WO2005107774A1 - Composition pharmaceutique pour la cicatrisation des plaies - Google Patents

Composition pharmaceutique pour la cicatrisation des plaies Download PDF

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Publication number
WO2005107774A1
WO2005107774A1 PCT/IB2005/001275 IB2005001275W WO2005107774A1 WO 2005107774 A1 WO2005107774 A1 WO 2005107774A1 IB 2005001275 W IB2005001275 W IB 2005001275W WO 2005107774 A1 WO2005107774 A1 WO 2005107774A1
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WO
WIPO (PCT)
Prior art keywords
composition according
pharmaceutical composition
cobalt
nickel
molybdenum
Prior art date
Application number
PCT/IB2005/001275
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English (en)
Inventor
Paolo Agostinini
Original Assignee
Icim International S.R.L.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Icim International S.R.L. filed Critical Icim International S.R.L.
Publication of WO2005107774A1 publication Critical patent/WO2005107774A1/fr

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Classifications

    • 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
    • A61K33/24—Heavy metals; Compounds thereof
    • A61K33/242—Gold; Compounds thereof
    • 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
    • A61K33/24—Heavy metals; Compounds thereof
    • A61K33/34—Copper; Compounds thereof
    • 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
    • A61K33/24—Heavy metals; Compounds thereof
    • A61K33/26—Iron; Compounds thereof
    • 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
    • A61K33/24—Heavy metals; Compounds thereof
    • A61K33/38—Silver; Compounds thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0014—Skin, i.e. galenical aspects of topical compositions
    • 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

