WO2007045407A2 - Nutraceutical and pharmaceutical compositions containing choline as adiuvants for the prevention and treatment of retinopathies and glaucoma - Google Patents

Nutraceutical and pharmaceutical compositions containing choline as adiuvants for the prevention and treatment of retinopathies and glaucoma Download PDF

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Publication number
WO2007045407A2
WO2007045407A2 PCT/EP2006/009926 EP2006009926W WO2007045407A2 WO 2007045407 A2 WO2007045407 A2 WO 2007045407A2 EP 2006009926 W EP2006009926 W EP 2006009926W WO 2007045407 A2 WO2007045407 A2 WO 2007045407A2
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choline
compositions according
treatment
nutraceutical
prevention
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PCT/EP2006/009926
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French (fr)
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WO2007045407A3 (en
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Massimo Ronchetti
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ARTMED Srl
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ARTMED Srl
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Priority claimed from IT001969A external-priority patent/ITMI20051969A1/en
Priority claimed from ITMI20051968 external-priority patent/ITMI20051968A1/en
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Priority to EP06806269A priority Critical patent/EP1951071A2/en
Publication of WO2007045407A2 publication Critical patent/WO2007045407A2/en
Publication of WO2007045407A3 publication Critical patent/WO2007045407A3/en
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    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/16—Inorganic salts, minerals or trace elements
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/105—Plant extracts, their artificial duplicates or their derivatives
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/115—Fatty acids or derivatives thereof; Fats or oils
    • A23L33/12—Fatty acids or derivatives thereof
    • 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
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs

Definitions

  • the present invention relates to nutraceutical and pharmaceutical compositions useful as adjuvant for the prevention and treatment of retinopathies (macular degeneration, diabetic retinopathy, etc.) and glaucoma, in particular to compositions containing choline.
  • retinopathies molecular degeneration, diabetic retinopathy, etc.
  • glaucoma compositions containing choline.
  • Age-Related Macular Degeneration is a degenerative disease of the macula (the central portion of the retina). This pathology is the most common cause of sight loss in persons generally over 50. The incidence statistically increase with age. ARMD is caused by several and different factors. Defective arterial circulation, whereby capillary perfusion and supply of oxygen and other nutrients essential for correct functioning of the retina are reduced, determine the typical macular damage with consequent loss of central vision.
  • Several systematic clinical studies have shown a close relationship between the diet and ARMD development: it has been demonstrated that a diet rich in fruit and vegetables (in particular green-leaf vegetables and berries) remarkably lowers ARMD incidence. Clinical studies recently carried out in the USA have shown that in patients whose diet was enriched in minerals and specific antioxidants, ARMD incidence was reduced by 25%.
  • Glaucoma is an optic neuropathy characterized by rise in intraocular pressure and loss of visual field, causing slight or severe loss of vision, as the increased intraocular pressure damages the optic nerve and retinal ganglion cells death by apoptosis.
  • the pharmacological therapy depends of the type of glaucoma, that can be primary (chronic or acute) or secondary.
  • Treatments can be either topical (administration of eye-drops containing, e.g., pilocarpine, beta-blockers, prostaglandin F2 analogues selective, alpha-agonists ff FP prostanoid receptor, carbonic anhydrase inhibitors) or systemic (administration of carbonic anhydrase inhibitors) which reduce intraocular pressure by decreasing aqueous humor production or increasing its drainage.
