WO2009084044A1 - Composition comprising superoxide dismutase and carboxv methyl beta-1,3 glucan - Google Patents

Composition comprising superoxide dismutase and carboxv methyl beta-1,3 glucan Download PDF

Info

Publication number
WO2009084044A1
WO2009084044A1 PCT/IT2007/000914 IT2007000914W WO2009084044A1 WO 2009084044 A1 WO2009084044 A1 WO 2009084044A1 IT 2007000914 W IT2007000914 W IT 2007000914W WO 2009084044 A1 WO2009084044 A1 WO 2009084044A1
Authority
WO
WIPO (PCT)
Prior art keywords
composition
glucan
superoxide dismutase
methyl beta
sodium
Prior art date
Application number
PCT/IT2007/000914
Other languages
French (fr)
Inventor
Luigi Mercuri
Original Assignee
D.M.G. Italia Srl
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 D.M.G. Italia Srl filed Critical D.M.G. Italia Srl
Priority to EP07866845A priority Critical patent/EP2229180A1/en
Priority to PCT/IT2007/000914 priority patent/WO2009084044A1/en
Publication of WO2009084044A1 publication Critical patent/WO2009084044A1/en
Priority to IL206273A priority patent/IL206273A0/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/44—Oxidoreductases (1)
    • A61K38/446—Superoxide dismutase (1.15)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/716—Glucans
    • 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
    • A61K9/0048—Eye, e.g. artificial tears
    • 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
    • A61K9/10—Dispersions; Emulsions
    • A61K9/127—Liposomes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • A61P27/04—Artificial tears; Irrigation solutions
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y115/00—Oxidoreductases acting on superoxide as acceptor (1.15)
    • C12Y115/01—Oxidoreductases acting on superoxide as acceptor (1.15) with NAD or NADP as acceptor (1.15.1)
    • C12Y115/01001—Superoxide dismutase (1.15.1.1)

Definitions

  • composition comprising superoxide dismutase and carboxy methyl beta 1,3- glucan Description of the invention
  • the present invention refers to the pharmaceutical field and in particular to a composition comprising superoxide dismutase and carboxy methyl beta 1-3 glucan in the form of liposomes or phosphoglucan to be used in the ophthalmic field for preventing the corneal epithelium degeneration caused by aging and oxidative stress.
  • CGM carboxy methyl beta 1-3 glucan
  • CGM is preferably in aqueous solution and more preferably in a concentration from 0,2 % to 2%.
  • the pharmaceutical preparation for ophthalmic use comprises CGM 0,5%, N-hydroxymethyl glicinate 0,001%, sodium edetate 0,1% and isotonic solution pH 7,2.
  • the International patent application N. PCT/IT2006/000543 discloses a pharmaceutical preparation for ophthalmic use or for oral administration comprising sodium carboxymethyl-beta-1,3- glucan CGM inside liposomes or bound to the liposome membrane, able to improve the lubrication of the eye and to protect the eye from irritation.
  • the complex between sodium CGM and liposomes is preferably in a concentration from 0,1% to 50%, more preferably from 0,1 % to 5%.
  • the same application discloses a cosmetic composition, comprising the same sodium CGM/liposomes complex, with a protective and regenerative effect on the skin.
  • CGM/liposomes complexs with a diameter lower than 100 ⁇ m, preferably lower than 50 ⁇ m, is disclosed.
  • said combination has a lubricating, moisturizing, antioxidative and photoprotective effect and it is particularly suitable for the protection and the treatment of eye degeneration caused by oxidative stresses, such as the exposure to light radiations or laser bean during refractive surgery, it is also suitable for the prevention and the treatment of cataract.
  • composition comprising superoxide dismutase and carboxy methyl 1,3-glucan CGM.
  • a further object of the present invention is a composition comprising superoxide dismutase and a sodium carboxy methyl 1,3-glucan/liposome complex as described in PCT/IT2006/000543, herein included by reference.
  • superoxide dismutase is in a concentration from 0,001% to 2% and CGM is in a concentration from 0,01 % to 5 %.
  • the composition, object of the present invention is used for the preparation of a medicament for the treatment and the prevention of corneal epithelium degeneration due to aging and oxidative stress caused by photoexposure.
  • Said medicament is preferably formulated as a collyrium.
  • the person with ordinary skills in the pharmaceutical field can appropriately add pharmaceutically acceptable adjuvants, carriers and excipients to be used in the preparation of collyrium.