Definitions

  • the present invention concerns a pharmaceutical composition intended in particular for the treatment of wounds, sores and burns and a process for its preparation.
  • the aim of the invention is a composition containing substantially one or more metals in ionic form such as Nickel, Cobalt, Cadmium, Iron, Chrome, Copper, Gold, Titanium, Zirconium and Molybdenum, and optionally Silver and/or Zinc, in an appropriate carrier for topical application.
  • metals in ionic form such as Nickel, Cobalt, Cadmium, Iron, Chrome, Copper, Gold, Titanium, Zirconium and Molybdenum, and optionally Silver and/or Zinc
  • sores of infected exudative wounds, of pressure and venous ulcers, and in particular of burns, normally contemplates the use of antibacterial or bacteriostatic substances, to avoid the risk of septicaemia, and cicatrizing substances which favour the healing processes of the damaged tissues.
  • the preferred form is a gel which allows better control of the wound micro- environment, with greater persistence and coverage of the affected area.
  • the main bacterial strains involved in the infective complications encountered in ulcers and exudative wounds belong to the families of staphylococci, gram+ and pseudomonas, gram -.
  • compositions are known containing antibacterial active ingredients and/or cicatrizing active ingredients or osmotic agents able to modulate the liquid content of the wound micro-environment, which are used for disinfecting and medicating infected ulcers, sores, burns and wounds.
  • One example is the formulation with a base of povidone-iodine, distributed on the market with the trade name Betadine ®
  • other examples are the gel Intrasite ® , with a base of propylene glycol, the hydrogel Cutinova ® , with a base of alginate polymers, the gel Convatec ® , the gel Nu- gel ® with a collagen base, the gel Duoderm ® , with a base of hydrocolloid polymers, the gel Algisite ® , with a base of alginates, the gel Citrizan ® , with a base of catalase, the gel Kathogel ® , with a silver base.
  • the aim of the present invention is to provide a pharmaceutical composition suitable for the treatment of ulcers, wounds and bums which at the same time performs a bacteriostatic action, osmotic regulation, and a surprising cicatrizing action.
  • the aims of the invention are achieved with a pharmaceutical composition which comprises as active ingredient one or more metals in ionic form chosen from Nickel, Cobalt, Cadmium, Iron, Chrome, Copper, Gold, Titanium, Zirconium and Molybdenum, in an appropriate carrier for topical application.
  • composition of the invention is particularly useful as a cicatrizing composition, that is it is suitable for treating a wide range of skin lesions comprising wounds, bums of any origin, ulcers, sores of different origin and nature, in particular bed sores, sores caused by infections, exudative sores, etc.
  • composition designates a composition for topical use for the treatment of the above-mentioned infections, and it may be a drug, a medical device, or a product classified in a different way, for example a product marketed through large-scale distribution.
  • the expression "appropriate carrier for topical application” means any carrier suitable for application on the skin which is able to transfer the metals in an ionic form according to the composition of the invention.
  • Appropriate carriers are for example water, ethyl alcohol, glycerol, the glycols and all the pharmaceutically acceptable polar solvents, that is which are compatible with application on the skin and on wounds; the mixtures of said carriers are also suitable for the preparation of the composition according to the invention.
  • the invention may comprise as a suitable carrier water, ethyl alcohol, a mixture of water and ethyl alcohol, glycerol, a mixture of water and a non toxic polar solvent, etc.
  • an appropriate carrier is water, advantageously water for pharmaceutical use, for example distilled water.
  • an appropriate carrier is alcohol, advantageously denatured or pure ethyl alcohol.
  • an appropriate carrier is a mixture of water and another appropriate carrier, for example a hydroalcoholic mixture of water and ethyl alcohol.
  • the composition of the invention comprises as an active ingredient at least two metals in ionic form chosen from Nickel, Cobalt, Cadmium, Iron, Chrome, Copper, Gold, Titanium, Zirconium and Molybdenum.
  • the composition of the present invention may also comprise other metals suitable for the purpose, for example Silver and Zinc.
  • the composition of the invention comprises as an active ingredient at least two metals in ionic form chosen from Nickel, Cobalt, Cadmium, Iron, Chrome, Copper, Gold, Titanium, Zirconium, Molybdenum, Silver and Zinc.
  • the composition of the present invention may comprise one of the following combinations of metals: - Nickel and Chrome, - Nickel and Cobalt, - Chrome and Cobalt, - Zinc and Nickel, - Silver and Nickel, - Silver and Zinc, - Cadmium and Molybdenum, - Cobalt and Molybdenum, - Cadmium and Cobalt, - Nickel, Cobalt and Molybdenum, - Nickel, Cadmium, Cobalt and Molybdenum, - Nickel, Cobalt and Molybdenum, - Nickel, Cobalt, Molybdenum, Silver and Zinc, - Nickel, Cobalt, Molybdenum, Silver and Cadmium, in ionic form, in un an appropriate carrier according to the invention; other combinations are also possible.