  • eye-drops containing, e.g., pilocarpine, beta-blockers, prostaglandin F2 analogues selective, alpha-agonists ff FP prostanoid receptor, carbonic anhydrase inhibitors
  • systemic administration of carbonic anhydrase inhibitors
  • compositions comprising biologically active compounds exerting protective action on the optic nerve.
  • WO 93/18028 claims compositions containing phospholipids and antioxidants for the treatment of macular degeneration.
  • GB 1431841 discloses ophthalmic-nutritional compositions containing vitamins and choline.
  • Choline has several biological functions, for example it's a precursor of phosphatidylcholine and sphingomyelin, which are components of the cell membranes, nervous cells membranes included; as a consequence, choline administration can facilitate the biosynthesis of membrane phospholipids and exert a neuro-protective function.
  • WO 93/15717 discloses the use of a choline salt for the treatment of diabetic retinopathy. It would be therefore advantageous to provide nutritional compositions which can be used as adjuvants for the prevention and/or treatment of retinopathies (ARMD, diabetic retinopathy, etc.).
  • WO 05/37262 discloses oral compositions containing citicholine as a choline donor, in combination with Vitamins A e B 6 for the treatment of eye disorders such as glaucoma and amblyopia.
  • WO 9315717 discloses the use of angiotensin II antagonists choline salts for the treatment of glaucoma.
  • compositions useful as adjutants in the prevention and/or treatment of retinopathies would therefore be advantageous. Disclosure of the invention
  • compositions containing choline or salts or derivatives thereof, unsaturated fatty acids and antioxidants are particularly effective as adjuvants for the prevention and/or treatment of retinopathies (ARMD, diabetic retinopathy, etc.), as well as for the prevention and/or treatment of glaucoma.
  • the invention relates to nutritional or pharmaceutical compositions containing a combination of choline, or biologically acceptable salts or derivatives thereof, unsaturated fatty acids and optionally antioxidants.
  • salts or derivatives thereof means biologically acceptable salts or derivatives, such as choline hydrochloride or choline bitartrate, preferably choline bitartrate.
  • the preferred choline derivative is cytidine-diphosphocholine, commonly known as citicholine.
  • the amount of choline in the formulations is comprised between 100 and 1000 mg.
  • saturated fatty acids indicates preferably linoleic acid, arachidonic acid, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).
  • the formulations intended for use in the prevention and/or treatment of retinopathies will contain antioxidants selected from lipoic acid, luteine, flavonoids and minerals such as zinc and copper.
  • flavonoids quercetine, anthocyanes, proanthocyanidins and soy isoflavones are preferred.
  • the proanthocyanidins will derive from Vitis vinifera.
  • the formulations intended for use in the prevention and/or treatment of glaucoma will contain docosahexaenoic acid as the unsaturated fatty acid.
  • the formulations intended for use in the prevention and/or treatment of glaucoma will further contain biologically active substances exerting neuro-protective action, particularly vitamins of the B group.
  • said formulations will further contain one or more substances selected from inositol, forskolin, folic acid, vitamin B 12 , vitamin B 6 and quercetin.
  • compositions of the invention can be prepared according to conventional techniques and with excipients well known to those skilled in the art and disclosed, for example, in Remington's Pharmaceutical Sciences Handbook, XVII ed. Mack Pub., N.Y., U.S.A..
  • the compositions of the invention can be in the form of tablets, capsules, powders, granules, beads, gels, solutions or suspensions, whose posology will be determined according to the patient's needs and age.