Abstract

Composition comprising superoxide dismutase and carboxy methyl beta 1-3 glucan for the prevention of the degeneration of the corneal epithelium due to aging and to oxidative stress.

Description

Composition comprising superoxide dismutase and carboxy methyl beta 1,3- glucan Description of the invention
The present invention refers to the pharmaceutical field and in particular to a composition comprising superoxide dismutase and carboxy methyl beta 1-3 glucan in the form of liposomes or phosphoglucan to be used in the ophthalmic field for preventing the corneal epithelium degeneration caused by aging and oxidative stress.
European patent N. 1 421 974 in the name of the same applicant, discloses the use of carboxy methyl beta 1-3 glucan (herein named CGM) in a pharmaceutical preparation for improving lubrication and hydration of the eye, for stimulating the regenerative processes and having an immunostimulating effect.
Usually, in the pharmaceutical preparations CGM is preferably in aqueous solution and more preferably in a concentration from 0,2 % to 2%.
In one embodiment, the pharmaceutical preparation for ophthalmic use comprises CGM 0,5%, N-hydroxymethyl glicinate 0,001%, sodium edetate 0,1% and isotonic solution pH 7,2.
The International patent application N. PCT/IT2006/000543, in the name of the same applicant, discloses a pharmaceutical preparation for ophthalmic use or for oral administration comprising sodium carboxymethyl-beta-1,3- glucan CGM inside liposomes or bound to the liposome membrane, able to improve the lubrication of the eye and to protect the eye from irritation. In the formulation, the complex between sodium CGM and liposomes is preferably in a concentration from 0,1% to 50%, more preferably from 0,1 % to 5%.
The same composition, for oral administration, exerting an immunostimulating effect on the body, is also described.
The same application discloses a cosmetic composition, comprising the same sodium CGM/liposomes complex, with a protective and regenerative effect on the skin.
Furthermore, a process for the preparation of the sodium CGM/liposomes complex by homogenization of a sodium CGM solution with a liposomes preparation or a mixture of water/glicerin/alcoho! followed by the filtration through a membrane with pores of 1-5 μm in order to obtain sodium
CGM/liposomes complexs with a diameter lower than 100 μm, preferably lower than 50 μm, is disclosed.
It is well known in the art that superoxide dismutase (hereinafter defined as
SOD) levels decrease with aging and in the presence of cataract (Scharf J et al., Ophthalmic Res. 1987;18:332-337; Scharf J et al., Arch Clin Exp
Ophthalmol, 1987;225:133-136).
It has been demonstrated that during cataract development, SOD becomes thermolabile and inactive (Ohrloff C et al., Mod Trends Aging Res
1986;147:365-371), the enzyme inactivation is caused by glycation of lysine
(Lys) residues in the molecule reaction centre (Takata I et al., Biochem
Biophys Res Commun. 1996;219:243-248.73). On the contrary, SOD expression prevents cataract formation (Lin D et al.,
Molecular Vision, 2005; 11:853-8) and protects the corneal endothelium from aging and oxidative stress (Behndig A et al., IOVS, 2001, 42-12).
There is a strong need to avoid degenerative processes due to oxidative stress and to prevent cataract formation which may dangerously compromise the eye functions.
It was proven that the combination between superoxide dismutase and carboxy methyl beta 1,3-glucan in liposomes exert a surprisingly synergic effect which is higher that the effect exerted by the single components alone.
In particular, said combination has a lubricating, moisturizing, antioxidative and photoprotective effect and it is particularly suitable for the protection and the treatment of eye degeneration caused by oxidative stresses, such as the exposure to light radiations or laser bean during refractive surgery, it is also suitable for the prevention and the treatment of cataract.
It is an object of the present invention a composition comprising superoxide dismutase and carboxy methyl 1,3-glucan CGM.
A further object of the present invention is a composition comprising superoxide dismutase and a sodium carboxy methyl 1,3-glucan/liposome complex as described in PCT/IT2006/000543, herein included by reference.
Preferably, superoxide dismutase is in a concentration from 0,001% to 2% and CGM is in a concentration from 0,01 % to 5 %. The composition, object of the present invention, is used for the preparation of a medicament for the treatment and the prevention of corneal epithelium degeneration due to aging and oxidative stress caused by photoexposure.
Said medicament is preferably formulated as a collyrium.
The person with ordinary skills in the pharmaceutical field can appropriately add pharmaceutically acceptable adjuvants, carriers and excipients to be used in the preparation of collyrium.
In a preferred embodiment the collyrium has the following composition:
Superoxide dismutase 0,001- 2%
CGM 0,01 - 5%
Edta disodium salt 0,05 - 1%
Microglicin-50 0,001- 0.5%
Copolymer PVA/MA 0,0005 - 1%
Sodium hydrate 0,0005 - 0.5%
Sodium Chloride 0,1 - 1%
Sodium phosphate monobasic 0,1 - 1%
Sodium phosphate dibasic 0,1- 2%
Demi water to 100

