EP4313022A1 - Nutraceutical composition comprising inulin for treating and preventing ocular disorders or intestinal microbiota imbalance - Google Patents

Nutraceutical composition comprising inulin for treating and preventing ocular disorders or intestinal microbiota imbalance

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Publication number
EP4313022A1
EP4313022A1 EP22717129.5A EP22717129A EP4313022A1 EP 4313022 A1 EP4313022 A1 EP 4313022A1 EP 22717129 A EP22717129 A EP 22717129A EP 4313022 A1 EP4313022 A1 EP 4313022A1
Authority
EP
European Patent Office
Prior art keywords
inulin
composition
composition according
vitamin
amount
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
EP22717129.5A
Other languages
German (de)
French (fr)
Inventor
Martine Claret
Claude Claret
Caroline CHATARD-BAPTISTE
Amir BONO
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.)
Ophtalmis
Original Assignee
Ophtalmis
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 Ophtalmis filed Critical Ophtalmis
Publication of EP4313022A1 publication Critical patent/EP4313022A1/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
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • 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
    • A61K31/205—Amine addition salts of organic acids; Inner quaternary ammonium salts, e.g. betaine, carnitine
    • 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
    • A61K31/28—Compounds containing heavy metals
    • A61K31/315—Zinc compounds
    • 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
    • A61K31/365—Lactones
    • A61K31/366—Lactones having six-membered rings, e.g. delta-lactones
    • A61K31/37—Coumarins, e.g. psoralen
    • 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
    • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/733—Fructosans, e.g. inulin
    • 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
    • A61K33/30—Zinc; Compounds thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/73—Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system

Definitions

  • the present invention relates to a nutraceutical composition
  • a nutraceutical composition comprising inulin and an extract of the maqui berry, as well as other ingredients such as amino acids, vitamins and/or trace elements, in particular for its use in the prevention and/or treatment of ocular pathologies and/or in the prevention and/or treatment of imbalances in the intestinal microbiota.
  • Ocular pathologies include many eye conditions that are often accompanied by discomfort. These different disorders can manifest themselves in various forms such as tingling, itching, a feeling of burning, sand or foreign bodies in the eyes, or sensitivity to light, visual disturbance, fatigue or eye pain. , or headaches, but they can also result from tear film instability, inflammation of corneal cells, or inflammation of goblet cells in the eyes.
  • prebiotics food compounds in the form of sugars such as oligosaccharides and polysaccharides with short carbon chains, are essential for the development and growth of bacteria in the intestinal flora.
  • the breakdown products of prebiotics are released into the circulation and act on various organs which may be distant from each other.
  • One of the well-known prebiotics is inulin.
  • This soluble fiber composed of fructose molecules is widely used as an ingredient and/or as an active compound in the food industry, for example as a supplement in infant milk powders to promote the growth of newborns with other supplements such as polyunsaturated fatty acids (Gold Mamil Growing Up Formula Step 3 from Mintel)5 but also in the pharmaceutical field (Hinrichs et al., Carbohydrate Polymers, 2015, 134, 418-428) and in particular for the prevention and treatment of allergies in children (WO 2013/062402), for the treatment of inflammation in combination with xylans (WO 2011/020853) or for the prevention or treatment of pathologies associated with people's lifestyle (JP 201317441). Mixtures of plants, including roots known to contain inulin are also described for treatments derived from traditional Chinese medicine (CN 1245187).
  • compositions exist for the treatment of ocular diseases. However, although these compositions may act on ocular disorders, they do not make it possible to treat all the associated symptoms, and in particular have no action on the inflammation responsible for the discomfort.
  • the inventors have therefore developed a nutraceutical composition based on inulin having beneficial effects on the entire system in the case of ocular pathologies.
  • the inventors have developed a nutraceutical composition based on inulin and maqui berry extract, having beneficial effects on the intestinal microbiota of people, in particular on its metabolic activity and/or on the membrane permeability of the intestines for the molecules involved in the phenomena of inflammation and/or on the composition of the microbiota, its diversity and its balance in certain microbial groups, good health.
  • composition can be used preventively and/or as part of a treatment.
  • the invention relates to a nutraceutical composition
  • a nutraceutical composition comprising inulin and an extract of maqui berry comprising anthocyanidins.
  • the invention relates to a formulation suitable for oral administration comprising inulin, an extract of maqui berry, one or more amino acids, preferably including carnitine, vitamins and minerals.
  • the present invention relates to a nutraceutical composition
  • a nutraceutical composition comprising inulin and a maqui berry extract comprising anthocyanidins for the prevention and/or treatment of ocular pathologies.
  • the present invention relates to a nutraceutical composition
  • a nutraceutical composition comprising inulin and a maqui berry extract comprising anthocyanidins for the prevention and/or treatment of an imbalance of the intestinal microbiota and pathologies associated with this imbalance.
  • nutraceutical refers to an edible product having a physiological beneficial effect.
  • nutraceutical composition is meant a composition whose purpose is supplementing the normal diet and constituting a concentrated source of nutrients or other substances having a nutritional or physiological effect, singly or in combination.
  • eye pathologies includes various diseases affecting the eyes. In some cases, they result in simple eye discomfort, but can sometimes become disabling. “Ocular pathologies” thus means tingling, itching, burning sensations, sand or foreign bodies in the eyes, sensitivity to light, visual disturbance, eye fatigue, eye pain, instability of the tear film, inflammation of corneal cells, inflammation of goblet cells in the eyes and/or headache.
  • the eye pathologies can also be chosen from dry eye syndrome, meibomian dysfunction, allergic conjunctivitis, keratoconjunctivitis, blepharoconjunctivitis, and/or be associated with eye surgery.
  • gut microbiota imbalance is meant an imbalance in the activity of the microbial community and/or an imbalance in the microbial composition and/or an increase in intestinal membrane permeability.
  • the "microbial community” is made up of all the microorganisms that make up the intestinal microbiota of an individual. Its composition, the diversity of the microbial groups present or the relative abundance of certain microbial groups are markers of an imbalance that impacts the state of health of an individual and in particular his sensitivity or his propensity to develop ocular pathologies. High diversity is a sign of good gut health.
  • Short-chain fatty acids are derived from the intestinal bacterial fermentation of indigestible foods, and are the primary source of energy for colon cells, making them makes it essential for gastrointestinal health.
  • Lactate is produced by lactic acid bacteria and lowers the pH of the environment, also acting as an antimicrobial agent. Lactate can also be rapidly converted to acetate, butyrate and propionate by other microorganisms.
  • the measurement of pH and the degree of acidification is a measure of the intensity of bacterial metabolism.
  • Ammonium is a proteolytic degradation product that results in the production of potentially toxic or carcinogenic compounds such as p-cresol and p-phenol. Excess gas production is considered a potentially negative effect of increased saccharolytic activity of the gut community.
  • the increase in membrane permeability will result from an imbalance in the composition of the intestinal microbiota (dysbiosis) and leads to an increase in inflammation of the digestive system and to a general inflammatory state which will promote the development of pathologies associated with the inflammation and in particular ocular pathologies.
  • the improvement in membrane permeability is the consequence of an improvement in the composition of the intestinal microbiota which, in particular, promotes the prevention and/or treatment of ocular pathologies.
  • NF-kB activity pro-inflammatory cytokines
  • pro-inflammatory cytokines human IL-1b, IL-6, IL-8, TNF-a, CXCL10 and MCP-1
  • NF-kB activity pro-inflammatory
  • a decrease in the production of these markers by the membrane epithelial cells of the intestine is the consequence of an improvement in the composition of the intestinal microbiota which, in particular, promotes the prevention and/or treatment of ocular pathologies.
  • the improvement in the imbalance of the intestinal microbiota can be quantified by the production of IL-10 (anti-inflammatory).
  • An increase in the production of IL-10 is the consequence of an improvement in the composition of the intestinal microbiota which, in particular, favors the prevention and/or treatment of ocular pathologies.
  • the composition comprises prebiotics, natural fibers present in many plants such as fruits, vegetables, cereals and legumes, and more particularly inulins.
  • Inulins or inulin are soluble dietary fibers consisting of fructose units with a terminal glucose. These natural or synthetic polysaccharides have an average degree of polymerization of between 2 and 60. Inulin is naturally present in many plants, such as artichokes, asparagus, bananas, leeks, Jerusalem artichokes, onions, tomatoes , barley and rye or even chicory roots, dandelion roots, and elecampane roots.
  • the inulin is of natural origin, and preferentially extracted from chicory roots, dandelions and Jerusalem artichokes. In a preferred embodiment, the inulin is extracted from chicory root.
  • the inulin is present in an amount of between 1,000 and 10,000 mg, preferably between 2,000 and 8,000 mg. In one embodiment, the amount of inulin is 3000 to 7000 mg, preferably 4000 to 6000 mg, even more preferably from 4,500 to 5,500 mg. In a preferred embodiment, the amount of inulin is about 5000 mg.
  • the inulin represents at least 50% by weight of the total composition, preferably at least 60%, and more preferably at least 70%. In one embodiment, the composition thus comprises between 70 and 90% by weight of inulin, more preferably between 80 and 90%. In a preferred embodiment, the amount of inulin represents between 82 and 89% by weight of the total composition, preferentially between 85 and 89%, and more preferentially between 86 and 88%. In a preferred embodiment, the composition comprises by weight about 87% inulin.
  • the composition additionally comprises an extract of the maqui berry.
  • This exotic fruit also known as Aristotelia Chilensis, has been used for several years in the pharmaceutical field. Several studies have shown that this natural antioxidant rich in anthocyanins and anthocyanidins has beneficial effects on the body. It can thus be used for example for the treatment of diabetes and metabolic syndrome (WO 2009/059218).
  • the molecules of interest present in the maqui berry are in particular anthocyanidins, also called anthocyanidins.
  • anthocyanidins also called anthocyanidins.
  • these compounds belonging to the subclass of flavonoids exist mainly in 6 forms: cyanidol, delphinidol, pelargonidol, malvidol, peonidol and petunidol.
  • delphinidol or delphinidin is an organic compound present in many plants with strong natural antioxidant activity.
  • the nutraceutical composition comprises, in addition to inulin, anthocyanidins from the maqui berry.
  • Maqui berry extracts are known and used pure or in high concentrations in in vitro studies ("Maqui Berry Extract”, from Oryza Oil & Fat Chemical Co.) or as active ingredients in pharmaceutical compositions or food supplements (ES 2685324; “Double Chocolate All-in-One Nutrition Bar” from Mintel).
  • the maqui berry extract is present in an amount of between 30 and 150 mg, preferably between 50 and 100 mg, more preferably between 50 and 75 mg. In another embodiment, the composition comprises between 55 and 70 mg, preferably between 55 and 65 mg of maqui berry extract. In a preferred embodiment, the composition comprises about 60 mg of maqui berry extract.
  • the amount of maqui berry extract represents between 0.5 and 5% by weight of the total composition. In one embodiment, the composition comprises between 0.5 and 3% by weight of maqui berry extract, more preferably between 0.5 and 2%. In a preferred embodiment, the amount of maqui berry extract represents between 0.6 and 1.5% by weight of the total composition, preferably between 0.8 and 1.2%, more preferably between 0.9 and 1.1%. In one embodiment, the composition comprises by weight about 1.05% maqui berry extract.
  • Maqui berry extract includes anthocyanidins and delphinidins. These compounds present in the composition represent at least 35% by weight and at least 25% by weight of the extract of the maqui berry.
  • the inulin/maqui berry extract weight ratio is at least 5, in particular at least 35, more particularly at least 50, advantageously at least 60, in particular at least 80.
  • the inulin/maqui berry extract weight ratio is at most 350, in particular at most 180, more particularly at most 140, advantageously at most 110, in particular at most 90.
  • the inulin/maqui berry extract weight ratio ranges from 5 to 350, in particular from 35 to 180, more particularly from 50 to 140, advantageously from 60 to 110, in particular from 80 to 90.
  • the inulin/maqui berry extract weight ratio is 82, 83, 84, 85, or 86.
  • composition according to the invention does not include toxic substances, or at least substances in toxic doses.
  • amino acids which can exist in a free form or in the form of salts.
  • stereochemistry can be of R or S configuration or of L or D type according to the plane of polarization of the light.
  • the amino acids can thus be employed in racemic or optically active forms.
  • carnitine as the amino acid of choice.
  • This amino acid synthesized from lysine and methionine has osmoprotective and antioxidant properties.
  • the carnitine is in the form of the R enantiomer.
  • L-carnitine will preferably be used in the formulation of the nutraceutical composition.
  • amino acids are in the form of salts, it is understood that these salts are acceptable salts for their use within the scope of the present invention. These are conventional non-toxic salts, and will be apparent to those skilled in the art. Examples of amino acid salts include tartrate, citrate, phosphate, borate, lactate, fumarate and oxalate.
  • the nutraceutical composition comprises, in addition to inulin and an extract of maqui berry, carnitine, and more preferentially L-carnitine.
  • the L-carnitine is in the form of a tartrate salt.
  • the L-carnitine in the form of the tartrate salt is present in an amount comprised between 100 and 500 mg, preferentially between 150 and 400 mg, more preferentially between 200 and 350 mg.
  • the quantity of L-carnitine tartrate is from 220 to 330 mg, preferably from 240 to 320 mg, it is more preferably between 270 and 320 mg.
  • the amount of L-carnitine in the tartrate salt form is between 280 and 310 mg, preferably between 290 and 305 mg.
  • the amount of L-carnitine in the tartrate salt form is between 295 and 302 mg. It is preferably around 298 mg.
  • the L-carnitine tartrate represents between 3 and 8% by weight of the total composition. In one embodiment, the composition thus comprises between 4 and 7% by weight of L-carnitine tartrate, more preferentially between 4.5 and 6%. In a preferred embodiment, the amount of L-carnitine tartrate represents between 5 and 5.5% by weight of the total composition, preferably between 5.1 and 5.3%. In a preferred embodiment, the composition comprises about 5.2% by weight carnitine tartrate.
  • ingredients such as vitamins and minerals can be added to the nutraceutical composition of the present invention.
  • vitamins include group B vitamins, i.e. vitamin B1 or thiamine, vitamin B2 or riboflavin, vitamin B3 or vitamin PP also called niacin, vitamin B5 or pantothenic acid, vitamin B6 or pyridoxine , vitamin B8 or biotin, vitamin B9 or folic acid and vitamin B12 or cobalamin, vitamin C or ascorbic acid, vitamin D, vitamin E and vitamin K.
  • group B vitamins i.e. vitamin B1 or thiamine, vitamin B2 or riboflavin, vitamin B3 or vitamin PP also called niacin, vitamin B5 or pantothenic acid, vitamin B6 or pyridoxine , vitamin B8 or biotin, vitamin B9 or folic acid and vitamin B12 or cobalamin, vitamin C or ascorbic acid, vitamin D, vitamin E and vitamin K.
