WO2023169664A1 - Composition for treatment of parasitic or viral infection in alimentary and/or respiratory tract - Google Patents

Composition for treatment of parasitic or viral infection in alimentary and/or respiratory tract Download PDF

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Publication number
WO2023169664A1
WO2023169664A1 PCT/EP2022/055947 EP2022055947W WO2023169664A1 WO 2023169664 A1 WO2023169664 A1 WO 2023169664A1 EP 2022055947 W EP2022055947 W EP 2022055947W WO 2023169664 A1 WO2023169664 A1 WO 2023169664A1
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composition
subject
dry weight
amount
organic acid
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PCT/EP2022/055947
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French (fr)
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Morten HARRINGTON RAAHOLT
Mikkel FLESSUM HARRINGTON RAAHOLT
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Vitality Innovation
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Priority to PCT/EP2022/055947 priority Critical patent/WO2023169664A1/en
Priority to PCT/EP2023/055944 priority patent/WO2023170183A1/en
Publication of WO2023169664A1 publication Critical patent/WO2023169664A1/en

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    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23K—FODDER
    • A23K50/00—Feeding-stuffs specially adapted for particular animals
    • A23K50/70—Feeding-stuffs specially adapted for particular animals for birds
    • A23K50/75—Feeding-stuffs specially adapted for particular animals for birds for poultry
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23K—FODDER
    • A23K10/00—Animal feeding-stuffs
    • A23K10/30—Animal feeding-stuffs from material of plant origin, e.g. roots, seeds or hay; from material of fungal origin, e.g. mushrooms
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23K—FODDER
    • A23K20/00—Accessory food factors for animal feeding-stuffs
    • A23K20/10—Organic substances
    • A23K20/158—Fatty acids; Fats; Products containing oils or fats
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23K—FODDER
    • A23K20/00—Accessory food factors for animal feeding-stuffs
    • A23K20/10—Organic substances
    • A23K20/174—Vitamins
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23K—FODDER
    • A23K20/00—Accessory food factors for animal feeding-stuffs
    • A23K20/20—Inorganic substances, e.g. oligoelements
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23K—FODDER
    • A23K50/00—Feeding-stuffs specially adapted for particular animals
    • A23K50/10—Feeding-stuffs specially adapted for particular animals for ruminants
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
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    • A23K50/00—Feeding-stuffs specially adapted for particular animals
    • A23K50/20—Feeding-stuffs specially adapted for particular animals for horses
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23K—FODDER
    • A23K50/00—Feeding-stuffs specially adapted for particular animals
    • A23K50/80—Feeding-stuffs specially adapted for particular animals for aquatic animals, e.g. fish, crustaceans or molluscs
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/105—Plant extracts, their artificial duplicates or their derivatives
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/115—Fatty acids or derivatives thereof; Fats or oils
    • A23L33/12—Fatty acids or derivatives thereof
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
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    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
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    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
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    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/194—Carboxylic acids, e.g. valproic acid having two or more carboxyl groups, e.g. succinic, maleic or phthalic acid
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4164—1,3-Diazoles
    • A61K31/4188—1,3-Diazoles condensed with other heterocyclic ring systems, e.g. biotin, sorbinil
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4415—Pyridoxine, i.e. Vitamin B6
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/455—Nicotinic acids, e.g. niacin; Derivatives thereof, e.g. esters, amides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/506—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
    • A61K31/51—Thiamines, e.g. vitamin B1
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A61K31/525—Isoalloxazines, e.g. riboflavins, vitamin B2
    • A—HUMAN NECESSITIES
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    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7135—Compounds containing heavy metals
    • A61K31/714—Cobalamins, e.g. cyanocobalamin, i.e. vitamin B12
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • A—HUMAN NECESSITIES
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    • A61K33/24—Heavy metals; Compounds thereof
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    • 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)
    • A61K36/54—Lauraceae (Laurel family), e.g. cinnamon or sassafras
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P33/00—Antiparasitic agents
    • A61P33/02—Antiprotozoals, e.g. for leishmaniasis, trichomoniasis, toxoplasmosis

Definitions

  • the present invention relates to compositions comprising at least one Cl - C12 organic acid and Ceylon cinnamon and its use wherein the organic acid is a carboxylic acid with acidic properties.
  • Organic acids are widely used for different purposes in different combinations all over the world. It’s used as a disinfectant, as a food/feed preservation technique, as a growth promoter in production animals and many more. Organic acids have been successfully used as a growth promoter in pigs for more than 25 years and they have also been found to be effective in poultry production. From the use of organic acids in poultry and pigs, one can expect an improvement in performance similar to or better than that of antibiotic growth promoters, without the public health concern.
  • Another aspect of observation in relation to present invention is the direct effect indicated on bacteria, virus and parasites. Especially in low -pH environments like stomach and abomasum(ruminants). The effects of organic acids on bacteria are known and the mechanism is assumed to relate to the non-dissociated organic acids.
  • the present invention aims to solve one of the aforementioned problems and provides a composition comprising at least one Cl -Cl 2 organic acid and/or its salts in combination with an iron component , Ceylon cinnamon and B -vitamins and wherein the organic acid is a carboxylic acid with acidic properties.
  • the present inventors have solved the above-mentioned need by providing in a first aspect a composition comprising at least one C1-C12 organic acid and/or its salt, an iron component, Ceylon cinnamon and B -vitamins in an amount from 0 to 200 mg/g dry matter of the composition and in amounts corresponding to at least that which theoretically can be consumed during metabolism of the COOH-groups present wherein the organic acid is a carboxylic acid with acidic properties according Bronsted definition of an acid which is a molecule that can donate a proton to another molecule.
  • the composition does not comprise L-camitine.
  • the organic acid is a C1-C8 and/or its salts wherein the total amount of the organic acids is in the range from 66 % (w/w) to 100% (w/w) by dry weight of the composition.
  • the organic acid is a C1-C8 and/or its salts wherein the total amount of the organic acids is in the range from 66 % (w/w) to 99% (w/w) by dry weight of the composition, such as from 60% (w/w) to 95% (w/w), such as from 75% (w/w) to 85% (w/w).
  • the organic acid is a fatty acid.
  • the organic acid is a Cl -Cl 2 fatty acid selected from short chain fatty acids, medium chain fatty acids and long chain fatty acids.
  • the organic acid is a C1-C8 fatty acid.