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  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Mycology (AREA)
  • Nutrition Science (AREA)
  • Food Science & Technology (AREA)
  • Polymers & Plastics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Inorganic Chemistry (AREA)
  • Botany (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

The invention relates to nutraceutical and pharmaceutical compositions containing choline, unsaturated fatty acids and optionally antioxidants useful as adjuvants in the prevention and treatment of retinopathies (ARMD, diabetic retinopathy, etc.) and glaucoma.

Description

NUTRACEUTICAL AND PHARMACEUTICAL COMPOSITIONS CONTAINING CHOLINE AS ADIUVANTS FOR THE PREVENTION AND TREATMENT OF RETINOPATHIES AND GLAUCOMA
Field of the invention
The present invention relates to nutraceutical and pharmaceutical compositions useful as adjuvant for the prevention and treatment of retinopathies (macular degeneration, diabetic retinopathy, etc.) and glaucoma, in particular to compositions containing choline. State of the art
Age-Related Macular Degeneration (ARMD) is a degenerative disease of the macula (the central portion of the retina). This pathology is the most common cause of sight loss in persons generally over 50. The incidence statistically increase with age. ARMD is caused by several and different factors. Defective arterial circulation, whereby capillary perfusion and supply of oxygen and other nutrients essential for correct functioning of the retina are reduced, determine the typical macular damage with consequent loss of central vision. Several systematic clinical studies have shown a close relationship between the diet and ARMD development: it has been demonstrated that a diet rich in fruit and vegetables (in particular green-leaf vegetables and berries) remarkably lowers ARMD incidence. Clinical studies recently carried out in the USA have shown that in patients whose diet was enriched in minerals and specific antioxidants, ARMD incidence was reduced by 25%.
Glaucoma is an optic neuropathy characterized by rise in intraocular pressure and loss of visual field, causing slight or severe loss of vision, as the increased intraocular pressure damages the optic nerve and retinal ganglion cells death by apoptosis. The pharmacological therapy depends of the type of glaucoma, that can be primary (chronic or acute) or secondary. Treatments can be either topical (administration of eye-drops containing, e.g., pilocarpine, beta-blockers, prostaglandin F2 analogues selective, alpha-agonists ff FP prostanoid receptor, carbonic anhydrase inhibitors) or systemic (administration of carbonic anhydrase inhibitors) which reduce intraocular pressure by decreasing aqueous humor production or increasing its drainage.
Recently, efforts have been made to support pharmacological therapy with compositions comprising biologically active compounds exerting protective action on the optic nerve. WO 93/18028 claims compositions containing phospholipids and antioxidants for the treatment of macular degeneration.
GB 1431841 discloses ophthalmic-nutritional compositions containing vitamins and choline. Choline has several biological functions, for example it's a precursor of phosphatidylcholine and sphingomyelin, which are components of the cell membranes, nervous cells membranes included; as a consequence, choline administration can facilitate the biosynthesis of membrane phospholipids and exert a neuro-protective function.
WO 93/15717 discloses the use of a choline salt for the treatment of diabetic retinopathy. It would be therefore advantageous to provide nutritional compositions which can be used as adjuvants for the prevention and/or treatment of retinopathies (ARMD, diabetic retinopathy, etc.).
WO 05/37262 discloses oral compositions containing citicholine as a choline donor, in combination with Vitamins A e B 6 for the treatment of eye disorders such as glaucoma and amblyopia.
WO 9315717 discloses the use of angiotensin II antagonists choline salts for the treatment of glaucoma.
Some compositions useful as adjutants in the prevention and/or treatment of retinopathies (ARMD, diabetic retinopathy, etc.) and glaucoma, would therefore be advantageous. Disclosure of the invention
It has now been found that compositions containing choline or salts or derivatives thereof, unsaturated fatty acids and antioxidants, are particularly effective as adjuvants for the prevention and/or treatment of retinopathies (ARMD, diabetic retinopathy, etc.), as well as for the prevention and/or treatment of glaucoma. Accordingly, the invention relates to nutritional or pharmaceutical compositions containing a combination of choline, or biologically acceptable salts or derivatives thereof, unsaturated fatty acids and optionally antioxidants. The expression "salts or derivatives thereof means biologically acceptable salts or derivatives, such as choline hydrochloride or choline bitartrate, preferably choline bitartrate. The preferred choline derivative is cytidine-diphosphocholine, commonly known as citicholine.
The amount of choline in the formulations is comprised between 100 and 1000 mg.
The term "unsaturated fatty acids" indicates preferably linoleic acid, arachidonic acid, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).
According to a preferred aspect of the invention, the formulations intended for use in the prevention and/or treatment of retinopathies (ARMD, diabetic retinopathy, etc.), will contain antioxidants selected from lipoic acid, luteine, flavonoids and minerals such as zinc and copper. Among flavonoids, quercetine, anthocyanes, proanthocyanidins and soy isoflavones are preferred. Preferably, the proanthocyanidins will derive from Vitis vinifera. According to a preferred aspect of the invention, the formulations intended for use in the prevention and/or treatment of glaucoma will contain docosahexaenoic acid as the unsaturated fatty acid.
According to a preferred aspect of the invention, the formulations intended for use in the prevention and/or treatment of glaucoma will further contain biologically active substances exerting neuro-protective action, particularly vitamins of the B group. According to a more preferred aspect of the invention, said formulations will further contain one or more substances selected from inositol, forskolin, folic acid, vitamin B12, vitamin B6 and quercetin.
The compositions of the invention can be prepared according to conventional techniques and with excipients well known to those skilled in the art and disclosed, for example, in Remington's Pharmaceutical Sciences Handbook, XVII ed. Mack Pub., N.Y., U.S.A.. The compositions of the invention can be in the form of tablets, capsules, powders, granules, beads, gels, solutions or suspensions, whose posology will be determined according to the patient's needs and age.
The following examples illustrate the invention in greater detail:
EXAMPLE 1
Figure imgf000005_0001
EXAMPLE 2
Figure imgf000006_0001

