EP4072515A1 - Combination product contributing to the well-being of pregnant women, comprising epa, dha, vitamins and minerals - Google Patents

Combination product contributing to the well-being of pregnant women, comprising epa, dha, vitamins and minerals

Info

Publication number
EP4072515A1
EP4072515A1 EP20820160.8A EP20820160A EP4072515A1 EP 4072515 A1 EP4072515 A1 EP 4072515A1 EP 20820160 A EP20820160 A EP 20820160A EP 4072515 A1 EP4072515 A1 EP 4072515A1
Authority
EP
European Patent Office
Prior art keywords
vitamin
combination product
iron
epa
acid
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.)
Pending
Application number
EP20820160.8A
Other languages
German (de)
French (fr)
Inventor
Marilyn GENTILHOMME
Tiphaine BRICOUT
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.)
Urgo Recherche Innovation et Developpement
Original Assignee
Urgo Recherche Innovation et Developpement
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 Urgo Recherche Innovation et Developpement filed Critical Urgo Recherche Innovation et Developpement
Publication of EP4072515A1 publication Critical patent/EP4072515A1/en
Pending legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/02—Nutrients, e.g. vitamins, minerals
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • 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
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • 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
    • A23L33/15—Vitamins
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • 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
    • A23L33/15—Vitamins
    • A23L33/155—Vitamins A or D
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • 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
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/20—Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids
    • A61K31/202—Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids having three or more double bonds, e.g. linolenic
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
    • A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline 
    • A61K31/353—3,4-Dihydrobenzopyrans, e.g. chroman, catechin
    • A61K31/355—Tocopherols, e.g. vitamin E
    • A—HUMAN NECESSITIES
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    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/365—Lactones
    • A61K31/375—Ascorbic acid, i.e. vitamin C; Salts thereof
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4164—1,3-Diazoles
    • A61K31/4188—1,3-Diazoles condensed with other heterocyclic ring systems, e.g. biotin, sorbinil
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4415—Pyridoxine, i.e. Vitamin B6
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/455—Nicotinic acids, e.g. niacin; Derivatives thereof, e.g. esters, amides
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/506—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
    • A61K31/51—Thiamines, e.g. vitamin B1
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A61K31/525—Isoalloxazines, e.g. riboflavins, vitamin B2
    • 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
    • A61K31/59—Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
    • A61K31/593—9,10-Secocholestane derivatives, e.g. cholecalciferol, i.e. vitamin D3
    • 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
    • A61K31/7135—Compounds containing heavy metals
    • A61K31/714—Cobalamins, e.g. cyanocobalamin, i.e. vitamin B12
    • 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
    • A61K33/04—Sulfur, selenium or tellurium; 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
    • A61K33/18—Iodine; 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
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    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/24—Heavy metals; Compounds thereof
    • A61K33/32—Manganese; Compounds thereof
    • A—HUMAN NECESSITIES
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    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/24—Heavy metals; Compounds thereof
    • A61K33/34—Copper; Compounds thereof
    • A—HUMAN NECESSITIES
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    • 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
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
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    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
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    • A61K9/4841—Filling excipients; Inactive ingredients
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Definitions

  • the present invention relates to a combination product comprising as active substances, at least eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), vitamin B1, B2, B3, B5 , B6, B8, B9, B12, C, E, manganese, copper, iodine, selenium, iron, zinc and vitamin D3 to contribute to the well-being of pregnant women, to maternal tissue growth during pregnancy, healthy fetal brain and eye development, calcium absorption and helps reduce fatigue.
  • EPA eicosapentaenoic acid
  • DHA docosahexaenoic acid
  • vitamin B1, B2, B3, B5 , B6, B8, B9, B12, C, E manganese
  • copper, iodine, selenium, iron, zinc and vitamin D3 to contribute to the well-being of pregnant women, to maternal tissue growth during pregnancy, healthy fetal brain and eye development, calcium absorption and helps reduce fatigue.
  • composition according to the invention contains at least eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), vitamin B1, B2, B3, B5, B6, B8, B9, B12, C , E, manganese, copper, iodine, selenium, iron, zinc and vitamin D3 to contribute to the well-being of the pregnant woman, to the growth of maternal tissues during pregnancy, to the good fetal brain and eye development, calcium absorption and helps reduce fatigue.
  • EPA eicosapentaenoic acid
  • DHA docosahexaenoic acid
  • vitamin B1, B2, B3, B5, B6, B8, B9, B12, C , E manganese, copper, iodine, selenium, iron, zinc and vitamin D3 to contribute to the well-being of the pregnant woman, to the growth of maternal tissues during pregnancy, to the good fetal brain and eye development, calcium absorption and helps reduce fatigue.
  • Such a product therefore makes it possible to overcome a deficit in the supply of vitamins, minerals, trace elements and omega 3s with a composition which contains neither lactose nor preservatives.
  • the product of the present invention has a galenic suitable for pregnant women.
  • the present invention relates to a combination product, comprising as active substances, at least at least eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), vitamin B1, B2, B3, B5, B6, B8, B9, B12, C, E, manganese, copper, iodine, selenium, iron, zinc and vitamin D3 to contribute to the well-being of the pregnant woman , growth of maternal tissues during pregnancy, healthy development of the fetal brain and eyes, absorption of calcium and helps reduce fatigue.
  • EPA eicosapentaenoic acid
  • DHA docosahexaenoic acid
  • vitamin B1, B2, B3, B5, B6, B8, B9, B12, C, E manganese
  • copper iodine
  • selenium iron
  • zinc and vitamin D3 to contribute to the well-being of the pregnant woman , growth of maternal tissues during pregnancy, healthy development of the fetal brain and eyes, absorption of calcium and helps reduce
  • the combination product according to the invention comprises, in addition to eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), vitamin B1, B2, B3, B5, B6, B8, B9, B12, C, E, manganese, copper, iodine, selenium, iron, zinc and vitamin D3, as active substances:
  • EPA eicosapentaenoic acid
  • DHA docosahexaenoic acid
  • vitamin B1, B2, B3, B5, B6, B8, B9, B12, C, E manganese, copper, iodine, selenium, iron, zinc and vitamin D3, as active substances:
  • the combination product of the invention is characterized in that eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), vitamin B1, B2, B3, B5, B6, B8, B9, B12, C, E, manganese, copper, iodine, selenium, iron, zinc and vitamin D3 are present in the following amounts: from 10 to 100 mg preferably 30 to 70 mg eicosapentaenoic acid 50 to 500 mg, preferably 100 to 300 mg docosahexaenoic acid 0.5 to 4 mg preferably 1 to 2 mg vitamin B1 0.5 to 4 mg preferably 1 to 2 mg of vitamin B2 from 5 to 30 mg preferably 10 to 20 mg of vitamin B3 from 3 to 10 mg preferably 5 to 7 mg of vitamin B5 from 0.5 to 4 mg, preferably 1 to 2 mg of vitamin B6 10 to 100 pg preferably 30 to 60 pg vitamin B8 100 to 1000 pg preferably 300 to 600 pg vitamin B9 1
  • EPA
  • the combination product is characterized in that the active ingredients, that is to say eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), vitamin B1, B2, B3, B5, B6, B8, B9, B12, C, E, manganese, copper, iodine, selenium, iron, zinc and vitamin D3 are in a medium suitable for oral administration.
  • the suitable medium is a solid medium.
  • the combination product is in the form of a soft capsule.
  • the Applicant has demonstrated that the combination of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), vitamin B1, B2, B3, B5, B6, B8, B9, B12, C, E, manganese, copper, iodine, selenium, iron, zinc and vitamin D3 exhibited a synergistic effect to contribute to the well-being of the pregnant woman, to the growth of maternal tissues during pregnancy, the proper development of the brain and eyes of the fetus, absorption of calcium and helps reduce fatigue.
  • EPA eicosapentaenoic acid
  • DHA docosahexaenoic acid
  • vitamin B1, B2, B3, B5, B6, B8, B9, B12, C, E manganese
  • copper, iodine, selenium, iron, zinc and vitamin D3 exhibited a synergistic effect to contribute to the well-being of the pregnant woman, to the growth of maternal tissues during pregnancy, the proper development of
  • omega-3s Several essential omega 3s, DHA (docosahexaenoic acid) and I ⁇ RA (eicosapentaenoic acid), are incorporated in large proportion in the cells of the retina and the brain of the future baby.
  • DHA docosahexaenoic acid
  • I ⁇ RA eicosapentaenoic acid
  • composition according to the present invention comprises from 10 to 100 mg, preferably 30 to 70 mg of eicosapentaenoic acid and from 50 to 500 mg, preferably 100 to 300 mg of docosahexaenoic acid. More preferably, the composition according to the present invention contains omega 3 whose EPA / DHA ratio is at least 1: 5
  • Thiamine or vitamin B1 is a metabolic precursor of thiamine pyrophosphate (TPP), a coenzyme essential for certain decarboxylases.
  • TPP thiamine pyrophosphate
  • thiamine is a water-soluble vitamin from the family of B vitamins that they must find in their diet.
  • it is synthesized by bacteria, plants and fungi. It is essential for the transformation of carbohydrates into energy by the Krebs cycle and is necessary for the proper functioning of the nervous system and muscles. It is in fact essential for the transformation of pyruvate produced by glycolysis and toxic for the nervous system.
  • a dietary vitamin B1 deficiency causes beriberi and can also cause Gayet-Wernicke encephalopathy.
  • composition according to the present invention comprises from 0.5 to 4 mg, preferably 1 to 2 mg of vitamin B1.
  • Vitamin B2 Vitamin B2 corresponding to riboflavin, or lactoflavin, is a water-soluble vitamin necessary for the synthesis of flavin adenine dinucleotide (FAD) and flavin mononucleotide (FMN), two cofactors essential to flavoproteins.
  • FAD flavin adenine dinucleotide
  • FMN flavin mononucleotide
  • Vitamin B2 plays an important role in the transformation of simple foods (carbohydrates, fats and proteins) into energy. It is involved in the repair metabolism of the muscles.
  • Riboflavin is found naturally in asparagus, popcorn, bananas, persimmons, okra, Swiss chard, cheese, milk, yogurt, meat, eggs, fish and beans greens, each of which contains at least 0.1 mg of vitamin B per 85-300g.
  • Other sources are green leafy vegetables, liver, kidneys, legumes, tomatoes, yeasts, mushrooms and almonds.
  • composition according to the present invention comprises from 0.5 to 4 mg, preferably 1 to 2 mg of vitamin B2.
  • Vitamin B3 is a water-soluble vitamin which corresponds to two molecules: niacin (nicotinic acid) and its amide, nicotinamide, sometimes called niacinamide. It is also called vitamin PP for preventive pellagra because a deficiency in this vitamin is responsible for pellagra.
  • Vitamin B3 precursor of NAD + (nicotinamide adenine dinucleotide) and of NADP + (nicotinamide adenine dinucleotide phosphate), is necessary as a redox cofactor in the metabolism of carbohydrates, lipids and proteins. It is part of the B vitamins.
  • Vitamin B3 is found mainly in poultry, calf's liver and cereals.
  • B vitamins facilitate the conversion of food (carbohydrates) into energy (glucose). Niacin is helpful in the process of regulating stress hormones and improves blood circulation. These vitamins are water soluble and the body does not store them. It is rare, in developed countries, to be a victim of severe vitamin B3 deficiency.
  • Symptoms of mild deficiency are indigestion, fatigue, vomiting, or depression. It may be due to pregnancy.
  • composition according to the present invention comprises from 5 to 30 mg, preferably 10 to 20 mg of vitamin B3.
  • Vitamin B5 corresponding to pantothenic acid, is a water soluble vitamin. It is a metabolic precursor of coenzyme A, essential for the synthesis and metabolism of proteins, carbohydrates and lipids.
  • Pantothenic acid consists of a pantoic acid molecule and a ⁇ -alanine molecule, linked by an amide function.
  • vitamin B5 promotes the growth and resistance of the skin and mucous membranes. It is necessary for the metabolism of carbohydrates, lipids and proteins and participates in the synthesis of certain hormones. Pantothenic acid is destroyed by heat in aqueous solution.
  • the needs of the human body are estimated at 5 mg per day from the age of 16, at 2 mg in infants and at 7 mg for breastfeeding mothers, but generally only under-nourishment can cause real deficiency.
  • composition according to the present invention comprises from 3 to 10 mg, preferably 5 to 7 mg of vitamin B5.
  • Vitamin B6 is a water-soluble vitamin existing in several forms, pyridoxal phosphate being its biologically active form, as a cofactor involved in several reactions of the metabolism of amino acids, in particular transaminations, deaminations and decarboxylations. Pyridoxal phosphate is also involved in the reaction of hydrolysis of glycogen to glucose.
  • Vitamin B6 is known in seven different forms, interconvertible with each other except the last:
  • pyridoxine the form in which vitamin B6 is administered as a food supplement
  • PBP pyridoxal phosphate
  • PA 4-pyridoxic acid
  • Vitamin B6 participates in the transformation of tryptophan into vitamin B3, and in the metabolism of lipids and amino acids (decarboxylation and transamination). Pyridoxal phosphate allows the conversion of glycogen into glucose (Glucose-1-Phospate) by Glycogen phosphorylase.
  • Vitamin B6 also participates in the biosynthesis of serotonin.
  • cystine Associated with cystine, it is administered to facilitate the development of integuments (hair, nails, etc.).
  • composition according to the present invention comprises from 0.5 to 4 mg, preferably 1 to 2 mg of vitamin B6
  • Vitamin B8 or biotin Biotin is a water soluble vitamin. Biotin is a coenzyme which participates in the metabolism of fatty acids, carbohydrates and amino acids, as well as in the biosynthesis of vitamins B9 and B12. It is therefore found, from a biological point of view, in all living species. In terms of diet, it is found in particular in whole grains, liver, eggs and milk, but also soybeans, hazelnuts, yeasts and in smaller amounts in other foods.