  • the fatty acids are selected from short chained fatty acids (SCFA): formic acid (Cl), acetic acid (C2), Propionic acid (C3), Butyric acid (C4), Fumaric acid (C4); Medium- chained fatty acids (MCFA): Sorbic acid (C6), Caprylic acid (C8) and Long-chained fatty acids (LCFA): Lauric acid (Cl 2).
  • SCFA short chained fatty acids
  • Cl formic acid
  • C2 acetic acid
  • Propionic acid C3
  • Butyric acid C4
  • Fumaric acid C4
  • MFA Medium- chained fatty acids
  • MCFA Sorbic acid
  • C8 Caprylic acid
  • LCFA Long-chained fatty acids
  • the at least one organic acid is formic acid and its salt.
  • the iron component is in an amount of 0 to 3.5% (w/w) by dry weight of the composition and the iron compound is preferably ferrous fumarate,
  • the iron component is in an amount of 0.5 to 3.5% (w/w) by dry weight of the composition. In a most preferred embodiment, the iron component is in an amount of 0.5 to 3.5% (w/w) by dry weight of the composition and the iron compound is ferrous fumarate.
  • the composition of B-vitamins comprises 0-10 mg/g Bl, 0-25mg/g B2, 0-40 mg/g B3, 0-25 mg/g B5, 0-60 mg/g B6, 0-25 mg/g B7, 0-60 mg/g B9 and 0-250 pg/g B12 based on dry weight of the composition.
  • the composition of B-vitamins comprises 2-10 mg/g Bl, 5-25mg/g B2, 10-25 mg/g B6, 0-25 mg/g B7, 0.1-60 mg/g B9 and 1-250 pg/g B12 based on dry weight of the composition.
  • the composition of B-vitamins comprises 0.5-10 mg/g Bl, 0.5-25mg/g B2, B6 0.5-25 mg/g, 0-25 mg/g B7, 0.1-60 mg/g B9 and 10-250 pg/g B12 based on dry weight of the composition.
  • the amount of vitamins, B6, B9 and B12 is in the range from 10-50mg/g dry weight of the composition and the amount of B9 and B12 should at least correspond to that which can be consumed during metabolism of the COOH-group of the carboxylic acids in particular in combination with formic acid and is salt.
  • the Ceylon cinnamon is bark from Cinnamomum verum and is in an amount from 0.1 to 6% (w/w) by dry weight of the composition, preferably in an amount from 0.5 to 6% (w/w) by dry weight of the composition.
  • the composition comprises the composition further comprises a desiccant in an amount of 0-6% (w/w) by dry weight of the composition, wherein the desiccant is selected from Silicone dioxide, Magnesium oxide or any combinations thereof.
  • the composition comprises an antioxidant in an amount of 0-1% (w/w) by dry weight of the composition, wherein the antioxidant is preferably selected from Vitamin C, Vitamin E or any combinations thereof.
  • the amount of salt and carboxylic acids will give a pH amounting to 2.0 to 7.5 when the composition is in form of a suspension.
  • the amount of salt and carboxylic acids will give a pH amounting to 2.0 to 7.5 when the composition is dissolved in water. In one embodiment according to the first aspect the amount of salt and carboxylic acids will give a pH amounting to 2.0 to 6.0 when the composition is in form of a suspension.
  • the amount of salt and carboxylic acids will give a pH amounting to 2.0 to 6.0 when the composition is dissolved in water.
  • the composition is a dietary supplement.
  • the composition is a pharmaceutical composition.
  • the composition is administrated in the state of powder, suspension, gel-suspension, supplemented directly to food or feed or is swallowed as a tablet or capsule.
  • the composition is for use in decreasing infectivity of a virus and/or a parasite in a subject.
  • the composition is for use in increasing virus and/or parasite resistance in a subject.
  • the composition is for use in reducing the risk of and/or aid in treatment of a parasitic infection and/or viral infection in a subject.
  • the parasite is caused by a parasite with a hard-shelled life cycle stage where it forms a cyst and/or oocyst.
  • the parasite and/or the virus is comprised in the gastrointestinal system such as the alimentary tract and/or respiratory system of the subject.
  • the virus is selected from rotaviruses, adenoviruses, coronaviruses, Hepatitis A, Hepatitis E, Norovirus, Enterovirus and Poliovirus.
  • the parasite is selected from coccidiosis and giardiasis.
  • the subject is an animal, a fish or a human.
  • the animal is selected from a ruminant, a horse, a race pigeon, a dog and a cat.
  • the daily dose is in the range 25-500 mg dry weight / kg body weight or 0.5- 10g per 20kg body weight In one embodiment the daily dose is about 1 g per 20kg body weight for use in reducing the risk of a parasitic infection and/or viral infection in a subject. In one embodiment the daily dose is 2g- 10g per 20kg body weight for use in treatment of or aid in treatment of a parasitic infection and/or viral infection in a subject.
  • a method decreasing infectivity of a virus and/or a parasite in a subject comprising administering to the subject the composition according to any one of claims 1 to 12 a daily dose in the range from 25 to 500 mg dry weight / kg body weight of the subject.
  • a method for use in reducing the risk of and/or aid in treatment of a parasitic infection and/or viral infection in a subject comprising administering to the subject the composition according to any one of claims 1 to 12 a daily dose in the range from 25 to 500 mg dry weight / kg body weight of the subject.
  • a composition comprising one or more C1-C12 organic acid and/or its salt, an iron component, and B -vitamins for use in reducing the risk of and/or treatment of a parasitic infection and/or viral infection in a subject, wherein the B-vitamins is in an amount of 0-200 mg/g dry weight of the composition and the amount of B-vitamins corresponding to at least that which theoretically can be consumed during metabolism of the COOH-groups of the organic acid and wherein the organic acid is a carboxylic acid wherein the organic acid is a carboxylic acid with acidic properties according Bronsted definition of an acid which is a molecule that can donate a proton to another molecule .
  • composition does not comprise D/L-camitine.
  • D/L-camitine is derived from lysine and methionine and is involved in metabolism of fatty acids.
  • composition is administration by inhalation or intranasal application in the state of powder, suspension, gel- suspension, supplemented directly to food/feed or is swallowed as a tablet or capsule.
  • the present invention provides a composition comprising at least one C1-C12 organic acid and/or its salts in combination with an iron component, Ceylon cinnamon and B -vitamins and wherein the organic acid is a carboxylic acid with acidic properties.
  • Cl -Cl 2 organic acid refers to a fatty acid compound comprising from 1 carbon atom to 12 carbon atoms and having acidic properties.
