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EP1696743A1 - Produit de combinaison de micronutriments adapte au regime bilan complementaire dans le cadre de la degenerescence maculaire liee a l'age - Google Patents

Produit de combinaison de micronutriments adapte au regime bilan complementaire dans le cadre de la degenerescence maculaire liee a l'age

Info

Publication number
EP1696743A1
EP1696743A1 EP04817575A EP04817575A EP1696743A1 EP 1696743 A1 EP1696743 A1 EP 1696743A1 EP 04817575 A EP04817575 A EP 04817575A EP 04817575 A EP04817575 A EP 04817575A EP 1696743 A1 EP1696743 A1 EP 1696743A1
Authority
EP
European Patent Office
Prior art keywords
combination product
weight
micronutrient combination
vitamin
micronutrient
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Withdrawn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
EP04817575A
Other languages
German (de)
English (en)
Inventor
Günter Bellmann
Gudrun Claus-Herz
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.)
Dr Gerhard Mann Chem Pharm Fabrik GmbH
Original Assignee
Dr Gerhard Mann Chem Pharm Fabrik GmbH
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 Dr Gerhard Mann Chem Pharm Fabrik GmbH filed Critical Dr Gerhard Mann Chem Pharm Fabrik GmbH
Publication of EP1696743A1 publication Critical patent/EP1696743A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • 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
    • A23L33/105—Plant extracts, their artificial duplicates or their derivatives
    • 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
    • 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 a mifaonutrient combination product.
  • the micronutrient combination product can be used, for example, for the supplementary balanced diet in the case of age-related macular degeneration.
  • Carotenoids lutein and zeaxanthin as well as the trace element zinc are decisively involved.
  • the system offers optimal protection only if all of its active components are available in sufficient quantities.
  • the organs that require a particularly high concentration of the carotenoids lutein and zeaxanthin include the macula of the eye.
  • the medical term "macula lutea” is to be understood as the center of the retina, ie the point of sharpest vision. This is where the most sensitive visual cells of the eye are located.
  • the vitamin preparations known in the prior art contain various, often high-dose, compositions of vitamins and trace elements, which, however, are not aimed at supplying the macula of the eye. Most of these compositions contain high levels of antioxidant vitamins and trace elements, but not lutein and zeaxanthin. A disadvantage of these preparations is their lack of consideration of the macula, which has a central function in the visual process.
  • antioxidant preparations Another disadvantage of commercially available antioxidant preparations is that the age-dependent vitamin and mineral requirements are not taken into account enough. Deficiency symptoms due to undersupply due to malnutrition or malnutrition or illness can quickly become noticeable in old age in particular with regard to diseases such as AMD, which are not adequately taken into account by means of coordinated preparations.
  • vitamin-like carotenoids lutein and zeaxanthin accumulate selectively in high concentrations in the macula and thus protect this area by filtering the light and trapping the harmful "free radicals".
  • the targeted supply These essential micronutrients can therefore help protect the eye from the development of age-related macular degeneration or slow its progression.
  • micronutrient combination product according to the invention has copper, which counteracts a possible copper deficiency which can result from the intake of zinc. It is advantageous that the invention
  • Mfconutrient combination product due to the low zinc content according to the invention and the resulting significant reduction in side effects caused by zinc, comprises an extremely low dose of copper.
  • Micronutrient combination product is available that provides a comprehensive and balanced supply of the macula. It continues through each other coordinated administration of the carotenoids and trace elements safely prevents overdosing and provides a coordinated supply