  • Biotin is necessary for cell growth, the production of fatty acids, and the metabolism of fats and amino acids. It plays a role in the Krebs cycle which is the biochemical process by which energy is produced during aerobic respiration. Biotin is not only involved in various metabolic reactions, but it also helps in the transfer of carbon dioxide. Biotin is also helpful in maintaining a constant level of sugar in the blood (blood sugar). Biotin is often recommended for strengthening hair and nails. As a result, it is a component of many cosmetics and health products for the hair and skin.
  • bioavailability of biotin may be low or variable depending on the type of food consumed.
  • biotin is found in foods as protein or as biocytin. Protease proteolysis is necessary before absorption. This process promotes the release of biotin from biocytin and proteins.
  • Biotin in corn is readily available, but most grains have 20-40% bioavailability of biotin.
  • a possible explanation for the great variability in the bioavailability of biotin would lie in the ease that an organism has to break the biotin-protein bonds of food, in other words if this one has the enzyme capable of breaking these bonds.
  • Biotin supplements are often recommended as a natural way to combat the problem of hair loss in children and adults. Signs and symptoms of biotin deficiency include hair loss which progresses in severity to loss of eyelashes and eyebrows in severely deficient individuals.
  • the composition according to the present invention comprises from 10 to 100 pg, preferably 30 to 60 pg of vitamin B8
  • Vitamin B9 also called folic acid or folate is essential from the first days of pregnancy. Throughout pregnancy, folic acid helps build new tissues, blood cells, the brain and the nervous system. A deficiency in folic acid can cause growth retardation, a birth defect, or a neural tube defect (for example, spina bifida). Physical disabilities or severe mental impairments can result.
  • a lack of folic acid results in macrocytic anemia, identifiable by a simple blood test: the red blood cells are insufficient in number and too large. But this anemia can be masked by iron deficiency. So be vigilant and know that half of French women lack folic acid. Indeed, not only does one in two women have folate intakes lower than 2/3 of the recommended nutritional intake, but more than 50% of women do not properly metabolize folic acid. This is why, within the framework of the National Health Nutrition Program (PNNS), systematic vitamin B9 supplementation is recommended, from the desire for a child and throughout the first trimester of pregnancy.
  • PNNS National Health Nutrition Program
  • the daily folic acid requirements of the pregnant woman vary from 0.4 mg to 1 mg per day. Those of women with a family or personal history of neural tube defect are even higher.
  • composition according to the present invention comprises from 100 to 1000 pg, preferably 300 to 600 pg of vitamin B9.
  • Vitamin B12 is essential for the production of red blood cells and for the proper functioning of the fetal nervous system. It works with folic acid to make DNA (the genetic material).
  • Vitamin B12 deficiency could impair cognitive functions in the infant and cause anemia as well as memory impairment and other lifelong neurological problems in the mother.
  • composition according to the present invention comprises from 1 to 6 pg, preferably 2 to 4 pg of vitamin B12.
  • Vitamin C is a water soluble heat and light sensitive vitamin playing an important role in the metabolism of humans and many other mammals. Chemically speaking, it is L-ascorbic acid, one of the stereoisomers of ascorbic acid, and its salts, the ascorbates. The most common are sodium ascorbate and calcium ascorbate.
  • Vitamin C is an enzymatic cofactor involved in a number of physiological reactions (hydroxylation). It is required in the synthesis of collagen and red blood cells and contributes to the immune system. It also plays a role in iron metabolism as a promoter of its absorption; its use is therefore not recommended in patients with an iron overload and particularly hemochromatosis. In oxidized form (dehydroascorbic acid), it crosses the blood-brain barrier to access the brain and several organs with a high concentration of vitamin C.
  • composition according to the present invention comprises from 50 to 200 mg, preferably 60 to 140 mg of vitamin C.
  • Cholecalciferol is a form of vitamin D, also called vitamin D3.
  • Vitamin D3 is a secosteroid rather related to testosterone, cholesterol and cortisol.
  • Vitamin D has a dual origin: it is provided by food and synthesized by the body in the skin under the action of UVB rays from the sun. Subjects with very little exposure to the sun may exhibit more or less significant deficiencies in vitamin D. People with fair skin synthesize vitamin D faster than those with dark skin, and therefore need a period of time. 'shorter exposure to convert vitamin D precursors produced by the liver into vitamin D. The amount of vitamin D that the skin can produce is limited; prolonged exposure to sunlight (more than 30 minutes for a fair-skinned person, up to three hours for a dark-skinned person) does not increase the amount of cholecalciferol produced by the body. For a person with fair skin, an exposure of 10 to 15 minutes a few times a week is enough to cover the needs in vitamin D3. Vitamin D produced by the skin is stored in the liver, muscle and fatty tissue and used on demand during winter periods.
  • vitamin D2 or ergocalciferol produced by plants Two forms of vitamin D exist: vitamin D2 or ergocalciferol produced by plants and vitamin D3 or cholecalciferol produced by animals, as well as by certain lichens. In humans, these two forms are converted to 1,25-dihydroxyvitamin D (commonly referred to as vitamin D), their main active metabolite.
  • vitamin D The essential function of vitamin D is to increase the absorption capacity of the intestine for calcium and phosphorus which allows:
  • vitamin D deficiency The clinical signs of vitamin D deficiency are: osteomalacia and rickets in the bones, decreased muscle tone, tetany attacks and convulsions (related to hypocalcemia) and sometimes anemia.
  • vitamin D deficiency constitutes a favorable ground for bone loss (therefore osteoporosis), and depression (as confirmed by a Dutch study mentioned in Archives of General Psychiatry (May 2008)) .
  • the recommended nutritional intakes of vitamin D were defined by considering that the endogenous production covers 50 to 70% of the daily requirements for this vitamin.
  • vitamin D A limited number of foods contain significant amounts of vitamin D. In fact, these contents are closely linked to the presence of fat in the foods.
  • the best sources of vitamin D are fatty sea fish, whatever their method of preparation and conservation (boiling, smoking, canning, grilling): herring, salmon, sardines, mackerel for example. Egg yolks, dairy products, soy and its derivatives (tofu and soy milk for example) and certain mushrooms (with great differences depending on the variety) are also sources of vitamin D. Low amounts of vitamin D are also provided by meats, offal and pâtés. Lean fish (ray, sole, hake, etc.) do not have them. Some lichens also produce cholecalciferol (vitamin D3), and are used to produce plant food supplements with this vitamin.
  • composition according to the present invention comprises from 2 to 30 pg, preferably 5 to 20 pg of vitamin D3
  • Vitamin E is a fat-soluble vitamin covering a set of eight organic molecules, four tocopherols and four tocotrienols.
  • the biologically most active form is ⁇ -tocopherol, the most abundant in the diet being ⁇ -tocopherol.
  • These molecules are present in large quantities in vegetable oils. They work alongside vitamin C and with glutathione, essentially as antioxidants against reactive oxygen derivatives produced in particular by the oxidation of fatty acids.
  • Vitamin E exists in eight natural forms, four tocopherols and four tocotrienols: a-tocopherol, b-tocopherol, y-tocopherol, d-tocopherol, a-tocotrienol, b-tocotrienol, g-tocotrienol (apoptotic properties), d-tocotrienol.
  • the body continuously produces free radicals, very reactive compounds comprising single electrons. Free radicals damage cell components as diverse as proteins, lipids or DNA. Radical reactions propagate in a chain: molecules destabilized by a single electron in turn become free radicals. The role of antioxidants is to stop this process by neutralizing free radicals, to reduce their harmfulness. Thus, vitamin E has the ability to capture and stabilize (by resonance) the unmarried electron of free radicals.
  • the tocopherol carrying a radical can react with a new free radical to form a neutral species, or be regenerated with vitamin C, glutathione or coenzyme Q10.
  • Vitamin E mainly plays its role as an antioxidant in biological membranes. Mitochondria, which generate free radicals, contain high levels of vitamin E in their lipid membrane, made up of polyunsaturated fatty acids and subjected to oxidative stress.
  • Vitamin E deficiency causes neuromuscular problems such as myopathies (degeneration of muscle tissue), disorders of the retina or of the immune system.
  • vitamin E prevents excessive aggregation of platelets responsible for thrombosis, has a protective action on red blood cells and could prevent, by this means cardiovascular diseases of atheromatous origin.
  • composition according to the present invention comprises from 1 to 25 mg, preferably 6 to 20 mg of vitamin E.
  • Manganese is a cofactor of numerous enzymes (glycosyltransferase, pyruvate carboxylase, GTP oxaloacetate carboxylase, isocitrate dehydrogenase, malic dehydrogenase, arginine synthetase, glutamine synthetase) involved in various metabolic processes. It is particularly present in the metabolism of carbohydrates and the synthesis of mucopolysaccharides. It is also an essential metal for the synthesis of enzymes (Mn-SOD) participating in the fight against oxidative stress and which prevent damage caused by free radicals. It also participates in the synthesis of vitamin E and the effectiveness of vitamin B1 (thiamine). This molecular oxygen activator plays a role in the functioning of metalloproteins such as superoxide dismutase.
  • composition according to the present invention comprises from 0.05 to 5 mg, preferably 0.5 to 2 mg of manganese.
  • Copper is a trace element essential for life (humans, plants, animals, and micro-organisms).
  • the human body normally contains copper at a concentration of about 1.4-2.1 mg per kg. Copper is found in the liver, muscles and bones. Copper is carried by the bloodstream by means of a protein called ceruleoplasmin. After absorption of copper in the intestine, it is transported to the liver, bound to albumin. The metabolism and excretion of copper is controlled by the delivery of ceruleoplasmin to the liver, and the copper is excreted in the bile. At the cellular level, copper is present in a number of enzymes and proteins, including cytochrome C oxidase and certain superoxide dismutases (SOD).
  • SOD superoxide dismutases
  • Copper is used for the biological transport of electrons, eg the “blue copper” proteins, azurine and plastocyanine.
  • the denomination "blue copper ” comes from their intense blue color due to an absorption band (around 600 nm) by ligand / metal charge transfer (LMCT).
  • composition according to the present invention comprises from 0.05 to 5 mg, preferably 0.5 to 2 mg of copper.
  • Iodine is a nutrient that has only recently become of concern in pregnant women.
  • Iodine is a mineral present in very small amounts in the body. It allows the body to make thyroid hormones, which are essential for bone building, muscle contraction, heartbeat, and nutrient absorption. Iodine also contributes to fetal brain growth, and a deficiency could cause developmental problems.
  • composition according to the present invention comprises from 50 to 500 pg, preferably 100 to 200 pg of iodine.
  • Selenium is a trace element constituting selenoproteins of which the main intracellular antioxidant, glutathione peroxidase, is a part. It is found in pork or beef kidneys, garlic, fish and shellfish. Western nutrition largely meets the daily requirement for this element, but it is impossible to predict body concentrations of selenium from nutritional intake because its use and retention is dependent on the presence of folic acid, vitamin B12 and negatively affected by the presence of homocysteine.
  • composition according to the present invention comprises from 10 to 100 pg, preferably 30 to 60 pg of selenium.
  • the iron reserves can be evaluated by means of a simple dosage of serum ferritin on medical prescription. They are generally lower when you have already had one or more children. If necessary, the gynecologist prescribes medicated iron during pregnancy (usually from the 5th month).
  • Pregnant women need more iron because their blood volume increases. In addition, they must provide it for their unborn baby. A baby's iron stores at birth last at most for the first 6 months of life.
  • Iron deficiency can cause anemia. It can cause fatigue and shortness of breath more quickly on exertion.
  • composition according to the present invention comprises from 1 to 30 mg, preferably 10 to 20 mg of iron.
  • the iron is present in the form of carbonyl iron.
  • carbonyl iron With over 98% iron, this substance has a much higher iron content than ferrous salts, such as ferrous gluconate, ferrous sulfate, and ferrous fumarate.
  • ferrous salts such as ferrous gluconate, ferrous sulfate, and ferrous fumarate.
  • significantly less iron supplementation is required to achieve the same unit dose as a ferrous salt, thereby reducing the weight of the tablets / capsules.
  • Carbonyl iron is therefore well suited to multivitamin applications with high levels of active ingredients.
  • zinc in assimilable form is an important trace element essential for plant and animal organisms. Duly assimilated by organisms, it activates enzymes in particular, influences growth, promotes reactions and biochemical controls at the level of lung surfaces.
  • the human body contains 2 g to 4 g of it. Daily needs can be estimated at a minimum of 15 mg for a normal man, and up to twice as much for a lactating woman.
  • composition according to the present invention comprises from 1 to 30 mg, preferably 5 to 20 mg of zinc.
  • a physiologically acceptable medium is a medium having no toxic or detrimental effect under the conditions of use and inert with respect to the active ingredients of the combination product.
  • a medium can for example comprise different adjuvants according to its therapeutic or cosmetic purpose, such as without limitation, aromas, colorants, fillers, preservatives, diluents, wetting or suspending agents, etc.
  • Such media can also allow immediate, modified or delayed release of one or other of the active ingredients.
  • the physiologically acceptable medium can be composed of texturizers, colorants, flavors, sugar (s).
  • texturizers is understood to mean the compounds which modify the texture of the products in which they are incorporated.
  • texturizers are: guar and carob flour; gum arabic, xanthan and gellan; carrageenans; starches (native or modified); microcrystalline cellulose; pectin; alginates (E400 to E405); agar-agar; and their mixtures.