  • the vitamins of the present invention are vitamins A, E, C, D and group B vitamins.
  • the composition comprises group B vitamins, and preferably vitamin B2 or riboflavin. In another embodiment, the composition comprises vitamins of group D, and preferably vitamin D3. In another embodiment, the composition according to the invention comprises vitamins of group B and vitamins of group D, preferably vitamins B2 and D3.
  • vitamin B2 is present in the form of riboflavin in an amount greater than 0.2 mg, preferably greater than 0.6 mg, more preferably greater than 0.8 mg. In one embodiment, the amount of riboflavin is less than 2 mg. In one embodiment, the quantity of riboflavin is between 0.9 and 1.9 mg, preferentially between 1.3 and 1.9 mg, more preferentially between 1.5 and 1.8 mg. In a another embodiment, the quantity of riboflavin is between 1.7 and 1.8 mg, preferentially between 1.72 and 1.79 mg, more preferentially between 1.75 and 1.78 mg. In a preferred embodiment, the amount of riboflavin is about 1.76 mg.
  • the riboflavin represents less than 1% by weight of the total composition, preferably less than 0.5%, more preferably less than 0.2%.
  • the composition thus comprises between 0.01 and 0.2% by weight of riboflavin, preferentially between 0.015 and 0.1%, more preferentially between 0.015 and 0.05%.
  • the amount of riboflavin represents between 0.02 and 0.04% by weight of the total composition, preferably between 0.025 and 0.035%.
  • the composition comprises about 0.03% by weight of riboflavin, a supply form of vitamin B2.
  • the formulation may also comprise vitamin D, preferably vitamin D2, also called ergocalciferol (CAS [50-14-6]), and/or vitamin D3, also called cholecalciferol [CAS 67-97-0] .
  • vitamin D preferably vitamin D2, also called ergocalciferol (CAS [50-14-6])
  • vitamin D3 also called cholecalciferol [CAS 67-97-0] .
  • the composition according to the invention comprises vitamin D2. In another embodiment, the composition includes vitamin D3. In another embodiment, the composition includes vitamin D2 and vitamin D3.
  • the vitamin D is vitamin D3.
  • the composition comprises vitamin D in the form of vitamin D3, the latter is present in an amount greater than 0.01 pg, preferably in an amount greater than 0.1 pg, even more preferably in an amount greater than 0 .5 pg.
  • the amount of vitamin D3 is less than 20 pg, or even less than 16 pg, or even less than 13 pg.
  • the amount of vitamin D3 is between 1 and 12 pg, preferentially between 2 and 12 pg, more preferentially between 5 and 12 pg.
  • vitamin D3 is present in an amount between 8 and 11 pg.
  • the composition comprises 9 pg of vitamin D3, preferably 10 pg.
  • Vitamin D3 is provided in the composition in the form of cholecalciferol.
  • the amount of cholecalciferol according to the composition of the invention is between 0.1 and 30 mg, preferentially between 0.5 and 20 mg, more preferentially between 1 and 15 mg. In another embodiment, the amount of cholecalciferol is less than 15 mg. In a preferred embodiment, the quantity is thus between 1 and 10 mg, preferentially between 3 and 7 mg, more preferentially between 4 and 6 mg. In a preferred embodiment, the amount of cholecalciferol is about 5 mg.
  • the amount of cholecalciferol represents less than 2.5% by weight of the total composition.
  • the composition thus comprises between 0.001 and 2% by weight of cholecalciferol, preferably between 0.01 and 1%, more preferably between 0.02 and 0.5%.
  • the amount of cholecalciferol represents between 0.05 and 0.2% by weight of the total composition, preferably between 0.05 and 0.1%.
  • the amount of cholecalciferol is less than or equal to 0.1% by weight, preferably less than or equal to 0.09%.
  • the amount of cholecalciferol is greater than or equal to 0.06% by weight, preferably greater than or equal to 0.07%.
  • the amount of cholecalciferol is thus between 0.07% and 0.09% by weight relative to the total weight of the composition.
  • the composition comprises approximately 0.087% by weight of cholecalciferol.
  • the minerals selected in the context of the present invention are zinc, iron, copper, selenium, manganese and chromium. These minerals can exist in a free form or in a complexed form.
  • zinc complexes are zinc oxide, zinc gluconate, zinc acetate, zinc citrate, zinc chloride, zinc lactate, zinc sulphate, zinc picolinate or even zinc bisglycinate. They can thus be used alone or in combination in the compositions according to the invention. Zinc bisglycinate will preferably be used in the context of the nutraceutical composition.
  • the zinc is present in an amount greater than 1 mg, greater than or equal to 2 mg, greater than or equal to 3 mg, greater than or equal to 4 mg. In one embodiment, the amount of zinc is less than 16 mg. In another embodiment, the amount of zinc is between 10 and 16 mg, preferentially between 12 and 16 mg, more preferentially between 14 and 16 mg. In one embodiment, the amount of zinc is 15 mg.
  • the zinc is in a complexed form, in particular in the form of zinc bisglycinate.
  • the quantity of zinc bisglycinate is between 5 and 60 mg, preferentially between 20 and 60 mg, more preferentially between 40 and 60 mg.
  • the amount of zinc bisglycinate is less than 60 mg. In a preferred embodiment, the amount is thus between 50 and 59 mg, preferentially between 52 and 58 mg, more preferentially between
  • the amount of zinc bisglycinate is about
  • the zinc bisglycinate represents less than 2% by weight of the total composition. In one embodiment, the composition thus comprises between 0.1 and 2% by weight of zinc bisglycinate, preferentially between 0.3 and 1.5%, more preferentially between 0.6 and 1.2%. In a preferred embodiment, the amount of zinc bisglycinate represents between 0.8 and 1.1% by weight of the total composition, preferably between 0.9 and 1.05%, more preferably between 0.95 and 1.0%. In a preferred embodiment, the composition comprises about 0.98% zinc bisglycinate by weight.
  • the nutraceutical composition comprises the following ingredients: inulin, an extract of the maqui berry comprising anthocyanidins and/or delphinidins, carnitine, vitamin B12, and zinc.
  • the carnitine is in the enantiomeric pure form L and in the form of a tartrate salt.
  • the zinc is in the form of zinc bisglycinate complex.
  • the composition comprises carnitine in the L form and in the form of the tartrate salt and zinc in the form of zinc bisglycinate.
  • the nutraceutical composition according to the invention comprising 1,000 to 10,000 mg of inulin, from 30 to 150 mg of maqui berry extract, from 100 to 500 mg of L-carnitine tartrate, from 0.15 to 5, 0 mg of vitamin B2 or riboflavin, and 5 to 56 mg of zinc bisglycinate, is particularly suitable for the prevention and/or treatment of ocular pathologies.
  • the nutraceutical composition may also comprise any additive making it possible to improve its preservation, taste, formulation and appearance.
  • preservatives, flavorings, colorings and formulating agents can be added.
  • Those skilled in the art will be able to choose these agents as well as the doses necessary for the formulation.
  • the nutraceutical composition of the invention may additionally comprise at least one excipient and/or at least one pharmaceutically acceptable vehicle.
  • excipient and the vehicle are "pharmaceutically acceptable” in the sense that they are compatible with the other ingredients of the composition and are non-toxic. Their use makes it possible in particular to facilitate the preparation, storage and administration of the active compound.
  • excipients and vehicles are well known to those skilled in the art, described in particular in the French or European pharmacopoeia.
  • compositions and vehicles include all solvents, dispersing media, coatings, antibacterial and antifungal agents, isotonic agents, absorbents, and others that are physiologically compatible.
  • the excipients also include pH-correcting additives such as anhydrous citric acid, flavoring agents or aromas, such as natural red fruit aromas, and, where appropriate, sweeteners such as sucralose or stevia.
  • the composition according to the invention comprising from 1,000 to 10,000 mg of inulin and from 30 to 150 mg of maqui berry extract and is formulated in a solid form.
  • the solid nutraceutical composition comprises:
  • maqui berry extract - 30 to 150 mg of maqui berry extract, - 100 to 500 mg of L-carnitine tartrate,
  • vitamin B2 riboflavin
  • vitamin D3 cholecalciferol
  • the nutraceutical composition comprises:
  • vitamin B2 riboflavin
  • vitamin D3 cholecalciferol
  • the nutraceutical composition comprises:
  • the nutraceutical composition comprises:
  • the nutraceutical composition comprises:
  • the nutraceutical composition comprises:
  • composition according to the invention is advantageously in a solid form.
  • composition of the present invention is in the form of a powder, tablet, capsule or capsule.
  • the powder is dissolved forming a solution or an emulsion.
  • the powder can also be in the form of a tablet that will be dissolved or swallowed.
  • the nutraceutical composition is formulated for oral administration.
  • the invention relates to a nutraceutical composition
  • a nutraceutical composition comprising inulin and a maqui berry extract comprising anthocyanidins as defined above for its use in the prevention and/or treatment of an imbalance of the intestinal microbiota.
  • the invention relates to a nutraceutical composition
  • a nutraceutical composition comprising inulin and an extract of maqui berry comprising anthocyanidins as defined above for its use in the prevention and/or treatment of ocular pathologies.
  • the invention relates to a method for the prevention and/or treatment of an imbalance of the intestinal microbiota in a patient in need thereof, said method comprising the administration to said patient of an appropriate quantity of nutraceutical composition comprising inulin and a maqui berry extract comprising anthocyanidins as defined above.
  • the invention also relates to a method for the prevention and/or treatment of ocular pathologies in a patient who needs it, said method comprising the administration to said patient of an appropriate quantity of nutraceutical composition comprising inulin and an extract of maqui berry comprising anthocyanidins as defined above.
  • the composition of the present invention is formulated to be administered daily, i.e. daily.
  • the composition is thus formulated to be administered one to four times a day.
  • the composition is formulated to be administered once a day. Dosage and frequency administration depends on several factors, including the symptoms, the severity of the disease, the extent of the disorder and the physical condition of the person being treated. A person skilled in the art will know how to adapt the dosage to be administered. It is understood that the dosage may be increased or decreased according to the physician's assessment.
  • the composition is administered three times per day.
  • the composition is administered twice daily.
  • it is administered once a day.
  • the inulin is advantageously present in an amount (daily dose) greater than or equal to 1000 mg.
  • the daily amount is greater than or equal to 2000 mg, greater than or equal to 3000 mg, or even greater than or equal to 4000 mg.
  • the quantity (daily dose) of inulin is approximately equal to 5000 mg.
  • the maqui berry extract is advantageously present in an amount (daily dose) greater than or equal to 30 mg, greater than or equal to 40 mg, or greater than or equal to 50 mg.
  • the daily amount is less than or equal to 150 mg, less than or equal to 100 mg, less than or equal to 70, preferably equal to approximately 60 mg.
  • the L-carnitine tartrate is advantageously present in an amount (daily dose) greater than or equal to 200 mg.
  • the daily amount is greater than or equal to 250 mg, greater than or equal to 260 mg, or even greater than or equal to 270 mg.
  • Vitamin B2 in the form of riboflavin is advantageously present in an amount (daily dose) greater than or equal to 0.10 mg.
  • the daily amount is greater than or equal to 0.20 mg, greater than or equal to 0.50 mg, or even greater than or equal to 0.80 mg.
  • the quantity (daily dose) of vitamin B2 is less than or equal to 5.0 mg, less than or equal to 4.5 mg, less than or equal to 3.5 mg.
  • the amount (daily dose) of riboflavin is about 1.76 mg.
  • the zinc bisglycinate is advantageously present in an amount (daily dose) greater than or equal to 5 mg.
  • the daily amount is greater than or equal to 20 mg, greater than or equal to 40 mg.
  • the amount (daily dose) of zinc bisglycinate is less than 60 mg, preferably less than 58 mg, more preferably less than or equal to 56 mg. According to a preferred embodiment, the amount (daily dose) of zinc bisglycinate is about 56 mg.
  • the quantity of cholecalciferol (form of supply of vitamin D3) is between 0.1 and 30 mg, preferentially between 0.5 and 20 mg, more preferentially between 1 and 15 mg.
  • the amount of cholecalciferol is less than 15 mg.
  • the amount is thus between 1 and 10 mg, preferably between 3 and 7 mg, more preferably between 4 and 6 mg.
  • the amount of cholecalciferol is about 5 mg.
  • a nutraceutical composition is formulated as a powder to be diluted in a large glass of water and includes 5000 mg of inulin, 60 mg of maqui berry extract, 298 mg of L-carnitine tartrate, 1.76 mg of riboflavin (vitamin B2), 56 mg of zinc bisglycinate, and 5 mg of cholecalciferol (vitamin D3).
  • Patients with ocular pathologies are selected to follow a treatment with the nutraceutical composition for at least 30 days on the basis of one intake per day.
  • the patients are questioned before and after taking the nutraceutical composition, at regular intervals, to monitor their response to the treatment, the evolution of their pathology and any side effects.
  • Example 1 The effect of the composition of Example 1 on the intestinal microbiota is analyzed in vitro on microbiota samples from healthy individuals.
  • the collected cells are suspended in an appropriate medium for their conservation. 4 samples are made (1) control, (2) with addition of inulin, (3) with addition of a maqui berry extract and (4) with addition of the composition of Example 1.
  • Microbial community composition and activity analyzes are performed and show improvement for the sample (4).
  • Membrane permeability is measured using transepithelial electrical resistance in an in vitro model of intestinal microbiota imbalance.
  • a drop in transepithelial electrical resistance is an indication of disruption of the intestinal epithelial cell monolayer. If the product to be tested avoids this drop, then it is capable of protecting the cells of the intestinal epithelium against hyperpermeability linked to dysbiosis.
  • the immune parameters are measured by the production of pro-inflammatory cytokines (human IL-1b, IL-6, IL-8, TNF-a, CXCL10 and MCP-1) as well as the NF- ⁇ B activity (pro-inflammatory). The production of IL10 (anti-inflammatory) will also be measured.

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Abstract

The present invention relates to a nutraceutical composition comprising inulin and a Chilean wineberry extract, and also other ingredients such as amino acids, vitamins and/or trace elements, in particular for the use thereof in preventing and/or treating ocular pathological conditions and/or in preventing and/or treating intestinal microbiota imbalances.

Description

COMPOSITION NUTRACEUTIQUE COMPRENANT DE L'INULINE POUR LE TRAITEMENT ET LA PREVENTION DES TROUBLES OCULAIRES OU LE DESEQUILIBRE DE LA MICROBIOTE INTESTINAL NUTRACEUTICAL COMPOSITION COMPRISING INULIN FOR THE TREATMENT AND PREVENTION OF EYE DISORDERS OR IMBALANCE OF THE INTESTINAL MICROBIOTA
DOMAINE DE L'INVENTION FIELD OF THE INVENTION
La prĂ©sente invention concerne une composition nutraceutique comprenant de 5 l’inuline et un extrait de la baie de maqui, ainsi que d’autres ingrĂ©dients tels que des acides aminĂ©s, des vitamines et/ou des oligo-Ă©lĂ©ments, en particulier pour son utilisation dans la prĂ©vention et/ou le traitement de pathologies oculaires et/ou dans la prĂ©vention et/ou le traitement des dĂ©sĂ©quilibres du microbiote intestinal. The present invention relates to a nutraceutical composition comprising inulin and an extract of the maqui berry, as well as other ingredients such as amino acids, vitamins and/or trace elements, in particular for its use in the prevention and/or treatment of ocular pathologies and/or in the prevention and/or treatment of imbalances in the intestinal microbiota.
