EP2229180A1 - Composition comprising superoxide dismutase and carboxv methyl beta-1,3 glucan - Google Patents

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

Info

Publication number
EP2229180A1
EP2229180A1 EP07866845A EP07866845A EP2229180A1 EP 2229180 A1 EP2229180 A1 EP 2229180A1 EP 07866845 A EP07866845 A EP 07866845A EP 07866845 A EP07866845 A EP 07866845A EP 2229180 A1 EP2229180 A1 EP 2229180A1
Authority
EP
European Patent Office
Prior art keywords
composition
glucan
superoxide dismutase
methyl beta
sodium
Prior art date
Legal status (The legal status 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 status listed.)
Withdrawn
Application number
EP07866845A
Other languages
German (de)
French (fr)
Inventor
Luigi Mercuri
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
DMG Italia SRL
Original Assignee
DMG 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 DMG Italia SRL filed Critical DMG Italia SRL
Publication of EP2229180A1 publication Critical patent/EP2229180A1/en
Withdrawn legal-status Critical Current

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.

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Ophthalmology & Optometry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Dispersion Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • General Engineering & Computer Science (AREA)
  • Genetics & Genomics (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

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
EP07866845A 2007-12-27 2007-12-27 Composition comprising superoxide dismutase and carboxv methyl beta-1,3 glucan Withdrawn EP2229180A1 (en)

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
EP2229180A1 true EP2229180A1 (en) 2010-09-22

Family

ID=39731080

Family Applications (1)

Application Number Title Priority Date Filing Date
EP07866845A Withdrawn EP2229180A1 (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)

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IT1277707B1 (en) * 1995-12-22 1997-11-11 Chemedica Sa OPHTHALMIC FORMULATION BASED ON SODIUM HYALURONATE FOR USE IN OCULAR SURGERY
JP4150501B2 (en) * 1997-12-24 2008-09-17 シャクリー コーポレイション Composition with high efficiency skin protection from the damaging effects of ultraviolet light
US7011845B2 (en) * 2000-05-09 2006-03-14 Mcp Hahnemann University β-glucans encapsulated in liposomes
DE60216612T2 (en) * 2002-06-10 2007-09-20 D.M.G. Italia S.R.L. Carboxy methyl beta-1,3 glucan-containing ophthalmic solution

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO2009084044A1 *

Also Published As

Publication number Publication date
WO2009084044A1 (en) 2009-07-09
IL206273A0 (en) 2010-12-30

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