  • dyes is understood to mean compounds of natural or synthetic origin capable of conferring on themselves a coloring on the composition. Examples of food colors are known in Europe under the codes E100 to E180. In the context of the present invention, dyes of natural origin such as: E140 (or chlorophylls), E 163 (or anthocyanins), E 160c (or paprika extract) or else E100 (or curcumin) will preferably be used.
  • the term “aromas” is understood to mean compounds of natural or synthetic origin which are capable on their own of modifying the taste of the composition.
  • flavors are apricot, pineapple, banana, blackcurrant, cherry, lemon, lime, strawberry, raspberry, passion fruit, tangerine, mint, orange, pistachio, pear, licorice, rose, anise, blueberry, cinnamon, ginger, grapefruit, apple, kiwi, lychee, melon, coconut, peach, currant, guava, grenadine, mango, blackberry, papaya, vanillin, natural vanilla extract, oils essentials and their mixtures.
  • the lemon flavor will preferably be used.
  • sucrose or sugars is understood to mean any sweetening carbohydrate, preferably glucose syrup, sucrose, glucose, fructose, invert sugar, honey, maltose, polyol or their mixtures.
  • the combination product may include, by way of example, vitamins, mineral salts, essential amino acids, essential fatty acids, trace elements, various plant extracts, fibers, antioxidants, flavonoids.
  • such an additional active agent can be intended to reinforce the desired effect as described above.
  • curcuminoids such as curcuminoids; carotenoids, in particular chosen from beta-carotene, astaxanthin, zeaxanthin, lutein or compounds containing them, such as goji berries; polyphenol compounds, flavonoids such as catechins; proanthocyanidins, anthocyanins, OPCs (procyanidolic oligomers); ubiquinones; coffee extracts containing polyphenols and / or diterpenes; chicory extracts; ginkgo biloba extracts; the grape extracts rich in proanthocyanidins; chilli extracts; soy extracts; Cocoa ; the grenade ; the Emblica; CoenzymeQIO;
  • sulfur-containing amino acids such as precursors of glutathione, amino acids of selenium, citrulline,
  • a combination product according to the invention is administered orally.
  • forms suitable for the oral route are soft capsules.
  • a physiologically acceptable vehicle such as lecithin and wax.
  • Example 1 of composition according to the invention [0137]
  • composition is obtained by mixing the various compounds according to the methods conventionally used for this type of preparation before introduction into a soft capsule.

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Abstract

The present invention relates to a combination product comprising, as active substances, at least eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), vitamin B1, B2, B3, B5, B6, B8, B9, B12, C, E, manganese, copper, iodine, selenium, iron, zinc and vitamin D3 to contribute to the well-being of pregnant women, to the growth of maternal tissue during pregnancy, to the proper development of the fetal brain and eyes, to the absorption of calcium and to helping reduce fatigue.

Description

Description Description
PRODUIT DE COMBINAISON, CONTRIBUANT AU BIEN-ETRE DE LA FEMME ENCEINTE, COMPRENANT EPA, DHA, DES VITAMINES ET DES MINERAUX COMBINATION PRODUCT, CONTRIBUTING TO THE WELL-BEING OF PREGNANT WOMEN, INCLUDING EPA, DHA, VITAMINS AND MINERALS
[0001 ] DOMAINE TECHNIQUE [0001] TECHNICAL FIELD
[0002] La présente invention a pour objet un produit de combinaison comprenant à titre de substances actives, au moins de l'acide eicosapentaénoïque (EPA), de l'acide docosahexaénoïque (DHA), de la vitamine B1 , B2, B3, B5, B6, B8, B9, B12, C, E, du manganèse, du cuivre, de l’iode, du sélénium, du fer, du zinc et de la vitamine D3 pour contribuer au bien-être de la femme enceinte, à la croissance des tissus maternelles durant la grossesse, au bon développement du cerveau et des yeux du foetus, à l’absorption du calcium et aide à réduire la fatigue. The present invention relates to a combination product comprising as active substances, at least eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), vitamin B1, B2, B3, B5 , B6, B8, B9, B12, C, E, manganese, copper, iodine, selenium, iron, zinc and vitamin D3 to contribute to the well-being of pregnant women, to maternal tissue growth during pregnancy, healthy fetal brain and eye development, calcium absorption and helps reduce fatigue.
[0003] ARRIERE PLAN [0003] BACKGROUND
[0004] Durant la grossesse, les besoins en nutriments, vitamines, minéraux et oligo éléments sont augmentés, les réserves de la mère sont largement sollicitées. La future maman manque souvent de certaines vitamines, minéraux ou oligo éléments. Ces déficits risquent de contrarier la santé de la maman et de son enfant, tant dans les premiers mois de sa vie que lorsqu'il sera adulte. Il est aujourd'hui possible de réduire ce risque de façon considérable. Deux axes essentiels sont à considérer : d'une part assurer au foetus un développement pondéral idéal, d'autre part, lui assurer la satisfaction de ses besoins micro-nutritionnels (vitamines, minéraux et autres éléments essentiels). En effet, chaque carence nutritionnelle peut avoir des répercussions identifiées sur la santé et le développement du bébé. [0004] During pregnancy, the requirements for nutrients, vitamins, minerals and trace elements are increased, the mother's reserves are widely used. The future mother often lacks certain vitamins, minerals or trace elements. These deficits risk adversely affecting the health of mother and child, both in the first months of her life and when she becomes an adult. Today it is possible to reduce this risk considerably. Two essential axes must be considered: on the one hand ensuring the fetus an ideal weight development, on the other hand, ensuring the satisfaction of its micro-nutritional needs (vitamins, minerals and other essential elements). Indeed, each nutritional deficiency can have identified repercussions on the health and development of the baby.
[0005] Pour pallier aux différentes carences en vitamines, minéraux et oligo-éléments durant la grossesse, il existe un certain nombre de produits commercialisés. On peut citer à titre d’exemple le produit GESTARELLE® commercialisé par les Laboratoires IPRAD. Ce produit contient des omégas 3, des vitamines B1 , B2, B5, B6, B8, B9, B12, C, E, D, du cuivre, de l’iode et du fer, mais, contrairement au produit de combinaison de la présente invention, ne contient pas de vitamine B3, de manganèse, de sélénium, ni de zinc. De plus, le fer est présent sous forme d’oxyde de fer. [0006] Aucun des produits proposés ne contient l’association objet de la présente invention. En particulier, le produit de combinaison selon la présente invention contient des omégas 3 dont le rapport EPA/DHA est d’au moins 1 :5. En effet, l’apport en DHA est important : c’est lui qui est le plus utile au foetus et à la mère. La Demanderesse a donc souhaité développer un produit qui puisse couvrir un maximum de carences possible, avec une biodisponibilité accrue des différentes vitamines, minéraux et oligo-éléments qu’elle contient. To overcome the various deficiencies in vitamins, minerals and trace elements during pregnancy, there are a number of products on the market. By way of example, mention may be made of the product GESTARELLE® sold by Laboratoires IPRAD. This product contains omega 3, vitamins B1, B2, B5, B6, B8, B9, B12, C, E, D, copper, iodine and iron, but unlike the combination product of this invention, does not contain vitamin B3, manganese, selenium or zinc. Additionally, iron is present as iron oxide. None of the products offered contains the association which is the subject of the present invention. In particular, the combination product according to the present invention contains omega 3 whose EPA / DHA ratio is at least 1: 5. Indeed, the intake of DHA is important: it is this which is most useful for the fetus and the mother. The Applicant therefore wished to develop a product which could cover as many deficiencies as possible, with increased bioavailability of the various vitamins, minerals and trace elements that it contains.
[0007] La composition selon l’invention contient au moins de l'acide eicosapentaénoïque (EPA), de l'acide docosahexaénoïque (DHA), de la vitamine B1 , B2, B3, B5, B6, B8, B9, B12, C, E, du manganèse, du cuivre, de l’iode, du sélénium, du fer, du zinc et de la vitamine D3 pour contribuer au bien-être de la femme enceinte, à la croissance des tissus maternelles durant la grossesse, au bon développement du cerveau et des yeux du foetus, à l’absorption du calcium et aide à réduire la fatigue. The composition according to the invention contains at least eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), vitamin B1, B2, B3, B5, B6, B8, B9, B12, C , E, manganese, copper, iodine, selenium, iron, zinc and vitamin D3 to contribute to the well-being of the pregnant woman, to the growth of maternal tissues during pregnancy, to the good fetal brain and eye development, calcium absorption and helps reduce fatigue.
[0008] Un tel produit permet donc de pallier un déficit d’apport en vitamines, minéraux, oligo-éléments et omégas 3 avec une composition qui ne contient ni lactose ni conservateurs. [0008] Such a product therefore makes it possible to overcome a deficit in the supply of vitamins, minerals, trace elements and omega 3s with a composition which contains neither lactose nor preservatives.
[0009] Le produit de la présente invention présente une galénique adaptée à la femme enceinte. The product of the present invention has a galenic suitable for pregnant women.
[0010] RESUME DE L’INVENTION SUMMARY OF THE INVENTION
[0011] La présente invention se rapporte à un produit de combinaison, comprenant à titre de substances actives, au moins au moins de l'acide eicosapentaénoïque (EPA), de l'acide docosahexaénoïque (DHA), de la vitamine B1 , B2, B3, B5, B6, B8, B9, B12, C, E, du manganèse, du cuivre, de l’iode, du sélénium, du fer, du zinc et de la vitamine D3 pour contribuer au bien-être de la femme enceinte, à la croissance des tissus maternelles durant la grossesse, au bon développement du cerveau et des yeux du foetus, à l’absorption du calcium et aide à réduire la fatigue. The present invention relates to a combination product, comprising as active substances, at least at least eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), vitamin B1, B2, B3, B5, B6, B8, B9, B12, C, E, manganese, copper, iodine, selenium, iron, zinc and vitamin D3 to contribute to the well-being of the pregnant woman , growth of maternal tissues during pregnancy, healthy development of the fetal brain and eyes, absorption of calcium and helps reduce fatigue.
[0012] Dans certains modes de réalisation, le produit de combinaison selon l'invention comprend, en plus de l'acide eicosapentaénoïque (EPA), de l'acide docosahexaénoïque (DHA), de la vitamine B1 , B2, B3, B5, B6, B8, B9, B12, C, E, du manganèse, du cuivre, de l’iode, du sélénium, du fer, du zinc et de la vitamine D3, à titre de substances actives : In some embodiments, the combination product according to the invention comprises, in addition to eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), vitamin B1, B2, B3, B5, B6, B8, B9, B12, C, E, manganese, copper, iodine, selenium, iron, zinc and vitamin D3, as active substances:
-Des plantes ou extraits de plantes -Plants or plant extracts
-Des vitamines et minéraux, tels que par exemple les vitamines A, K, le magnésium ou le calcium -Vitamins and minerals, such as for example vitamins A, K, magnesium or calcium
[0013] Dans certains modes de réalisation, le produit de combinaison de l'invention est caractérisé en ce que l'acide eicosapentaénoïque (EPA), de l'acide docosahexaénoïque (DHA), de la vitamine B1 , B2, B3, B5, B6, B8, B9, B12, C, E, du manganèse, du cuivre, de l’iode, du sélénium, du fer, du zinc et de la vitamine D3 sont présents dans les quantités suivantes : de 10 à 100 mg de préférence 30 à 70 mg d’acide eicosapentaénoïque de 50 à 500 mg, de préférence 100 à 300 mg d'acide docosahexaénoïque de 0,5 à 4 mg de préférence 1 à 2 mg de vitamine B1 de 0,5 à 4 mg de préférence 1 à 2 mg de vitamine B2 de 5 à 30 mg de préférence 10 à 20 mg de vitamine B3 de 3 à 10 mg de préférence 5 à 7 mg de vitamine B5 de 0,5 à 4 mg, de préférence 1 à 2 mg de vitamine B6 de 10 à 100 pg de préférence 30 à 60 pg de vitamine B8 de 100 à 1000 pg de préférence 300 à 600 pg de vitamine B9 de 1 à 6 pg de préférence 2 à 4 pg de vitamine B12 de 50 à 200 mg de préférence 60 à 140 mg de vitamine C de 2 à 30 pg de préférence 5 à 20 pg de vitamine D3 de 1 à 25 mg de préférence 6 à 20 mg de vitamine E de 0,05 à 5 mg de préférence 0,5 à 2 mg de manganèse de 0,05 à 5 mg de préférence 0,5 à 2 mg de cuivre de 50 à 500 pg de préférence 100 à 200 pg d’iode de 10 à 100 pg de préférence 30 à 60 pg de sélénium de 1 à 30 mg de préférence 10 à 20 mg de fer de 1 à 30 mg de préférence 5 à 20 mg de zinc dans un milieu physiologiquement acceptable. In some embodiments, the combination product of the invention is characterized in that eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), vitamin B1, B2, B3, B5, B6, B8, B9, B12, C, E, manganese, copper, iodine, selenium, iron, zinc and vitamin D3 are present in the following amounts: from 10 to 100 mg preferably 30 to 70 mg eicosapentaenoic acid 50 to 500 mg, preferably 100 to 300 mg docosahexaenoic acid 0.5 to 4 mg preferably 1 to 2 mg vitamin B1 0.5 to 4 mg preferably 1 to 2 mg of vitamin B2 from 5 to 30 mg preferably 10 to 20 mg of vitamin B3 from 3 to 10 mg preferably 5 to 7 mg of vitamin B5 from 0.5 to 4 mg, preferably 1 to 2 mg of vitamin B6 10 to 100 pg preferably 30 to 60 pg vitamin B8 100 to 1000 pg preferably 300 to 600 pg vitamin B9 1 to 6 pg preferably 2 to 4 pg vitamin B12 preferably 50 to 200 mg 60 to 140 mg of vitamin C from 2 to 30 pg of p reference 5 to 20 pg of vitamin D3 from 1 to 25 mg preferably 6 to 20 mg of vitamin E from 0.05 to 5 mg preferably 0.5 to 2 mg of manganese from 0.05 to 5 mg preferably 0, 5 to 2 mg of copper 50 to 500 pg preferably 100 to 200 pg iodine 10 to 100 pg preferably 30 to 60 pg selenium from 1 to 30 mg, preferably 10 to 20 mg of iron from 1 to 30 mg, preferably 5 to 20 mg of zinc in a physiologically acceptable medium.