ETAT DE LA TECHNIQUE 0 Les pathologies oculaires regroupent de nombreuses affections de l’Ɠil qui sont souvent accompagnĂ©es d’un inconfort. Ces diffĂ©rents troubles peuvent se manifester sous diverses formes telles que des picotements, des dĂ©mangeaisons, une sensation de brulure, de sable ou de corps Ă©trangers dans les yeux, ou encore une sensibilitĂ© Ă  la lumiĂšre, un trouble visuel, une fatigue ou une douleur oculaire, ou des maux de tĂȘtes, mais ils peuvent aussi5 rĂ©sulter d’une instabilitĂ© du film lacrymal, une inflammation des cellules cornĂ©ennes, ou une inflammation des cellules caliciformes au niveau des yeux. STATE OF THE ART Ocular pathologies include many eye conditions that are often accompanied by discomfort. These different disorders can manifest themselves in various forms such as tingling, itching, a feeling of burning, sand or foreign bodies in the eyes, or sensitivity to light, visual disturbance, fatigue or eye pain. , or headaches, but they can also result from tear film instability, inflammation of corneal cells, or inflammation of goblet cells in the eyes.
Ces symptĂŽmes peuvent par ailleurs ĂȘtre associĂ©s Ă  d’autres maladies telles que le syndrome des yeux secs, un dysfonctionnement des glandes de meibomius, une conjonctivite allergique, une kĂ©ratoconjonctivite ou une blĂ©pharoconjonctivite. Enfin cet inconfort peut ĂȘtre0 la consĂ©quence intervention chirurgicale. These symptoms may also be associated with other diseases such as dry eye syndrome, meibomian gland dysfunction, allergic conjunctivitis, keratoconjunctivitis or blepharoconjunctivitis. Finally this discomfort can be the consequence of surgical intervention.
Des Ă©tudes ont montrĂ© qu’il existe une relation entre le microbiote et les maladies oculaires (Baim et al. Experimental Biology and Medicine, 2019, 244, 419-429), et que l’administration de prĂ©biotiques permet de diminuer les troubles oculaires (Flanagan et al., Antibiotics, 2019, 8, 1-23). 5 Les prĂ©biotiques, composĂ©s alimentaires sous forme de sucres de type oligosaccharides et polysaccharides Ă  courtes chaĂźnes carbonĂ©es sont essentiels pour le dĂ©veloppement et la croissance des bactĂ©ries de la flore intestinale. Les produits de la dĂ©gradation des prĂ©biotiques sont libĂ©rĂ©s dans la circulation et agissent sur divers organes qui peuvent ĂȘtre distants les uns des autres. 0 Un des prĂ©biotiques bien connus est l’inuline. Cette fibre soluble composĂ©e de molĂ©cules de fructose est largement utilisĂ©e comme ingrĂ©dient et/ou comme composĂ© actif dans l’industrie agro-alimentaire, par exemple comme complĂ©ment dans des poudres de laits infantiles pour favoriser la croissance des nouveaux nĂ©s avec d’autres complĂ©ments comme des acides gras polyinsaturĂ©s ( Gold Mamil Growing Up Formula Step 3 de la sociĂ©tĂ© Mintel)5 mais aussi dans le domaine pharmaceutique (Hinrichs et al., Carbohydrate Polymers, 2015, 134, 418-428) et notamment pour la prĂ©vention et le traitement des allergies chez l’enfant (WO 2013/062402), pour le traitement de l’inflammation en association avec des xylanes (WO 2011/020853) ou pour la prĂ©vention ou le traitement de pathologies associĂ©es au mode de vie des personnes (JP 201317441 ). Des mĂ©langes de plantes, parmi lesquelles des racines connues pour contenir de l’inuline sont Ă©galement dĂ©crits pour des traitements dĂ©rivĂ©s de la mĂ©decine traditionnelle chinoise (CN 1245187). Studies have shown that there is a relationship between the microbiota and eye diseases (Baim et al. Experimental Biology and Medicine, 2019, 244, 419-429), and that the administration of prebiotics can reduce eye disorders ( Flanagan et al., Antibiotics, 2019, 8, 1-23). 5 Prebiotics, food compounds in the form of sugars such as oligosaccharides and polysaccharides with short carbon chains, are essential for the development and growth of bacteria in the intestinal flora. The breakdown products of prebiotics are released into the circulation and act on various organs which may be distant from each other. 0 One of the well-known prebiotics is inulin. This soluble fiber composed of fructose molecules is widely used as an ingredient and/or as an active compound in the food industry, for example as a supplement in infant milk powders to promote the growth of newborns with other supplements such as polyunsaturated fatty acids (Gold Mamil Growing Up Formula Step 3 from Mintel)5 but also in the pharmaceutical field (Hinrichs et al., Carbohydrate Polymers, 2015, 134, 418-428) and in particular for the prevention and treatment of allergies in children (WO 2013/062402), for the treatment of inflammation in combination with xylans (WO 2011/020853) or for the prevention or treatment of pathologies associated with people's lifestyle (JP 201317441). Mixtures of plants, including roots known to contain inulin are also described for treatments derived from traditional Chinese medicine (CN 1245187).
De nombreuses compositions pharmaceutiques et nutraceutiques existent pour le traitement des maladies oculaires. Cependant, bien que ces compositions puissent agir sur les troubles oculaires, elles ne permettent pas de traiter l’ensemble des symptĂŽmes associĂ©s, et sont notamment sans action sur l’inflammation responsable de l’inconfort. Numerous pharmaceutical and nutraceutical compositions exist for the treatment of ocular diseases. However, although these compositions may act on ocular disorders, they do not make it possible to treat all the associated symptoms, and in particular have no action on the inflammation responsible for the discomfort.
Les inventeurs ont donc dĂ©veloppĂ© une composition nutraceutique Ă  base d’inuline ayant des effets bĂ©nĂ©fiques sur l’ensemble du systĂšme dans le cas de pathologies oculaires. The inventors have therefore developed a nutraceutical composition based on inulin having beneficial effects on the entire system in the case of ocular pathologies.
En particulier, les inventeurs ont dĂ©veloppĂ© une composition nutraceutique Ă  base d’inuline et d’extrait de baie de maqui, ayant des effets bĂ©nĂ©fiques sur le microbiote intestinal des personnes, en particulier sur son activitĂ© mĂ©tabolique et/ou sur la permĂ©abilitĂ© membranaire des intestins pour les molĂ©cules impliquĂ©es dans les phĂ©nomĂšnes d’inflammation et/ou sur la composition du microbiote, sa diversitĂ© et son Ă©quilibre en certains groupes microbiens une bonne santĂ©. In particular, the inventors have developed a nutraceutical composition based on inulin and maqui berry extract, having beneficial effects on the intestinal microbiota of people, in particular on its metabolic activity and/or on the membrane permeability of the intestines for the molecules involved in the phenomena of inflammation and/or on the composition of the microbiota, its diversity and its balance in certain microbial groups, good health.
La composition peut ĂȘtre utilisĂ©e de maniĂšre prĂ©ventive et/ou dans le cadre d’un traitement. The composition can be used preventively and/or as part of a treatment.
EXPOSE DE L'INVENTION DISCLOSURE OF THE INVENTION
Selon un premier mode, l’invention concerne une composition nutraceutique comprenant de l’inuline et un extrait de baie de maqui comprenant des anthocyanidines. According to a first embodiment, the invention relates to a nutraceutical composition comprising inulin and an extract of maqui berry comprising anthocyanidins.
Selon un autre mode, l’invention concerne une formulation adaptĂ©e pour une administration orale comprenant de l’inuline, un extrait de la baie de maqui, un ou des acides aminĂ©s, dont prĂ©fĂ©rentiellement de la carnitine, des vitamines et des minĂ©raux. According to another embodiment, the invention relates to a formulation suitable for oral administration comprising inulin, an extract of maqui berry, one or more amino acids, preferably including carnitine, vitamins and minerals.
Selon un autre mode, la prĂ©sente invention concerne une composition nutraceutique comprenant de l’inuline et un extrait de baie de maqui comprenant des anthocyanidines pour la prĂ©vention et/ou le traitement de pathologies oculaires. According to another embodiment, the present invention relates to a nutraceutical composition comprising inulin and a maqui berry extract comprising anthocyanidins for the prevention and/or treatment of ocular pathologies.
Selon un autre mode, la prĂ©sente concerne une composition nutraceutique comprenant de l’inuline et un extrait de baie de maqui comprenant des anthocyanidines pour la prĂ©vention et/ou le traitement d’un dĂ©sĂ©quilibre du microbiote intestinal et des pathologies associĂ©es Ă  ce dĂ©sĂ©quilibre. According to another embodiment, the present invention relates to a nutraceutical composition comprising inulin and a maqui berry extract comprising anthocyanidins for the prevention and/or treatment of an imbalance of the intestinal microbiota and pathologies associated with this imbalance.
DESCRIPTION DETAILLEE DE L'INVENTION DETAILED DESCRIPTION OF THE INVENTION
DĂ©finitions Definitions
Le terme « nutraceutique » dĂ©signe un produit comestible ayant un effet bĂ©nĂ©fique physiologique. Ainsi, on entend par composition nutraceutique une composition dont le but est de complĂ©ter le rĂ©gime alimentaire normal et constituant une source concentrĂ©e de nutriments ou d’autres substances ayant un effet nutritionnel ou physiologique, seuls ou combinĂ©s. The term "nutraceutical" refers to an edible product having a physiological beneficial effect. Thus, by nutraceutical composition is meant a composition whose purpose is supplementing the normal diet and constituting a concentrated source of nutrients or other substances having a nutritional or physiological effect, singly or in combination.
Le terme « pathologies oculaires » regroupe diverses maladies affectant les yeux. Dans certains cas, elles se traduisent par un simple inconfort oculaire, mais peuvent parfois devenir handicapantes. On entend ainsi par « pathologies oculaires » les picotements, les dĂ©mangeaisons, les sensations de brĂ»lure, de sable ou de corps Ă©trangers dans les yeux, une sensibilitĂ© Ă  la lumiĂšre, un trouble visuel, une fatigue oculaire, une douleur oculaire, une instabilitĂ© du film lacrymal, une inflammation des cellules cornĂ©ennes, une inflammation des cellules caliciformes au niveau des yeux et/ou des maux de tĂȘte. Les pathologies oculaires peuvent aussi ĂȘtre choisies parmi un syndrome de sĂ©cheresse oculaire, un dysfonctionnement meibomien, une conjonctivite allergique, une kĂ©ratoconjonctivite, une blĂ©pharoconjonctivite, et/ou ĂȘtre associĂ©s Ă  une chirurgie des yeux. The term “ocular pathologies” includes various diseases affecting the eyes. In some cases, they result in simple eye discomfort, but can sometimes become disabling. “Ocular pathologies” thus means tingling, itching, burning sensations, sand or foreign bodies in the eyes, sensitivity to light, visual disturbance, eye fatigue, eye pain, instability of the tear film, inflammation of corneal cells, inflammation of goblet cells in the eyes and/or headache. The eye pathologies can also be chosen from dry eye syndrome, meibomian dysfunction, allergic conjunctivitis, keratoconjunctivitis, blepharoconjunctivitis, and/or be associated with eye surgery.
Par « dĂ©sĂ©quilibre du microbiote intestinal » on entend un dĂ©sĂ©quilibre de l’activitĂ© de la communautĂ© microbienne et/ou un dĂ©sĂ©quilibre de la composition microbienne et/ou une augmentation de la permĂ©abilitĂ© membranaire intestinale. By “gut microbiota imbalance” is meant an imbalance in the activity of the microbial community and/or an imbalance in the microbial composition and/or an increase in intestinal membrane permeability.
La « communautĂ© microbienne » est constituĂ©e par l’ensemble des microorganismes qui constituent le microbiote intestinal d’un individu. Sa composition, la diversitĂ© des groupes microbiens prĂ©sents ou l'abondance relative des certains groupes microbiens sont des marqueurs d’un dĂ©sĂ©quilibre qui impacte l’état de santĂ© d’un individu et en particulier sa sensibilitĂ© ou sa propension Ă  dĂ©velopper des pathologies oculaires. Une diversitĂ© Ă©levĂ©e est un signe de bonne santĂ© intestinale. The "microbial community" is made up of all the microorganisms that make up the intestinal microbiota of an individual. Its composition, the diversity of the microbial groups present or the relative abundance of certain microbial groups are markers of an imbalance that impacts the state of health of an individual and in particular his sensitivity or his propensity to develop ocular pathologies. High diversity is a sign of good gut health.
Une amĂ©lioration d’un dĂ©sĂ©quilibre de l’activitĂ© de la communautĂ© microbienne sera observĂ©e en particulier sur la capacitĂ© de cette communautĂ© Ă  libĂ©rer des acides gras Ă  chaĂźnes courtes, sur la modulation de la concentration en lactate, sur le pH, sur la rĂ©duction de la quantitĂ© d’ammonium libĂ©rĂ© et/ou sur la production de gaz. An improvement of an imbalance of the activity of the microbial community will be observed in particular on the capacity of this community to release fatty acids with short chains, on the modulation of the concentration of lactate, on the pH, on the reduction of the amount of ammonium released and/or on gas production.
Les acides gras à chaßnes courtes (acétate, propionate, butyrate, iso butyrate, iso valérate and isocaproate) sont issus de la fermentation bactérienne intestinale d'aliments non digestibles, et sont la principale source d'énergie des cellules du cÎlon, ce qui les rend essentiels à la santé gastro-intestinale. Short-chain fatty acids (acetate, propionate, butyrate, isobutyrate, isovalerate and isocaproate) are derived from the intestinal bacterial fermentation of indigestible foods, and are the primary source of energy for colon cells, making them makes it essential for gastrointestinal health.
L'intestin abrite Ă  la fois des bactĂ©ries productrices de lactate et des bactĂ©ries qui l'utilisent. Le lactate est produit par les bactĂ©ries lactiques et diminue le pH de l'environnement, agissant Ă©galement comme agent antimicrobien. Le lactate peut Ă©galement ĂȘtre rapidement converti en acĂ©tate, butyrate et propionate par d'autres micro-organismes. The gut is home to both lactate-producing bacteria and bacteria that use it. Lactate is produced by lactic acid bacteria and lowers the pH of the environment, also acting as an antimicrobial agent. Lactate can also be rapidly converted to acetate, butyrate and propionate by other microorganisms.