  • Acidic property is defined herein as a molecule that can donate a proton to another molecule according to Bronsted definition of acids, Bronsted, J. N. (1923). " Bristol Bemerkache uber denWORK der Sauren und Basen” [Remarks on the concept of acids and bases]. Recueil des Travaux Chimiques des Pays-Bas. 42 (8): 718-728
  • the Cl -Cl 2 carboxylic acids are selected from short chained fatty acids (SCFA): formic acid (Cl), acetic acid (C2), Propionic acid (C3), Butyric acid (C4), Fumaric acid (C4); Medium-chained fatty acids (MCFA): Sorbic acid (C6), Caprylic acid (C8) and Long-chained fatty acids (LCFA): Lauric acid (Cl 2).
  • SCFA short chained fatty acids
  • Cl formic acid
  • C2 acetic acid
  • Propionic acid C3
  • Butyric acid C4
  • Fumaric acid C4
  • MFA Medium-chained fatty acids
  • MCFA Sorbic acid
  • Caprylic acid C8
  • LCFA Long-chained fatty acids
  • At least one of the carboxylic acids is formic acid and its salt.
  • Ceylon cinnamon as applied herein is bark from the Cinnamomum verum tree. Ceylon cinnamon from the Cinnamomum verum tree is often called true cinnamon and comprises lower amount of the toxin coumarin compared to Cassia cinnamon. The most produced cinnamon oil comes from Cassia cinnamon. Ceylon cinnamon is used herein.
  • Cinnamon oil can be made from either the bark or the leaves which will also give different ratios between the different essential oils. The composition of these two is very different in relation to the relationship between the different essential oils.
  • Cisa cinnamon contains approx. 250x more coumarin which in excessive doses can be toxic to the liver and kidneys. Too high doses of coumarin can also prevent Vitamin K synthesis in the gut and "Vitamin K bleeding deficiency" The toxic effects of Coumarin probably affect most people.
  • Cinnamon oil from leaves often contains a lot of eugenol and very little cinnamondehyde, while it is the other way around when using bark.
  • Cinnamon oil from leaves often contains a lot of eugenol and very little cinnamondehyde, while it is the other way around when using bark.
  • Cinnemaldehyde has health -promoting effects by reducing the activity of important enzymes that trigger inflammatory reactions and allergic reactions.
  • viruses that are highly dependent on the fecal- oral route include Hepatitis A, Hepatitis E, Norovirus, Corona viruses (especially feline and equine coronaviruses), Enterovirus, Poliovirus and Rotavirus.
  • Decrease infectivity is the reduction of a virus or parasites ability to infect a cell in a subject, i.e. increasing virus or parasitic resistance.
  • Some of the most common causes for protozoan parasitic diarrhoea in dogs and cats include coccidiosis and giardiasis.
  • Isospora and Cryptosporidium species are two of the most common causes of clinical manifestation of coccidiosis in dogs and cats.
  • Other species may include Besnoitia, Toxoplasma, Hammondia and Sarcocystis.
  • Coccidian parasites are known for their infectious oocysts with an obligate fecal-oral route of infection.
  • Giardia parasites are another protozoan parasite with similar presentation of symptoms, however their life cycle do not include an oocyst.
  • Wild and farmed fish are also sometimes infected with viruses and parasites that has a hard-shelled life cycle stage. Examples include many coccidian parasites like Calyptospora, Goussia, Eimeria, Epieimeria, Cryptosporidium, Crystallospora, and Octosporella(fungi).
  • coccidian parasites like Calyptospora, Goussia, Eimeria, Epieimeria, Cryptosporidium, Crystallospora, and Octosporella(fungi).
  • coccidiosis in farmed fish in Norway seems to be a problem rather in lumpfish than in other farmed fish like atlantic salmon and rainbow trout.
  • Atlantic salmon and rainbow trout (salmonids)
  • several viral diseases poses a threat to the industry.
  • Cardiomyopathy syndrome Pancreas disease, Infectious salmon anemia, infectious pancreatic necrosis, Heart and skeletal muscle inflammation, Viral hemorrhagic septicaemia, Infectious hematopoietic necrosis and Salmon gill pox virus.
  • protozoan diseases There are many different antiprotozoal agents commercially available. This is a class of pharmaceuticals used in the treatment of protozoan diseases. Some of the most important protozoan diseases include amebiasis, giardiasis, cryptosporidiosis, microsporidiosis, malaria, babesiosis, trypanosomiasis, Chagas disease, leishmaniasis and toxoplasmosis. Currently, many of the treatments for these infections are limited by their toxicity and present invention may aid in the treatment of these.
  • composition comprising as the basic component at least one Cl -Cl 2 organic acid and/or its salt, an iron component, Ceylon cinnamon and B-vitamins in 0-200mg/g dry matter and in amounts corresponding to at least that which theoretically can be consumed during metabolism of the COOH- groups present.
  • composition also contains a desiccant and an antioxidant.
  • composition may also be administered in a suspension with pH amounting to 2-7.5.
  • composition contains 66-100% of one or more C1-C8 organic acids and/or its salts.
  • the composition is characterized by an iron component consisting of 0-3.5% (w/w) iron, and the component preferably used is ferrous fumarate.
  • the composition may also contain B-vitamins in amounts of 0- 200mg/g dry matter, wherein 0-10 mg/g Bl, 0-25mg/g B2, 0-40mg/g B3, 0-25mg/g B5, 0-60mg/g B6, 0-25mg/g B7, 0-60mg/g B9 and 0-250pg/g B12.
  • composition is characterized by 0-6% cinnamon, preferably from the plant Cinnamomum vera.
  • composition is characterized by 0-6% (w/w) desiccant, preferably Silicone dioxide and/or Magnesium oxide.
  • composition is characterized by 0-1% (w/w) antioxidant, preferably Vitamin C or Vitamin E.
  • composition is used to treat or to aid in treatment against infection by parasites that contain hard-shelled life cycle stages like cysts and oocysts.
  • composition is used to treat or aid in treatment against infection by viruses with an affinity towards gastrointestinal system and respiratory system like rotaviruses, adenoviruses, coronaviruses, etc.
  • composition is administrated by a daily dosage which may be applied, is in the range 25-500mg/kg bodyweight (0.5-10g per 20kg body weight).
  • composition is administration by inhalation or intranasal application in the state of powder, suspension, gel-suspension, supplemented directly to food/feed or is swallowed as a tablet or capsule.