[0014] Selon un mode de réalisation particulier de l'invention, le produit de combinaison est caractérisé en ce que les ingrédients actifs, c’est-à-dire l'acide eicosapentaénoïque (EPA), l'acide docosahexaénoïque (DHA), la vitamine B1 , B2, B3, B5, B6, B8, B9, B12, C, E, le manganèse, le cuivre, l’iode, le sélénium, le fer, le zinc et la vitamine D3 sont dans un milieu adapté à l'administration par voie orale. De préférence, le milieu adapté est un milieu solide. De manière préférentielle, le produit de combinaison se présente sous la forme d’une capsule molle. According to a particular embodiment of the invention, the combination product is characterized in that the active ingredients, that is to say eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), vitamin B1, B2, B3, B5, B6, B8, B9, B12, C, E, manganese, copper, iodine, selenium, iron, zinc and vitamin D3 are in a medium suitable for oral administration. Preferably, the suitable medium is a solid medium. Preferably, the combination product is in the form of a soft capsule.
[0015] Les différents modes de réalisations de l'invention sont particulièrement décrits dans la description détaillée ci-après. Ces modes de réalisation peuvent être pris séparément ou en combinaison les uns avec les autres. The various embodiments of the invention are particularly described in the detailed description below. These embodiments can be taken separately or in combination with each other.
[0016] DESCRIPTION DETAILLEE DE L'INVENTION : DETAILED DESCRIPTION OF THE INVENTION:
[0017] Dans la présente invention, la demanderesse a mis en évidence que l'association l'acide eicosapentaénoïque (EPA), l'acide docosahexaénoïque (DHA), la vitamine B1 , B2, B3, B5, B6, B8, B9, B12, C, E, le manganèse, le cuivre, l’iode, le sélénium, le fer, le zinc et la vitamine D3 présentait un effet synergique pour contribuer au bien-être de la femme enceinte, à la croissance des tissus maternelles durant la grossesse, au bon développement du cerveau et des yeux du foetus, à l’absorption du calcium et aide à réduire la fatigue. In the present invention, the Applicant has demonstrated that the combination of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), vitamin B1, B2, B3, B5, B6, B8, B9, B12, C, E, manganese, copper, iodine, selenium, iron, zinc and vitamin D3 exhibited a synergistic effect to contribute to the well-being of the pregnant woman, to the growth of maternal tissues during pregnancy, the proper development of the brain and eyes of the fetus, absorption of calcium and helps reduce fatigue.
[0018] Les Omégas 3 [0018] The Omega 3s
[0019] Tout au long de la grossesse, certains oméga 3 essentiels, le DHA (acide docosahexaénoïque) et IΈRA (acide eicosapentaénoïque), s'incorporent en grosse proportion dans les cellules de la rétine et du cerveau du futur bébé. Des tests effectués sur de jeunes enfants ont montré qu'un bon statut en oméga 3 à la naissance, accélère la maturation visuelle, et peut même augmenter le quotient intellectuel (Q I). Par ailleurs, des études suggèrent que les femmes qui consomment le moins d'oméga 3, souffrent davantage du " baby blues" après un accouchement. [0020] Les bienfaits des oméga-3 chez les femmes enceintes sont de mieux en mieux démontrés. Ces bons gras contribuent à la fois à la santé de la femme enceinte et à celle du foetus. En effet, les oméga-3 participent au développement du cerveau et des yeux du futur bébé. De plus, il a été montré qu’ils aident la mère à garder un bon moral tout au long de la grossesse et après la naissance. Throughout pregnancy, certain essential omega 3s, DHA (docosahexaenoic acid) and IΈRA (eicosapentaenoic acid), are incorporated in large proportion in the cells of the retina and the brain of the future baby. Tests carried out on young children have shown that a good omega 3 status at birth, accelerates visual maturation, and can even increase the intelligence quotient (IQ). In addition, studies suggest that women who consume the least omega 3, suffer more from the "baby blues" after childbirth. The benefits of omega-3 in pregnant women are increasingly demonstrated. These good fats contribute to both the health of the pregnant woman and that of the fetus. In fact, omega-3s participate in the development of the brain and eyes of the future baby. In addition, they have been shown to help the mother maintain good morale throughout pregnancy and after birth.
[0021] Une analyse de 70 études a conclu que la prise de suppléments d’oméga-3 pendant la grossesse diminuait le risque de naissances prématurées (avant 37 semaines) et très prématurées (avant 34 semaines). [0021] An analysis of 70 studies concluded that taking omega-3 supplements during pregnancy decreased the risk of both premature (before 37 weeks) and very premature (before 34 weeks) births.
[0022] La composition selon la présente invention comprend de 10 à 100 mg de préférence 30 à 70 mg d’acide eicosapentaénoïque et de 50 à 500 mg, de préférence 100 à 300 mg d'acide docosahexaénoïque. Plus préférentiellement, la composition selon la présente invention contient des omégas 3 dont le rapport EPA/DHA est d’au moins 1 :5 The composition according to the present invention comprises from 10 to 100 mg, preferably 30 to 70 mg of eicosapentaenoic acid and from 50 to 500 mg, preferably 100 to 300 mg of docosahexaenoic acid. More preferably, the composition according to the present invention contains omega 3 whose EPA / DHA ratio is at least 1: 5
[0023] La vitamine B1 [0023] Vitamin B1
[0024] La thiamine ou vitamine B1 (ou encore aneurine) est un précurseur métabolique de la thiamine pyrophosphate (TPP), une coenzyme essentielle à certaines décarboxylases. Chez les animaux, la thiamine est une vitamine hydrosoluble de la famille des vitamines B qu'ils doivent trouver dans leur alimentation. Elle est en revanche synthétisée par les bactéries, les plantes et les champignons. Elle est indispensable à la transformation des glucides en énergie par le cycle de Krebs et est nécessaire au bon fonctionnement du système nerveux et des muscles. Elle est en effet indispensable à la transformation du pyruvate produit par la glycolyse et toxique pour le système nerveux. Thiamine or vitamin B1 (or also aneurine) is a metabolic precursor of thiamine pyrophosphate (TPP), a coenzyme essential for certain decarboxylases. In animals, thiamine is a water-soluble vitamin from the family of B vitamins that they must find in their diet. On the other hand, it is synthesized by bacteria, plants and fungi. It is essential for the transformation of carbohydrates into energy by the Krebs cycle and is necessary for the proper functioning of the nervous system and muscles. It is in fact essential for the transformation of pyruvate produced by glycolysis and toxic for the nervous system.
[0025] Chez l'homme, une carence alimentaire en vitamine B1 cause le béribéri et peut aussi causer une encéphalopathie de Gayet-Wernicke. In humans, a dietary vitamin B1 deficiency causes beriberi and can also cause Gayet-Wernicke encephalopathy.
[0026] Chez l'homme, les besoins estimés sont de 1 ,3 mg à 1 ,5 mg par jour. Chez l'adulte en bonne santé, l'absorption digestive est de 4,5 % de la dose ingérée, et baisse à 1 ,5 % en cas d'alcoolo-dépendance. In humans, the estimated needs are 1.3 mg to 1.5 mg per day. In healthy adults, digestive absorption is 4.5% of the ingested dose, and drops to 1.5% in alcohol dependence.
[0027] La composition selon la présente invention comprend de 0,5 à 4 mg de préférence 1 à 2 mg de vitamine B1 . The composition according to the present invention comprises from 0.5 to 4 mg, preferably 1 to 2 mg of vitamin B1.
[0028] La vitamine B2 [0029] La vitamine B2, correspondant à la riboflavine, ou lactoflavine, est une vitamine hydrosoluble nécessaire à la synthèse de la flavine adénine dinucléotide (FAD) et de la flavine mononucléotide (FMN), deux cofacteurs essentiels aux flavoprotéines. [0028] Vitamin B2 Vitamin B2, corresponding to riboflavin, or lactoflavin, is a water-soluble vitamin necessary for the synthesis of flavin adenine dinucleotide (FAD) and flavin mononucleotide (FMN), two cofactors essential to flavoproteins.
[0030] La vitamine B2 joue un rôle important dans la transformation des aliments simples (glucides, lipides et protéines) en énergie. Elle intervient dans le métabolisme de réparation des muscles. [0030] Vitamin B2 plays an important role in the transformation of simple foods (carbohydrates, fats and proteins) into energy. It is involved in the repair metabolism of the muscles.
[0031] La riboflavine se trouve naturellement dans les asperges, le maïs soufflé, les bananes, les kakis, le gombo, les blettes à carde, le fromage, le lait, le yaourt, la viande, les œufs, le poisson et les haricots verts, dont chacun contient au moins 0,1 mg de vitamine B par 85-300g. D'autres sources sont les légumes verts feuillus, le foie, les reins, les légumineuses, les tomates, les levures, les champignons et les amandes. Riboflavin is found naturally in asparagus, popcorn, bananas, persimmons, okra, Swiss chard, cheese, milk, yogurt, meat, eggs, fish and beans greens, each of which contains at least 0.1 mg of vitamin B per 85-300g. Other sources are green leafy vegetables, liver, kidneys, legumes, tomatoes, yeasts, mushrooms and almonds.
[0032] Elle est également utilisée en tant que traitement de fond de la migraine. It is also used as a basic treatment for migraine.
[0033] La composition selon la présente invention comprend de 0,5 à 4 mg de préférence 1 à 2 mg de vitamine B2. The composition according to the present invention comprises from 0.5 to 4 mg, preferably 1 to 2 mg of vitamin B2.
[0034] La vitamine B3 [0034] Vitamin B3
[0035] La vitamine B3 est une vitamine hydrosoluble qui correspond à deux molécules : la niacine (acide nicotinique) et son amide, le nicotinamide, parfois appelée niacinamide. Elle est aussi appelée vitamine PP pour pellagra préventive car une carence en cette vitamine est responsable de la pellagre. Vitamin B3 is a water-soluble vitamin which corresponds to two molecules: niacin (nicotinic acid) and its amide, nicotinamide, sometimes called niacinamide. It is also called vitamin PP for preventive pellagra because a deficiency in this vitamin is responsible for pellagra.
[0036] La vitamine B3, précurseur du NAD+ (nicotinamide adénine dinucléotide) et du NADP+ (nicotinamide adénine dinucléotide phosphate), est nécessaire comme cofacteur d'oxydoréduction au métabolisme des glucides, des lipides et des protéines. Elle fait partie des vitamines B. Vitamin B3, precursor of NAD + (nicotinamide adenine dinucleotide) and of NADP + (nicotinamide adenine dinucleotide phosphate), is necessary as a redox cofactor in the metabolism of carbohydrates, lipids and proteins. It is part of the B vitamins.
[0037] La vitamine B3 se trouve principalement dans les volailles, le foie de veau et les céréales. [0037] Vitamin B3 is found mainly in poultry, calf's liver and cereals.
[0038] Les vitamines B facilitent la conversion de la nourriture (glucides) en énergie (glucose). La niacine est utile dans le processus de régulation des hormones liées au stress et améliore la circulation sanguine. Ces vitamines sont hydrosolubles et le corps ne les stocke pas. [0039] Il est rare, dans les pays développés, d'être victime d'une carence sévère en vitamine B3. B vitamins facilitate the conversion of food (carbohydrates) into energy (glucose). Niacin is helpful in the process of regulating stress hormones and improves blood circulation. These vitamins are water soluble and the body does not store them. It is rare, in developed countries, to be a victim of severe vitamin B3 deficiency.
[0040] Les symptômes d'une carence légère sont l'indigestion, la fatigue, le vomissement, ou la dépression. Elle peut être due à une grossesse. Symptoms of mild deficiency are indigestion, fatigue, vomiting, or depression. It may be due to pregnancy.
[0041] La composition selon la présente invention comprend de 5 à 30 mg de préférence 10 à 20 mg de vitamine B3. The composition according to the present invention comprises from 5 to 30 mg, preferably 10 to 20 mg of vitamin B3.
[0042] La vitamine B5 [0042] Vitamin B5
[0043] La vitamine B5, correspondant à l’acide pantothénique, est une vitamine hydrosoluble. C'est un précurseur métabolique de la coenzyme A, essentielle à la synthèse et au métabolisme des protéines, des glucides et des lipides. [0043] Vitamin B5, corresponding to pantothenic acid, is a water soluble vitamin. It is a metabolic precursor of coenzyme A, essential for the synthesis and metabolism of proteins, carbohydrates and lipids.
[0044] La racine étnique provient de pάntoqen (pântothen) qui, en grec, signifie « partout » : cette vitamine se trouve en effet dans presque tous les aliments. Cependant, on la trouve en proportions particulièrement concentrées dans les germes et céréales complètes et dans les variétés d'ortie piquante. La gelée royale est l'un des produits naturels connu le plus riche qui soit en vitamine B5. The ethnic root comes from pάntoqen (pntothen) which, in Greek, means "everywhere": this vitamin is in fact found in almost all foods. However, it is found in particularly concentrated proportions in sprouts and whole grains and in varieties of stinging nettle. Royal jelly is one of the richest known natural products in vitamin B5.