La mesure du pH et le degré d'acidification est une mesure de l'intensité du métabolisme bactérien. The measurement of pH and the degree of acidification is a measure of the intensity of bacterial metabolism.
L'ammonium est un produit de dégradation protéolytique qui entraßne la production de composés potentiellement toxiques ou cancérigÚnes tels que le p-crésol et le p-phénol. La production excessive de gaz est considérée comme un effet potentiellement négatif d'une activité saccharolytique accrue de la communauté intestinale. Ammonium is a proteolytic degradation product that results in the production of potentially toxic or carcinogenic compounds such as p-cresol and p-phenol. Excess gas production is considered a potentially negative effect of increased saccharolytic activity of the gut community.
L’augmentation de la permĂ©abilitĂ© membranaire va rĂ©sulter d’un dĂ©sĂ©quilibre de la composition du microbiote intestinal (dysbiose) et conduit Ă  une augmentation de l’inflammation du systĂšme digestif et Ă  un Ă©tat inflammatoire gĂ©nĂ©ral qui va favoriser le dĂ©veloppement de pathologies associĂ©es Ă  l’inflammation et notamment des pathologies oculaires. The increase in membrane permeability will result from an imbalance in the composition of the intestinal microbiota (dysbiosis) and leads to an increase in inflammation of the digestive system and to a general inflammatory state which will promote the development of pathologies associated with the inflammation and in particular ocular pathologies.
L’amĂ©lioration de la permĂ©abilitĂ© membranaire est la consĂ©quence d’une amĂ©lioration de la composition du microbiote intestinal qui, en particulier, favorise la prĂ©vention et/ou le traitement de pathologies oculaires. The improvement in membrane permeability is the consequence of an improvement in the composition of the intestinal microbiota which, in particular, promotes the prevention and/or treatment of ocular pathologies.
D’autres marqueurs du dĂ©sĂ©quilibre du microbiote intestinal sont les marqueurs de l’inflammation que sont les cytokines pro-inflammatoires (IL-1 b humaine, IL-6, IL-8, TNF-a, CXCL10 et MCP-1) ainsi que l'activitĂ© de NF-kB (pro inflammatoire). Other markers of gut microbiota imbalance are the inflammation markers pro-inflammatory cytokines (human IL-1b, IL-6, IL-8, TNF-a, CXCL10 and MCP-1) as well as NF-kB activity (pro-inflammatory).
Une diminution de la production de ces marqueurs par les cellules Ă©pithĂ©liales membranaires de l’intestin est la consĂ©quence d’une amĂ©lioration de la composition du microbiote intestinal qui, en particulier, favorise la prĂ©vention et/ou le traitement de pathologies oculaires. A decrease in the production of these markers by the membrane epithelial cells of the intestine is the consequence of an improvement in the composition of the intestinal microbiota which, in particular, promotes the prevention and/or treatment of ocular pathologies.
L’amĂ©lioration du dĂ©sĂ©quilibre du microbiote intestinal peut ĂȘtre quantifiĂ©e par la production d’IL-10 (anti-inflammatoire). Une augmentation de la production d’IL-10 est la consĂ©quence d’une amĂ©lioration de la composition du microbiote intestinal qui, en particulier, favorise la prĂ©vention et/ou le traitement de pathologies oculaires. The improvement in the imbalance of the intestinal microbiota can be quantified by the production of IL-10 (anti-inflammatory). An increase in the production of IL-10 is the consequence of an improvement in the composition of the intestinal microbiota which, in particular, favors the prevention and/or treatment of ocular pathologies.
Composition Nutraceutique Nutraceutical composition
La composition comprend des prébiotiques, fibres naturelles présentes dans de nombreux végétaux comme les fruits, les légumes, les céréales et les légumineuses, et plus particuliÚrement des inulines. The composition comprises prebiotics, natural fibers present in many plants such as fruits, vegetables, cereals and legumes, and more particularly inulins.
Les inulines ou l’inuline (CAS [9005-80-5]), sont des fibres alimentaires solubles constituĂ©es d’unitĂ©s de fructose avec un glucose terminal. Ces polysaccharides naturels ou synthĂ©tiques ont un degrĂ© moyen de polymĂ©risation compris entre 2 et 60. L’inuline est naturellement prĂ©sente dans de nombreux vĂ©gĂ©taux, tels que les artichauts, les asperges, les bananes, les poireaux, les topinambours, les oignons, les tomates, l’orge et le seigle ou encore les racines de chicorĂ©e, les racines de pissenlit, et les racines d’aunĂ©e. Inulins or inulin (CAS [9005-80-5]), are soluble dietary fibers consisting of fructose units with a terminal glucose. These natural or synthetic polysaccharides have an average degree of polymerization of between 2 and 60. Inulin is naturally present in many plants, such as artichokes, asparagus, bananas, leeks, Jerusalem artichokes, onions, tomatoes , barley and rye or even chicory roots, dandelion roots, and elecampane roots.
Dans le cadre de la prĂ©sente invention, l’inuline est d’origine naturelle, et prĂ©fĂ©rentiellement extraite des racines de chicorĂ©e, des pissenlits et des topinambours. Dans un mode de rĂ©alisation prĂ©fĂ©rĂ©, l’inuline est extraite de la racine de chicorĂ©e. In the context of the present invention, the inulin is of natural origin, and preferentially extracted from chicory roots, dandelions and Jerusalem artichokes. In a preferred embodiment, the inulin is extracted from chicory root.
L’inuline est prĂ©sente en une quantitĂ© comprise entre 1 000 et 10 000 mg, prĂ©fĂ©rentiellement entre 2 000 et 8 000 mg. Dans un mode de rĂ©alisation, la quantitĂ© d’inuline est de 3 000 Ă  7 000 mg, prĂ©fĂ©rentiellement de 4 000 Ă  6 000 mg, encore plus prĂ©fĂ©rentiellement de 4 500 Ă  5 500 mg. Dans un mode de rĂ©alisation prĂ©fĂ©rĂ©, la quantitĂ© d’inuline est d’environ 5 000 mg. The inulin is present in an amount of between 1,000 and 10,000 mg, preferably between 2,000 and 8,000 mg. In one embodiment, the amount of inulin is 3000 to 7000 mg, preferably 4000 to 6000 mg, even more preferably from 4,500 to 5,500 mg. In a preferred embodiment, the amount of inulin is about 5000 mg.
Dans un autre mode de rĂ©alisation, l’inuline reprĂ©sente au moins 50% en poids de la composition totale, prĂ©fĂ©rentiellement au moins 60%, et plus prĂ©fĂ©rentiellement au moins 70%. Dans un mode de rĂ©alisation, la composition comprend ainsi entre 70 et 90% en poids d’inuline, plus prĂ©fĂ©rentiellement entre 80 et 90%. Dans un mode de rĂ©alisation prĂ©fĂ©rĂ©, la quantitĂ© d’inuline reprĂ©sente entre 82 et 89% en poids de la composition totale, prĂ©fĂ©rentiellement entre 85 et 89%, et plus prĂ©fĂ©rentiellement entre 86 et 88%. Dans un mode de rĂ©alisation prĂ©fĂ©rĂ©, la composition comprend en poids environ 87% d’inuline. In another embodiment, the inulin represents at least 50% by weight of the total composition, preferably at least 60%, and more preferably at least 70%. In one embodiment, the composition thus comprises between 70 and 90% by weight of inulin, more preferably between 80 and 90%. In a preferred embodiment, the amount of inulin represents between 82 and 89% by weight of the total composition, preferentially between 85 and 89%, and more preferentially between 86 and 88%. In a preferred embodiment, the composition comprises by weight about 87% inulin.
La composition comprend en plus un extrait de la baie de maqui. Ce fruit exotique, aussi connu sous le nom Aristotelia Chilensis, est utilisĂ© depuis plusieurs annĂ©es dans le domaine pharmaceutique. Plusieurs Ă©tudes ont en effet montrĂ© que cet anti-oxydant naturel riche en anthocyanines et anthocyanidines a des effets bĂ©nĂ©fiques sur l’organisme. Il peut ainsi ĂȘtre utilisĂ© par exemple pour le traitement du diabĂšte et du syndrome mĂ©tabolique (WO 2009/059218). The composition additionally comprises an extract of the maqui berry. This exotic fruit, also known as Aristotelia Chilensis, has been used for several years in the pharmaceutical field. Several studies have shown that this natural antioxidant rich in anthocyanins and anthocyanidins has beneficial effects on the body. It can thus be used for example for the treatment of diabetes and metabolic syndrome (WO 2009/059218).
Les molĂ©cules d’intĂ©rĂȘt prĂ©sentes dans la baie de maqui sont notamment les anthocyanidines, aussi appelĂ©es anthocyanidols. Sous forme hydroxylĂ©e, ces composĂ©s appartenant Ă  la sous-classe des flavonoĂŻdes, existent principalement sous 6 formes : le cyanidol, le delphinidol, le pĂ©largonidol, le malvidol, le pĂ©onidol et le pĂ©tunidol. Parmi ces diffĂ©rentes formes, le delphinidol ou delphinidine est un composĂ© organique prĂ©sent dans de nombreux vĂ©gĂ©taux possĂ©dant une forte activitĂ© antioxydante naturelle. The molecules of interest present in the maqui berry are in particular anthocyanidins, also called anthocyanidins. In hydroxylated form, these compounds belonging to the subclass of flavonoids, exist mainly in 6 forms: cyanidol, delphinidol, pelargonidol, malvidol, peonidol and petunidol. Among these different forms, delphinidol or delphinidin is an organic compound present in many plants with strong natural antioxidant activity.
Dans le cadre de la prĂ©sente invention, la composition nutraceutique comprend en plus de l’inuline des anthocyanidines issues de la baie de maqui. Les extraits de baie de baie de maqui sont connus et employĂ©s purs ou Ă  forte concentration dans des Ă©tudes in vitro (« Maqui Berry Extract », de la sociĂ©tĂ© Oryza Oil & Fat Chemical Co.) ou comme principes actifs dans des compositions pharmaceutiques ou des complĂ©ments alimentaires (ES 2685324 ; « Double ChocolatĂ© All-in-One Nutrition Bar » de la sociĂ©tĂ© Mintel). In the context of the present invention, the nutraceutical composition comprises, in addition to inulin, anthocyanidins from the maqui berry. Maqui berry extracts are known and used pure or in high concentrations in in vitro studies ("Maqui Berry Extract", from Oryza Oil & Fat Chemical Co.) or as active ingredients in pharmaceutical compositions or food supplements (ES 2685324; “Double Chocolate All-in-One Nutrition Bar” from Mintel).
L’extrait de la baie de maqui est prĂ©sent en une quantitĂ© comprise entre 30 et 150 mg, prĂ©fĂ©rentiellement entre 50 et 100 mg, plus prĂ©fĂ©rentiellement entre 50 et 75 mg. Dans un autre mode de rĂ©alisation, la composition comprend entre 55 et 70 mg, prĂ©fĂ©rentiellement entre 55 et 65 mg d’extrait de la baie de maqui. Dans un mode de rĂ©alisation prĂ©fĂ©rĂ©, la composition comprend environ 60 mg d’extrait de la baie de maqui. The maqui berry extract is present in an amount of between 30 and 150 mg, preferably between 50 and 100 mg, more preferably between 50 and 75 mg. In another embodiment, the composition comprises between 55 and 70 mg, preferably between 55 and 65 mg of maqui berry extract. In a preferred embodiment, the composition comprises about 60 mg of maqui berry extract.
Dans un mode de rĂ©alisation, la quantitĂ© d’extrait de la baie de maqui reprĂ©sente entre 0.5 et 5% en poids de la composition totale. Dans un mode de rĂ©alisation, la composition comprend entre 0.5 et 3% en poids d’extrait de la baie de maqui, plus prĂ©fĂ©rentiellement entre 0.5 et 2%. Dans un mode de rĂ©alisation prĂ©fĂ©rĂ©, la quantitĂ© d’extrait de la baie de maqui reprĂ©sente entre 0.6 et 1 .5% en poids de la composition totale, prĂ©fĂ©rentiellement entre 0.8 et 1 .2%, plus prĂ©fĂ©rentiellement entre 0.9 et 1 .1%. Dans un mode de rĂ©alisation, la composition comprend en poids environ 1 .05% d’extrait de la baie de maqui. In one embodiment, the amount of maqui berry extract represents between 0.5 and 5% by weight of the total composition. In one embodiment, the composition comprises between 0.5 and 3% by weight of maqui berry extract, more preferably between 0.5 and 2%. In a preferred embodiment, the amount of maqui berry extract represents between 0.6 and 1.5% by weight of the total composition, preferably between 0.8 and 1.2%, more preferably between 0.9 and 1.1%. In one embodiment, the composition comprises by weight about 1.05% maqui berry extract.
L’extrait de la baie de maqui comprend notamment des anthocyanidines et des delphinidines. Ces composĂ©s prĂ©sents dans la composition reprĂ©sentent au moins 35% en poids et au moins 25% en poids de l’extrait de la baie de maqui. Maqui berry extract includes anthocyanidins and delphinidins. These compounds present in the composition represent at least 35% by weight and at least 25% by weight of the extract of the maqui berry.
Selon un mode particulier, le rapport pondĂ©ral inuline/extrait de baie de maqui est d’au moins 5, en particulier d’au moins 35, plus particuliĂšrement d’au moins 50, avantageusement d’au moins 60, notamment d’au moins 80. According to a particular embodiment, the inulin/maqui berry extract weight ratio is at least 5, in particular at least 35, more particularly at least 50, advantageously at least 60, in particular at least 80.
Selon un autre mode particulier, le rapport pondéral inuline/extrait de baie de maqui est au plus de 350, en particulier au plus de 180, plus particuliÚrement au plus de 140, avantageusement au plus de 110, notamment au plus de 90. According to another particular embodiment, the inulin/maqui berry extract weight ratio is at most 350, in particular at most 180, more particularly at most 140, advantageously at most 110, in particular at most 90.
Selon un autre mode particulier, le rapport pondéral inuline/extrait de baie de maqui va de 5 à 350, en particulier de 35 à 180, plus particuliÚrement de 50 à 140, avantageusement de 60 à 110, notamment de 80 à 90. According to another particular embodiment, the inulin/maqui berry extract weight ratio ranges from 5 to 350, in particular from 35 to 180, more particularly from 50 to 140, advantageously from 60 to 110, in particular from 80 to 90.
Selon un moid eplus particulier, le rapport pondéral inuline/extrait de baie de maqui est de 82, 83, 84, 85, ou 86. According to a particular embodiment, the inulin/maqui berry extract weight ratio is 82, 83, 84, 85, or 86.