  • the mtoonutrient combination product according to the invention can be used for a supplementary balanced diet or for accompanying administration, for example in the treatment of age-related macular degeneration.
  • the micronutrient combination product based on the total weight of the micronutrient combination product, has the active ingredients: a. 0.5% by weight to 5% by weight, preferably 0.75% by weight to 2.5% by weight, particularly preferably 0.8% by weight to 1.2% by weight, lutein; b. 0.01% by weight to 0.1% by weight, preferably 0.02% by weight to 0.08% by weight, particularly preferably 0.04% by weight to 0.06% by weight, zeaxanthin ; c. 0.005% by weight to 0.1% by weight, preferably 0.01% by weight to 0.08% by weight, particularly preferably 0.015% by weight to 0.05% by weight, copper; d. 0.5% by weight to 5% by weight, preferably 1% by weight to 2.5% by weight, particularly preferably 1.3% by weight to 2% by weight, zinc
  • micronutrients are the substances which the micronutrient combination product has, preferably selected from the group comprising zeaxanthin, lutein, zinc, copper, vitamin E and / or vitamin C.
  • the micronutrient combination product advantageously has at least one vitamin, preferably vitamin C and / or vitamin E.
  • the mtoonutrient combination ion product based on the total weight of the micronutrient combination ion product, has 5% by weight to 30% by weight, preferably 10% by weight to 20% by weight, particularly preferably 10% by weight to 15% by weight % Vitamin C and / or 0.5% by weight to 3% by weight, preferably 1% by weight to 2% by weight, particularly preferably 1.0% by weight to 1.5% by weight, of vitamin E.
  • the micronutrient combination product has lutein, zeaxanthin, zinc, copper, vitamin C and vitamin E.
  • the micronutrient combination product based on the total weight of the micronutrient combination product, comprises the active ingredients: a. 1 wt% lutein; b. 0.05 wt% zeaxanthin c. 12.5% by weight of vitamin C; d. 1.25% by weight of vitamin E; e. 0.033% by weight copper; f. 1.67% by weight zinc.
  • Suitable salts are selected, for example, from the group comprising sulfates and / or oxides.
  • zinc and copper are in the form of zinc gluconate and copper (II) gluconate.
  • the use of zinc gluconate and copper (II) gluconate advantageously improves the bioavailability.
  • Zinc gluconate shows better absorption than the commonly used zinc oxide. Zinc gluconate can also show better absorption than zinc sulfate. This increased bioavailability enables a much smaller amount of zinc to be used as a daily dose or as a single dose, thereby reducing the risk of
  • Zinc gluconate in particular shows a significantly better absorption than the frequently used zinc oxide.
  • the supply of zinc to the macula is believed to be improved by using zinc gluconate. It is it is also conceivable that the necessary amount of zinc of the micronutrient combination product can be reduced by the use of the readily absorbable zinc gluconate, and thus a possible overdosing can be avoided.
  • the mücronutrient combination product which is optimally formulated with regard to its constituents, based on a daily dose of the micronutrient combination product, comprises the active ingredients: a. 2 mg to 40 mg, preferably 6 mg to 24 mg, lutein; b. 0.1 mg to 2 mg, preferably 0.3 mg to 1.2 mg, zeaxanthin; c. 50 mg to 500 mg, preferably 75 mg to 300 mg, vitamin C; d. 2 mg to 60 mg, preferably 7.5 mg to 30 mg, vitamin E; e. 0.02 mg to 2 mg, preferably 0.2 mg to 0.8 mg, copper; f. 1 mg to 80 mg, preferably 10 mg to 40 mg, zinc.
  • active ingredients a. 2 mg to 40 mg, preferably 6 mg to 24 mg, lutein; b. 0.1 mg to 2 mg, preferably 0.3 mg to 1.2 mg, zeaxanthin; c. 50 mg to 500 mg, preferably 75 mg to 300 mg, vitamin C; d. 2 mg to 60 mg, preferably
  • the micronutrient combination product according to the invention has zeaxanthin, which, in a balanced combination with lutein, the trace elements zinc and copper and other vilamines with an antioxidative effect, through a balanced supply of the macula to prevent radical damage to the effect of the agent according to the invention contributes, which has a positive influence on the improvement of vision in old age and the development of age-related macular degeneration is made more difficult. It has surprisingly been found that in particular the use of zeaxanthine in accordance with the invention combined with zinc has a positive effect on the supply to consumers compared to the use of monopreparations.