[0045] L'acide pantothénique est constitué d'une molécule d'acide pantoïque et d'une molécule de b-alanine, liées par une fonction amide. Pantothenic acid consists of a pantoic acid molecule and a β-alanine molecule, linked by an amide function.
[0046] Précurseur et constituant du coenzyme A, la vitamine B5 favorise la croissance et la résistance de la peau et des muqueuses. Elle est nécessaire au métabolisme des glucides, lipides et protéines et participe à la synthèse de certaines hormones. L'acide pantothénique est détruit par la chaleur en solution aqueuse. Precursor and constituent of coenzyme A, vitamin B5 promotes the growth and resistance of the skin and mucous membranes. It is necessary for the metabolism of carbohydrates, lipids and proteins and participates in the synthesis of certain hormones. Pantothenic acid is destroyed by heat in aqueous solution.
[0047] Les besoins du corps humain sont estimés à 5 mg par jour à partir de 16 ans, à 2 mg chez les nourrissons et à 7 mg pour les allaitantes mais généralement seule une sous-alimentation peut entraîner une réelle carence. The needs of the human body are estimated at 5 mg per day from the age of 16, at 2 mg in infants and at 7 mg for breastfeeding mothers, but generally only under-nourishment can cause real deficiency.
[0048] La composition selon la présente invention comprend de 3 à 10 mg de préférence 5 à 7 mg de vitamine B5. The composition according to the present invention comprises from 3 to 10 mg, preferably 5 to 7 mg of vitamin B5.
[0049] La vitamine B6 [0049] Vitamin B6
[0050] La vitamine B6 est une vitamine hydrosoluble existant sous plusieurs formes, le phosphate de pyridoxal étant sa forme biologiquement active, en tant que cofacteur intervenant dans plusieurs réactions du métabolisme des acides aminés, notamment des transaminations, désaminations et décarboxylations. Le phosphate de pyridoxal intervient également dans la réaction d'hydrolyse du glycogène en glucose. Vitamin B6 is a water-soluble vitamin existing in several forms, pyridoxal phosphate being its biologically active form, as a cofactor involved in several reactions of the metabolism of amino acids, in particular transaminations, deaminations and decarboxylations. Pyridoxal phosphate is also involved in the reaction of hydrolysis of glycogen to glucose.
[0051 ] La vitamine B6 est connue sous sept formes différentes, interconvertibles entre elles hormis la dernière : Vitamin B6 is known in seven different forms, interconvertible with each other except the last:
1 . pyridoxine (PN), forme sous laquelle la vitamine B6 est administrée en complément alimentaire, 1. pyridoxine (PN), the form in which vitamin B6 is administered as a food supplement,
2. phosphate de pyridoxine (PNP), 2.pyridoxine phosphate (PNP),
3. pyridoxal (PL), 3.pyridoxal (PL),
4. phosphate de pyridoxal (PLP), forme biologiquement active (distribuée comme supplément vitaminique « P-5-P »), 4.pyridoxal phosphate (PLP), biologically active form (distributed as vitamin supplement "P-5-P"),
5. pyridoxamine (PM), 5.pyridoxamine (PM),
6. phosphate de pyridoxamine (PMP), 6.pyridoxamine phosphate (PMP),
7. acide 4-pyridoxique (PA), catabolite excrété par voie urinaire. 7. 4-pyridoxic acid (PA), a catabolite excreted in the urine.
[0052] La vitamine B6 participe à la transformation du tryptophane en vitamine B3, et au métabolisme des lipides et des acides aminés (décarboxylation et transamination). Le phosphate de pyridoxal permet la conversion du glycogène en glucose (Glucose-1-Phospate) par la Glycogène phosphorylase. Vitamin B6 participates in the transformation of tryptophan into vitamin B3, and in the metabolism of lipids and amino acids (decarboxylation and transamination). Pyridoxal phosphate allows the conversion of glycogen into glucose (Glucose-1-Phospate) by Glycogen phosphorylase.
[0053] La vitamine B6 participe également à la biosynthèse de la sérotonine. Vitamin B6 also participates in the biosynthesis of serotonin.
[0054] Elle est présente en quantités importantes dans les volailles, les foies (bœuf, agneau, veau), les bananes, les différentes formes de choux, les tomates, les épinards, les pommes de terre... It is present in large quantities in poultry, livers (beef, lamb, veal), bananas, various forms of cabbage, tomatoes, spinach, potatoes ...
[0055] Associée à la cystine, elle est administrée pour faciliter le développement des phanères (cheveux, ongles...). Associated with cystine, it is administered to facilitate the development of integuments (hair, nails, etc.).
[0056] La composition selon la présente invention comprend de 0,5 à 4 mg, de préférence 1 à 2 mg de vitamine B6 The composition according to the present invention comprises from 0.5 to 4 mg, preferably 1 to 2 mg of vitamin B6
[0057] La vitamine B8 ou biotine [0058] La biotine, est une vitamine hydrosoluble. La biotine est une coenzyme qui participe au métabolisme des acides gras, des glucides et des acides aminés, ainsi qu'à la biosynthèse des vitamines B9 et B12. On la retrouve donc, d'un point de vue biologique, dans toutes les espèces vivantes. Au plan diététique, on la trouve notamment dans les céréales complètes, le foie, les œufs et le lait, mais aussi le soja, les noisettes, les levures et en moindres quantités dans les autres aliments. [0057] Vitamin B8 or biotin Biotin is a water soluble vitamin. Biotin is a coenzyme which participates in the metabolism of fatty acids, carbohydrates and amino acids, as well as in the biosynthesis of vitamins B9 and B12. It is therefore found, from a biological point of view, in all living species. In terms of diet, it is found in particular in whole grains, liver, eggs and milk, but also soybeans, hazelnuts, yeasts and in smaller amounts in other foods.
[0059] La biotine est nécessaire à la croissance cellulaire, à la production d'acides gras, et au métabolisme des graisses et des acides aminés. Elle joue un rôle dans le cycle de Krebs qui est le processus biochimique par lequel l'énergie est produite au cours de la respiration aérobie. La biotine participe non seulement à diverses réactions métaboliques, mais elle aide aussi au transfert du dioxyde de carbone. La biotine est également utile dans le maintien d'un niveau constant de sucre dans le sang (glycémie). La biotine est souvent recommandée pour renforcer les cheveux et les ongles. En conséquence, c'est un composant de nombreux cosmétiques et produits de santé pour les cheveux et la peau. Biotin is necessary for cell growth, the production of fatty acids, and the metabolism of fats and amino acids. It plays a role in the Krebs cycle which is the biochemical process by which energy is produced during aerobic respiration. Biotin is not only involved in various metabolic reactions, but it also helps in the transfer of carbon dioxide. Biotin is also helpful in maintaining a constant level of sugar in the blood (blood sugar). Biotin is often recommended for strengthening hair and nails. As a result, it is a component of many cosmetics and health products for the hair and skin.
[0060] Des études sur la biodisponibilité de la biotine ont été menées sur les rats et les poussins. De ces études, il a été conclu que la biodisponibilité de la biotine peut être faible ou variable selon le type d'aliment consommé. En général, la biotine existe dans les aliments sous forme de protéines ou de biocytine. La protéolyse par protéase est nécessaire avant l'absorption. Ce processus favorise la libération de la biotine de la biocytine et des protéines. La biotine du maïs est facilement disponible, mais la plupart des céréales ont une biodisponibilité en biotine de 20 à 40 %. Une possible explication à la grande variabilité de la biodisponibilité de la biotine résiderait dans la facilité qu'un organisme a à briser les liens biotine- protéine des aliments, en clair si celui-ci possède l'enzyme capable de briser ces liens. [0060] Studies on the bioavailability of biotin were carried out on rats and chicks. From these studies, it was concluded that the bioavailability of biotin may be low or variable depending on the type of food consumed. Usually, biotin is found in foods as protein or as biocytin. Protease proteolysis is necessary before absorption. This process promotes the release of biotin from biocytin and proteins. Biotin in corn is readily available, but most grains have 20-40% bioavailability of biotin. A possible explanation for the great variability in the bioavailability of biotin would lie in the ease that an organism has to break the biotin-protein bonds of food, in other words if this one has the enzyme capable of breaking these bonds.
[0061 ] Des suppléments de biotine sont souvent recommandés comme moyen naturel pour lutter contre le problème de perte de cheveux chez les enfants et les adultes. Les signes et les symptômes de la carence en biotine incluent la perte de cheveux qui progresse en gravité pour aller jusqu'à la perte des cils et des sourcils chez des sujets fortement carencés. [0062] La composition selon la présente invention comprend de 10 à 100 pg de préférence 30 à 60 pg de vitamine B8 Biotin supplements are often recommended as a natural way to combat the problem of hair loss in children and adults. Signs and symptoms of biotin deficiency include hair loss which progresses in severity to loss of eyelashes and eyebrows in severely deficient individuals. The composition according to the present invention comprises from 10 to 100 pg, preferably 30 to 60 pg of vitamin B8
[0063] La vitamine B9 [0063] Vitamin B9
[0064] La vitamine B9 également appelée acide folique ou folates est essentielle dès les premiers jours de la grossesse. Tout au long de la grossesse, l’acide folique participe à la formation des nouveaux tissus, des cellules du sang, du cerveau et du système nerveux. Une carence en acide folique peut causer un retard de croissance, une malformation congénitale ou une anomalie du tube neural (par exemple, le spina-bifida). Des handicaps physiques ou des déficiences mentales sévères peuvent en découler. Vitamin B9 also called folic acid or folate is essential from the first days of pregnancy. Throughout pregnancy, folic acid helps build new tissues, blood cells, the brain and the nervous system. A deficiency in folic acid can cause growth retardation, a birth defect, or a neural tube defect (for example, spina bifida). Physical disabilities or severe mental impairments can result.
[0065] Un manque d'acide folique se traduit par une anémie macrocytaire, identifiable par une simple prise de sang : les globules rouges sont en nombre insuffisant et de trop grande taille. Mais cette anémie peut être masqué par une carence en fer. Alors soyez vigilante et sachez que la moitié des Françaises manquent d'acide folique. En effet, non seulement une femme sur deux a des apports en folates inférieurs aux 2/3 des apports nutritionnels recommandés, mais de plus 50 % des femmes ne métabolisent pas correctement l'acide folique. C'est pourquoi, dans le cadre du Programme National Nutrition Santé (PNNS), on recommande une supplémentation systématique en vitamine B9, dès le désir d'enfant et durant tout le premier trimestre de grossesse. A lack of folic acid results in macrocytic anemia, identifiable by a simple blood test: the red blood cells are insufficient in number and too large. But this anemia can be masked by iron deficiency. So be vigilant and know that half of French women lack folic acid. Indeed, not only does one in two women have folate intakes lower than 2/3 of the recommended nutritional intake, but more than 50% of women do not properly metabolize folic acid. This is why, within the framework of the National Health Nutrition Program (PNNS), systematic vitamin B9 supplementation is recommended, from the desire for a child and throughout the first trimester of pregnancy.
[0066] Les besoins quotidiens en acide folique de la femme enceinte varient de 0,4 mg à 1 mg par jour. Ceux des femmes ayant une histoire familiale ou personnelle d’anomalie du tube neural sont encore plus élevés. The daily folic acid requirements of the pregnant woman vary from 0.4 mg to 1 mg per day. Those of women with a family or personal history of neural tube defect are even higher.
[0067] La composition selon la présente invention comprend de 100 à 1000 pg de préférence 300 à 600 pg de vitamine B9. The composition according to the present invention comprises from 100 to 1000 pg, preferably 300 to 600 pg of vitamin B9.
[0068] La vitamine B12 [0068] Vitamin B12
[0069] La vitamine B12 est essentielle à la fabrication des globules rouges du sang et au bon fonctionnement du système nerveux du foetus. Elle travaille avec l’acide folique pour fabriquer l’ADN (le matériel génétique). Vitamin B12 is essential for the production of red blood cells and for the proper functioning of the fetal nervous system. It works with folic acid to make DNA (the genetic material).
[0070] Comme cette vitamine se trouve presque uniquement dans des aliments d’origine animale, les femmes végétariennes ou celles qui mangent très peu de viande, de poisson, d’œufs et de produits laitiers doivent y porter une attention particulière. As this vitamin is found almost only in foods of animal origin, vegetarian women or those who eat very little meat, fish, eggs and dairy products should pay special attention.
[0071 ] Une carence en vitamine B12 pourrait nuire aux fonctions cognitives de l’enfant et provoquer l’anémie ainsi que des troubles de mémoire et d’autres problèmes neurologiques permanents chez la mère. [0071] Vitamin B12 deficiency could impair cognitive functions in the infant and cause anemia as well as memory impairment and other lifelong neurological problems in the mother.
[0072] La composition selon la présente invention comprend de 1 à 6 pg de préférence 2 à 4 pg de vitamine B12. The composition according to the present invention comprises from 1 to 6 pg, preferably 2 to 4 pg of vitamin B12.
[0073] La vitamine C [0073] Vitamin C
[0074] La vitamine C est une vitamine hydrosoluble sensible à la chaleur et à la lumière jouant un rôle important dans le métabolisme de l'être humain et de nombreux autres mammifères. Chimiquement parlant, il s'agit de l'acide L-ascorbique, un des stéréoisomères de l'acide ascorbique, et de ses sels, les ascorbates. Les plus courants sont l'ascorbate de sodium et l'ascorbate de calcium. Vitamin C is a water soluble heat and light sensitive vitamin playing an important role in the metabolism of humans and many other mammals. Chemically speaking, it is L-ascorbic acid, one of the stereoisomers of ascorbic acid, and its salts, the ascorbates. The most common are sodium ascorbate and calcium ascorbate.