En plus de l’inuline et de la baie de maqui, d’autres ingrĂ©dients peuvent entrer dans la composition de l’invention. Ces ingrĂ©dients sont bien connus de l’homme du mĂ©tier. Il est entendu que la composition selon l’invention ne comprend pas de substances toxiques, ou pour le moins des substances Ă  des doses toxiques. In addition to inulin and maqui berry, other ingredients may enter into the composition of the invention. These ingredients are well known to those skilled in the art. It is understood that the composition according to the invention does not include toxic substances, or at least substances in toxic doses.
Parmi les composĂ©s pouvant entrer dans la composition nutraceutique, on citera notamment les acides aminĂ©s, qui peuvent exister sous une forme libre ou sous une forme de sels. De mĂȘme que leur stĂ©rĂ©ochimie peut ĂȘtre de configuration R ou S ou de type L ou D suivant le plan de polarisation de la lumiĂšre. Les acides aminĂ©s peuvent ainsi ĂȘtre employĂ©s sous des formes racĂ©miques ou optiquement actives. Among the compounds that can enter into the nutraceutical composition, mention will be made in particular of amino acids, which can exist in a free form or in the form of salts. Just as their stereochemistry can be of R or S configuration or of L or D type according to the plane of polarization of the light. The amino acids can thus be employed in racemic or optically active forms.
Dans le cadre de la prĂ©sente invention, on citera la carnitine comme acide aminĂ© de choix. Cet acide aminĂ© synthĂ©tisĂ© Ă  partir de la lysine et de la mĂ©thionine prĂ©sente des propriĂ©tĂ©s osmoprotectrices et antioxydantes. Dans un mode de rĂ©alisation de l’invention, la carnitine se trouve sous la forme d’énantiomĂšre R. Ainsi la L-carnitine sera prĂ©fĂ©rentiellement employĂ©e dans la formulation de la composition nutraceutique. In the context of the present invention, mention will be made of carnitine as the amino acid of choice. This amino acid synthesized from lysine and methionine has osmoprotective and antioxidant properties. In one embodiment of the invention, the carnitine is in the form of the R enantiomer. Thus L-carnitine will preferably be used in the formulation of the nutraceutical composition.
Lorsque les acides aminĂ©s sont sous forme de sels, on entend que ces sels sont des sels acceptables pour leur utilisation dans le cadre de la prĂ©sente invention. Il s’agit de sels non toxiques conventionnels, et apparaĂźtront de maniĂšre Ă©vidente pour l’homme du mĂ©tier. Comme exemples de sels d’acide aminĂ©, on citera le tartrate, le citrate, le phosphate, le borate, le lactate, le fumarate et l’oxalate. When the amino acids are in the form of salts, it is understood that these salts are acceptable salts for their use within the scope of the present invention. These are conventional non-toxic salts, and will be apparent to those skilled in the art. Examples of amino acid salts include tartrate, citrate, phosphate, borate, lactate, fumarate and oxalate.
Dans le cadre de la prĂ©sente invention, la composition nutraceutique comprend en plus de l’inuline et d’un extrait de la baie de maqui, de la carnitine, et plus prĂ©fĂ©rentiellement de la L-carnitine. Dans un mode de rĂ©alisation, la L-carnitine se trouve sous forme de sel de tartrate. In the context of the present invention, the nutraceutical composition comprises, in addition to inulin and an extract of maqui berry, carnitine, and more preferentially L-carnitine. In one embodiment, the L-carnitine is in the form of a tartrate salt.
Dans la formulation, la L-carnitine sous la forme de sel de tartrate est prĂ©sente en une quantitĂ© comprise entre 100 et 500 mg, prĂ©fĂ©rentiellement entre 150 et 400 mg, plus prĂ©fĂ©rentiellement entre 200 et 350 mg. Dans un mode de rĂ©alisation, la quantitĂ© de L-carnitine tartrate est de 220 Ă  330 mg, prĂ©fĂ©rentiellement de 240 Ă  320 mg, elle est plus prĂ©fĂ©rentiellement comprise entre 270 et 320 mg. Dans un autre mode de rĂ©alisation, la quantitĂ© de L-carnitine sous la forme de sel tartrate est comprise entre 280 et 310 mg, prĂ©fĂ©rentiellement entre 290 et 305 mg. Dans un mode de rĂ©alisation prĂ©fĂ©rĂ©, la quantitĂ© de L-carnitine sous la forme de sel de tartrate est comprise entre 295 et 302 mg. Elle est prĂ©fĂ©rentiellement d’environ 298 mg. In the formulation, the L-carnitine in the form of the tartrate salt is present in an amount comprised between 100 and 500 mg, preferentially between 150 and 400 mg, more preferentially between 200 and 350 mg. In one embodiment, the quantity of L-carnitine tartrate is from 220 to 330 mg, preferably from 240 to 320 mg, it is more preferably between 270 and 320 mg. In another embodiment, the amount of L-carnitine in the tartrate salt form is between 280 and 310 mg, preferably between 290 and 305 mg. In a preferred embodiment, the amount of L-carnitine in the tartrate salt form is between 295 and 302 mg. It is preferably around 298 mg.
Dans un autre mode de réalisation, la L-carnitine tartrate représente entre 3 et 8% en poids de la composition totale. Dans un mode de réalisation, la composition comprend ainsi entre 4 et 7% en poids de L-carnitine tartrate, plus préférentiellement entre 4.5 et 6%. Dans un mode de réalisation préféré, la quantité de L-carnitine tartrate représente entre 5 et 5.5% en poids de la composition totale, préférentiellement entre 5.1 et 5.3%. Dans un mode de réalisation préféré, la composition comprend environ 5.2% en poids da carnitine tartrate. In another embodiment, the L-carnitine tartrate represents between 3 and 8% by weight of the total composition. In one embodiment, the composition thus comprises between 4 and 7% by weight of L-carnitine tartrate, more preferentially between 4.5 and 6%. In a preferred embodiment, the amount of L-carnitine tartrate represents between 5 and 5.5% by weight of the total composition, preferably between 5.1 and 5.3%. In a preferred embodiment, the composition comprises about 5.2% by weight carnitine tartrate.
D’autres ingrĂ©dients tels que des vitamines et des minĂ©raux peuvent ĂȘtre ajoutĂ©s Ă  la composition nutraceutique de la prĂ©sente invention. Other ingredients such as vitamins and minerals can be added to the nutraceutical composition of the present invention.
Ces vitamines comprennent les vitamines du groupe B, c’est-Ă -dire la vitamine B1 ou thiamine, la vitamine B2 ou riboflavine, la vitamine B3 ou vitamine PP encore appelĂ©e niacine, la vitamine B5 ou acide pantothĂ©nique, la vitamine B6 ou pyridoxine, la vitamine B8 ou biotine, la vitamine B9 ou acide folique et la vitamine B12 ou cobalamine, la vitamine C ou acide ascorbique, la vitamine D, la vitamine, E et les vitamines K. These vitamins include group B vitamins, i.e. vitamin B1 or thiamine, vitamin B2 or riboflavin, vitamin B3 or vitamin PP also called niacin, vitamin B5 or pantothenic acid, vitamin B6 or pyridoxine , vitamin B8 or biotin, vitamin B9 or folic acid and vitamin B12 or cobalamin, vitamin C or ascorbic acid, vitamin D, vitamin E and vitamin K.
De maniÚre avantageuse, les vitamines de la présente invention sont les vitamines A, E, C, D et les vitamines du groupe B. Advantageously, the vitamins of the present invention are vitamins A, E, C, D and group B vitamins.
Dans un mode de rĂ©alisation prĂ©fĂ©rĂ©, la composition comprend des vitamines du groupe B, et prĂ©fĂ©rentiellement de la vitamine B2 ou riboflavine. Dans un autre mode de rĂ©alisation, la composition comprend des vitamines du groupe D, et prĂ©fĂ©rentiellement de la vitamine D3. Dans un autre mode de rĂ©alisation, la composition selon l’invention comprend des vitamines du groupe B et des vitamines du groupe D, prĂ©fĂ©rentiellement les vitamines B2 et D3. In a preferred embodiment, the composition comprises group B vitamins, and preferably vitamin B2 or riboflavin. In another embodiment, the composition comprises vitamins of group D, and preferably vitamin D3. In another embodiment, the composition according to the invention comprises vitamins of group B and vitamins of group D, preferably vitamins B2 and D3.
Dans la formulation, la vitamine B2 est prĂ©sente sous forme de riboflavine en une quantitĂ© supĂ©rieure Ă  0.2 mg, prĂ©fĂ©rentiellement supĂ©rieure Ă  0.6 mg, plus prĂ©fĂ©rentiellement supĂ©rieure Ă  0.8 mg. Dans un mode de rĂ©alisation, la quantitĂ© de riboflavine est infĂ©rieure Ă  2 mg. Dans un mode de rĂ©alisation, la quantitĂ© de riboflavine est comprise entre 0.9 et 1 .9 mg, prĂ©fĂ©rentiellement entre 1.3 et 1.9 mg, plus prĂ©fĂ©rentiellement entre 1.5 et 1.8 mg. Dans un autre mode de rĂ©alisation, la quantitĂ© de riboflavine est comprise entre 1.7 et 1.8 mg, prĂ©fĂ©rentiellement entre 1 .72 et 1 .79 mg, plus prĂ©fĂ©rentiellement entre 1 .75 et 1 .78 mg. Dans un mode de rĂ©alisation prĂ©fĂ©rĂ©, la quantitĂ© de riboflavine est d’environ 1 .76 mg. In the formulation, vitamin B2 is present in the form of riboflavin in an amount greater than 0.2 mg, preferably greater than 0.6 mg, more preferably greater than 0.8 mg. In one embodiment, the amount of riboflavin is less than 2 mg. In one embodiment, the quantity of riboflavin is between 0.9 and 1.9 mg, preferentially between 1.3 and 1.9 mg, more preferentially between 1.5 and 1.8 mg. In a another embodiment, the quantity of riboflavin is between 1.7 and 1.8 mg, preferentially between 1.72 and 1.79 mg, more preferentially between 1.75 and 1.78 mg. In a preferred embodiment, the amount of riboflavin is about 1.76 mg.
Selon un autre mode de rĂ©alisation, la riboflavine reprĂ©sente moins de 1% en poids de la composition totale, prĂ©fĂ©rentiellement moins de 0.5%, plus prĂ©fĂ©rentiellement moins de 0.2%. Dans un mode de rĂ©alisation, la composition comprend ainsi entre 0.01 et 0.2% en poids de riboflavine, prĂ©fĂ©rentiellement entre 0.015 et 0.1%, plus prĂ©fĂ©rentiellement entre 0.015 et 0.05%. Dans un mode de rĂ©alisation prĂ©fĂ©rĂ©, la quantitĂ© de riboflavine reprĂ©sente entre 0.02 et 0.04% en poids de la composition totale, prĂ©fĂ©rentiellement entre 0.025 et 0.035%. Dans un autre mode de rĂ©alisation prĂ©fĂ©rĂ©, la composition comprend environ 0.03% poids de riboflavine, forme d’apport de vitamine B2. According to another embodiment, the riboflavin represents less than 1% by weight of the total composition, preferably less than 0.5%, more preferably less than 0.2%. In one embodiment, the composition thus comprises between 0.01 and 0.2% by weight of riboflavin, preferentially between 0.015 and 0.1%, more preferentially between 0.015 and 0.05%. In a preferred embodiment, the amount of riboflavin represents between 0.02 and 0.04% by weight of the total composition, preferably between 0.025 and 0.035%. In another preferred embodiment, the composition comprises about 0.03% by weight of riboflavin, a supply form of vitamin B2.
La formulation peut par ailleurs comprendre de la vitamine D, préférentiellement de la vitamine D2, aussi appelée ergocalciférol (CAS [50-14-6]), et/ou de la vitamine D3, aussi appelée cholécalciférol [CAS 67-97-0]. The formulation may also comprise vitamin D, preferably vitamin D2, also called ergocalciferol (CAS [50-14-6]), and/or vitamin D3, also called cholecalciferol [CAS 67-97-0] .
Dans un mode de rĂ©alisation, la composition selon l’invention comprend de la vitamine D2. Dans un autre mode de rĂ©alisation, la composition comprend de la vitamine D3. Dans un autre mode de rĂ©alisation, la composition comprend de la vitamine D2 et de la vitamine D3. In one embodiment, the composition according to the invention comprises vitamin D2. In another embodiment, the composition includes vitamin D3. In another embodiment, the composition includes vitamin D2 and vitamin D3.
Avantageusement, selon l’invention la vitamine D est de la vitamine D3. Advantageously, according to the invention, the vitamin D is vitamin D3.
Lorsque la composition comprend de la vitamine D sous la forme de vitamine D3, celle-ci est prĂ©sente en une quantitĂ© supĂ©rieure Ă  0,01 pg, prĂ©fĂ©rentiellement en une quantitĂ© supĂ©rieure Ă  0,1 pg, encore plus prĂ©fĂ©rentiellement en une quantitĂ© supĂ©rieure Ă  0,5 pg. Dans un mode de rĂ©alisation, la quantitĂ© de vitamine D3 est infĂ©rieure Ă  20 pg, voire infĂ©rieure Ă  16 pg, voire mĂȘme infĂ©rieure Ă  13 pg. Dans un mode de rĂ©alisation, la quantitĂ© de vitamine D3 est comprise entre 1 et 12 pg, prĂ©fĂ©rentiellement entre 2 et 12 pg, plus prĂ©fĂ©rentiellement entre 5 et 12 pg. Dans un autre mode de rĂ©alisation, la vitamine D3 est prĂ©sente en une quantitĂ© comprise entre 8 et 11 pg. Avantageusement, la composition comprend 9 pg de vitamine D3, prĂ©fĂ©rentiellement 10 pg. When the composition comprises vitamin D in the form of vitamin D3, the latter is present in an amount greater than 0.01 pg, preferably in an amount greater than 0.1 pg, even more preferably in an amount greater than 0 .5 pg. In one embodiment, the amount of vitamin D3 is less than 20 pg, or even less than 16 pg, or even less than 13 pg. In one embodiment, the amount of vitamin D3 is between 1 and 12 pg, preferentially between 2 and 12 pg, more preferentially between 5 and 12 pg. In another embodiment, vitamin D3 is present in an amount between 8 and 11 pg. Advantageously, the composition comprises 9 pg of vitamin D3, preferably 10 pg.