  • the use of vilamin-like carotenoids with antioxidant properties together with zinc and copper in accordance with the invention shows that
  • Micronutrient combination product has an improved nutritional or dietary effect.
  • the advantageous properties result from the optimized selection of the individual components, which were specifically selected to combat oxidative damage to the macula by radicals and compensate for a deficit in antioxidants caused by nutritional deficits or risk factors such as smoking and alcohol consumption, environmental pollution, stress or UV radiation ,
  • Another advantage of the nutrient combination product according to the invention is the synergistic effect with regard to a comprehensive holistic care of the macula.
  • the macula is strengthened by the optimized combination of vitamins and trace elements, especially the vitamins carotenoids lutein and zeaxanthin and zinc and copper.
  • the dosages of the agent according to the invention do not cause any damaging side effects and can be used for prophylaxis and to compensate for an existing deficiency in the macula.
  • This is advantageous for the supplementary balanced diet as well as for the dietary treatment for age-related macular degeneration.
  • a positive effect is shown in particular by a supplementary balanced diet or dietary administration in deficiency states and the prevention of the development of a deficiency situation that can lead to age-related macular degeneration.
  • Embodiments of the mifaonutrient combination product which contain no further carotenoids may be suitable. Administration of additional carotenoids can have an adverse effect on absorption and / or cause a possible interaction of the carotenoids.
  • the micronutrient combination product can be in solid, liquid and / or gel form; the micronutrient combination product is preferably in preparation forms selected from the group comprising tablets, film-coated tablets, dragées, capsules, powder, granules, solutions and / or effervescent tablets with the same or different compositions ,
  • the micronutrient combination product is in a solid dosage form, the core of the dosage form being 200 mg to 1000 mg, preferably 400 mg to 800 mg, and preferably 600 mg.
  • the core of the dosage form can preferably be coated with a film coating.
  • the dosage forms can be produced by the generally customary methods.
  • the micronutrient combination product according to the invention is preferably in the form of a tablet, in particular a film tablet.
  • the tablet preferably comprises a tablet core which can be coated with a film coating.
  • the micronutrient combination product can have coating agents, also referred to as coating substances.
  • suitable coating materials for film coating selected from the group comprising cellulose and or cellulose derivatives, hydroxypropyl cellulose, hydroxypropylmethyl cellulose and / or microcrystalline cellulose, titanium dioxide, dyes, talc, polymethacrylates, shellac, polyvinylpolyirolidone, polyvinylpolyirolidone , Triacetin, triethyl citrate, propylene glycol, glycerol, gum arabic, silicon dioxide, glycerol monostearate and / or cottonseed oil.
  • Coating materials are preferably selected from the group comprising hydroxypropyl cellulose, hydroxypropyl methyl cellulose, microcrystalline cellulose, glycerol, talc, cottonseed oil, titanium dioxide and / or dyes.
  • Preferred dyes are selected from the group comprising iron oxides, indigo
  • AtLacke are selected from the group comprising yellow orange S AtLack and / or Chochenillerot A AI-Lack.
  • the micronutrient combination product in the form of a film tablet comprising a tablet core and a film coating, comprises a film amount in the range from 1% by weight to 12% by weight, preferably 2% by weight to 10% by weight, particularly preferably 5% by weight to 8% by weight, based on the weight of the tablet core.
  • the micronutrient combination product can have further additives which are compatible with the micronutrients in galenics.