[0075] La vitamine C est un cofacteur enzymatique impliqué dans un certain nombre de réactions physiologiques (hydroxylation). Elle est requise dans la synthèse du collagène et des globules rouges et contribue au système immunitaire. Elle joue également un rôle dans le métabolisme du fer en tant que promoteur de son absorption ; son utilisation est donc déconseillée chez les patients porteurs d'une surcharge en fer et particulièrement d'une hémochromatose. Sous forme oxydée (acide déshydroascorbique), elle traverse la barrière hémato-encéphalique pour accéder au cerveau et à plusieurs organes à forte concentration en vitamine C. Vitamin C is an enzymatic cofactor involved in a number of physiological reactions (hydroxylation). It is required in the synthesis of collagen and red blood cells and contributes to the immune system. It also plays a role in iron metabolism as a promoter of its absorption; its use is therefore not recommended in patients with an iron overload and particularly hemochromatosis. In oxidized form (dehydroascorbic acid), it crosses the blood-brain barrier to access the brain and several organs with a high concentration of vitamin C.
[0076] La composition selon la présente invention comprend de 50 à 200 mg de préférence 60 à 140 mg de vitamine C. The composition according to the present invention comprises from 50 to 200 mg, preferably 60 to 140 mg of vitamin C.
[0077] La vitamine D3 [0077] Vitamin D3
[0078] Le cholécalciférol est une forme de vitamine D, également appelée vitamine D3. La vitamine D3 est un sécostéroïde plutôt parent de la testostérone, du cholestérol et du cortisol. Cholecalciferol is a form of vitamin D, also called vitamin D3. Vitamin D3 is a secosteroid rather related to testosterone, cholesterol and cortisol.
[0079] La vitamine D possède une double origine : elle est apportée par l'alimentation et synthétisée par l'organisme au niveau de la peau sous l'action des rayons UVB du soleil. [0080] Les sujets s'exposant très peu au soleil peuvent présenter des carences plus ou moins importantes en vitamine D. Les personnes à peau claire synthétisent la vitamine D plus vite que celles à peau foncée, et ont donc besoin d'une durée d'exposition moins longue pour transformer les précurseurs de la vitamine D produits par le foie en vitamine D. La quantité de vitamine D que la peau peut produire est limitée ; une exposition prolongée à la lumière solaire (plus de 30 minutes pour une personne à peau claire, jusqu'à trois heures pour les personnes à peau sombre) n'augmente pas la quantité de cholécalciférol produite par l'organisme. Pour une personne à peau claire, une exposition de 10 à 15 minutes quelques fois par semaine suffit à couvrir les besoins en vitamine D3. La vitamine D fabriquée par la peau est mise en réserve au niveau du foie, du muscle et du tissu gras et utilisée à la demande au cours des périodes hivernales. Vitamin D has a dual origin: it is provided by food and synthesized by the body in the skin under the action of UVB rays from the sun. Subjects with very little exposure to the sun may exhibit more or less significant deficiencies in vitamin D. People with fair skin synthesize vitamin D faster than those with dark skin, and therefore need a period of time. 'shorter exposure to convert vitamin D precursors produced by the liver into vitamin D. The amount of vitamin D that the skin can produce is limited; prolonged exposure to sunlight (more than 30 minutes for a fair-skinned person, up to three hours for a dark-skinned person) does not increase the amount of cholecalciferol produced by the body. For a person with fair skin, an exposure of 10 to 15 minutes a few times a week is enough to cover the needs in vitamin D3. Vitamin D produced by the skin is stored in the liver, muscle and fatty tissue and used on demand during winter periods.
[0081] Deux formes de vitamine D existent : la vitamine D2 ou ergocalciférol produite par les végétaux et la vitamine D3 ou cholécalciférol produite par les animaux, ainsi que par certains lichens. Chez l'homme, ces deux formes sont converties en 1 ,25- dihydroxyvitamine D (communément appelé vitamine D), leur principal métabolite actif. Two forms of vitamin D exist: vitamin D2 or ergocalciferol produced by plants and vitamin D3 or cholecalciferol produced by animals, as well as by certain lichens. In humans, these two forms are converted to 1,25-dihydroxyvitamin D (commonly referred to as vitamin D), their main active metabolite.
[0082] La fonction essentielle de la vitamine D est d'augmenter la capacité d'absorption de l'intestin pour le calcium et le phosphore ce qui permet : The essential function of vitamin D is to increase the absorption capacity of the intestine for calcium and phosphorus which allows:
1 . d'assurer une minéralisation optimale des tissus minéralisés, notamment os, cartilage et dents ; 1. to ensure optimal mineralization of mineralized tissues, in particular bone, cartilage and teeth;
2. de contribuer au maintien des concentrations plasmatiques du calcium et du phosphore. 2. to help maintain plasma concentrations of calcium and phosphorus.
Les signes cliniques de carence en vitamine D sont : l'ostéomalacie et le rachitisme au niveau osseux, la baisse de tonus musculaire, les crises de tétanie et les convulsions (en relation avec une hypocalcémie) et parfois l'anémie. Chez les personnes âgées, la carence en vitamine D constitue un terrain favorable à la perte osseuse (donc à l'ostéoporose), et à la dépression (comme l'a confirmé une étude néerlandaise évoquée dans Archives of General Psychiatry (mai 2008)). The clinical signs of vitamin D deficiency are: osteomalacia and rickets in the bones, decreased muscle tone, tetany attacks and convulsions (related to hypocalcemia) and sometimes anemia. In the elderly, vitamin D deficiency constitutes a favorable ground for bone loss (therefore osteoporosis), and depression (as confirmed by a Dutch study mentioned in Archives of General Psychiatry (May 2008)) .
[0083] Plusieurs tranches d'âge constituent des populations à risque de carence en vitamine D : ce sont les nouveau-nés, les nourrissons, les femmes enceintes et les personnes âgées, particulièrement celles placées en institution, qui s'exposent peu au soleil et/ou ont des besoins accrus. D'autres facteurs peuvent aggraver ces risques de carence, la forte pigmentation cutanée, les régimes alimentaires spécifiques (végétarien, macrobiotique), les pathologies induisant une malabsorption intestinale. Several age groups constitute populations at risk of vitamin D deficiency: these are newborns, infants, pregnant women and children. elderly people, particularly those placed in institutions, who do not get much sun and / or have increased needs. Other factors can aggravate these risks of deficiency, the strong skin pigmentation, specific diets (vegetarian, macrobiotic), pathologies inducing intestinal malabsorption.
[0084] Les apports nutritionnels conseillés en vitamine D ont été définis en considérant que la production endogène couvre 50 à 70 % des besoins quotidiens en cette vitamine. The recommended nutritional intakes of vitamin D were defined by considering that the endogenous production covers 50 to 70% of the daily requirements for this vitamin.
[0085] Un nombre limité d'aliments contient des quantités significatives de vitamine D. En effet, ces teneurs sont étroitement liées à la présence de matières grasses dans les aliments. Les meilleures sources de vitamine D sont les poissons de mer gras, quel que soit leur mode de préparation et de conservation (cuisson à l'eau, fumage, appertisation, grillade) : harengs, saumons, sardines, maquereaux par exemple. Le jaune d’œuf, les produits laitiers, le soja et ses dérivés (tofu et lait de soja par exemple) et certains champignons (avec de grandes différences selon les variétés) sont aussi des sources de vitamine D. De faibles quantités de vitamine D sont également apportées par les viandes, les abats et les pâtés. Les poissons maigres (raie, sole, colin...) en sont dépourvus. Certains lichens produisent également du cholécalciférol (vitamine D3), et sont utilisés pour produire des compléments alimentaires végétaux en cette vitamine. A limited number of foods contain significant amounts of vitamin D. In fact, these contents are closely linked to the presence of fat in the foods. The best sources of vitamin D are fatty sea fish, whatever their method of preparation and conservation (boiling, smoking, canning, grilling): herring, salmon, sardines, mackerel for example. Egg yolks, dairy products, soy and its derivatives (tofu and soy milk for example) and certain mushrooms (with great differences depending on the variety) are also sources of vitamin D. Low amounts of vitamin D are also provided by meats, offal and pâtés. Lean fish (ray, sole, hake, etc.) do not have them. Some lichens also produce cholecalciferol (vitamin D3), and are used to produce plant food supplements with this vitamin.
[0086] Des études suggèrent que la supplémentation des femmes enceintes en vitamine D puisse contribuer à réduire le risque de prééclampsie, de diabète gestationnel et de bébé de faible poids à la naissance. [0086] Studies suggest that supplementing pregnant women with vitamin D may help reduce the risk of preeclampsia, gestational diabetes and low birth weight babies.
[0087] La composition selon la présente invention comprend de 2 à 30 pg de préférence 5 à 20 pg de vitamine D3 The composition according to the present invention comprises from 2 to 30 pg, preferably 5 to 20 pg of vitamin D3
[0088] La vitamine E Vitamin E
[0089] La vitamine E est une vitamine liposoluble recouvrant un ensemble de huit molécules organiques, quatre tocophérols et quatre tocotriénols. La forme biologiquement la plus active est I'a-tocophérol, la plus abondante dans l'alimentation étant le g-tocophérol. Ces molécules sont présentes en grande quantité dans les huiles végétales. Elles agissent, parallèlement à la vitamine C et au glutathion, essentiellement comme antioxydants contre les dérivés réactifs de l'oxygène produits notamment par l'oxydation des acides gras. Vitamin E is a fat-soluble vitamin covering a set of eight organic molecules, four tocopherols and four tocotrienols. The biologically most active form is α-tocopherol, the most abundant in the diet being α-tocopherol. These molecules are present in large quantities in vegetable oils. They work alongside vitamin C and with glutathione, essentially as antioxidants against reactive oxygen derivatives produced in particular by the oxidation of fatty acids.
[0090] La vitamine E existe sous huit formes naturelles, quatre tocophérols et quatre tocotriénols : a-tocophérol, b-tocophérol, y-tocophérol, d-tocophérol, a-tocotriénol, b-tocotriénol, g-tocotriénol (propriétés apoptotiques), d-tocotriénol. Vitamin E exists in eight natural forms, four tocopherols and four tocotrienols: a-tocopherol, b-tocopherol, y-tocopherol, d-tocopherol, a-tocotrienol, b-tocotrienol, g-tocotrienol (apoptotic properties), d-tocotrienol.
[0091] L'organisme produit continuellement des radicaux libres, composés très réactifs comportant des électrons célibataires. Les radicaux libres endommagent des composants cellulaires aussi divers que les protéines, les lipides ou l'ADN. Les réactions radicalaires se propagent en chaîne : les molécules déstabilisées par un électron célibataire deviennent à leur tour des radicaux libres. Les antioxydants ont pour rôle de stopper ce processus en neutralisant les radicaux libres, pour réduire leur nocivité. Ainsi, la vitamine E a la capacité de capter et de stabiliser (par résonance) l'électron célibataire des radicaux libres. The body continuously produces free radicals, very reactive compounds comprising single electrons. Free radicals damage cell components as diverse as proteins, lipids or DNA. Radical reactions propagate in a chain: molecules destabilized by a single electron in turn become free radicals. The role of antioxidants is to stop this process by neutralizing free radicals, to reduce their harmfulness. Thus, vitamin E has the ability to capture and stabilize (by resonance) the unmarried electron of free radicals.
[0092] Le tocophérol porteur d'un radical peut réagir avec un nouveau radical libre pour former une espèce neutre, ou être régénéré par la vitamine C, le glutathion ou le coenzyme Q10. The tocopherol carrying a radical can react with a new free radical to form a neutral species, or be regenerated with vitamin C, glutathione or coenzyme Q10.
[0093] La vitamine E joue principalement son rôle d'antioxydant dans les membranes biologiques. Les mitochondries, qui sont génératrices de radicaux libres, contiennent de forts taux de vitamine E dans leur membrane lipidique, constituée d'acides-gras polyinsaturés et soumis au stress oxydant. Vitamin E mainly plays its role as an antioxidant in biological membranes. Mitochondria, which generate free radicals, contain high levels of vitamin E in their lipid membrane, made up of polyunsaturated fatty acids and subjected to oxidative stress.
[0094] La carence en vitamine E occasionne des problèmes neuromusculaires tels que des myopathies (dégénérescence du tissu musculaire), des troubles de la rétine ou du système immunitairel . Vitamin E deficiency causes neuromuscular problems such as myopathies (degeneration of muscle tissue), disorders of the retina or of the immune system.
[0095] En plus de son rôle antioxydant, la vitamine E évite l'agrégation excessive des plaquettes responsable des thromboses, a une action protectrice sur les globules rouges et pourrait prévenir, par ce biais les maladies cardio-vasculaires d'origine athéromateuse. In addition to its antioxidant role, vitamin E prevents excessive aggregation of platelets responsible for thrombosis, has a protective action on red blood cells and could prevent, by this means cardiovascular diseases of atheromatous origin.
[0096] La composition selon la présente invention comprend de 1 à 25 mg de préférence 6 à 20 mg de vitamine E. The composition according to the present invention comprises from 1 to 25 mg, preferably 6 to 20 mg of vitamin E.
[0097] Le manganèse [0098] Le manganèse est un oligo-élément (nécessaire à l'homme pour survivre) ; la carence en manganèse (moins de 2 à 3 mg/jour pour un adulte moyen), conduit à des troubles de la reproduction pour les deux sexes, des malformations osseuses, des dépigmentations, une ataxie et une altération du système nerveux central. Manganese Manganese is a trace element (necessary for humans to survive); manganese deficiency (less than 2 to 3 mg / day for an average adult), leads to reproductive disorders for both sexes, bone malformations, depigmentations, ataxia and impairment of the central nervous system.