  • composition of the invention may be presented in various forms for topical example, for example in liquid form, in the form of gel, cream, ointment, or in any other form suitable to exert the cicatrizing effect.
  • the different final preparations may be obtained by mixing the basic composition of the invention with other convenient substances and carriers, according to the methods known in the art.
  • composition of the invention may also be dispensed through supports such as sticking plasters, medicated gauze, bandages and similar, prepared according to the techniques known to the skilled in the art.
  • known gelling substances may be added to the composition of the invention to thicken it and obtain a gel to be used directly on the affected parts or to be dispensed by means of adequate supports.
  • the invention concerns the composition of the invention which also comprises a gelling agent, for example inert polymers, such as the alkylic derivates of cellulose or other gelling agents suitable for use on wounds.
  • the composition of the invention in gel form comprises a sufficient amount of gelling agent to give it a sufficient consistency for use as gel, for example, in the case of the alkylic derivates of cellulose an amount generally less than or equal to about 10%.
  • the amount of gelling agent varies, clearly, according to the nature of the agent itself and its gelling capacity.
  • the composition of the invention also comprises lactic acid. Though not obligatory, the presence of lactic acid may help give the composition a pH suitable for treating the skin. According to another of its aspects, the composition of the invention also comprises a disinfectant, for example a salt of quaternary ammonium, such as benzalkonium chloride.
  • a disinfectant for example a salt of quaternary ammonium, such as benzalkonium chloride.
  • composition of the invention may also comprise lactic acid, for example an amount of 0.1-0.4%, and/or disinfectants, for example an amount of 0.05-0.4%.
  • composition of the invention may also comprise other substances, for example antifungals such as fuchsine. If these substances are present, the relative amounts in the composition are generally less than 1%.
  • composition of the invention may also comprise enzymatic inhibitors, for example metallo proteinases, in amounts between 0.001% and 5%, for example between 0.2% and 5%.
  • enzymatic inhibitors for example metallo proteinases
  • the composition of the invention may comprise other constituents, generally present in small amounts, for example in amounts between 10% and 0.1% with respect to the total weight of the composition.
  • the composition of the invention comprises as an appropriate carrier a hydroalcoholic mixture, composed of 5-15% ethyl alcohol and 75-95% water (total).
  • composition of the invention may be prepared according to any method known to the technique, for example by mixing the various components in the appropriate carrier chosen.
  • the metals in ionic form may be added to the composition according to any possible method, for example in the form of salts suitable for topical application, or in the form of ions in a solution in a suitable solvent.
  • the metals in ionic form are obtained by electrolysis in a suitable polar solvent, said solvent containing the metals in ionic form being then mixed with the other components of the mixture.
  • the invention concerns a process for preparing the composition of the invention which comprises: a. subjecting water or another suitable polar solvent to electrolytic enrichment with one or more elements chosen from Nickel, Cobalt, Cadmium, Iron, Chrome, Copper, Gold, Titanium, Zirconium, Molybdenum; b. optionally mixing the mixture obtained in step (a) with one or more appropriate carriers for topical application and with the other optional components of the composition; c. optionally packing the composition of the invention thus obtained in single- dose or multidose packs.
  • the invention concerns a process in which, in step (a), electrolytic enriching is carried out with two or more metals in ionic form chosen from Nickel, Cobalt, Cadmium, Iron, Chrome, Copper, Gold, Titanium, Zirconium,
  • the invention concerns a process in which, in step
  • electrolytic enriching is carried out with two or more metals in ionic form chosen from Nickel, Cobalt, Cadmium, Iron, Chrome, Copper, Gold, Titanium, Zirconium,
  • Electrolysis in water or another suitable polar solvent may be carried out according to the methods known to the technique.
  • step (b) of the process the solution enriched with metals in ionic form is mixed with the other selected carriers according to the invention, that is for example with more water or with ethyl alcohol, glycerol, etc. as described above and any desired optional components are added.
  • step (b) therefore comprises all the components of the composition and, if desired or necessary, it may be further treated in step (c) to pack it in various ways or to apply it on suitable supports.
  • composition of the invention To exert its cicatrizing effect, the composition of the invention must be applied on the wounds.
  • composition of the invention in liquid form, it may be applied by swabbing, as a spray, or directly distributed from a bottle.