  • the micronutrients are preferably used in a form that can be processed for the selected dosage form.
  • the micronutrient combination product preferably has vitamin E in the form of vitamin E acetate.
  • the mineral nutrient combination product preferably has vitamin C in the form of granules.
  • the micronutrient combination product further preferably has vitamin C in the form of ascorbic acid.
  • the micronutrient combination product has zeaxanthin, lutein, zinc gluconate, copper (H) gluconate, vitamin eacetate, ascorbic acid, cellulose, lactose and / or magnesium stearate.
  • the micronutrient combination product based on a daily dose of the micronutrient combination product, comprises the active ingredients: a. 12 mg lutein; b. 0.6 mg zeaxanthin; c. 150 mg vitamin C; d. 15 mg vitamin E; e. 0.4 mg copper; f. 20 mg zinc.
  • the micronutrient preparation can also contain additives, accompanying substances and / or raw materials that are heavier than the actual active substances, so that the amounts given can be lower or higher, based on a daily dose or single dose.
  • the MU ⁇ ronutrient combination product based on a single dose of the micronutrient combination product, comprises the active ingredients: a. 6 mg lutein; b. 0.3 mg zeaxanthin c. 75 mg vitamin C; d. 7.5 mg vitamin E; e. 0.2 mg copper; f. 10 mg zinc.
  • a single dose is understood to mean an administration unit of the micronutrient combination product; a single dose of the micronutrient combination product corresponds, for example, to a tablet, a film-coated tablet, a dragee, a capsule or a single administration unit of another form of preparation, such as powder or granules.
  • a daily dose is understood to mean the amount of the micronutrient combination product that is administered per day.
  • the daily dose and / or single dose is preferably distributed over several identical or different preparation forms, the preparation forms being able to have the same or different active substances and or active substance weight contents.
  • the micronutrient combination product can be used to produce an agent for the dietary prevention and / or treatment of eye diseases, preferably in the case of age-related macular degeneration.
  • the micronutrient combination product according to the invention is furthermore suitable as an agent for a supplementary balanced diet.
  • the term "dietary treatment” is explained in more detail in EU Directive 1999/21 / EC, which has been implemented as the 10th regulation to amend the diet regulation in German law since 01.01.2002 Thanks to the beneficial active ingredients of the micronutrient combination product, it can also be used as a supplement to the balanced diet, in particular food, as part of a dietary nutritional consultation.
  • the micronutrient combination product can preferably be used for the supplementary balanced diet in the case of age-related macular degeneration. It has been shown that, in particular, an impending nutrient deficiency can be compensated for in older people.
  • micronutrient combination ion products examples include:
  • preparation forms selected from the group comprising tablets, film-coated tablets, dragees, capsules, powders, granules, solutions and / or effervescent tablets, have the customary auxiliaries used for formulating the respective preparation forms, so that in the examples only those contained are included Active ingredients can be listed.
  • Micronutrient combination product comprising 1 film-coated tablet with the following active ingredients: 6 mg lutein; 0.3 mg zeaxanthin - 75 mg vitamin C; 7.5 mg vitamin E; 0.2 mg copper; 10 mg zinc.
  • Micronutrient combination product daily dose comprising 2 film-coated tablets, each with the following active ingredients: 6 mg lutein; 0.3 mg zeaxanthin 75 mg vitamin C; 7.5 mg vitamin E; - 0.2 mg copper; 10 mg zinc.
  • 635 mg film-coated tablet comprising the following active ingredients: 6 mg lutein; 0.3 mg zeaxanthin 75 mg vitamin C; 7.5 mg vitamin E; - 0.2 mg copper; 10 mg zinc, hypromellose, hydroxypropyl cellulose, glycerol, yellow orange varnish S, cochineal red varnish A, titanium dioxide and talc being contained as auxiliaries, and the tablet core accounting for 600 mg and the film coating 35 mg.