[0099] Le manganèse est cofacteur de nombreuses enzymes (glycosyltransférase, pyruvate carboxylase, GTP oxaloacétate carboxylase, isocitrate déshydrogénase, malique déshydrogénase, arginine synthétase, glutamine synthétase) intervenant dans des processus métaboliques variés. Il est particulièrement présent dans le métabolisme des hydrates de carbone et la synthèse des mucopolysaccharides. C'est aussi un métal essentiel pour la synthèse d'enzymes (Mn-SOD) participant à la lutte contre le stress oxydant et qui préviennent des dommages causés par les radicaux libres. Il participe aussi à la synthèse de la vitamine E et à l'efficacité de la vitamine B1 (thiamine). Cet activateur de l'oxygène moléculaire joue un rôle dans le fonctionnement de métalloprotéines telles que la superoxyde dismutase. Manganese is a cofactor of numerous enzymes (glycosyltransferase, pyruvate carboxylase, GTP oxaloacetate carboxylase, isocitrate dehydrogenase, malic dehydrogenase, arginine synthetase, glutamine synthetase) involved in various metabolic processes. It is particularly present in the metabolism of carbohydrates and the synthesis of mucopolysaccharides. It is also an essential metal for the synthesis of enzymes (Mn-SOD) participating in the fight against oxidative stress and which prevent damage caused by free radicals. It also participates in the synthesis of vitamin E and the effectiveness of vitamin B1 (thiamine). This molecular oxygen activator plays a role in the functioning of metalloproteins such as superoxide dismutase.
[0100] De nombreux systèmes enzymatiques qui utilisent le magnésium peuvent fonctionner avec le manganèse, mais avec des caractéristiques enzymatiques (Km, Vmax) modifiées. Il peut parfois aussi remplacer le Zinc dans d'autres enzymes[0100] Numerous enzymatic systems which use magnesium can operate with manganese, but with modified enzymatic characteristics (Km, Vmax). It can sometimes also replace Zinc in other enzymes
[0101] La composition selon la présente invention comprend de 0,05 à 5 mg de préférence 0,5 à 2 mg de manganèse. The composition according to the present invention comprises from 0.05 to 5 mg, preferably 0.5 to 2 mg of manganese.
[0102] Le cuivre [0102] Copper
[0103] Le cuivre est un oligo-élément indispensable à la vie (hommes, plantes, animaux, et micro-organismes). Le corps humain contient normalement du cuivre à une concentration d’environ 1 ,4 à 2,1 mg par kg. On trouve du cuivre dans le foie, les muscles et les os. Le cuivre est transporté par la circulation sanguine au moyen d’une protéine nommée céruléoplasmine. Après absorption du cuivre au niveau de l’intestin, il est acheminé vers le foie, lié à l’albumine. Le métabolisme et l’excrétion du cuivre sont contrôlés par la fourniture au foie de céruléoplasmine, et le cuivre est excrété dans la bile. Au niveau cellulaire, le cuivre est présent dans nombre d’enzymes et de protéines, y compris le cytochrome C oxydase et certaines superoxydes dismutases (SOD). Le cuivre sert au transport biologique d’électrons, e.g. les protéines « bleu cuivre », azurine et plastocyanine. La dénomination « bleu cuivre » vient de leur intense couleur bleue due à une bande d’absorption (autour de 600 nm) par transfert de charge coordinat / métal (LMCT). [0103] Copper is a trace element essential for life (humans, plants, animals, and micro-organisms). The human body normally contains copper at a concentration of about 1.4-2.1 mg per kg. Copper is found in the liver, muscles and bones. Copper is carried by the bloodstream by means of a protein called ceruleoplasmin. After absorption of copper in the intestine, it is transported to the liver, bound to albumin. The metabolism and excretion of copper is controlled by the delivery of ceruleoplasmin to the liver, and the copper is excreted in the bile. At the cellular level, copper is present in a number of enzymes and proteins, including cytochrome C oxidase and certain superoxide dismutases (SOD). Copper is used for the biological transport of electrons, eg the “blue copper” proteins, azurine and plastocyanine. The denomination "blue copper ”comes from their intense blue color due to an absorption band (around 600 nm) by ligand / metal charge transfer (LMCT).
[0104] La composition selon la présente invention comprend de 0,05 à 5 mg de préférence 0,5 à 2 mg de cuivre. The composition according to the present invention comprises from 0.05 to 5 mg, preferably 0.5 to 2 mg of copper.
[0105] L’iode [0105] Iodine
[0106] L’iode est un nutriment dont on se préoccupe seulement depuis peu chez la femme enceinte. [0106] Iodine is a nutrient that has only recently become of concern in pregnant women.
[0107] L’iode est un minéral présent en très petite quantité dans le corps. Il permet au corps de fabriquer les hormones thyroïdiennes, essentielles à la formation des os, à la contraction musculaire, aux battements cardiaques et à l’absorption des nutriments. L’iode contribue également à la croissance du cerveau du foetus, et une carence pourrait entraîner des troubles dans son développement. [0107] Iodine is a mineral present in very small amounts in the body. It allows the body to make thyroid hormones, which are essential for bone building, muscle contraction, heartbeat, and nutrient absorption. Iodine also contributes to fetal brain growth, and a deficiency could cause developmental problems.
[0108] La composition selon la présente invention comprend de 50 à 500 pg de préférence 100 à 200 pg d’iode. [0108] The composition according to the present invention comprises from 50 to 500 pg, preferably 100 to 200 pg of iodine.
[0109] Le sélénium [0109] Selenium
[0110] Le sélénium est un oligo-élément constituant des sélénoprotéines dont fait partie le principal antioxydant intracellulaire, la glutathion péroxydase. On en trouve dans les rognons de porc ou de bœuf, l’ail, le poisson et les mollusques. La nutrition occidentale satisfait largement les besoins quotidiens en cet élément mais il est impossible de prédire les concentrations corporelles de sélénium à partir de l'apport nutritionnel parce que son utilisation et sa rétention sont dépendantes de la présence d'acide folique, de vitamine B12 et négativement affectées par la présence d'homocystéine. [0110] Selenium is a trace element constituting selenoproteins of which the main intracellular antioxidant, glutathione peroxidase, is a part. It is found in pork or beef kidneys, garlic, fish and shellfish. Western nutrition largely meets the daily requirement for this element, but it is impossible to predict body concentrations of selenium from nutritional intake because its use and retention is dependent on the presence of folic acid, vitamin B12 and negatively affected by the presence of homocysteine.
[0111] La composition selon la présente invention comprend de 10 à 100 pg de préférence 30 à 60 pg de sélénium. The composition according to the present invention comprises from 10 to 100 pg, preferably 30 to 60 pg of selenium.
[0112] Le fer [0112] Iron
[0113] Le manque de fer est fréquent chez les femmes. Comme c'est un constituant des globules rouges, il y a des pertes mensuelles au cours des menstruations, qui ne sont pas forcément compensées par l'apport alimentaire. Il permet notamment aux globules rouges de capter l’oxygène dans les poumons et de le transporter dans tout le corps, et au foetus par le placenta. Une carence en fer au cours de la grossesse peut occasionner une hypotrophie (petit bébé) ou un accouchement prématuré. Après la grossesse, elle est cause pour la maman d'anémie (manque de globules rouges) et de fatigue. [0113] The lack of iron is frequent in women. As it is a constituent of red blood cells, there is monthly loss during menstruation, which is not necessarily compensated for by food intake. In particular, it allows red blood cells to capture oxygen in the lungs and transport it throughout the body, and to the fetus through the placenta. Iron deficiency during pregnancy can cause hypotrophy (small baby) or premature delivery. After pregnancy, it is the cause for the mother of anemia (lack of red blood cells) and fatigue.
[0114] Les réserves en fer peuvent être évaluées grâce à un simple dosage de ferritine sérique sur prescription médicale. Elles sont généralement plus basses quand on a déjà eu un ou plusieurs enfants. Le cas échéant, le gynécologue prescrit du fer médicamenteux en cours de grossesse (généralement à partir du 5e mois). [0114] The iron reserves can be evaluated by means of a simple dosage of serum ferritin on medical prescription. They are generally lower when you have already had one or more children. If necessary, the gynecologist prescribes medicated iron during pregnancy (usually from the 5th month).
[0115] Les femmes enceintes ont besoin de plus de fer, car leur volume de sang augmente. De plus, elles doivent en fournir à leur futur bébé. Les réserves en fer du bébé à la naissance durent tout au plus pendant les 6 premiers mois de sa vie. [0115] Pregnant women need more iron because their blood volume increases. In addition, they must provide it for their unborn baby. A baby's iron stores at birth last at most for the first 6 months of life.
[0116] Un apport adéquat en fer diminue le risque d’accouchement prématuré, de bébé de faible poids à la naissance ou de mortalité précoce du nouveau-né. [0116] Adequate iron intake decreases the risk of preterm delivery, low birth weight babies or early newborn mortality.
[0117] Une carence en fer peut causer de l’anémie. Elle peut provoquer de la fatigue et un essoufflement plus rapide à l’effort. [0117] Iron deficiency can cause anemia. It can cause fatigue and shortness of breath more quickly on exertion.
[0118] La composition selon la présente invention comprend de 1 à 30 mg de préférence 10 à 20 mg de fer. The composition according to the present invention comprises from 1 to 30 mg, preferably 10 to 20 mg of iron.
[0119] De manière préférentielle, le fer est présent sous la forme d’un fer carbonylique. Avec plus de 98% de fer, cette substance a une teneur en fer beaucoup plus élevée que les sels ferreux, tels que le gluconate ferreux, le sulfate ferreux et le fumarate ferreux. En conséquence, il faut sensiblement moins de supplément de fer pour atteindre la même dose unitaire qu'un sel ferreux, ce qui réduit le poids des comprimés/ capsules. Le fer carbonylique est donc bien adapté aux applications multivitaminiques à taux d'actifs élevés. [0119] Preferably, the iron is present in the form of carbonyl iron. With over 98% iron, this substance has a much higher iron content than ferrous salts, such as ferrous gluconate, ferrous sulfate, and ferrous fumarate. As a result, significantly less iron supplementation is required to achieve the same unit dose as a ferrous salt, thereby reducing the weight of the tablets / capsules. Carbonyl iron is therefore well suited to multivitamin applications with high levels of active ingredients.
[0120] Le zinc [0120] Zinc
[0121] En très faible quantité, le zinc sous forme assimilable est un oligo-élément important, indispensable aux organismes végétaux et animaux. Dûment assimilé par les organismes, il active en particulier les enzymes, influence la croissance, favorise les réactions et contrôles biochimiques au niveau des surfaces pulmonaires. Le corps humain en contient 2 g à 4 g. Les besoins journaliers peuvent être estimés a minima à 15 mg pour un homme normal, et jusqu'à deux fois plus pour une femme allaitante. [0121] In very small quantities, zinc in assimilable form is an important trace element essential for plant and animal organisms. Duly assimilated by organisms, it activates enzymes in particular, influences growth, promotes reactions and biochemical controls at the level of lung surfaces. The human body contains 2 g to 4 g of it. Daily needs can be estimated at a minimum of 15 mg for a normal man, and up to twice as much for a lactating woman.
[0122] Un déficit, même léger, a un impact sur certaines fonctions, dont immunitaires responsable de la défense vis-à-vis de certaines infections. [0122] A deficit, even a slight one, has an impact on certain functions, including the immune system responsible for the defense against certain infections.
[0123] La composition selon la présente invention comprend de 1 à 30 mg de préférence 5 à 20 mg de zinc. The composition according to the present invention comprises from 1 to 30 mg, preferably 5 to 20 mg of zinc.
[0124] Milieu physiologiquement acceptable [0124] Physiologically acceptable medium
[0125] Un milieu physiologiquement acceptable est un milieu n'ayant aucun effet toxique ou préjudiciable dans les conditions d'utilisation et inerte vis-à-vis des ingrédients actifs du produit de combinaison. Un tel milieu peut par exemple comprendre différents adjuvants selon sa finalité thérapeutique ou cosmétique, comme de façon non limitative, des arômes, des colorants, des charges, des conservateurs, des diluants, des agents mouillants ou de suspension, etc. De tels milieux peuvent également permettre une libération immédiate, modifiée ou retardée de l'un ou l'autre des ingrédients actifs. A physiologically acceptable medium is a medium having no toxic or detrimental effect under the conditions of use and inert with respect to the active ingredients of the combination product. Such a medium can for example comprise different adjuvants according to its therapeutic or cosmetic purpose, such as without limitation, aromas, colorants, fillers, preservatives, diluents, wetting or suspending agents, etc. Such media can also allow immediate, modified or delayed release of one or other of the active ingredients.
[0126] Le milieu physiologiquement acceptable peut être composé de texturants, de colorants, d’arômes, de sucre (s). [0126] The physiologically acceptable medium can be composed of texturizers, colorants, flavors, sugar (s).
[0127] Par « texturants », on entend les composés qui modifient la texture des produits dans lesquels ils sont incorporés. Des exemples de texturants sont : les farines de guar et de caroube ; les gommes arabique, de xanthane et de gellane ; les carraghénanes ; les amidons (natifs ou modifiés) ; la cellulose microcristalline ; la pectine ; les alginates (E400 à E405) ; l'agar-agar ; et leurs mélanges. The term "texturizers" is understood to mean the compounds which modify the texture of the products in which they are incorporated. Examples of texturizers are: guar and carob flour; gum arabic, xanthan and gellan; carrageenans; starches (native or modified); microcrystalline cellulose; pectin; alginates (E400 to E405); agar-agar; and their mixtures.