  • composition of the invention in the form of a gel which may be conveniently packed in a tube, in bottles or in dispensers, in single-dose or multidose packs.
  • the composition may be used in combination with gauzes, wet or dry packs, which favour its permanence on the wound and guarantees the humidity of the same, depending on the type of medication protocol applied.
  • the invention concerns a method for the cicatrizing of bums and of wounds in general, which comprises the application of a composition according to the invention on the parts to be treated.
  • composition of the invention has also been subjected to tests on human f ⁇ broblasts which demonstrated its good tolerability.
  • compositions of the invention were subjected to the determination of the MIC (Minimum inhibiting Concentration) on Staphylococcus aureus and Pseudomonas aeruginosa, giving very satisfactory results.
  • MIC Minimum inhibiting Concentration
  • compositions in use for the treatment of wounds are also free from cytotoxic effects and it does not cause irritations.
  • Example 1 Composition in the form of a hydroalcoholic solution: Ethyl alcohol g l8 Benzalkonium chloride g ⁇ .5 Fuchsine g ⁇ .8 Lactic acid g ⁇ .7 Water g 230 Concentration in Nickel ions 1.8 mg/1 of solution (1.8 ppm) * Concentration in Cobalt ions 2.4 mg/1 of solution (2.4 ppm) * (* determined by analysis with optical emission spectrometry with a plasma source)
  • Example 2 Composition in the form of a hydroalcoholic solution: Ethyl alcohol g 25.5 Benzalkonium chloride g 0.5 Lactic acid g 1 Water g 223 Concentration in Nickel ions 2 mg/1 of solution (2 ppm) * Concentration in Cobalt ions 4.2 mg/1 of solution (4.2 ppm) * (*determined by analysis with optical emission spectrometry with a plasma source)
  • Example 3 Composition in the form of an aqueous solution: Benzalkonium chloride g 1 Fuchsine
  • the cytotoxicity test to which this study refers was carried out to check the potential toxicity of a product intended to be applied on the skin, in comparison with the principal type of cell that composes the skin, the fibroblast.
  • Products tested Compositions of Example 1 and Example 2: The finished product is presented as a solution with an aqueous base, red in colour where basic fuchsine has been added (Example 1), colourless if without fuchsine (Example 2).
  • SLS sodium lauryl sulfate
  • the culture medium of the cells was used.
  • Preparing the sample For the test the compositions were used just as they were, diluting them in the culture medium of the cells in concentrations of 10- 5-2.5-1.25-0.6-0.3-0.15 mg/ml.
  • the positive control (SLS) was diluted in the culture medium in concentrations between 500 and 0.01 ug/ml.
  • Experimental model The primary human fibroblasts come from biopsies of paediatric skin, obtained with the permission of the ethical committee during routine surgical operations.
  • the fibroblasts were cultivated in DMEM enriched with 10% FCS (W/v) and with specific supplements. Treatment and exposure In this study the cells were plated out into 96 well plates till semiconfluence.
  • Fresh culture medium containing the substance to be tested was then added so as to reach 6 final dilutions between 10 and 0.15 mg/ml. Each sample was tested in triplicate. Non treated cells were uses as a negative control, and cells treated with a surfactant with known toxicity (sodium lauryl sulfate) dissolved in the culture medium in concentrations between 0.5 mg/ml and 0.001 mg/ml were used as a positive control. Exposure was protracted for 24 hours and then the cytotoxicity test (MTT) was carried out to assess the percentage of cell survival. Test procedures: 1. MTT cell vitality test The MTT test is simple, accurate, and supplies reproducible results.
  • the key reagent is 3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyl tetrazolium bromide or MTT, a substance which gives a yellow colour in an aqueous solution.
  • the mitochondrial dehydrogenase of the vital cells cuts the tetrazolic ring, leading to the formation of purple coloured formazan crystals that do not dissolve in water.
  • the crystals are dissolved in acidified isopropanol and the resulting violet solution is measured by spectrophotometry.
  • An increase or decrease of vital cells results in a concomitant change in the amount of formazan that is formed and that may be considered an indicator of the degree of cytotoxicity caused by the exposure to the irritating substances.
  • MTT test description of the method: After the treatment, the cells are washed with a washing solution (Dulbecco's Phosphate Buffered Saline). After the removal of the solution, the medium containing MTT is added to each well and the cells are incubated for 4 h at 37°C. At the end of the incubation period, the MTT medium is removed and the MTT solubilising solution (Triton X-100,Hcl, isopropanol) is added to each well. The plate is stirred on a plate stirrer for 20-30 minutes, ensuring that all the crystals have dissolved and have formed a homogeneous solution. The absorbance is read using a spectrophotometer with specific wavelengths.
  • a washing solution Dulbecco's Phosphate Buffered Saline
  • Example 8 Determination of the MIC The MIC was assessed on the solution of Example 1 (A), on the solution of Example 2 (B) and on the commercial product Betadine® (C). The samples were tested at dilutions between 0.025 and 1%.