La vitamine D3 est apportĂ©e dans la composition sous la forme de cholĂ©calcifĂ©rol. La quantitĂ© de cholĂ©calcifĂ©rol selon la composition de l’invention est comprise entre 0,1 et 30 mg, prĂ©fĂ©rentiellement entre 0,5 et 20 mg, plus prĂ©fĂ©rentiellement entre 1 et 15 mg. Dans un autre mode de rĂ©alisation, la quantitĂ© de cholĂ©calcifĂ©rol est infĂ©rieure Ă  15 mg. Dans un mode de rĂ©alisation prĂ©fĂ©rĂ©, la quantitĂ© est ainsi comprise entre 1 et 10 mg, prĂ©fĂ©rentiellement entre 3 et 7 mg, plus prĂ©fĂ©rentiellement entre 4 et 6 mg. Dans un mode de rĂ©alisation prĂ©fĂ©rĂ©, la quantitĂ© de cholĂ©calcifĂ©rol est d’environ 5 mg. Vitamin D3 is provided in the composition in the form of cholecalciferol. The amount of cholecalciferol according to the composition of the invention is between 0.1 and 30 mg, preferentially between 0.5 and 20 mg, more preferentially between 1 and 15 mg. In another embodiment, the amount of cholecalciferol is less than 15 mg. In a preferred embodiment, the quantity is thus between 1 and 10 mg, preferentially between 3 and 7 mg, more preferentially between 4 and 6 mg. In a preferred embodiment, the amount of cholecalciferol is about 5 mg.
Selon un autre mode de réalisation, la quantité de cholécalciférol représente moins de 2,5% en poids de la composition totale. Dans un mode de réalisation, la composition comprend ainsi entre 0.001 et 2% en poids de cholécalciférol, préférentiellement entre 0,01 et 1%, plus préférentiellement entre 0,02 et 0,5%. Dans un mode de réalisation préféré, la quantité de cholécalciférol représente entre 0,05 et 0,2% en poids de la composition totale, préférentiellement entre 0,05 et 0,1%. De maniÚre avantageuse, la quantité de cholécalciférol est inférieure ou égale à 0,1% en poids, préférentiellement inférieure ou égale à 0,09%. Dans un autre mode de réalisation, la quantité de cholécalciférol est supérieure ou égale à 0,06% en poids, préférentiellement supérieure ou égale à 0,07%. Dans un autre mode de réalisation, la quantité de cholécalciférol est ainsi comprise entre 0,07% et 0,09% en poids par rapport au poids total de la composition. Avantageusement, la composition comprend environ 0,087% en poids de cholécalciférol. According to another embodiment, the amount of cholecalciferol represents less than 2.5% by weight of the total composition. In one embodiment, the composition thus comprises between 0.001 and 2% by weight of cholecalciferol, preferably between 0.01 and 1%, more preferably between 0.02 and 0.5%. In a preferred embodiment, the amount of cholecalciferol represents between 0.05 and 0.2% by weight of the total composition, preferably between 0.05 and 0.1%. Advantageously, the amount of cholecalciferol is less than or equal to 0.1% by weight, preferably less than or equal to 0.09%. In another embodiment, the amount of cholecalciferol is greater than or equal to 0.06% by weight, preferably greater than or equal to 0.07%. In another embodiment, the amount of cholecalciferol is thus between 0.07% and 0.09% by weight relative to the total weight of the composition. Advantageously, the composition comprises approximately 0.087% by weight of cholecalciferol.
Les minéraux sélectionnés dans le cadre de la présente invention sont le zinc, le fer, cuivre, le sélénium, le manganÚse et le chrome. Ces minéraux peuvent exister sous forme libre ou sous une forme complexée. The minerals selected in the context of the present invention are zinc, iron, copper, selenium, manganese and chromium. These minerals can exist in a free form or in a complexed form.
Des exemples de complexes Ă  base de zinc sont l’oxide de zinc, le gluconate de zinc, l’acĂ©tate de zinc, le citrate de zinc, le chlorure de zinc, le lactate de zinc, le sulfate de zinc, le picolinate de zinc ou encore le bisglycinate de zinc. Ils peuvent ainsi ĂȘtre utilisĂ©s seuls ou en combinaison dans les compositions selon l’invention. Le bisglycinate de zinc sera prĂ©fĂ©rentiellement employĂ© dans le cadre de la composition nutraceutique. Examples of zinc complexes are zinc oxide, zinc gluconate, zinc acetate, zinc citrate, zinc chloride, zinc lactate, zinc sulphate, zinc picolinate or even zinc bisglycinate. They can thus be used alone or in combination in the compositions according to the invention. Zinc bisglycinate will preferably be used in the context of the nutraceutical composition.
Dans la formulation, le zinc est présent en une quantité supérieure à 1 mg, supérieure ou égale à 2 mg, supérieure ou égale à 3 mg, supérieure ou égale à 4 mg. Dans un mode de réalisation, la quantité de zinc est inférieure à 16 mg. Dans un autre mode de réalisation, la quantité de zinc est comprise entre 10 et 16 mg, préférentiellement entre 12 et 16 mg, plus préférentiellement entre 14 et 16 mg. Dans un mode de réalisation, la quantité de zinc est de 15 mg. In the formulation, the zinc is present in an amount greater than 1 mg, greater than or equal to 2 mg, greater than or equal to 3 mg, greater than or equal to 4 mg. In one embodiment, the amount of zinc is less than 16 mg. In another embodiment, the amount of zinc is between 10 and 16 mg, preferentially between 12 and 16 mg, more preferentially between 14 and 16 mg. In one embodiment, the amount of zinc is 15 mg.
Dans la composition selon l’invention, le zinc se trouve sous une forme complexĂ©e, notamment sous la forme de zinc bisglycinate. Selon un mode de rĂ©alisation, la quantitĂ© de zinc bisglycinate est comprise entre 5 et 60 mg, prĂ©fĂ©rentiellement entre 20 et 60 mg, plus prĂ©fĂ©rentiellement entre 40 et 60 mg. Dans un autre mode de rĂ©alisation, la quantitĂ© de zinc bisglycinate est infĂ©rieure Ă  60 mg. Dans un mode de rĂ©alisation prĂ©fĂ©rĂ©, la quantitĂ© est ainsi comprise entre 50 et 59 mg, prĂ©fĂ©rentiellement entre 52 et 58 mg, plus prĂ©fĂ©rentiellement entreIn the composition according to the invention, the zinc is in a complexed form, in particular in the form of zinc bisglycinate. According to one embodiment, the quantity of zinc bisglycinate is between 5 and 60 mg, preferentially between 20 and 60 mg, more preferentially between 40 and 60 mg. In another embodiment, the amount of zinc bisglycinate is less than 60 mg. In a preferred embodiment, the amount is thus between 50 and 59 mg, preferentially between 52 and 58 mg, more preferentially between
55 et 57 mg. Dans un mode de rĂ©alisation prĂ©fĂ©rĂ©, la quantitĂ© de zinc bisglycinate est d’environ55 and 57mg. In a preferred embodiment, the amount of zinc bisglycinate is about
56 mg. 56mg.
Dans un mode de réalisation, la zinc bisglycinate représente moins de 2% en poids de la composition totale. Dans un mode de réalisation, la composition comprend ainsi entre 0.1 et 2% en poids de zinc bisglycinate, préférentiellement entre 0.3 et 1.5%, plus préférentiellement entre 0.6 et 1 .2%. Dans un mode de réalisation préféré, la quantité de zinc bisglycinate représente entre 0.8 et 1.1% en poids de la composition totale, préférentiellement entre 0.9 et 1.05%, plus préférentiellement entre 0.95 et 1.0%. Dans un mode de réalisation préféré, la composition comprend environ 0.98% de zinc bisglycinate en poids. In one embodiment, the zinc bisglycinate represents less than 2% by weight of the total composition. In one embodiment, the composition thus comprises between 0.1 and 2% by weight of zinc bisglycinate, preferentially between 0.3 and 1.5%, more preferentially between 0.6 and 1.2%. In a preferred embodiment, the amount of zinc bisglycinate represents between 0.8 and 1.1% by weight of the total composition, preferably between 0.9 and 1.05%, more preferably between 0.95 and 1.0%. In a preferred embodiment, the composition comprises about 0.98% zinc bisglycinate by weight.
Ainsi selon l’invention, la composition nutraceutique comprend les ingrĂ©dients suivants : de l’inuline, un extrait de la baie de maqui comprenant des anthocyanidines et/ou des delphinidines, de la carnitine, de la vitamine B12, et du zinc. Dans un mode de rĂ©alisation prĂ©fĂ©rĂ©, la carnitine se trouve sous la forme Ă©nantiomĂšre pure L et sous la forme d’un sel de tartrate. Dans un autre mode de rĂ©alisation, le zinc est sous la forme de complexe de zinc bisglycinate. Enfin dans un autre mode de rĂ©alisation, la composition comprend de la carnitine sous la forme L et sous forme de sel de tartrate et le zinc sous la forme de zinc bisglycinate. Thus according to the invention, the nutraceutical composition comprises the following ingredients: inulin, an extract of the maqui berry comprising anthocyanidins and/or delphinidins, carnitine, vitamin B12, and zinc. In a preferred embodiment, the carnitine is in the enantiomeric pure form L and in the form of a tartrate salt. In another embodiment, the zinc is in the form of zinc bisglycinate complex. Finally in another embodiment, the composition comprises carnitine in the L form and in the form of the tartrate salt and zinc in the form of zinc bisglycinate.
La composition nutraceutique selon l’invention comprenant 1 000 Ă  10 000 mg d’inuline, de 30 Ă  150 mg d’extrait de la baie de maqui, de 100 Ă  500 mg de L-carnitine tartrate, de 0,15 Ă  5,0 mg de vitamine B2 ou riboflavine, et de 5 Ă  56 mg de zinc bisglycinate, est particuliĂšrement adaptĂ©e pour la prĂ©vention et/ou le traitement de pathologies oculaires. The nutraceutical composition according to the invention comprising 1,000 to 10,000 mg of inulin, from 30 to 150 mg of maqui berry extract, from 100 to 500 mg of L-carnitine tartrate, from 0.15 to 5, 0 mg of vitamin B2 or riboflavin, and 5 to 56 mg of zinc bisglycinate, is particularly suitable for the prevention and/or treatment of ocular pathologies.
Additifs et Excipients Additives and Excipients
La composition nutraceutique peut aussi comprendre tout additif permettant d’en amĂ©liorer la conservation, le goĂ»t, la formulation ainsi que l’aspect. Ainsi des agents conservateurs, des arĂŽmes, des colorants et des agents de formulation peuvent ĂȘtre ajoutĂ©s. L’homme du mĂ©tier saura choisir ces agents ainsi que les doses nĂ©cessaires Ă  la formulation. The nutraceutical composition may also comprise any additive making it possible to improve its preservation, taste, formulation and appearance. Thus preservatives, flavorings, colorings and formulating agents can be added. Those skilled in the art will be able to choose these agents as well as the doses necessary for the formulation.
La composition nutraceutique de l’invention peut comprendre en plus au moins un excipient et/ou au moins un vĂ©hicule pharmaceutiquement acceptable. The nutraceutical composition of the invention may additionally comprise at least one excipient and/or at least one pharmaceutically acceptable vehicle.
L’excipient et le vĂ©hicule sont « pharmaceutiquement acceptables » dans le sens oĂč ils sont compatibles avec les autres ingrĂ©dients de la composition et sont non-toxiques. Leur utilisation permet notamment de faciliter la prĂ©paration, la conservation et l’administration du composĂ© actif. De tels excipients et vĂ©hicules sont bien connus de l’homme du mĂ©tier, dĂ©crits notamment dans la pharmacopĂ©e française ou europĂ©enne. The excipient and the vehicle are "pharmaceutically acceptable" in the sense that they are compatible with the other ingredients of the composition and are non-toxic. Their use makes it possible in particular to facilitate the preparation, storage and administration of the active compound. Such excipients and vehicles are well known to those skilled in the art, described in particular in the French or European pharmacopoeia.
Les excipients et vĂ©hicules pharmaceutiquement acceptables comprennent tous les solvants, les milieux de dispersion, les revĂȘtements, les agents antibactĂ©riens et antifongiques, les agents isotoniques, les agents d’absorption, et autres qui sont physiologiquement compatibles. Les excipients comprennent Ă©galement les additifs correcteurs de pH comme l’acide citrique anhydre, les agents aromatisants ou arĂŽmes, comme par exemple les arĂŽmes naturels de fruits rouges, et le cas Ă©chĂ©ant des Ă©dulcorants comme le sucralose ou le stĂ©via. Pharmaceutically acceptable excipients and vehicles include all solvents, dispersing media, coatings, antibacterial and antifungal agents, isotonic agents, absorbents, and others that are physiologically compatible. The excipients also include pH-correcting additives such as anhydrous citric acid, flavoring agents or aromas, such as natural red fruit aromas, and, where appropriate, sweeteners such as sucralose or stevia.
Selon un mode particulier, la composition selon l’invention comprenant de 1 000 Ă  10 000 mg d’inuline et de 30 Ă  150 mg d’extrait de baie de maqui et est formulĂ©e sous une forme solide. According to a particular embodiment, the composition according to the invention comprising from 1,000 to 10,000 mg of inulin and from 30 to 150 mg of maqui berry extract and is formulated in a solid form.
Dans un mode de réalisation, la composition nutraceutique solide comprend : In one embodiment, the solid nutraceutical composition comprises:
- 1 000 à 10 000 mg d’inuline, - 1,000 to 10,000 mg of inulin,
- 30 à 150 mg d’extrait de baie de maqui, - 100 à 500 mg de L-carnitine tartrate, - 30 to 150 mg of maqui berry extract, - 100 to 500 mg of L-carnitine tartrate,
- 0.15 Ă  5.0 mg de riboflavine (vitamine B2), - 0.15 to 5.0 mg of riboflavin (vitamin B2),
- 5 Ă  60 mg de zinc bisglycinate, et - 5 to 60 mg of zinc bisglycinate, and
- 0,1 à 30 mg de cholécalciférol (vitamine D3). - 0.1 to 30 mg of cholecalciferol (vitamin D3).
Dans un autre mode de réalisation, la composition nutraceutique comprend : In another embodiment, the nutraceutical composition comprises:
- 3 000 à 7000 mg d’inuline, - 3000 to 7000 mg of inulin,
- 40 à 80 mg d’extrait de baie de maqui, - 40 to 80 mg of maqui berry extract,
- 150 Ă  400 mg de L-carnitine tartrate, - 150 to 400 mg of L-carnitine tartrate,
- 0.5 Ă  3.0 mg de riboflavine (vitamine B2), - 0.5 to 3.0 mg of riboflavin (vitamin B2),
- 30 Ă  56 mg de zinc bisglycinate, et - 30 to 56 mg of zinc bisglycinate, and
0,5 à 20 mg de cholécalciférol (vitamine D3). 0.5 to 20 mg of cholecalciferol (vitamin D3).
Dans un autre mode de réalisation, la composition nutraceutique comprend : In another embodiment, the nutraceutical composition comprises:
- 4000 à 6000 mg d’inuline, - 4000 to 6000 mg of inulin,
- 45 à 75 mg d’extrait de baie de maqui, - 45 to 75 mg of maqui berry extract,
- 200 Ă  400 mg de L-carnitine tartrate, - 200 to 400 mg of L-carnitine tartrate,
- 1.0 Ă  2.30 mg de riboflavine (vitamine B2), - 1.0 to 2.30 mg of riboflavin (vitamin B2),
- 40 Ă  56 mg de zinc bisglycinate, et - 40 to 56 mg of zinc bisglycinate, and
- 1 à 10 mg de cholécalciférol (vitamine D3). - 1 to 10 mg of cholecalciferol (vitamin D3).