Claims

Claims
1. Composition comprising superoxide dismutase and carboxy methyl beta 1,3- glucan.
2. Composition according to claim 1 wherein carboxy methyl beta 1,3-glucan is in a complex with liposomes.
3. Composition according to claim 2 wherein carboxy methyl beta 1,3-glucan is in the form of a sodium (Na) salt.
4. Composition according to claim 1 wherein superoxide dismutase is in a concentration from 0,001% to 2%.
5. Composition according to any one of the claims from 1 to 3 wherein carboxy methyl beta 1,3-glucan is in a concentration from 0,01 % to 5 %.
6. Use of the composition of any one of the claims from 1 to 5 for the preparation of a medicament.
7. Use of the composition of any one of the claims from 1 to 5 for the preparation of a medicament for the prevention of the degeneration of the corneal epithelium due to aging and oxidative stress.
8. Formulation in the form of collyrium having the following composition: Superoxide Dismutase 0,001- 2%
Phosphoglucan 0,01 - 5%
Edta disodium salt 0,05 - 1%
Microglicin-50 0,001- 0.5%
Copolymer PVA/MA 0,0005 - 1%
Sodium hydrate 0,0005 - 0.5% Sodium Chloride 0,1 - 1%
Sodium phosphate monobasic 0,1 - 1%
Sodium phosphate dibasic 0,1- 2%
Water demi to 100
PCT/IT2007/000914 2007-12-27 2007-12-27 Composition comprising superoxide dismutase and carboxv methyl beta-1,3 glucan WO2009084044A1 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
EP07866845A EP2229180A1 (en) 2007-12-27 2007-12-27 Composition comprising superoxide dismutase and carboxv methyl beta-1,3 glucan
PCT/IT2007/000914 WO2009084044A1 (en) 2007-12-27 2007-12-27 Composition comprising superoxide dismutase and carboxv methyl beta-1,3 glucan
IL206273A IL206273A0 (en) 2007-12-27 2010-06-09 Composition comprising superoxide dismutase and carboxy methyl beta-1,3 glucan

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/IT2007/000914 WO2009084044A1 (en) 2007-12-27 2007-12-27 Composition comprising superoxide dismutase and carboxv methyl beta-1,3 glucan

Publications (1)

Publication Number Publication Date
WO2009084044A1 true WO2009084044A1 (en) 2009-07-09

Family

ID=39731080

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IT2007/000914 WO2009084044A1 (en) 2007-12-27 2007-12-27 Composition comprising superoxide dismutase and carboxv methyl beta-1,3 glucan

Country Status (3)