  • the main feature of the composition according to the invention comprises a basic component having at least one C1-C8 organic acid and/or its salt comprising at least formic acid, an iron component preferably iron fumarate, Ceylon cinnamon, and B6, B9 and B12-vitamins in the range from 10-50mg/g dry matter and in an amount corresponding to at least that which theoretically can be consumed during metabolism of the COOH -groups present and wherein the organic acid is a carboxylic acid having acidic properties and wherein the carboxylic acids are fatty acids and wherein the total amount of organic acids is at least 66% (w/w) by dry weight of the composition.
  • the composition in addition may comprise antioxidants and desiccants and further components depending on its intended use wherein these further components don’t change the effect of the composition.
  • Mortality in fish may be caused by several factors including viruses and parasites as discussed above.
  • a study conducted on 600 Atlantic salmon showed a 5% reduction in mortality rate.
  • the study design was constructed as follows:
  • Feed A Control carrier pellet with no additives
  • Feed B Carrier pellet with 1.5% of present invention.
  • the fish were 40 grams and adapted to sea water at starting point.
  • Results showed a 5% reduction in mortality rate after 9 and 10 weeks. Growth and length was significantly improved within the first 5 weeks along with hepatic weight and intestinal tissue damage significantly reduced as well.
  • a study investigating the effects of present invention on gastric ulcers of the squamous mucosa in trotting racehorses went public.
  • the study was performed as a randomized, double-blinded, single center study with stratified semi crossover design with breed as stratification factors.
  • the horses were clinically and endoscopically examined prior to start and after 3 and 5 or 7 weeks of treatment.
  • the ulcerations were scored in accordance with Equine Gastric Ulcer Council (EGUC) recommendations on a 5 point scale and on a 10 cm Visual Analogue Scale (VAS).
  • the patients were responder-classified after 3 weeks. Responders in need of ulcer treatment were randomly allocated to 2 or 4 weeks of additional treatment. Non-responders to placebo were crossed to present invention.
  • the present invention contains salts of organic acids with established antibacterial effects, however results may suggest an even wider efficiency across viruses and parasites. Especially those involved in gastrointestinal illness.
  • a laboratory study was conducted to test the effect of powder from cinnamon bark from Ceylon cinnamon on the infectivity of a virus (Experiment A and B) and to test the effect on the infectivity of a virus, using a combination of the following organic acids: Sodium format, Calcium format, iron fumarate and potassium sorbate (experiment C and D).
  • the virus used for the experiments was Bovine Coronavirus (BCoV).
  • BCoV Bovine Coronavirus
  • the infectivity of the virus was tested with the use of human colorectal adenocarcinoma cells (HCT-8) and the infectivity of the virus was evaluated using microscope.

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Abstract

The present invention relates to a combination of different components and its use, where the invention comprises as the basic component at least one organic acid and/or its salt, an iron component, Ceylon cinnamon and B-vitamins. The combination may also contain a desiccant and an antioxidant. The invention will have a pH in the range of 2.0-7.5 when dissolved into a solution and is intended for all animals including primates. The present invention can be used in animal feed production, but can also be administered through other applications or as is. The daily dosage which may be applied, is in the range 25-500mg/kg body weight (0.5- 10g per 20kg body weight).

Description

Title: composition for treatment of parasitic or viral infection in alimentary and/or respiratory tract
FIELD OF THE INVENTION
The present invention relates to compositions comprising at least one Cl - C12 organic acid and Ceylon cinnamon and its use wherein the organic acid is a carboxylic acid with acidic properties.
INTRODUCTION
Organic acids are widely used for different purposes in different combinations all over the world. It’s used as a disinfectant, as a food/feed preservation technique, as a growth promoter in production animals and many more. Organic acids have been successfully used as a growth promoter in pigs for more than 25 years and they have also been found to be effective in poultry production. From the use of organic acids in poultry and pigs, one can expect an improvement in performance similar to or better than that of antibiotic growth promoters, without the public health concern.
It has been observed that animals exposed to severe stress or when high performance is demanded, suffer from fatigue, diarrhea, resistance to feed intake, anemia, etc. when they only are fed standard feed. However, it is usually difficult to define what the causes for the observed problems are, and thus which additive to use. There are known numerous additives and feed supplements, but none have proved to solve all the above problems. Some additives are primarily intended for increased growth of the animal, while others claim to improve its health. Vitamin deficiencies might be part of the problem, but then one should understand why this occur even when feed is expected to contain sufficient amounts of vitamins.
Another aspect of observation in relation to present invention is the direct effect indicated on bacteria, virus and parasites. Especially in low -pH environments like stomach and abomasum(ruminants). The effects of organic acids on bacteria are known and the mechanism is assumed to relate to the non-dissociated organic acids.
Less is known about the direct effects of organic acids on viruses and parasites.
The present invention aims to solve one of the aforementioned problems and provides a composition comprising at least one Cl -Cl 2 organic acid and/or its salts in combination with an iron component , Ceylon cinnamon and B -vitamins and wherein the organic acid is a carboxylic acid with acidic properties. SUMMARY OF THE INVENTION
The present inventors have solved the above-mentioned need by providing in a first aspect a composition comprising at least one C1-C12 organic acid and/or its salt, an iron component, Ceylon cinnamon and B -vitamins in an amount from 0 to 200 mg/g dry matter of the composition and in amounts corresponding to at least that which theoretically can be consumed during metabolism of the COOH-groups present wherein the organic acid is a carboxylic acid with acidic properties according Bronsted definition of an acid which is a molecule that can donate a proton to another molecule. The composition does not comprise L-camitine.
In one embodiment according to the first aspect the organic acid is a C1-C8 and/or its salts wherein the total amount of the organic acids is in the range from 66 % (w/w) to 100% (w/w) by dry weight of the composition.
In one embodiment according to the first aspect the organic acid is a C1-C8 and/or its salts wherein the total amount of the organic acids is in the range from 66 % (w/w) to 99% (w/w) by dry weight of the composition, such as from 60% (w/w) to 95% (w/w), such as from 75% (w/w) to 85% (w/w).
In one embodiment according to the first aspect the organic acid is a fatty acid.
In one embodiment according to the first aspect the organic acid is a Cl -Cl 2 fatty acid selected from short chain fatty acids, medium chain fatty acids and long chain fatty acids.
In one embodiment according to the first aspect the organic acid is a C1-C8 fatty acid.