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  • Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Inorganic Chemistry (AREA)
  • Dermatology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

L'invention porte sur une composition pharmaceutique contenant sensiblement un ou plusieurs métaux, sous forme ionique, tels que le nickel, le cobalt, le cadmium, le fer, le chrome, le cuivre, l'or, le titane, le zirconium et le molybdène, et éventuellement l'argent et/ou le zinc, dans un excipient approprié, cette composition étant destinée à être appliquée localement. L'invention porte également sur l'utilisation de cette composition dans le traitement des plaies et des brûlures et sur son procédé de préparation.
PCT/IB2005/001275 2004-05-11 2005-05-11 Composition pharmaceutique pour la cicatrisation des plaies WO2005107774A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ITMI2004A000943 2004-05-11
IT000943A ITMI20040943A1 (it) 2004-05-11 2004-05-11 Composizione farmaceutica cicatrizzante

Publications (1)

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WO2005107774A1 true WO2005107774A1 (fr) 2005-11-17

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WO (1) WO2005107774A1 (fr)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014190227A1 (fr) * 2013-05-24 2014-11-27 Blaine Laboratories, Inc. Produit de soins de plaie à base de membrane de coquille d'œuf
US10932952B2 (en) 2015-11-11 2021-03-02 Biovotec As Dry biocompatible disintegratable films for delivering particulate egg shell membrane to a wound
US11045578B2 (en) 2015-06-24 2021-06-29 Biovotec As Tissue engineering scaffolds comprising particulate egg shell membrane
US11992508B2 (en) 2014-10-28 2024-05-28 Biovotec As Micronized eggshell membrane particles and the use thereof to promote the healing of wounds

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1985001208A1 (fr) * 1983-09-12 1985-03-28 Research Corporation Compositions antimicrobiennes contenant de l'acide carboxylique de 1-ethyl-6-fluoro-1,4-dihydro-oxo-7-(1-piperazinyl)-3-quinoline ou ses sels metalliques et de la sulfadiazine d'argent
EP0363696A1 (fr) * 1988-09-22 1990-04-18 Siegfried Natterer Préparation pharmaceutique ainsi que procédé pour sa fabrication
EP0480189A1 (fr) * 1990-10-05 1992-04-15 Altergon S.A. Composition pharmaceutique à usage topique contenant du sel de sodium de l'acide hyaluronique et des désinfectants
WO1999037312A1 (fr) * 1998-01-27 1999-07-29 Vlaams Interuniversitair Instituut Voor Biotechnologie Vzw Preparation pharmaceutique a base de vanadium ou de l'un de ses sels pour le traitement des brulures
EP1319407A1 (fr) * 2001-12-14 2003-06-18 Montoie Import-Export S.A. Composition pharmaceutique pour le traitement topique des affections cutanées et des blessures cutanées

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1985001208A1 (fr) * 1983-09-12 1985-03-28 Research Corporation Compositions antimicrobiennes contenant de l'acide carboxylique de 1-ethyl-6-fluoro-1,4-dihydro-oxo-7-(1-piperazinyl)-3-quinoline ou ses sels metalliques et de la sulfadiazine d'argent
EP0363696A1 (fr) * 1988-09-22 1990-04-18 Siegfried Natterer Préparation pharmaceutique ainsi que procédé pour sa fabrication
EP0480189A1 (fr) * 1990-10-05 1992-04-15 Altergon S.A. Composition pharmaceutique à usage topique contenant du sel de sodium de l'acide hyaluronique et des désinfectants
WO1999037312A1 (fr) * 1998-01-27 1999-07-29 Vlaams Interuniversitair Instituut Voor Biotechnologie Vzw Preparation pharmaceutique a base de vanadium ou de l'un de ses sels pour le traitement des brulures
EP1319407A1 (fr) * 2001-12-14 2003-06-18 Montoie Import-Export S.A. Composition pharmaceutique pour le traitement topique des affections cutanées et des blessures cutanées

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014190227A1 (fr) * 2013-05-24 2014-11-27 Blaine Laboratories, Inc. Produit de soins de plaie à base de membrane de coquille d'œuf
US10166260B2 (en) 2013-05-24 2019-01-01 Blaine Laboratories, Inc. Wound care product with egg shell membrane
US11992508B2 (en) 2014-10-28 2024-05-28 Biovotec As Micronized eggshell membrane particles and the use thereof to promote the healing of wounds
US11045578B2 (en) 2015-06-24 2021-06-29 Biovotec As Tissue engineering scaffolds comprising particulate egg shell membrane
US10932952B2 (en) 2015-11-11 2021-03-02 Biovotec As Dry biocompatible disintegratable films for delivering particulate egg shell membrane to a wound

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