Claims

1. Nutraceutical and pharmaceutical compositions containing choline or a salt or a biologically acceptable derivative thereof in combination with unsaturated fatty acids in admixture with suitable excipients and/or vehicles.
2. Compositions according to claim 1 wherein the salt is choline hydrochloride or choline bitartrate.
3. Compositions according to claim 2 wherein the choline salt is choline bitartrate.
4 Compositions according to claim 1 wherein the choline derivative is citicholine.
5. Compositions according to any one of claims 1-4 wherein the unsaturated fatty acid is selected from linoleic acid, arachidonic acid, eicosapentaenoic acid, docosahexaenoic acid.
6. Compositions according to any one of claims 1-5, further containing antioxidants.
7. Compositions according to claim 6 wherein the antioxidants are selected from: lipoic acid, lutein, flavonoids, zinc and copper.
8. Compositions according to claim 7 wherein the flavonoids are selected from quercetine, anthocyanin, proanthocyanidins and soy isoflavones.
9. Compositions according to claim 8 wherein the proanthocyanidins are Vitis Vinifera proanthocyanidins.
10. Compositions according to any one of claims 1-5 further contain one or more substances selected from inositol, forskolin, folic acid, vitamin B12, vitamin B6 e quercetin.
11. Compositions according to any one of claims 1-10 in the form of tablets, capsules, powders, granules, beads, gels, solutions or suspensions.
12. The use of a combination of choline or a pharmacologically acceptable derivative thereof with unsaturated fatty acids, for the preparation of nutraceutical and pharmaceutical compositions for the prevention and/or treatment of retinopathies and glaucoma.
13. The use of a combination of choline or a pharmacologically acceptable derivative thereof with unsaturated fatty acids and antioxidants, for the preparation of nutraceutical and pharmaceutical compositions for the prevention and/or treatment of retinopathies.
14. The use of a combination of choline or a pharmacologically acceptable derivative thereof with unsaturated fatty acids, for the preparation of nutraceutical and pharmaceutical compositions for the prevention and/or treatment of glaucoma.
PCT/EP2006/009926 2005-10-18 2006-10-13 Nutraceutical and pharmaceutical compositions containing choline as adiuvants for the prevention and treatment of retinopathies and glaucoma Ceased WO2007045407A2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP06806269A EP1951071A2 (en) 2005-10-18 2006-10-13 Nutraceutical and pharmaceutical compositions containing choline as adiuvants for the prevention and treatment of retinopathies and glaucoma

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
ITMI2005A001968 2005-10-18
IT001969A ITMI20051969A1 (en) 2005-10-18 2005-10-18 CHINA-BASED NEUTRACEUTICAL COMPOSITIONS GIVEN IN THE PREVENTION AND TREATMENT OF MACULAR DEGENERATION AND RETINOPATHIES
ITMI2005A001969 2005-10-18
ITMI20051968 ITMI20051968A1 (en) 2005-10-18 2005-10-18 COLINA-BASED NEUTRACEUTICAL COMPOSITIONS IN THE PREVENTION AND TREATMENT OF GLAUCOMA

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WO2007045407A2 true WO2007045407A2 (en) 2007-04-26
WO2007045407A3 WO2007045407A3 (en) 2007-07-26

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ITRM20120284A1 (en) * 2012-06-18 2013-12-19 Omikron Italia S R L CITICOLINE FOR THE TREATMENT OF DIABETIC RETINOPATHY.

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IL104756A0 (en) * 1992-02-17 1993-06-10 Ciba Geigy Ag Composition for the treatment of glaucoma
US5626849A (en) * 1995-06-07 1997-05-06 Reliv International, Inc. Weight loss composition for burning and reducing synthesis of fats
US7208180B2 (en) * 2000-05-08 2007-04-24 N.V. Nutricia Method and preparation for the preventing and/or treating vascular disorders and secondary disorders associated therewith
US7226916B1 (en) * 2000-05-08 2007-06-05 N.V. Nutricia Preparation for the prevention and/or treatment of vascular disorders
CN102319266B (en) * 2001-06-18 2014-12-17 海王星技术&生物资源有限公司 Krill and/or seafood extracts for the prevention and/or treatment of cardiovascular disease, arthritis, skin cancer, diabetes, PMS and transdermal delivery
AU2002320251A1 (en) * 2001-07-05 2003-01-21 Vital Basics, Inc. Compositions for improving mental performance
US6541043B2 (en) * 2001-08-28 2003-04-01 Dexgen Pharmaceuticals, Inc. Method and synergistic composition for treating attention deficit/hyperactivity disorder
MXPA05009933A (en) * 2003-03-18 2005-11-04 Novartis Ag Compositions comprising fatty acids and amino acids.
ITRM20030485A1 (en) * 2003-10-22 2005-04-23 Tubilux Pharma S P A COMPOSITION BASED ON CITICOLINE IN ASSOCIATION WITH VITAMINS FOR THE PREVENTION AND TREATMENT OF EYE PATOLGIES.
WO2006121421A2 (en) * 2004-01-14 2006-11-16 Robert Ritch Methods and formulations for treating glaucoma
JP4587442B2 (en) * 2004-02-12 2010-11-24 株式会社クレハ Novel antihyperlipidemic agent and food
JP4587441B2 (en) * 2004-02-12 2010-11-24 株式会社クレハ Novel diabetes treatment and food

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ITRM20120284A1 (en) * 2012-06-18 2013-12-19 Omikron Italia S R L CITICOLINE FOR THE TREATMENT OF DIABETIC RETINOPATHY.

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EP1951071A2 (en) 2008-08-06

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