Preferably the fatty acids are selected from short chained fatty acids (SCFA): formic acid (Cl), acetic acid (C2), Propionic acid (C3), Butyric acid (C4), Fumaric acid (C4); Medium- chained fatty acids (MCFA): Sorbic acid (C6), Caprylic acid (C8) and Long-chained fatty acids (LCFA): Lauric acid (Cl 2).
In one embodiment according to the first aspect the at least one organic acid is formic acid and its salt.
In one embodiment according to the first aspect the iron component is in an amount of 0 to 3.5% (w/w) by dry weight of the composition and the iron compound is preferably ferrous fumarate,
In one preferred embodiment the iron component is in an amount of 0.5 to 3.5% (w/w) by dry weight of the composition. In a most preferred embodiment, the iron component is in an amount of 0.5 to 3.5% (w/w) by dry weight of the composition and the iron compound is ferrous fumarate.
In one embodiment according to the first aspect the composition of B-vitamins comprises 0-10 mg/g Bl, 0-25mg/g B2, 0-40 mg/g B3, 0-25 mg/g B5, 0-60 mg/g B6, 0-25 mg/g B7, 0-60 mg/g B9 and 0-250 pg/g B12 based on dry weight of the composition.
In one embodiment according to the first aspect the composition of B-vitamins comprises 2-10 mg/g Bl, 5-25mg/g B2, 10-25 mg/g B6, 0-25 mg/g B7, 0.1-60 mg/g B9 and 1-250 pg/g B12 based on dry weight of the composition.
In one embodiment according to the first aspect the composition of B-vitamins comprises 0.5-10 mg/g Bl, 0.5-25mg/g B2, B6 0.5-25 mg/g, 0-25 mg/g B7, 0.1-60 mg/g B9 and 10-250 pg/g B12 based on dry weight of the composition.
The amount of vitamins, B6, B9 and B12 is in the range from 10-50mg/g dry weight of the composition and the amount of B9 and B12 should at least correspond to that which can be consumed during metabolism of the COOH-group of the carboxylic acids in particular in combination with formic acid and is salt.
In one embodiment according to the first aspect the Ceylon cinnamon is bark from Cinnamomum verum and is in an amount from 0.1 to 6% (w/w) by dry weight of the composition, preferably in an amount from 0.5 to 6% (w/w) by dry weight of the composition.
In one embodiment according to the first aspect the composition comprises the composition further comprises a desiccant in an amount of 0-6% (w/w) by dry weight of the composition, wherein the desiccant is selected from Silicone dioxide, Magnesium oxide or any combinations thereof.
In one embodiment according to the first aspect the composition comprises an antioxidant in an amount of 0-1% (w/w) by dry weight of the composition, wherein the antioxidant is preferably selected from Vitamin C, Vitamin E or any combinations thereof.
In one embodiment according to the first aspect the amount of salt and carboxylic acids will give a pH amounting to 2.0 to 7.5 when the composition is in form of a suspension.
In one embodiment according to the first aspect the amount of salt and carboxylic acids will give a pH amounting to 2.0 to 7.5 when the composition is dissolved in water. In one embodiment according to the first aspect the amount of salt and carboxylic acids will give a pH amounting to 2.0 to 6.0 when the composition is in form of a suspension.
In one embodiment according to the first aspect the amount of salt and carboxylic acids will give a pH amounting to 2.0 to 6.0 when the composition is dissolved in water.
In one embodiment according to the first aspect the composition is a dietary supplement.
In one embodiment according to the first aspect the composition is a pharmaceutical composition.
In one embodiment according to the first aspect the composition is administrated in the state of powder, suspension, gel-suspension, supplemented directly to food or feed or is swallowed as a tablet or capsule.
In one embodiment according to the first aspect the composition is for use in decreasing infectivity of a virus and/or a parasite in a subject.
In one embodiment according to the first aspect the composition is for use in increasing virus and/or parasite resistance in a subject.
In one embodiment according to the first aspect the composition is for use in reducing the risk of and/or aid in treatment of a parasitic infection and/or viral infection in a subject.
In one embodiment the parasite is caused by a parasite with a hard-shelled life cycle stage where it forms a cyst and/or oocyst.
In one embodiment the parasite and/or the virus is comprised in the gastrointestinal system such as the alimentary tract and/or respiratory system of the subject.
In one embodiment the virus is selected from rotaviruses, adenoviruses, coronaviruses, Hepatitis A, Hepatitis E, Norovirus, Enterovirus and Poliovirus.
In one embodiment the parasite is selected from coccidiosis and giardiasis.
In one embodiment the subject is an animal, a fish or a human.
In one embodiment the animal is selected from a ruminant, a horse, a race pigeon, a dog and a cat.
In one embodiment the daily dose is in the range 25-500 mg dry weight / kg body weight or 0.5- 10g per 20kg body weight In one embodiment the daily dose is about 1 g per 20kg body weight for use in reducing the risk of a parasitic infection and/or viral infection in a subject. In one embodiment the daily dose is 2g- 10g per 20kg body weight for use in treatment of or aid in treatment of a parasitic infection and/or viral infection in a subject.
In a second aspect there is provided a method decreasing infectivity of a virus and/or a parasite in a subject, comprising administering to the subject the composition according to any one of claims 1 to 12 a daily dose in the range from 25 to 500 mg dry weight / kg body weight of the subject.
In a third aspect there is provided a method for use in reducing the risk of and/or aid in treatment of a parasitic infection and/or viral infection in a subject comprising administering to the subject the composition according to any one of claims 1 to 12 a daily dose in the range from 25 to 500 mg dry weight / kg body weight of the subject.
In a fourth aspect there is provided a composition comprising one or more C1-C12 organic acid and/or its salt, an iron component, and B -vitamins for use in reducing the risk of and/or treatment of a parasitic infection and/or viral infection in a subject, wherein the B-vitamins is in an amount of 0-200 mg/g dry weight of the composition and the amount of B-vitamins corresponding to at least that which theoretically can be consumed during metabolism of the COOH-groups of the organic acid and wherein the organic acid is a carboxylic acid wherein the organic acid is a carboxylic acid with acidic properties according Bronsted definition of an acid which is a molecule that can donate a proton to another molecule .
The composition does not comprise D/L-camitine. D/L-camitine is derived from lysine and methionine and is involved in metabolism of fatty acids.
In one embodiment according to the fourth aspect the composition is administration by inhalation or intranasal application in the state of powder, suspension, gel- suspension, supplemented directly to food/feed or is swallowed as a tablet or capsule.