Country Link
EP (1) EP2229180A1 (en)
IL (1) IL206273A0 (en)
WO (1) WO2009084044A1 (en)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0781547A1 (en) * 1995-12-22 1997-07-02 Chemedica S.A. Sodium hyaluronate based ophthalmic formulation for use in eye surgery
WO1999033439A1 (en) * 1997-12-24 1999-07-08 Shaklee Corporation Composition with high efficiency skin protection from damaging effects of ultraviolet light
WO2001085141A1 (en) * 2000-05-09 2001-11-15 Mcp Hahnemann University β-GLUCANS ENCAPSULATED IN LIPOSOMES
EP1421974A1 (en) * 2002-06-10 2004-05-26 D.M.G. Italia Srl Carboxy methyl beta-1, 3 glucan containing ophthalmic solution

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0781547A1 (en) * 1995-12-22 1997-07-02 Chemedica S.A. Sodium hyaluronate based ophthalmic formulation for use in eye surgery
WO1999033439A1 (en) * 1997-12-24 1999-07-08 Shaklee Corporation Composition with high efficiency skin protection from damaging effects of ultraviolet light
WO2001085141A1 (en) * 2000-05-09 2001-11-15 Mcp Hahnemann University β-GLUCANS ENCAPSULATED IN LIPOSOMES
EP1421974A1 (en) * 2002-06-10 2004-05-26 D.M.G. Italia Srl Carboxy methyl beta-1, 3 glucan containing ophthalmic solution

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
BABINCOVA M ET AL: "ANTIOXIDANT PROPERTIES OF CARBOXYMETHYL GLUCAN: COMPARATIVE ANALYSIS", JOURNAL OF MEDICINAL FOOD, MARY ANN LIEBERT, LARCHMONT, NY, US, vol. 5, no. 2, 1 June 2002 (2002-06-01), pages 79 - 83, XP009073120, ISSN: 1096-620X *
ZUELLI F ET AL: "Improving skin function with CM-glucan, a biological response modifier from yeast", INTERNATIONAL JOURNAL OF COSMETIC SCIENCE, KLUWER ACADEMIC PUBLISHERS, DORDRECHT, NL, vol. 20, no. 2, 1 April 1998 (1998-04-01), pages 79 - 86, XP002213159, ISSN: 0142-5463 *

Also Published As

Publication number Publication date
IL206273A0 (en) 2010-12-30
EP2229180A1 (en) 2010-09-22

Similar Documents

Publication Publication Date Title
JP2005104862A (en) Aged macular degeneration therapeutic agent
JP5167499B2 (en) Use of pirenoxine to protect corneal tissue in photokeratotomy
WO2020021481A1 (en) Compositions and methods for treating the eye
JP3362501B2 (en) Corneal disorder treatment
US11878041B2 (en) Compositions and methods for treating the eye
JP2005516017A (en) Pharmaceutical conjugates exhibiting improved pharmacokinetic properties
AU2019311849B2 (en) Compositions and methods for treating the eye
AU2022263530A1 (en) Compositions and methods for treating the eye
WO2009084044A1 (en) Composition comprising superoxide dismutase and carboxv methyl beta-1,3 glucan
JP2011144111A (en) Axial myopia-preventing or treating agent
RU2795913C2 (en) Compositions and methods for treating eye disorders
RU2792627C2 (en) Compositions and methods for treating eye disorders
EP3824877A1 (en) Compositions and methods for treating the eye
RU2793736C2 (en) Compositions and methods for eye treatment
US20210145909A1 (en) Compositions and Methods for Treating the Eye
US8916543B1 (en) Inhibitors of alpha-toxin
RU2118523C1 (en) Ophthalmological agent used for glaucoma treatment mainly
WO2022079664A1 (en) Benzalkonium chloride for use in treating conjunctivitis and/or covid-19
RU2171659C2 (en) Method for applying medication treatment of keratoconus
JP2005200411A (en) Lacrimal fluid layer stabilizing agent
WO2005058932A1 (en) Tear layer stabilizer

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 07866845

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

WWE Wipo information: entry into national phase

Ref document number: 2007866845

Country of ref document: EP