[0128] Par « colorants », on entend des composés d'origine naturelle ou synthétique susceptibles de conférer à eux seuls une coloration à la composition. Des exemples de colorants alimentaires sont connus en Europe sous les codes E100 à E180. Dans le cadre de la présente invention, on utilisera de préférence les colorants d’origine naturelle tels que : E140 (ou chlorophylles), E 163 (ou anthocyanes), E 160c (ou extrait de paprika) ou encore E100 (ou curcumine). The term "dyes" is understood to mean compounds of natural or synthetic origin capable of conferring on themselves a coloring on the composition. Examples of food colors are known in Europe under the codes E100 to E180. In the context of the present invention, dyes of natural origin such as: E140 (or chlorophylls), E 163 (or anthocyanins), E 160c (or paprika extract) or else E100 (or curcumin) will preferably be used.
[0129] Par « arômes », on entend des composés d'origine naturelle ou synthétique susceptibles à eux seuls de modifier le goût de la composition. Des exemples d'arômes sont l’abricot, l’ananas, la banane, le cassis, la cerise, le citron, le lime, la fraise, la framboise, les fruits de la passion, la mandarine, la menthe, l’orange, la pistache, la poire, le réglisse, la rose, l’anis, la myrtille, la cannelle, le gingembre, le pamplemousse, la pomme, le kiwi, le lychee, le melon, la noix de coco, la pêche, la groseille, la goyave, la grenadine, la mangue, la mûre, la papaye, la vanilline, l'extrait naturel de vanille, les huiles essentielles et leurs mélanges. Dans le cadre de la présente invention, on utilisera de préférence l’arôme de citron. The term “aromas” is understood to mean compounds of natural or synthetic origin which are capable on their own of modifying the taste of the composition. Examples of flavors are apricot, pineapple, banana, blackcurrant, cherry, lemon, lime, strawberry, raspberry, passion fruit, tangerine, mint, orange, pistachio, pear, licorice, rose, anise, blueberry, cinnamon, ginger, grapefruit, apple, kiwi, lychee, melon, coconut, peach, currant, guava, grenadine, mango, blackberry, papaya, vanillin, natural vanilla extract, oils essentials and their mixtures. In the context of the present invention, the lemon flavor will preferably be used.
[0130] Par sucre ou sucres, on entend, au sens de la présente invention, tout hydrate de carbone édulcorant, de préférence du sirop de glucose, du saccharose, glucose, fructose, sucre inverti, miel, maltose, polyol ou leurs mélanges. For the purposes of the present invention, the term “sugar or sugars” is understood to mean any sweetening carbohydrate, preferably glucose syrup, sucrose, glucose, fructose, invert sugar, honey, maltose, polyol or their mixtures.
[0131 ] Actif(s) additionnel(s) [0131] Additional asset (s)
[0132] Tout actif additionnel présentant un intérêt nutritionnel et/ou aidant à retrouver la forme peut également être ajouté aux produits de combinaison de l'invention sous forme pharmaceutique ou cosmétique. Le produit de combinaison pourra comprendre, à titre d'exemple, des vitamines, des sels minéraux, des acides aminés essentiels, des acides gras essentiels, des oligoéléments, divers extraits végétaux, des fibres, des antioxydants, des flavonoïdes. Any additional active having a nutritional interest and / or helping to regain shape can also be added to the combination products of the invention in pharmaceutical or cosmetic form. The combination product may include, by way of example, vitamins, mineral salts, essential amino acids, essential fatty acids, trace elements, various plant extracts, fibers, antioxidants, flavonoids.
[0133] Avantageusement, un tel actif additionnel peut être destiné à renforcer l'effet souhaité tel que décrit précédemment. Advantageously, such an additional active agent can be intended to reinforce the desired effect as described above.
[0134] Bien entendu, l'homme du métier veillera à choisir les actifs additionnels ainsi que leur quantité de telle manière que les propriétés avantageuses de la composition conforme à l'invention ne soient pas, ou substantiellement pas, altérées par l'adjonction envisagée. Of course, a person skilled in the art will take care to choose the additional active agents as well as their quantity in such a way that the advantageous properties of the composition in accordance with the invention are not, or substantially not, altered by the addition envisaged. .
[0135] A titre d'actif additionnel utilisable, on peut citer : [0135] As an additional active ingredient that can be used, there may be mentioned:
- les vitamines hydrosolubles et les vitamines liposolubles. - water-soluble vitamins and fat-soluble vitamins.
- les antioxydants, tels que les curcuminoïdes ; les caroténoïdes, notamment choisis parmi le beta.-carotène, l'astaxanthine, la zéaxanthine, la lutéine ou les composés en contenant comme les baies de goji ; des composés polyphénols, les flavonoïdes tels que les catéchines ; les proanthocyanidines, les anthocyanines, les OPC (oligomères procyanidoliques) ; les ubiquinones ; les extraits de café contenant des polyphénols et/ou des diterpènes ; les extraits de chicorés ; les extraits de ginkgo biloba ; les extraits de raisins riches en proanthocyanidines; les extraits de piment ; les extraits de soja ; le cacao ; la grenade ; l'Emblica ; le CoenzymeQIO ; - antioxidants, such as curcuminoids; carotenoids, in particular chosen from beta-carotene, astaxanthin, zeaxanthin, lutein or compounds containing them, such as goji berries; polyphenol compounds, flavonoids such as catechins; proanthocyanidins, anthocyanins, OPCs (procyanidolic oligomers); ubiquinones; coffee extracts containing polyphenols and / or diterpenes; chicory extracts; ginkgo biloba extracts; the grape extracts rich in proanthocyanidins; chilli extracts; soy extracts; Cocoa ; the grenade ; the Emblica; CoenzymeQIO;
- les minéraux, tels que le calcium, le chrome (III), - minerals, such as calcium, chromium (III),
- les acides aminés, notamment les acides aminés soufrés, tels que des précurseurs de glutathion, les acides aminés du sélénium, la citrulline, - amino acids, in particular sulfur-containing amino acids, such as precursors of glutathione, amino acids of selenium, citrulline,
-les phytostérols, le resvératrol, l'hespéridine, la néohesperidine, l'acide orthosilicique, le monométhylsilanetriol, et leurs mélanges. - phytosterols, resveratrol, hesperidin, neohesperidin, orthosilicic acid, monomethylsilanetriol, and mixtures thereof.
[0136] De façon préférée, un produit de combinaison selon l'invention est administré par voie orale. Les formes appropriées pour la voie orale sont les capsules molles. Dans le cas de la préparation d'une composition sous forme de capsule molle, on pourra par exemple mélanger les ingrédients actifs principaux avec un véhicule physiologiquement acceptable tel que la lécithine et la cire. Preferably, a combination product according to the invention is administered orally. Forms suitable for the oral route are soft capsules. In the case of the preparation of a composition in the form of a soft capsule, it is possible, for example, to mix the main active ingredients with a physiologically acceptable vehicle such as lecithin and wax.
[0137] Exemple 1 de composition selon l’invention [0137] Example 1 of composition according to the invention
[0138] [Tableau 1] [0138] [Table 1]
[0139] Procédé de fabrication : [0139] Manufacturing process:
[0140] Cette composition est obtenue en mélangeant les différents composés selon les procédés classiquement utilisés pour ce type de préparation avant introduction dans une capsule molle. This composition is obtained by mixing the various compounds according to the methods conventionally used for this type of preparation before introduction into a soft capsule.

Claims

Revendications Claims
[Revendication 1 ] Produit de combinaison comprenant, à titre de substances actives, au moins de l'acide eicosapentaénoïque (EPA), de l'acide docosahexaénoïque (DMA), de la vitamine B1 , B2, B3, B5, B6, B9, B12, C, E, de la biotine, du manganèse, du cuivre, de l’iode, du sélénium, du fer sous forme de fer carbonylique, du zinc et de la vitamine D3 pour contribuer au bien- être de la femme enceinte, à la croissance des tissus maternelles durant la grossesse, au bon développement du cerveau et des yeux du fœtus, à l’absorption du calcium et aide à réduire la fatigue. [Claim 1] Combination product comprising, as active substances, at least eicosapentaenoic acid (EPA), docosahexaenoic acid (DMA), vitamin B1, B2, B3, B5, B6, B9, B12, C, E, biotin, manganese, copper, iodine, selenium, iron in the form of carbonyl iron, zinc and vitamin D3 to contribute to the well-being of pregnant women, to the growth of maternal tissues during pregnancy, to the proper development of the fetal brain and eyes, to the absorption of calcium and to help reduce fatigue.
[Revendication 2] Produit de combinaison selon la revendication 1 , caractérisé en ce que l'acide eicosapentaénoïque (EPA) et l'acide docosahexaénoïque (DMA) sont présents dans un rapport d’au moins 1 :5. [Claim 2] A combination product according to claim 1, characterized in that eicosapentaenoic acid (EPA) and docosahexaenoic acid (DMA) are present in a ratio of at least 1: 5.
[Revendication 3] Produit de combinaison selon l’une des revendications précédente, caractérisé en ce qu'il est sous la forme d'une composition unique contenant au moins : de 10 à 100 mg de préférence 30 à 70 mg d’acide eicosapentaénoïque de 50 à 500 mg, de préférence 100 à 300 mg d'acide docosahexaénoïque de 0,5 à 4 mg de préférence 1 à 2 mg de vitamine B1 de 0,5 à 4 mg de préférence 1 à 2 mg de vitamine B2 de 5 à 30 mg de préférence 10 à 20 mg de vitamine B3 de 3 à 10 mg de préférence 5 à 7 mg de vitamine B5 de 0,5 à 4 mg, de préférence 1 à 2 mg de vitamine B6 de 10 à 100 pg de préférence 30 à 60 pg de vitamine B8 de 100 à 1000 pg de préférence 300 à 600 pg de vitamine B9 de 1 à 6 pg de préférence 2 à 4 pg de vitamine B12 de 50 à 200 mg de préférence 60 à 140 mg de vitamine C de 2 à 30 pg de préférence 5 à 20 pg de vitamine D3 de 1 à 25 mg de préférence 6 à 20 mg de vitamine E de 0,05 à 5 mg de préférence 0,5 à 2 mg de manganèse de 0,05 à 5 mg de préférence 0,5 à 2 mg de cuivre de 50 à 500 pg de préférence 100 à 200 pg d’iode de 10 à 100 pg de préférence 30 à 60 pg de sélénium de 1 à 30 mg de préférence 10 à 20 mg de fer de 1 à 30 mg de préférence 5 à 20 mg de zinc dans un milieu physiologiquement acceptable. [Claim 3] Combination product according to one of the preceding claims, characterized in that it is in the form of a single composition containing at least: from 10 to 100 mg, preferably 30 to 70 mg of eicosapentaenoic acid. 50 to 500 mg, preferably 100 to 300 mg of docosahexaenoic acid from 0.5 to 4 mg preferably 1 to 2 mg of vitamin B1 from 0.5 to 4 mg preferably 1 to 2 mg of vitamin B2 from 5 to 30 mg preferably 10 to 20 mg of vitamin B3 from 3 to 10 mg preferably 5 to 7 mg of vitamin B5 from 0.5 to 4 mg, preferably 1 to 2 mg of vitamin B6 from 10 to 100 pg preferably 30 at 60 pg of vitamin B8 from 100 to 1000 pg preferably 300 to 600 pg of vitamin B9 from 1 to 6 pg preferably 2 to 4 pg of vitamin B12 from 50 to 200 mg preferably 60 to 140 mg of vitamin C from 2 at 30 pg preferably 5 to 20 pg of vitamin D3 from 1 to 25 mg preferably 6 to 20 mg of vitamin E from 0.05 to 5 mg preferably 0.5 to 2 mg of manganese from 0.05 to 5 mg preferably 0.5 to 2 mg of copper 50 500 pg preferably 100-200 pg iodine from 10 to 100 pg, preferably 30 to 60 pg of selenium from 1 to 30 mg, preferably 10 to 20 mg of iron from 1 to 30 mg, preferably 5 to 20 mg of zinc in a physiologically acceptable medium.
[Revendication 4] Produit de combinaison selon l'une des revendications précédentes caractérisé en ce que le milieu physiologiquement acceptable est adapté à l’administration par voie orale. [Claim 4] Combination product according to one of the preceding claims, characterized in that the physiologically acceptable medium is suitable for oral administration.
[Revendication 5] Produit de combinaison selon l'une des revendications précédentes caractérisé en ce qu’il se présente sous la forme d’une capsule molle. [Claim 5] Combination product according to one of the preceding claims, characterized in that it is in the form of a soft capsule.
EP20820160.8A 2019-12-10 2020-12-09 Combination product contributing to the well-being of pregnant women, comprising epa, dha, vitamins and minerals Pending EP4072515A1 (en)

Applications Claiming Priority (2)

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FR1914072A FR3104023B1 (en) 2019-12-10 2019-12-10 Combination product contributing to the well-being of pregnant women
PCT/EP2020/085317 WO2021116188A1 (en) 2019-12-10 2020-12-09 Combination product contributing to the well-being of pregnant women, comprising epa, dha, vitamins and minerals

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US6818228B1 (en) * 1996-06-21 2004-11-16 Mission Pharmacal Company Dietary supplements containing ultradense calcium citrate and carbonyl iron
AU2008100822A4 (en) * 2007-08-28 2008-10-16 Blackmores Limited Nutrition supplement
EP2929879B1 (en) * 2014-04-07 2020-03-18 Gonadosan GmbH Combination preparation for treating infertility which is associated to endometriosis
FR3076982B1 (en) * 2018-01-23 2021-09-10 Laboratoires Gilbert FABACEAN PROTEIN HYDROLYSATE AS A HYPOALLERGENIC PROTEIN SOURCE IN FOOD COMPOSITIONS

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