DETAILED DESCRIPTION
Where a numerical limit or range is stated herein, the endpoints are included. Also, all values and sub ranges within a numerical limit or range are specifically included as if explicitly written out. All methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, with suitable methods and materials being described herein. All publications, patent applications, patents, and other references mentioned herein are incorporated by reference in their entirety. In case of conflict, the present specification, including definitions, will prevail.
In the following description, various examples and embodiments of the invention are set forth in order to provide the skilled person with a more thorough understanding of the invention. The specific details described in the context of the various embodiments and with reference to the attached drawings are not intended to be construed as limitations.
As mentioning above, the present invention provides a composition comprising at least one C1-C12 organic acid and/or its salts in combination with an iron component, Ceylon cinnamon and B -vitamins and wherein the organic acid is a carboxylic acid with acidic properties. The term Cl -Cl 2 organic acid as used herein refers to a fatty acid compound comprising from 1 carbon atom to 12 carbon atoms and having acidic properties. Acidic property is defined herein as a molecule that can donate a proton to another molecule according to Bronsted definition of acids, Bronsted, J. N. (1923). "Einige Bemerkungen uber den Begriff der Sauren und Basen" [Remarks on the concept of acids and bases]. Recueil des Travaux Chimiques des Pays-Bas. 42 (8): 718-728
Preferably the Cl -Cl 2 carboxylic acids are selected from short chained fatty acids (SCFA): formic acid (Cl), acetic acid (C2), Propionic acid (C3), Butyric acid (C4), Fumaric acid (C4); Medium-chained fatty acids (MCFA): Sorbic acid (C6), Caprylic acid (C8) and Long-chained fatty acids (LCFA): Lauric acid (Cl 2).
Most preferably at least one of the carboxylic acids is formic acid and its salt.
Ceylon cinnamon as applied herein is bark from the Cinnamomum verum tree. Ceylon cinnamon from the Cinnamomum verum tree is often called true cinnamon and comprises lower amount of the toxin coumarin compared to Cassia cinnamon. The most produced cinnamon oil comes from Cassia cinnamon. Ceylon cinnamon is used herein.
Cinnamon oil can be made from either the bark or the leaves which will also give different ratios between the different essential oils. The composition of these two is very different in relation to the relationship between the different essential oils.
Cassia cinnamon contains approx. 250x more coumarin which in excessive doses can be toxic to the liver and kidneys. Too high doses of coumarin can also prevent Vitamin K synthesis in the gut and "Vitamin K bleeding deficiency" The toxic effects of Coumarin probably affect most people.
There is a big difference in the ratio of essential oils between cinnamon bark and cinnamon leaves. Cinnamon oil from leaves often contains a lot of eugenol and very little cinnamondehyde, while it is the other way around when using bark. We specify that we use the bark. Cinnemaldehyde has health -promoting effects by reducing the activity of important enzymes that trigger inflammatory reactions and allergic reactions.
The applicant and owners listed in this document is also the owner of European patent no. EP 1 691 626 Bl which is fully disclosed herein.
While the effects of organic acids on different pathogenic bacteria are widely described, less is known about their effects on viruses and parasites, especially in antiseptic use-cases. The infection route of many viruses does not involve fecal-oral route
However, for some viruses the fecal-oral rout seem to be more important than for others. Examples of viruses that are highly dependent on the fecal- oral route include Hepatitis A, Hepatitis E, Norovirus, Corona viruses (especially feline and equine coronaviruses), Enterovirus, Poliovirus and Rotavirus.
In viruses that depends largely on the fecal -oral route, recent findings may suggest that present invention decrease infectivity and aid in treatment and preventive treatment of infection.
Decrease infectivity as used herein is the reduction of a virus or parasites ability to infect a cell in a subject, i.e. increasing virus or parasitic resistance.
The effects of organic acids on different pathogenic parasites also seems to be lacking knowledge.
Some of the most common causes for protozoan parasitic diarrhoea in dogs and cats include coccidiosis and giardiasis. Among the coccidian parasites, Isospora and Cryptosporidium species are two of the most common causes of clinical manifestation of coccidiosis in dogs and cats. Other species may include Besnoitia, Toxoplasma, Hammondia and Sarcocystis. Coccidian parasites are known for their infectious oocysts with an obligate fecal-oral route of infection. Giardia parasites are another protozoan parasite with similar presentation of symptoms, however their life cycle do not include an oocyst. Their infectious stage is presented with cysts shed in the feces of its host with an obligate fecal -oral route. Cysts and oocysts share many common properties including the hard-shelled structure that envelopes them. This makes them both highly resistant to chemical interference and environmental factors. Recent findings may suggest that present invention may treat or aid in the treatment of these.
Wild and farmed fish are also sometimes infected with viruses and parasites that has a hard-shelled life cycle stage. Examples include many coccidian parasites like Calyptospora, Goussia, Eimeria, Epieimeria, Cryptosporidium, Crystallospora, and Octosporella(fungi). However, coccidiosis in farmed fish in Norway seems to be a problem rather in lumpfish than in other farmed fish like atlantic salmon and rainbow trout. In Atlantic salmon and rainbow trout (salmonids), several viral diseases poses a threat to the industry. Examples include Cardiomyopathy syndrome, Pancreas disease, Infectious salmon anemia, infectious pancreatic necrosis, Heart and skeletal muscle inflammation, Viral hemorrhagic septicaemia, Infectious hematopoietic necrosis and Salmon gill pox virus.
There are many different antiprotozoal agents commercially available. This is a class of pharmaceuticals used in the treatment of protozoan diseases. Some of the most important protozoan diseases include amebiasis, giardiasis, cryptosporidiosis, microsporidiosis, malaria, babesiosis, trypanosomiasis, Chagas disease, leishmaniasis and toxoplasmosis. Currently, many of the treatments for these infections are limited by their toxicity and present invention may aid in the treatment of these.
Further details of the invention:
In one aspect it is described herein a combination of different components and its use against oocysts, cysts and other hard-shelled parasitic life cycle stages, and its use against coronaviruses, rotaviruses and other viruses with affinity towards alimentary tract and respiratory tract.
In a further aspect it is described a composition comprising as the basic component at least one Cl -Cl 2 organic acid and/or its salt, an iron component, Ceylon cinnamon and B-vitamins in 0-200mg/g dry matter and in amounts corresponding to at least that which theoretically can be consumed during metabolism of the COOH- groups present.