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

Abstract

La présente invention concerne un produit de combinaison de micronutriments comprenant de la zéaxanthine, de la lutéine, du zinc et du cuivre.
EP04817575A 2003-12-23 2004-12-17 Produit de combinaison de micronutriments adapte au regime bilan complementaire dans le cadre de la degenerescence maculaire liee a l'age Withdrawn EP1696743A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE20320101U DE20320101U1 (de) 2003-12-23 2003-12-23 Mikronährstoffkombinationsprodukt geeignet zur ergänzenden bilanzierten Diät bei altersbedingter Makuladegeneration
PCT/EP2004/053579 WO2005063051A1 (fr) 2003-12-23 2004-12-17 Produit de combinaison de micronutriments adapte au regime bilan complementaire dans le cadre de la degenerescence maculaire liee a l'age

Publications (1)

Publication Number Publication Date
EP1696743A1 true EP1696743A1 (fr) 2006-09-06

Family

ID=32240734

Family Applications (1)

Application Number Title Priority Date Filing Date
EP04817575A Withdrawn EP1696743A1 (fr) 2003-12-23 2004-12-17 Produit de combinaison de micronutriments adapte au regime bilan complementaire dans le cadre de la degenerescence maculaire liee a l'age

Country Status (5)

Country Link
US (1) US8883221B2 (fr)
EP (1) EP1696743A1 (fr)
DE (1) DE20320101U1 (fr)
RU (1) RU2006120614A (fr)
WO (1) WO2005063051A1 (fr)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE202004010212U1 (de) * 2004-06-30 2004-09-23 Dr. Mann Pharma, Chem.-Pharm. Fabrik Gmbh Lutein-enthaltende Zusammensetzung
US20060134226A1 (en) * 2004-11-16 2006-06-22 Todd Leonard Compositions useful to treat ocular neovascular diseases and macular degeneration
CN101262855A (zh) * 2005-09-08 2008-09-10 帝斯曼知识产权资产管理有限公司 治疗或预防年龄相关性黄斑变性的方法
DE202007012373U1 (de) * 2007-09-04 2009-01-08 Omnivision Gmbh Nahrungsergänzungsmittel, Beutel mit einem Nahrungsergänzungsmittel sowie Verwendung eines Nahrungsergänzungsmittels
CN108042504A (zh) * 2017-12-15 2018-05-18 拜尔普兰（厦门）生物药业有限公司 一种叶黄素片组合物及其制备方法
DE202021104882U1 (de) * 2021-09-10 2021-09-28 Lighthouse Pharma GmbH Zusammensetzung und Darreichungsform

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ATE355832T1 (de) * 1995-06-07 2007-03-15 Howard Foundation Pharmazeutisch aktive karotenoide
US5948443A (en) * 1996-02-23 1999-09-07 Medical Doctor's Research Institute, Inc. Acetylsalicylic acid and micronutrient supplementation for nutritional losses and coronary heart disease
US6914073B2 (en) * 1999-03-18 2005-07-05 Bristol Myers Squibb Company Vitamin formulation for cardiovascular health
US6582721B1 (en) * 1999-09-17 2003-06-24 Alcon, Inc. Stable carotene-xanthophyll beadlet compositions and methods of use
US6579544B1 (en) * 2000-05-31 2003-06-17 Nutriex, L.L.C. Method for supplementing the diet
EP1214893A1 (fr) 2000-12-16 2002-06-19 Aventis Pharma Deutschland GmbH Compositions pour améliorer la santé
US6660297B2 (en) * 2001-03-23 2003-12-09 Bausch & Lomb Incorporated Nutritional supplement to treat macular degeneration
ES2299687T3 (es) 2002-01-30 2008-06-01 Dsm Ip Assets B.V. Luteina/zeaxantina para la proteccion contra el encandilamiento.
US20030228392A1 (en) 2002-06-06 2003-12-11 Wyeth Infant formula compositions containing lutein and zeaxanthin

Non-Patent Citations (1)

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Title
See references of WO2005063051A1 *

Also Published As

Publication number Publication date
WO2005063051A1 (fr) 2005-07-14
US8883221B2 (en) 2014-11-11
RU2006120614A (ru) 2007-12-27
DE20320101U1 (de) 2004-04-29
US20080014287A1 (en) 2008-01-17

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