used in combination with the solutions, or optionally with other topically applied materials. A mixture of inorganic salts and, optionally minerals, is used in order to mimic the electrolyte concentration and mixture of body fluid in an isotonic state. The solution typically comprises of one halide salt of lithium, sodium, potassium, calcium, and other cations. Typically the halide is fluoride, chloride, bromide, or iodide, and most typically chloride. A typical electrolyzed solution of the present invention has a pH within the range of about 2 to about 5, an oxidation reduction potential within the range of about +600 mV to about +1200 mV, and hypohalous acid concentration in the range of about 10 ppm to about 200 ppm. The solution has bactericidal, fungicidal, and sporicidal properties. The composition of the invention is nontoxic and has antibacterial properties, and is useful in any application in which antimicrobial properties are desirable.

Claims

1. A method for the treatment of a medical condition selected from the groups consisting of disinfection or decontamination of open wounds and burns, promotion of wound healing, and ocular disinfection or decontamination in a patient in need of such treatment comprising:

applying to a treatment site with an effective amount of a stable aqueous physiologically balanced, ionized solution comprising an acidic solution of hypohalous acid with a concentration from about 10 ppm to about 200 ppm;

a halide comprising salt, from about 0.4 g/L to about 20.4 g/L, said solution having a pH range from about 3.0 to about 4.0, an original oxidation reduction potential (ORP) at room temperature ranging from about +600 mV to about +1200 mV, and said ORP ranging from no less than about 90 to 97.5% of the original ORP after three months at room temperature; and

said solution when stored in a chemically non-reactive container at room temperature over at least three months, the solution is characterized as having a reduced hypohalous acid concentration of between 1-95% as determined by UV-VIS or by iodometric titration.

5. The method of claim 1, wherein the halide comprising salt is in concentration from about 4 g/L to about 10 g/L.

6. The method of claim 1, wherein the hypohalous acid is selected from the group consisting of HOBr, HOI, HOCl and HOF.

7. The method of claim 1, wherein the halide comprising salt is selected from the group consisting of lithium, sodium, potassium, magnesium, zinc, cesium, and barium halide.

2. A method for the treatment of a medical condition selected from the groups consisting of disinfection or decontamination of open wounds and burns, promotion of wound healing, and ocular disinfection or decontamination in a patient in need of such treatment comprising:

applying to a treatment site with an effective amount of a stable aqueous physiologically balanced, ionized solution comprising an acidic solution of hypohalous acid with a concentration from about 10 ppm to about 200 ppm;

a halide comprising salt, from about 0.4 g/L to about 20.4 g/L, said solution having a pH range from about 3.5 to about 4.0, an original oxidation reduction potential (ORP) at room temperature ranging from about +600 mV to about +1200 mV, and said ORP ranging from no less than about 90 to 97.5% of the original ORP after three months at room temperature; and

said solution when stored in a chemically non-reactive container at room temperature over at least three months, the solution is characterized as having a reduced hypohalous acid concentration of between 1-95% as determined by UV-VIS or by iodometric titration.

3. A method of disinfecting or decontaminating open wounds and burns, promoting wound healing, or disinfecting or decontaminating in or around the eye, by treating a patient in need thereof with an effective amount of a stable aqueous physiologically balanced, ionized solution comprising an acidic solution of hypohalous acid with a concentration from about 10 ppm to about 200 ppm;

a halide comprising salt, from about 0.4 g/L to about 20.4 g/L, said solution having a pH range from about 3.0 to about 4.0, an original oxidation reduction potential (ORP) at room temperature ranging from about +600 mV to about +1200 mV, and said ORP ranging from no less than about 90 to 97.5% of the original ORP after three months at room temperature; and

said solution when stored in a chemically non-reactive container at room temperature over at least three months, the solution is characterized as having a reduced hypohalous acid concentration of between 1-95% as determined by UV-VIS or by iodometric titration.

4. The method of claim 3, comprising:

a) exposing area of damaged tissue;

b) applying the solution to dermal tissue;

c) irrigation of damaged tissue using the solution; and

d) cleaning or treating tissue using the solution.