In a further aspect the composition also contains a desiccant and an antioxidant.
In a further aspect the composition may also be administered in a suspension with pH amounting to 2-7.5.
In a further aspect the composition contains 66-100% of one or more C1-C8 organic acids and/or its salts.
In a further aspect the composition is characterized by an iron component consisting of 0-3.5% (w/w) iron, and the component preferably used is ferrous fumarate. In a further aspect the composition may also contain B-vitamins in amounts of 0- 200mg/g dry matter, wherein 0-10 mg/g Bl, 0-25mg/g B2, 0-40mg/g B3, 0-25mg/g B5, 0-60mg/g B6, 0-25mg/g B7, 0-60mg/g B9 and 0-250pg/g B12.
In a further aspect the composition is characterized by 0-6% cinnamon, preferably from the plant Cinnamomum vera.
In a further aspect the composition is characterized by 0-6% (w/w) desiccant, preferably Silicone dioxide and/or Magnesium oxide.
In a further aspect the composition is characterized by 0-1% (w/w) antioxidant, preferably Vitamin C or Vitamin E.
In a further aspect the composition is used to treat or to aid in treatment against infection by parasites that contain hard-shelled life cycle stages like cysts and oocysts.
In a further aspect the composition is used to treat or aid in treatment against infection by viruses with an affinity towards gastrointestinal system and respiratory system like rotaviruses, adenoviruses, coronaviruses, etc.
In a further aspect the composition is administrated by a daily dosage which may be applied, is in the range 25-500mg/kg bodyweight (0.5-10g per 20kg body weight).
In a further aspect the composition is administration by inhalation or intranasal application in the state of powder, suspension, gel-suspension, supplemented directly to food/feed or is swallowed as a tablet or capsule.
Having generally described this invention, a further understanding can be obtained by reference to certain specific examples. The examples illustrate the properties and effects of the composition according to the invention, and are provided herein for purposes of illustration only, and are not intended to be limiting.
The skilled person will understand that the main feature of the composition according to the invention comprises a basic component having at least one C1-C8 organic acid and/or its salt comprising at least formic acid, an iron component preferably iron fumarate, Ceylon cinnamon, and B6, B9 and B12-vitamins in the range from 10-50mg/g dry matter and in an amount corresponding to at least that which theoretically can be consumed during metabolism of the COOH -groups present and wherein the organic acid is a carboxylic acid having acidic properties and wherein the carboxylic acids are fatty acids and wherein the total amount of organic acids is at least 66% (w/w) by dry weight of the composition. The skilled person will further understand that the composition in addition may comprise antioxidants and desiccants and further components depending on its intended use wherein these further components don’t change the effect of the composition.
EXAMPLES
Example 1
Mortality in fish may be caused by several factors including viruses and parasites as discussed above. A study conducted on 600 Atlantic salmon showed a 5% reduction in mortality rate. The study design was constructed as follows:
Feed A: Control carrier pellet with no additives
Feed B: Carrier pellet with 1.5% of present invention.
The fish were 40 grams and adapted to sea water at starting point.
Feeds were tested on four parallel tanks (total 12 tanks) with 50 fish in each tank (total 600 fish).
Results showed a 5% reduction in mortality rate after 9 and 10 weeks. Growth and length was significantly improved within the first 5 weeks along with hepatic weight and intestinal tissue damage significantly reduced as well.
Example 2
A study investigating the effects of present invention on gastric ulcers of the squamous mucosa in trotting racehorses went public. The study was performed as a randomized, double-blinded, single center study with stratified semi crossover design with breed as stratification factors. The horses were clinically and endoscopically examined prior to start and after 3 and 5 or 7 weeks of treatment. The ulcerations were scored in accordance with Equine Gastric Ulcer Council (EGUC) recommendations on a 5 point scale and on a 10 cm Visual Analogue Scale (VAS). The patients were responder-classified after 3 weeks. Responders in need of ulcer treatment were randomly allocated to 2 or 4 weeks of additional treatment. Non-responders to placebo were crossed to present invention. The 5 -point EGUC score and VAS recorded score was significantly reduced (P < 0.01) in both placebo and present invention groups after 3 weeks of treatment. From 3 weeks to the end of treatment the score was further significantly reduced in the group with present invention(P < 0.05). After the end of treatment, 78% in the group with present invention and 54.8% in the placebo group were classified as responders. The difference was significant (P = 0.04). There are several factors that may contribute to the manifestation of Equine gastric ulcer syndrome, but increased stress from gastrointestinal illness caused by viruses, parasites and bacteria are among them.
Example 3
Feedback from hundreds to thousands of customer clients who has purchased and used the present invention indicate that increased health, especially gastrointestinal health and symptoms of diarrhea is has been tested in indicative studies. The present invention contains salts of organic acids with established antibacterial effects, however results may suggest an even wider efficiency across viruses and parasites. Especially those involved in gastrointestinal illness.
Feedback from present invention against unstable stomach function in dogs: 91.6% were free from symptoms after 2-3 days.
Indicative study with present invention against unstable stomach function in horses: 100 %
Feedback after administering in calves was overwhelmingly positive as well. Customer satisfaction rate is estimated to 100% and included cases like
“1 month old calf with diarrhea was given present invention mixed with milk and was free from symptoms the next day.“
“A calf with bloody diarrhea was given two meals supplemented with present invention and was immediately free from symptoms.”
“A newborn calf with diarrhea and decreased appetite was given present invention and was completely healthy after two days.”
Example 4
A field study on calves was conducted. A group of 39 calves equally divided by random into 7 groups where 3 of these groups were given present invention and 4 of these groups were control groups. The results from this study showed that none of the calves fed with present invention developed diarrhea, 50% of the calves in the control group developed diarrhea, but were free from diarrhea within 3 days after being fed with present invention. The cause of diarrhea in these calves was unknown. Example 5
Present invention was tested on a livestock farm that had previously been diagnosed with a rich establishment of Cryptosporidium pathogens. The calves in the barn recently started to show the same symptoms as before and the time of year also corresponded with cryptosporidium. It was regarded likely that Cryptosporidium was the cause of symptoms yet again. The first calf displaying symptoms of Cryptosporidium was treated with antibiotics, B -vitamins and present invention. Previous experience with this treatment method excluding present invention was rather bad, so usually supportive treatments like fluid pre- and probiotics and pH- regulators were tried first. The veterinarian expressed that the first calf displaying symptoms was free from symptoms unusually fast when treated with present invention and that the effect was not expected to be as fast and sufficient. The calves that previously shared pen with the sick calf also started to display symptoms of Cryptosporidium. These were treated with present invention without antibiotics or additional B -vitamins. They were free from symptoms shortly after treatment.
