US20020182262A1 - Super-oxidized water, preparation and use thereof as sterilizers and medicaments - Google Patents

Super-oxidized water, preparation and use thereof as sterilizers and medicaments Download PDF

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Publication number
US20020182262A1
US20020182262A1 US10/084,518 US8451802A US2002182262A1 US 20020182262 A1 US20020182262 A1 US 20020182262A1 US 8451802 A US8451802 A US 8451802A US 2002182262 A1 US2002182262 A1 US 2002182262A1
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Prior art keywords
super
oxidized water
medicament
oxidized
treatment
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Abandoned
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US10/084,518
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Joe Selkon
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Puricore Europe Ltd
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Sterilox Medical Europe Ltd
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Assigned to STERILOX MEDICAL ( EUROPE) LIMITED reassignment STERILOX MEDICAL ( EUROPE) LIMITED ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: SELKON, JOE B.
Publication of US20020182262A1 publication Critical patent/US20020182262A1/en
Priority to US10/830,878 priority Critical patent/US7276255B2/en
Priority to US11/844,826 priority patent/US20090092685A1/en
Priority to US11/962,464 priority patent/US8632823B2/en
Abandoned legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/40—Peroxides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • C—CHEMISTRY; METALLURGY
    • C02—TREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02F—TREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02F1/00—Treatment of water, waste water, or sewage
    • C02F1/46—Treatment of water, waste water, or sewage by electrochemical methods
    • C02F1/461—Treatment of water, waste water, or sewage by electrochemical methods by electrolysis
    • C02F1/467—Treatment of water, waste water, or sewage by electrochemical methods by electrolysis by electrochemical disinfection; by electrooxydation or by electroreduction
    • C02F1/4672—Treatment of water, waste water, or sewage by electrochemical methods by electrolysis by electrochemical disinfection; by electrooxydation or by electroreduction by electrooxydation
    • C02F1/4674—Treatment of water, waste water, or sewage by electrochemical methods by electrolysis by electrochemical disinfection; by electrooxydation or by electroreduction by electrooxydation with halogen or compound of halogens, e.g. chlorine, bromine
    • C—CHEMISTRY; METALLURGY
    • C02—TREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02F—TREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02F2103/00—Nature of the water, waste water, sewage or sludge to be treated
    • C02F2103/02—Non-contaminated water, e.g. for industrial water supply
    • C02F2103/026—Treating water for medical or cosmetic purposes
    • C—CHEMISTRY; METALLURGY
    • C02—TREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02F—TREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02F2209/00—Controlling or monitoring parameters in water treatment
    • C02F2209/04—Oxidation reduction potential [ORP]
    • C—CHEMISTRY; METALLURGY
    • C02—TREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02F—TREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02F2209/00—Controlling or monitoring parameters in water treatment
    • C02F2209/06—Controlling or monitoring parameters in water treatment pH
    • C—CHEMISTRY; METALLURGY
    • C02—TREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02F—TREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02F2303/00—Specific treatment goals
    • C02F2303/04—Disinfection