Dans un autre mode de réalisation, la composition nutraceutique comprend : In another embodiment, the nutraceutical composition comprises:
- 4500 à 5500 mg d’inuline, - 4500 to 5500 mg of inulin,
- 50 à 70 mg d’extrait de baie de maqui, - 50 to 70 mg of maqui berry extract,
- 250 Ă  350 mg de L-carnitine tartrate, - 250 to 350 mg of L-carnitine tartrate,
- 1.50 Ă  1 .90 mg de riboflavine (vitamine B2), - 1.50 to 1.90 mg of riboflavin (vitamin B2),
- 50 Ă  56 mg de zinc bisglycinate, et - 50 to 56 mg of zinc bisglycinate, and
- 3 à 7 mg de cholécalciférol (vitamine D3). - 3 to 7 mg of cholecalciferol (vitamin D3).
Dans un mode de réalisation préféré, la composition nutraceutique comprend :In a preferred embodiment, the nutraceutical composition comprises:
- 5000 mg d’inuline, - 5000 mg of inulin,
- 60 mg d’extrait de baie de maqui, - 60 mg of maqui berry extract,
- 298 mg de L-carnitine tartrate, - 298 mg of L-carnitine tartrate,
- 1 ,76 mg de riboflavine (vitamine B2) - 1.76 mg of riboflavin (vitamin B2)
- 56 mg de zinc bisglycinate. - 56 mg of zinc bisglycinate.
- 4 à 6 mg de cholécalciférol (vitamine D3) - 4 to 6 mg of cholecalciferol (vitamin D3)
Dans un autre mode de réalisation préféré, la composition nutraceutique comprend :In another preferred embodiment, the nutraceutical composition comprises:
- 5000 mg d’inuline, - 5000 mg of inulin,
- 60 mg d’extrait de baie de maqui, - 60 mg of maqui berry extract,
- 298 mg de L-carnitine tartrate, - 298 mg of L-carnitine tartrate,
- 1 ,76 mg de riboflavine (vitamine B2), - 56 mg de zinc bisglycinate, et - 1.76 mg of riboflavin (vitamin B2), - 56 mg of zinc bisglycinate, and
- 5 mg de cholécalciférol (vitamine D3). - 5 mg of cholecalciferol (vitamin D3).
Forme Galénique Pharmaceutical form
Concernant la formulation galĂ©nique, plusieurs formes peuvent ĂȘtre envisagĂ©es telles que des gommes Ă  mĂącher, des comprimĂ©s Ă  croquer, avaler ou effervescents, des gĂ©lules, des pastilles, des pilules, des granulĂ©s, des poudres, des solutions ou des suspensions buvables. La composition selon l’invention est avantageusement sous une forme solide. Regarding the galenic formulation, several forms can be envisaged such as chewing gum, chewable, swallowable or effervescent tablets, capsules, lozenges, pills, granules, powders, solutions or drinkable suspensions. The composition according to the invention is advantageously in a solid form.
Dans un mode de rĂ©alisation prĂ©fĂ©rĂ©, la composition de la prĂ©sente invention est sous la forme d’une poudre, d’un comprimĂ©, d’une gĂ©lule ou d’une capsule. In a preferred embodiment, the composition of the present invention is in the form of a powder, tablet, capsule or capsule.
De maniĂšre avantageuse, la poudre est dissoute formant une solution ou une Ă©mulsion. La poudre peut par ailleurs se trouver sous la forme d’un comprimĂ© qui sera dissout ou avalĂ©. Advantageously, the powder is dissolved forming a solution or an emulsion. The powder can also be in the form of a tablet that will be dissolved or swallowed.
Ainsi, dans un mode de réalisation, la composition nutraceutique est formulée pour une administration par voie orale. Thus, in one embodiment, the nutraceutical composition is formulated for oral administration.
Dosage et Administration Dosage and Administration
Selon un mode l’invention concerne une composition nutraceutique comprenant de l’inuline et un extrait de baie de maqui comprenant des anthocyanidines telle que dĂ©finie prĂ©cĂ©demment pour son utilisation dans la prĂ©vention et/ou le traitement d’un dĂ©sĂ©quilibre du microbiote intestinal. According to one mode, the invention relates to a nutraceutical composition comprising inulin and a maqui berry extract comprising anthocyanidins as defined above for its use in the prevention and/or treatment of an imbalance of the intestinal microbiota.
Selon un autre mode l’invention concerne une composition nutraceutique comprenant de l’inuline et un extrait de baie de maqui comprenant des anthocyanidines telle que dĂ©finie prĂ©cĂ©demment pour son utilisation dans la prĂ©vention et/ou le traitement de pathologies oculaires. According to another embodiment, the invention relates to a nutraceutical composition comprising inulin and an extract of maqui berry comprising anthocyanidins as defined above for its use in the prevention and/or treatment of ocular pathologies.
L’invention concerne une mĂ©thode pour la prĂ©vention et/ou le traitement d’un dĂ©sĂ©quilibre du microbiote intestinal chez un patient qui en a besoin, ladite mĂ©thode comprenant l’administration audit patient d’une quantitĂ© appropriĂ©e de composition nutraceutique comprenant de l’inuline et un extrait de baie de maqui comprenant des anthocyanidines telle que dĂ©finie prĂ©cĂ©demment. The invention relates to a method for the prevention and/or treatment of an imbalance of the intestinal microbiota in a patient in need thereof, said method comprising the administration to said patient of an appropriate quantity of nutraceutical composition comprising inulin and a maqui berry extract comprising anthocyanidins as defined above.
L’invention concerne aussi une mĂ©thode pour la prĂ©vention et/ou le traitement de pathologies oculaires chez un patient qui en a besoin, ladite mĂ©thode comprenant l’administration audit patient d’une quantitĂ© appropriĂ©e de composition nutraceutique comprenant de l’inuline et un extrait de baie de maqui comprenant des anthocyanidines telle que dĂ©finie prĂ©cĂ©demment. The invention also relates to a method for the prevention and/or treatment of ocular pathologies in a patient who needs it, said method comprising the administration to said patient of an appropriate quantity of nutraceutical composition comprising inulin and an extract of maqui berry comprising anthocyanidins as defined above.
La composition de la prĂ©sente invention est formulĂ©e pour ĂȘtre administrĂ©e quotidiennement, Ă  savoir de maniĂšre journaliĂšre. La composition est ainsi formulĂ©e pour ĂȘtre administrĂ©e en une Ă  quatre fois par jour. De maniĂšre avantageuse, la composition est formulĂ©e pour ĂȘtre administrĂ©e une seule fois par jour. Le dosage et la frĂ©quence d’administration dĂ©pend de plusieurs facteurs, notamment des symptĂŽmes, de la sĂ©vĂ©ritĂ© de la pathologie, de l’étendue du trouble et de la condition physique de la personne Ă  traiter. L’homme du mĂ©tier saura adapter la posologie Ă  administrer. Il est entendu que la posologie pourra ĂȘtre augmentĂ©e ou diminuĂ©e en fonction de l’évaluation du mĂ©decin. Dans un mode de rĂ©alisation, la composition est administrĂ©e trois fois par jours. Dans un autre mode de rĂ©alisation, la composition est administrĂ©e deux fois par jours. De maniĂšre avantageuse, elle est administrĂ©e une fois par jour. The composition of the present invention is formulated to be administered daily, i.e. daily. The composition is thus formulated to be administered one to four times a day. Advantageously, the composition is formulated to be administered once a day. Dosage and frequency administration depends on several factors, including the symptoms, the severity of the disease, the extent of the disorder and the physical condition of the person being treated. A person skilled in the art will know how to adapt the dosage to be administered. It is understood that the dosage may be increased or decreased according to the physician's assessment. In one embodiment, the composition is administered three times per day. In another embodiment, the composition is administered twice daily. Advantageously, it is administered once a day.
L’inuline est avantageusement prĂ©sente en une quantitĂ© (dose journaliĂšre) supĂ©rieure ou Ă©gale Ă  1 000 mg. Selon un mode de rĂ©alisation, la quantitĂ© journaliĂšre est supĂ©rieure ou Ă©gale Ă  2 000 mg, supĂ©rieure ou Ă©gale Ă  3 000 mg, voire supĂ©rieure ou Ă©gale Ă  4000 mg. Avantageusement, la quantitĂ© (dose journaliĂšre) d’inuline est environ Ă©gale Ă  5 000 mg. The inulin is advantageously present in an amount (daily dose) greater than or equal to 1000 mg. According to one embodiment, the daily amount is greater than or equal to 2000 mg, greater than or equal to 3000 mg, or even greater than or equal to 4000 mg. Advantageously, the quantity (daily dose) of inulin is approximately equal to 5000 mg.
L’extrait de baie de maqui est avantageusement prĂ©sent en une quantitĂ© (dose journaliĂšre) supĂ©rieure ou Ă©gale Ă  30 mg, supĂ©rieure ou Ă©gale Ă  40 mg, ou supĂ©rieure ou Ă©gale Ă  50 mg. Dans un autre mode de rĂ©alisation, la quantitĂ© journaliĂšre est infĂ©rieure ou Ă©gale Ă  150 mg, infĂ©rieure ou Ă©gale Ă  100 mg, infĂ©rieure ou Ă©gale Ă  70 prĂ©fĂ©rentiellement Ă©gale Ă  environ 60 mg. The maqui berry extract is advantageously present in an amount (daily dose) greater than or equal to 30 mg, greater than or equal to 40 mg, or greater than or equal to 50 mg. In another embodiment, the daily amount is less than or equal to 150 mg, less than or equal to 100 mg, less than or equal to 70, preferably equal to approximately 60 mg.
La L-carnitine tartrate est avantageusement présente en une quantité (dose journaliÚre) supérieure ou égale à 200 mg. Selon un mode de réalisation, la quantité journaliÚre est supérieure ou égale à 250 mg, supérieure ou égale à 260 mg, voire supérieure ou égale à 270 mg. The L-carnitine tartrate is advantageously present in an amount (daily dose) greater than or equal to 200 mg. According to one embodiment, the daily amount is greater than or equal to 250 mg, greater than or equal to 260 mg, or even greater than or equal to 270 mg.
La vitamine B2 sous forme de riboflavine est avantageusement prĂ©sente en une quantitĂ© (dose journaliĂšre) supĂ©rieure ou Ă©gale Ă  0.10 mg. Selon un mode de rĂ©alisation, la quantitĂ© journaliĂšre est supĂ©rieure ou Ă©gale Ă  0.20 mg, supĂ©rieure ou Ă©gale Ă  0.50 mg, voire supĂ©rieure ou Ă©gale Ă  0.80 mg. Avantageusement, la quantitĂ© (dose journaliĂšre) de vitamine B2 est infĂ©rieure ou Ă©gale Ă  5.0 mg, infĂ©rieure ou Ă©gale Ă  4.5 mg, infĂ©rieure ou Ă©gale Ă  3.5 mg. Selon un mode de rĂ©alisation prĂ©fĂ©rĂ©, la quantitĂ© (dose journaliĂšre) de riboflavine est d’environ 1.76 mg. Vitamin B2 in the form of riboflavin is advantageously present in an amount (daily dose) greater than or equal to 0.10 mg. According to one embodiment, the daily amount is greater than or equal to 0.20 mg, greater than or equal to 0.50 mg, or even greater than or equal to 0.80 mg. Advantageously, the quantity (daily dose) of vitamin B2 is less than or equal to 5.0 mg, less than or equal to 4.5 mg, less than or equal to 3.5 mg. According to a preferred embodiment, the amount (daily dose) of riboflavin is about 1.76 mg.
Le zinc bisglycinate est avantageusement prĂ©sente en une quantitĂ© (dose journaliĂšre) supĂ©rieure ou Ă©gale Ă  5 mg. Selon un mode de rĂ©alisation, la quantitĂ© journaliĂšre est supĂ©rieure ou Ă©gale Ă  20 mg, supĂ©rieure ou Ă©gale Ă  40 mg. Avantageusement, la quantitĂ© (dose journaliĂšre) de zinc bisglycinate est infĂ©rieure Ă  60 mg, prĂ©fĂ©rentiellement infĂ©rieure Ă  58 mg, plus prĂ©fĂ©rentiellement infĂ©rieure ou Ă©gale Ă  56 mg. Selon un mode de rĂ©alisation prĂ©fĂ©rĂ©, la quantitĂ© (dose journaliĂšre) de zinc bisglycinate est d’environ 56 mg. The zinc bisglycinate is advantageously present in an amount (daily dose) greater than or equal to 5 mg. According to one embodiment, the daily amount is greater than or equal to 20 mg, greater than or equal to 40 mg. Advantageously, the amount (daily dose) of zinc bisglycinate is less than 60 mg, preferably less than 58 mg, more preferably less than or equal to 56 mg. According to a preferred embodiment, the amount (daily dose) of zinc bisglycinate is about 56 mg.
Selon un mode particulier de composition selon l’invention, la quantitĂ© de cholĂ©calcifĂ©rol (forme d’apport de la vitamine D3) est comprise entre 0,1 et 30 mg, prĂ©fĂ©rentiellement entre 0,5 et 20 mg, plus prĂ©fĂ©rentiellement entre 1 et 15 mg. Dans un autre mode de rĂ©alisation, la quantitĂ© de cholĂ©calcifĂ©rol est infĂ©rieure Ă  15 mg. Dans un mode de rĂ©alisation prĂ©fĂ©rĂ©, la quantitĂ© est ainsi comprise entre 1 et 10 mg, prĂ©fĂ©rentiellement entre 3 et 7 mg, plus prĂ©fĂ©rentiellement entre 4 et 6 mg. Dans un mode de rĂ©alisation prĂ©fĂ©rĂ©, la quantitĂ© de cholĂ©calcifĂ©rol est d’environ 5 mg. According to a particular mode of composition according to the invention, the quantity of cholecalciferol (form of supply of vitamin D3) is between 0.1 and 30 mg, preferentially between 0.5 and 20 mg, more preferentially between 1 and 15 mg. In another embodiment, the amount of cholecalciferol is less than 15 mg. In a mode of preferred embodiment, the amount is thus between 1 and 10 mg, preferably between 3 and 7 mg, more preferably between 4 and 6 mg. In a preferred embodiment, the amount of cholecalciferol is about 5 mg.
