EP4072515A1 - Kombinationsprodukt, das zum wohlbefinden von schwangeren beiträgt und epa, dha, vitamine und mineralien umfasst - Google Patents

Kombinationsprodukt, das zum wohlbefinden von schwangeren beiträgt und epa, dha, vitamine und mineralien umfasst

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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
English (en)
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/de
Pending legal-status Critical Current

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    • 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
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • 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
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • 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
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    • 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
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    • 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
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    • 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
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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
    • A61K31/495—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
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • 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
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    • A61K33/24—Heavy metals; Compounds thereof
    • A61K33/26—Iron; Compounds thereof
    • A—HUMAN NECESSITIES
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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
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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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    • 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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EP20820160.8A 2019-12-10 2020-12-09 Kombinationsprodukt, das zum wohlbefinden von schwangeren beiträgt und epa, dha, vitamine und mineralien umfasst Pending EP4072515A1 (de)

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