Definitions

  • This invention relates to mixtures of oxidants which are referred to in this specification as “super-oxidized water,” a term which is known in the art.
  • Super-oxidized water may be used as a sterilizing, disinfecting and biocidal solution.
  • One form of super-oxidized water is produced by the applicant under the trademark STERILOX®.
  • This STERILOX super-oxidized water is generated at the point of use, for example in a hospital, by passing saline solution over coated titanium electrodes separated by a semi-permeable ceramic membrane at a current of about 6 to 9 Amps.
  • An apparatus having coated titanium electrodes separated by a semi-permeable ceramic membrane is disclosed in the specifications of UK Patent Nos. 2253860 and 2274113.
  • the basic structure of the apparatus is disclosed in GB2253860 and can be used to produce the STERILOX super-oxidized water.
  • STERILOX super-oxidized water contains a mixture of oxidizing species, predominantly hypochlorous acid (HOCl) and sodium hypochlorite.
  • the STERILOX super-oxidized water has a pH of 5-7 and an oxidation reduction potential (redox) of around 1000 mV.
  • redox oxidation reduction potential
  • the high redox potential allows for the quick and efficient destruction of microbes (bacteria, viruses, fungi and spores).
  • Hypochlorous acid and hypochlorite are in equilibrium and the position of the equilibrium is determined solely by the pH.
  • hypochlorous acid exerts its biocidal effect by attacking the surface and plasma membrane proteins, impairing transport of solutes and the salt balance of bacterial cells (Pieterson et al, Water SA, 22(1): 43-48 (1996)).
  • HOCl does not enter freely into eukaryotic cells, which may explain the selectivity of hypochlorous solutions.
  • the STERILOX process produces an extremely effective sterilizing, cold, non-toxic solution, which is free from highly toxic chemicals and acts against a wide variety of bacteria, fungi, viruses and spores.
  • the generation of STERILOX solutions requires only water, electricity and pure, vacuum-dried crystalline salt.
  • Applicant considers that the STERILOX super-oxidized water will be suitable for a broad range of applications in both medical and non-medical environments, such as the preservation of poultry and fish and general agricultural and petrochemical uses, the breaking down of bacterial biofilm, water treatment and general disinfection in medical and veterinary applications.
  • the STERILOX super-oxidized water has been found to be particularly useful for the disinfection of endoscopes which are sensitive to other cold disinfectants, such as peracetic acid, which are commonly used.
  • glutaraldehyde may be used as a reliable disinfecting agent of flexible fiber-optic endoscopes and other heat-sensitive instruments, although being widely practiced in many hospitals, its use can cause asthma and dermatitis in healthcare staff as a result of exposure to glutaraldehyde fumes, hence a predilection to the use of peracetic acid and the relatively recent move towards the use of STERILOX super-oxidized water in such applications.
  • leg ulcers There are two types of leg ulcers: arterial and venous. Arterial ulcers, which are much harder to treat, are caused by ischaemia, while venous ulcers are caused by blood stasis in the veins.
  • the most useful treatment for venous ulcers is the use of compression bandages together with elevation of the leg(s). This mimics the pumping action of the calf muscles which return the blood back to the body and maximizes the removal of blood from the leg(s).
  • other treatment strategies include the use of topical treatments such as GRANUFLEX® to aid granulation and skin repair, alginates to clean the wound of debris, dry inert dressings to protect the wound (but which do not promote healing), and bacteriostatic or bactericidal ointments to reduce the infection. While antibiotics have been used to reduce infection in the past, nowadays this is not a treatment of choice due to the increased risk of antibiotic resistance.
  • potassium permanganate is an oxidant which has stood the test of time in the treatment of leg ulcers, it still nevertheless has the disadvantages of irritating and injuring newly grown skin and causing skin discoloration.
  • Known hypochlorites such as EUSOL (Edinburgh University Solution of Lime) and Daikin's solution, rely on a high concentration of hypochlorite ions for their disinfectant properties. In fact, these compounds are no longer recommended for use due to their irritant and painful effects and impairment of cell growth which outweigh their therapeutic value, resulting in these preparations falling out of use. Attempts have been made to reduce the alkaline effect of the high hypochlorite ion content of these solutions, e.g. by the use of suitable buffers, but have been found to be ineffective in such circumstances.
  • in vitro tests were carried out on single layers of cultured human dermal fibroblast cells and keratinocyte cells to ascertain whether or not super-oxidized water had any effect on the viability of the cells.