EXEMPLES EXAMPLES
Exemple 1 Example 1
Une composition nutraceutique est formulĂ©e sous forme de poudre Ă  diluer dans un grand verre d’eau et comprend 5 000 mg d’inuline, 60 mg d’extrait de baie de maqui, 298 mg de L-carnitine tartrate, 1 ,76 mg de riboflavine (vitamine B2), 56 mg de zinc bisglycinate, et 5 mg de cholĂ©calcifĂ©rol (vitamine D3). A nutraceutical composition is formulated as a powder to be diluted in a large glass of water and includes 5000 mg of inulin, 60 mg of maqui berry extract, 298 mg of L-carnitine tartrate, 1.76 mg of riboflavin (vitamin B2), 56 mg of zinc bisglycinate, and 5 mg of cholecalciferol (vitamin D3).
Des patients atteints de pathologies oculaires (picotements, dĂ©mangeaisons, sensations de brĂ»lure, de corps Ă©trangers, sensibilitĂ© Ă  la lumiĂšre, trouble visuel, fatigue oculaire, douleur oculaire, instabilitĂ© du film lacrymal, inflammation des cellules cornĂ©ennes, inflammation des cellules caliciformes au niveau des yeux et/ou maux de tĂȘte) sont sĂ©lectionnĂ©s pour suivre un traitement avec la composition nutraceutique pendant au minimum 30 jours Ă  raison d’une prise par jour. Patients with ocular pathologies (tingling, itching, burning sensations, foreign body sensations, sensitivity to light, visual disturbance, eye fatigue, eye pain, tear film instability, inflammation of corneal cells, inflammation of goblet cells in the eyes and/or headaches) are selected to follow a treatment with the nutraceutical composition for at least 30 days on the basis of one intake per day.
Les patients sont interrogĂ©s avant et aprĂšs la prise de la composition nutraceutique, Ă  intervalle rĂ©gulier, pour suivre leur rĂ©ponse au traitement, l’évolution de leur pathologie et les Ă©ventuels effets secondaires. The patients are questioned before and after taking the nutraceutical composition, at regular intervals, to monitor their response to the treatment, the evolution of their pathology and any side effects.
Un effet bénéfique est observé pour la majorité des patients. A beneficial effect is observed for the majority of patients.
Exemple 2 Example 2
L’effet de la composition de l’exemple 1 sur le microbiote intestinal est analysĂ© in vitro sur des prĂ©lĂšvements de microbiote d’individus sains. Les cellules prĂ©levĂ©es sont mises en suspension dans un milieu appropriĂ© pour leur conservation. 4 Ă©chantillons sont rĂ©alisĂ©s (1) contrĂŽle, (2) avec ajout d’inuline, (3) avec ajout d’un extrait de baie de maqui et (4) avec ajout de la composition de l’exemple 1 . The effect of the composition of Example 1 on the intestinal microbiota is analyzed in vitro on microbiota samples from healthy individuals. The collected cells are suspended in an appropriate medium for their conservation. 4 samples are made (1) control, (2) with addition of inulin, (3) with addition of a maqui berry extract and (4) with addition of the composition of Example 1.
Les analyses de la composition et de l’activitĂ© de la communautĂ© microbienne sont rĂ©alisĂ©es et montrent une amĂ©lioration pour l’échantillon (4). Microbial community composition and activity analyzes are performed and show improvement for the sample (4).
Exemple 3 Example 3
Des analyses de permĂ©abilitĂ© membranaire des cellules Ă©pithĂ©liales intestinales associĂ©es Ă  des paramĂštres immunitaires sont rĂ©alisĂ©es, (1) contrĂŽle sans autre ajout, (2) avec ajout d’inuline, (3) avec ajout d’un extrait de baie de maqui et (4) avec ajout de la composition de l’exemple 1. Analyzes of membrane permeability of the intestinal epithelial cells associated with immune parameters are carried out, (1) control without other addition, (2) with addition of inulin, (3) with addition of an extract of maqui berry and (4 ) with the addition of the composition of Example 1.
La permĂ©abilitĂ© membranaire est mesurĂ©e grĂące Ă  la rĂ©sistance Ă©lectrique transĂ©pithĂ©liale sur un modĂšle in vitro de dĂ©sĂ©quilibre du microbiote intestinal. Une baisse de la rĂ©sistance Ă©lectrique transĂ©pithĂ©liale est une indication de la rupture de la monocouche de cellule Ă©pithĂ©liale intestinale. Si le produit Ă  tester Ă©vite cette baisse, alors il est capable de protĂ©ger les cellules de l’épithĂ©lium intestinal contre l’hyperpermĂ©abilitĂ© liĂ©e Ă  une dysbiose. Les paramĂštres immunitaires sont mesurĂ©s par la production de cytokines pro inflammatoire (IL-1 b humaine, IL-6, IL-8, TNF-a, CXCL10 et MCP-1) ainsi que l'activitĂ© NF-KB (pro inflammatoire). La production d’IL10 (anti inflammatoire) sera Ă©galement mesurĂ©e. Membrane permeability is measured using transepithelial electrical resistance in an in vitro model of intestinal microbiota imbalance. A drop in transepithelial electrical resistance is an indication of disruption of the intestinal epithelial cell monolayer. If the product to be tested avoids this drop, then it is capable of protecting the cells of the intestinal epithelium against hyperpermeability linked to dysbiosis. The immune parameters are measured by the production of pro-inflammatory cytokines (human IL-1b, IL-6, IL-8, TNF-a, CXCL10 and MCP-1) as well as the NF-ÎșB activity (pro-inflammatory). The production of IL10 (anti-inflammatory) will also be measured.
Une amĂ©lioration est observĂ©e pour la composition de l’exemple 1. An improvement is observed for the composition of Example 1.
REFERENCES REFERENCES
- Baim et al. Experimental Biology and Medicine, 2019, 244, 419-429 - Flanagan et al., Antibiotics, 2019, 8, 1-23 - Baim et al. Experimental Biology and Medicine, 2019, 244, 419-429 - Flanagan et al., Antibiotics, 2019, 8, 1-23
- Hinrichs et al., Carbohydrate Polymers, 2015, 134, 418-428 - Hinrichs et al., Carbohydrate Polymers, 2015, 134, 418-428
- WO 2009/059218, WO 2011/020853, WO 2013/062402 - WO 2009/059218, WO 2011/020853, WO 2013/062402
- JP 201317441 - JP 201317441
- CN 1245187 - ES 2685324 - CN 1245187 - ES 2685324

Claims

REVENDICATIONS
1. Composition nutraceutique caractĂ©risĂ©e en ce qu’elle comprend de l’inuline et un extrait de baie de maqui comprenant des anthrocyanidines. 1. Nutraceutical composition characterized in that it comprises inulin and a maqui berry extract comprising anthrocyanidins.
2. Composition selon la revendication 1 , caractĂ©risĂ© en ce qu’elle comprend 1 Ă  10 g d’inuline et de 30 Ă  150 mg d’extrait de baie de maqui. 2. Composition according to claim 1, characterized in that it comprises 1 to 10 g of inulin and 30 to 150 mg of maqui berry extract.
3. Composition selon l’une des revendications 1 ou 2, caractĂ©risĂ©e en ce que le rapport pondĂ©ral inuline/extrait de baie de maqui va de 5 Ă  350, en particulier de 35 Ă  180.3. Composition according to one of Claims 1 or 2, characterized in that the inulin/maqui berry extract weight ratio ranges from 5 to 350, in particular from 35 to 180.
4. Composition selon l’une des revendications 1 Ă  3, caractĂ©risĂ©e en ce que le rapport pondĂ©ral inuline/extrait de baie de maqui va de 80 Ă  90. 4. Composition according to one of claims 1 to 3, characterized in that the inulin/maqui berry extract weight ratio ranges from 80 to 90.
5. Composition selon l’une des revendications 1 Ă  4, caractĂ©risĂ©e en ce que l’inuline est extraite de la racine de chicorĂ©e. 5. Composition according to one of claims 1 to 4, characterized in that the inulin is extracted from chicory root.
6. Composition selon l’une des revendications 1 Ă  5, caractĂ©risĂ©e en ce qu’elle comprend du cholĂ©calcifĂ©rol. 6. Composition according to one of claims 1 to 5, characterized in that it comprises cholecalciferol.
7. Composition selon la revendication 6, caractĂ©risĂ©e en ce qu’elle comprend de 0,1 Ă  30 mg de cholĂ©calcifĂ©rol. 7. Composition according to claim 6, characterized in that it comprises from 0.1 to 30 mg of cholecalciferol.
8. Composition selon l’une des revendications 1 Ă  7, caractĂ©risĂ©e en ce qu’elle comprend de la carnitine, de la riboflavine et du zinc. 8. Composition according to one of claims 1 to 7, characterized in that it comprises carnitine, riboflavin and zinc.
9. Composition selon l’une des revendications 1 Ă  8, caractĂ©risĂ©e en ce qu’elle comprend de 1 Ă  10 g d’inuline, de 30 Ă  150 mg d’extrait de maqui, de 100 Ă  500 mg de L-carnitine tartrate, de 0,15 Ă  5 mg riboflavine, de 5 Ă  56 mg de zinc bisglycinate, et de 0,1 Ă  30 mg de cholĂ©calcifĂ©rol. 9. Composition according to one of claims 1 to 8, characterized in that it comprises from 1 to 10 g of inulin, from 30 to 150 mg of maqui extract, from 100 to 500 mg of L-carnitine tartrate , 0.15 to 5 mg riboflavin, 5 to 56 mg zinc bisglycinate, and 0.1 to 30 mg cholecalciferol.
10. Composition selon l’une des revendications 1 Ă  9, caractĂ©risĂ©e en ce qu’elle comprend en plus au moins un excipient et/ou au moins un vĂ©hicule pharmaceutiquement acceptable. 10. Composition according to one of claims 1 to 9, characterized in that it additionally comprises at least one excipient and/or at least one pharmaceutically acceptable vehicle.
11. Composition selon l’une des revendications 1 Ă  10, caractĂ©risĂ©e en ce qu’elle est sous une forme solide. 11. Composition according to one of claims 1 to 10, characterized in that it is in a solid form.
12. Composition selon la revendication 11 , caractĂ©risĂ©e en ce qu’elle est sous la forme d’une poudre en sachet pour une solution ou une suspension buvable, d’un comprimĂ©, d’une gĂ©lule ou d’une capsule. 12. Composition according to claim 11, characterized in that it is in the form of a powder in a sachet for a drinkable solution or suspension, a tablet, a capsule or a capsule.
13. Composition selon la revendication 12, caractĂ©risĂ©e en ce qu’elle est adaptĂ©e pour une administration par voie orale. 13. Composition according to claim 12, characterized in that it is suitable for oral administration.
14. Composition selon l’une des revendications 1 Ă  13, pour son utilisation dans la prĂ©vention et/ou le traitement de pathologies oculaires. 14. Composition according to one of claims 1 to 13, for its use in the prevention and/or treatment of ocular pathologies.
15. Composition pour son utilisation selon la revendication 14, caractĂ©risĂ© en ce que les pathologies oculaires comprennent : les picotements, les dĂ©mangeaisons, les sensations de brulure, de sable ou de corps Ă©trangers dans les yeux, une sensibilitĂ© Ă  la lumiĂšre, un trouble visuel, une fatigue oculaire, une douleur oculaire, une instabilitĂ© du film lacrymal, une inflammation des cellules cornĂ©ennes, une inflammation des cellules caliciformes au niveau des yeux et/ou des maux de tĂȘte. 15. Composition for its use according to claim 14, characterized in that the ocular pathologies include: tingling, itching, burning, gritty or foreign body sensation in the eyes, sensitivity to light, visual disturbance, eye fatigue, eye pain, tear film instability, corneal cell inflammation, goblet cell inflammation in the eye level and/or headaches.
16. Composition pour son utilisation selon la revendication 14, caractérisée en ce que les pathologies oculaires sont associées à un syndrome de sécheresse oculaire, un dysfonctionnement meibomien, une conjonctivite allergique, une kératoconjonctivite, une blépharoconjonctivite, et/ou une chirurgie des yeux. 16. Composition for its use according to claim 14, characterized in that the ocular pathologies are associated with dry eye syndrome, meibomian dysfunction, allergic conjunctivitis, keratoconjunctivitis, blepharoconjunctivitis, and/or eye surgery.
17. Composition selon l’une des revendications 1 Ă  13, pour son utilisation dans la prĂ©vention et/ou le traitement d’un dĂ©sĂ©quilibre du microbiote intestinal. 17. Composition according to one of claims 1 to 13, for its use in the prevention and/or treatment of an imbalance of the intestinal microbiota.
18. Composition pour son utilisation selon l’une des revendications 14 Ă  17, caractĂ©risĂ©e en ce qu’elle est formulĂ©e pour ĂȘtre administrĂ©e une fois par jour. 18. Composition for its use according to one of claims 14 to 17, characterized in that it is formulated to be administered once a day.
EP22717129.5A 2021-03-22 2022-03-22 Nutraceutical composition comprising inulin for treating and preventing ocular disorders or intestinal microbiota imbalance Pending EP4313022A1 (en)

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FR2102836A FR3120788B1 (en) 2021-03-22 2021-03-22 NUTRACEUTICAL COMPOSITION FOR THE TREATMENT AND PREVENTION OF EYE DISORDERS
PCT/EP2022/057466 WO2022200334A1 (en) 2021-03-22 2022-03-22 Nutraceutical composition comprising inulin for treating and preventing ocular disorders or intestinal microbiota imbalance

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SG87040A1 (en) 1998-07-21 2002-03-19 Sumitomo Bakelite Co Silane-crosslinked polyolefin resin composition and insulated cable covered with the composition
CN1245187C (en) * 2003-09-15 2006-03-15 ćŸäž‡ćŻŒ Medicine for treating eye disease caused by visceral disease
WO2009059218A1 (en) 2007-10-31 2009-05-07 Phytomedics, Inc. Berry preparations for treatment of diabetes and metabolic syndrome
BE1019755A3 (en) * 2009-08-18 2012-12-04 Cosucra Groupe Warcoing S A COMPOSITIONS CONTAINING MIXTURES OF FERMENTABLE FIBERS.
JP5744652B2 (en) 2011-07-13 2015-07-08 ăƒ€ăƒłăƒžăƒŒæ ȘćŒäŒšç€Ÿ Passenger rice transplanter
CN104039175A (en) * 2011-10-24 2014-09-10 N·V·ćŠȘç‰čé‡Œć„‡äșš Allergy treatment with non- digestible oligosaccharide
JP5562986B2 (en) * 2012-01-18 2014-07-30 æ ȘćŒäŒšç€Ÿăƒ—ăƒ©ă‚čă‚ąăƒ«ăƒ•ă‚ĄăƒŒ Preventive or ameliorating agent for lifestyle-related diseases
ES2685324B1 (en) * 2017-03-30 2019-07-22 Phidinut S L Pharmaceutical composition or nutritional supplement for the prevention and / or treatment of dry eye

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WO2022200334A1 (en) 2022-09-29
US20240165149A1 (en) 2024-05-23
FR3120788A1 (en) 2022-09-23

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