  • the cells were incubated under sterile conditions in a super-oxidized water based on hypochlorous acid and including sodium hypochlorite and other oxidized chlorine species, having a pH range from 4 to 7 and a redox potential of around 1000 mV.
  • Applicant believes that the effects which have been observed can be explained by the low concentration of oxidized (free available) chlorine present in a super-oxidized water based on hypochlorous acid. This is in contrast to commonly known hypochlorite solutions which owe their biocidal activity to a high concentration of free chlorine (including hypochlorite) as indicated by their characteristic smell.
  • a super-oxidized water which is based on hypochlorous acid, acts as a biocide and allows cell growth.
  • the present invention resides in a super-oxidized water in which the biocidal effect is due to hypochlorous acid and the non-inhibitory effect on cell growth is dependent on the level of the pH of the hypochlorous acid solution.
  • the solution in a super-oxidized water based on hypochlorous acid and having a pH of 4 to 7, the solution has a pH selected in a range of about 4.3 to 6.2.
  • a super-oxidized water or other formulation such as a gel, which is based on hypochlorous acid, acts as a biocide and allows cell growth.
  • the super-oxidized water or other preparation based on hypochlorous acid may have a pH of 4 to 7, with the pH preferably being selected in a range of about 4.0 to 6.5, and more preferably in a range of about 4.0 to 6.2.
  • the super-oxidized water has a biocide rate (D Value) of approximately 1 log unit reduction unit of bacillus subtilis spores in less than 1 minute with a 9:1 super-oxidized water:innoculum mix.
  • D Value biocide rate
  • a biocide rate of about 3.4 seconds may be achieved and is particularly preferred.
  • the super-oxidized water based on hypochlorous acid may be obtained by the electrolysis of a saline solution. Accordingly, from another aspect of the invention there is provided a method of obtaining a super-oxidized water based on hypochlorous acid, the method comprising passing the saline solution through an electrochemical cell having electrodes separated by a semi-permeable membrane and operating in such manner as to produce a super-oxidized water based on hypochlorous acid which acts as a biocide and allows cell growth.
  • the super-oxidized water is obtained and the pH level of the solution is adjusted by a buffering action, which involves the use of an alkaline feed from the cell.
  • a buffering action which involves the use of an alkaline feed from the cell.
  • the pH of the super-oxidized water is preferably adjusted to be in a range of about 4.3 to 6.5
  • Applicant has found that, in the case of wounds, such as leg ulcers, it is advantageous if the pH is adjusted to about 5.4.
  • the invention resides in a method of producing a medicament containing super-oxidized water as defined above for use in the treatment of leg ulcers or other open wounds.
  • the invention also comprehends, in a super-oxidized water or other formulation having a pH of 4 to 7, the selection of a pH in a range of about 4.3 to 6.5, and preferably about 5.4, that is used for the treatment of leg ulcers or other open wounds.
  • the disinfection of wounds such as leg ulcers is readily achieved without irritation and pain, the spread of infection is reduced, and cell growth and regeneration are facilitated, thereby enhancing healing.
  • An added advantage is that there is no resistance or tolerance developed to disinfection which would occur with antibiotics.
  • the super-oxidized water of the invention lends itself readily to the treatment being carried out in many ways, although it has been found that a hydrobath in which the leg is immersed is soothing and generally pleasant for the patient.
  • preparations other than solutions may be used, for example gels.
  • the invention also resides in a method of treating a human or animal body having a leg ulcer or other open wound using any of the super-oxidized water based on hypochlorous acid herein referred to above and any of the methods defined hereinabove.
  • FIG. 1 a is a bar graph illustrating the effect on dermal fibroblast proliferation, measured by absorption assay at 3 and 6 days, of various concentrations super-oxidized water;
  • FIG. 1 b is a bar graph similar to FIG. 1 a , showing the results of the absorption assay at 6 days.
  • Example 1 describes an in vitro study, which investigated the effect of super-oxidized water based on hypochlorous acid on the proliferation of cultured human dermal fibroblast cells.
  • Example 2 describes an in vitro study, which investigated the cytotoxic effect of super-oxidized water based on hypochlorous acid on cultured human dermal fibroblast cells.
  • Example 3 describes an in vitro study, which investigated the effect of super-oxidized water based on hypochlorous acid on the proliferation of cultured human keratinocyte cells.
  • Example 4 describes a clinical trial of super-oxidized water on a patient with chronic leg ulcers.
  • Fibroblasts are flattened, irregular-shaped, connective tissue cells which are ubiquitous in fibrous connective tissue. They secrete components of the extracellular matrix, including collagen, and play an important role in tissue regeneration.
  • the super-oxidized water used in the trials was the product of the electrolysis of an aqueous saline solution passed over a mixture of proprietary catalysts on titanium electrodes to give a mixture of oxidizing species, particularly hypochlorous acid (HOCl) at a concentration of about 144 mg/l to 400 mg/l available free chlorine (Cl).
  • HOCl hypochlorous acid
  • the super-oxidized water was produced as required for each test; the apparatus (supplied by Sterilox Medical Limited, Abingdon, UK) was operated to give a final solution redox potential of >950 mV as recommended by the company. Appropriate dilutions of the super-oxidized water were made, and the pH of the final solution was adjusted using a phosphate buffer.
  • HDF cells were seeded in normal (10%) fetal calf serum (FCS) and Dulbecco's Modified Eagle Medium (DMEM) at 1.5 ⁇ 10 3 cells/well. After 24 hours the medium was changed to low (0.4%) FCS/DMEM. After a further 48 hours incubation super-oxidized water at varying concentrations was added to the cells. The viability of the cells was observed, using a standard absorption assay, 3 and 6 days after the application of super-oxidized water.
  • FCS fetal calf serum
  • DMEM Dulbecco's Modified Eagle Medium
  • Trial 2 Using the same conditions as Trial 1, HDF cells were incubated with super-oxidized water in a range of dilutions at a pH of 6.2. The dilutions used were: 1/20, 1/40, 1/60, 1/80, 1/100, 1/120, 1/1000, 1/1500, 1/2000, 1/3000, 1/4000 and 0.
  • HDF cells were incubated at 31° C. with super-oxidized water in a range of dilutions at a pH of 5.4.
  • the dilutions used were: 1/10, 1/20, 1/40, 1/60, 1/80, 1/100, 1/150, 1/1000, 1/1500, 1/2000, 1/4000 and 0.
  • HDF cells incubated with super-oxidized water at pH 5.4 showed no inhibition of cell growth, even in the presence of a 1/7 dilution of super-oxidized water.
  • HDF cells were seeded in 10% FCS/DMEM at 5 ⁇ 103 cells/well. After incubation at 31° C. for 72 hours, dilutions of super-oxidized water were prepared in HBSS and added to the cells. The viability of the cells was ascertained by a standard absorption assay at time intervals of 15 minutes up to one hour from the addition of the super-oxidized water.
  • Trial 2 Using the same conditions as trial 1, HDF cells were incubated with super-oxidized water in a range of dilutions at a pH of 6.2. The dilutions used were: 1, 1/4, 1/8, 1/12, 1/16, 1/20, 1/24, 1/28, 1/32, 1/36, 1/40 and 0.
  • Trial 3 Using the same conditions as Trials 1 and 2, HDF cells were incubated with super-oxidized water in a range of dilutions at a pH of 4.0. The dilutions used were: 1, 1/4, 1/8, 1/12, 1/16, 1/20, 1/24, 1/28, 1/50, 1/100, 1/200 and 0.
  • HK cells (subcultured, P2, FS, 7 years) were seeded at 8 ⁇ 10 3 cells/well and incubated at 31° C. in CLONETICS® (Biowhittaker, US) serum-free medium with complete supplements, hereinafter referred to as keratinocyte growth medium (KGM), in four 24-well plates. After 24 hours incubation the medium in plates 1 and 2 was changed to CLONETICS® (Biowhittaker, US) serum-free medium without complete supplements, hereinafter referred to as keratinocyte basal medium (KBM).
  • CLONETICS® Biowhittaker, US serum-free medium with complete supplements
  • the absorption assay showed that, on both day 3 and day 5, cell proliferation had occurred in the presence of all dilutions of super-oxidized water. At day 5, the level of cell proliferation had reached a significant level compared to cell growth in the absence of super-oxidized water.
  • HK cells (thawed, P2, FS, 7 years) were seeded to six 96-well plates at 3 ⁇ 10 3 cells/well in KGM. After incubation for 24 hours, the medium in plates 1 and 2 was changed to KBM with 20% supplements, and the medium in plates 3 and 4 was changed to KBM with 50% supplements.
  • a second treatment with super-oxidized water was repeated after two weeks in which the patient was subjected to three fifteen-minute washes at approximately three-hour intervals.
  • Post-treatment clinical evaluation was carried out one and several days after the second treatment.
  • the main objectives of the clinical study were to examine patient comfort and safety, as well as the efficiency of a treatment of super-oxidized water based on hypochlorous acid.
  • the invention has been described with reference to the examples in relation to the treatment of leg ulcers, it should be appreciated that the invention has considerably wider applicability.
  • the invention has applicability to burns, to organ transplants in relation to which current practice is to disinfect organs with antibiotics for two weeks before they are used in a patient, to disinfection of valve-replacements, and to surface wounds, open wounds and plural cavity infections which are exhibiting drug-resistance.

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  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
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  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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  • Communicable Diseases (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Dermatology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
US10/084,518 1999-08-23 2002-02-25 Super-oxidized water, preparation and use thereof as sterilizers and medicaments Abandoned US20020182262A1 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
US10/830,878 US7276255B2 (en) 1999-08-23 2004-04-23 Wound and ulcer treatment with super-oxidized water
US11/844,826 US20090092685A1 (en) 1999-08-23 2007-08-24 Wound and ulcer treatment with super-oxidized water
US11/962,464 US8632823B2 (en) 1999-08-23 2007-12-21 Treatment of infected tissues with hypochlorous acid

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GB9919951A GB2355190B (en) 1999-08-23 1999-08-23 Improvements in or relating to sterilising preparations
GBGB9919951.5 1999-08-23
PCT/GB2000/003264 WO2001013926A2 (fr) 1999-08-23 2000-08-23 Ameliorations relatives a des preparations sterilisantes

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PCT/GB2000/003264 Continuation WO2001013926A2 (fr) 1999-08-23 2000-08-23 Ameliorations relatives a des preparations sterilisantes

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US10/830,878 Division US7276255B2 (en) 1999-08-23 2004-04-23 Wound and ulcer treatment with super-oxidized water

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US10/084,518 Abandoned US20020182262A1 (en) 1999-08-23 2002-02-25 Super-oxidized water, preparation and use thereof as sterilizers and medicaments
US10/830,878 Expired - Lifetime US7276255B2 (en) 1999-08-23 2004-04-23 Wound and ulcer treatment with super-oxidized water
US11/844,826 Abandoned US20090092685A1 (en) 1999-08-23 2007-08-24 Wound and ulcer treatment with super-oxidized water
US11/962,464 Expired - Lifetime US8632823B2 (en) 1999-08-23 2007-12-21 Treatment of infected tissues with hypochlorous acid

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US10/830,878 Expired - Lifetime US7276255B2 (en) 1999-08-23 2004-04-23 Wound and ulcer treatment with super-oxidized water
US11/844,826 Abandoned US20090092685A1 (en) 1999-08-23 2007-08-24 Wound and ulcer treatment with super-oxidized water
US11/962,464 Expired - Lifetime US8632823B2 (en) 1999-08-23 2007-12-21 Treatment of infected tissues with hypochlorous acid

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US (4) US20020182262A1 (fr)
EP (1) EP1214081B1 (fr)
AU (1) AU6712500A (fr)
CA (1) CA2382569C (fr)
DE (1) DE60025369T2 (fr)
GB (1) GB2355190B (fr)
WO (1) WO2001013926A2 (fr)

Cited By (40)

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US20050232847A1 (en) * 2004-04-20 2005-10-20 Bromberg Steven E Method for diluting hypochlorite
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DE60025369T2 (de) 2006-09-21
CA2382569A1 (fr) 2001-03-01
GB9919951D0 (en) 1999-10-27
US20040208940A1 (en) 2004-10-21
US8632823B2 (en) 2014-01-21
WO2001013926A2 (fr) 2001-03-01
WO2001013926A3 (fr) 2001-09-13
AU6712500A (en) 2001-03-19
GB2355190B (en) 2004-07-28
US7276255B2 (en) 2007-10-02
DE60025369D1 (de) 2006-03-30
US20090092685A1 (en) 2009-04-09
EP1214081B1 (fr) 2006-01-04
CA2382569C (fr) 2009-11-17

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