Example 6
A laboratory study was conducted where present invention was tested on a parasite and a virus. The parasite chosen was Cryptosporidium (Crypto) and the virus was Bovine Coronavirus (BCoV). These pathogens were tested with the use of human colorectal adenocarcinoma cells (HCT-8).
Results from BCoV:
Virus incubated 1 hour with present invention prior to transferring to HCT-8 cells
Figure imgf000013_0001
Results from Cryptosporidium:
In this setup, oocysts of Cryptosporidium were treated with our invention at pH 3 and 7.
Figure imgf000014_0001
In the first two rows, we see no effect of the low pH as such, but in the last two rows, we see the effect when the present invention was added at similar pH levels.
The results from this setup shows how present invention is especially effective in low pH environment like stomach or abomasum or when present invention itself has a low pH.
Example 7
A laboratory study was conducted to test the effect of powder from cinnamon bark from Ceylon cinnamon on the infectivity of a virus (Experiment A and B) and to test the effect on the infectivity of a virus, using a combination of the following organic acids: Sodium format, Calcium format, iron fumarate and potassium sorbate (experiment C and D). The virus used for the experiments was Bovine Coronavirus (BCoV). The infectivity of the virus was tested with the use of human colorectal adenocarcinoma cells (HCT-8) and the infectivity of the virus was evaluated using microscope.
Experiment A
Cinnamon, pH 7 % Infectivity virus 3,75 mg/ml 42 0 mg/ml 100
Experiment B
Cinnamon, pH3 % Infectivity virus 3,75 mg/ml 1 0 mg/ml 100
Experiment C
Salts, pH7 % Infectivity virus 3,75 mg/ml 88 9,4 mg/ml 54 0 mg/ml 100
Experiment D Salts, pH3 % Infectivity virus 3,75 mg/ml 10 9,4 mg/ml 16
0 mg/ml 100

Claims

1. A composition comprising at least one Cl -Cl 2 organic acid and/or its salt, an iron component, Ceylon cinnamon and B -vitamins in an amount from 0 to 200mg/g dry matter of the composition and in amounts corresponding to at least that which theoretically can be consumed during metabolism of the COOH -groups present wherein the organic acid is a carboxylic acid with acidic properties according Bronsted definition of an acid which is a molecule that can donate a proton to another molecule .
2. The composition according to claim 1, wherein the organic acid is a C1-C8 and/or its salts in an amount of 66 % (w/w) to 100% (w/w) by dry weight of the composition.
3. The composition according to claim 1 or claim 2, wherein the organic acid is a fatty acid.
4. The composition for use according to claim 1 or claim 2, wherein the iron component is in an amount of 0 to 3.5% (w/w) by dry weight of the composition and the iron compound is preferably ferrous fumarate.
5. The composition according to any one of claims 1 to 3, wherein the composition comprises 0-10 mg/g Bl, 0-25mg/g B2, 0-40 mg/g B3, 0-25 mg/g B5, 0-60 mg/g B6, 0-25 mg/g B7, 0-60 mg/g B9 and 0-250 pg/g B12 based on dry weight of the composition.
6. The composition according to any one of claims 1 to 4, wherein the Ceylon cinnamon is bark from Cinnamomum verum and is in an amount from 0.001 to 6% (w/w) by dry weight of the composition, preferably in an amount from 0.5 to 6% (w/w) by dry weight of the composition, and more preferably in an amount from 1 to 6% (w/w) by dry weight of the composition.
7. The composition according to any one of claims 1 to 5, wherein the composition comprises a desiccant in an amount of 0-6% (w/w) by dry weight of the composition, wherein the desiccant is selected from Silicone dioxide, Magnesium oxide or any combinations thereof.
8. The composition according to any one of claims 1 to 6, characterized in that the composition comprises an antioxidant in an amount of 0-1% (w/w) by dry weight of the composition , wherein the antioxidant is preferably selected from Vitamin C, Vitamin E or any combinations thereof.
9. The composition according to any one of claims 1 to 7, wherein the amount of salt and carboxylic acids will give a pH amounting to 2.0 to 7.5 when the composition is in form of a suspension.
10. The composition according to any one of claims 1 to 8, wherein the composition is a dietary supplement.
11. The composition according to any one of claims 1 to 8, wherein the composition is a pharmaceutical composition.
12. The composition according to any one of claims 1 to 11, wherein the composition is administrated in the state of powder, suspension, gel-suspension, supplemented directly to food or feed or is swallowed as a tablet or capsule.
13. The composition according to any one of claims 1 to 12 for use in decreasing infectivity of a virus and/or a parasite in a subject.
14. The composition according to any one of claims 1 to 12 for use in increasing virus and/or parasite resistance in a subject.
15. The composition according to any one of claims 1 to 12 for use in reducing the risk of and/or aid in treatment of a parasitic infection and/or viral infection in a subject.
16. The composition for use according to any one of claims 13 to 15, wherein the parasite is caused by a parasite with a hard-shelled life cycle stage where it forms a cyst and/or oocyst.
17. The composition for use according to any one of claims claim 13 to 16 wherein the parasite and the virus is comprised in the gastrointestinal system such as the alimentary tract and/or respiratory system of the subject.
18. The composition for use according to any one of claims 13 to 15 and 17, wherein the virus is selected from rotaviruses, adenoviruses, coronaviruses, Hepatitis A, Hepatitis E, Norovirus, Enterovirus and Poliovirus.
19. The composition for use according to any one of claims 13 to 16 and 17, wherein the parasite is selected from coccidiosis and giardiasis.
20. The composition for use according to any one of claims 13 to 15 and 17 wherein the subject is an animal, a fish or a human.
21. The composition for use according to claim 20, wherein the animal is selected from a ruminant, a horse, a race pigeon, a dog and a cat.
22. The composition for use according to claims 13 to 20, wherein the daily dose is in the range from 25 to 500 mg dry weight / kg body weight.
22. A method decreasing infectivity of a virus and/or a parasite in a subject, comprising administering to the subject the composition according to any one of claims 1 to 12 a daily dose in the range from 25 to 500 mg dry weight / kg body weight of the subject.
23. A method for use in reducing the risk of and/or aid in treatment of a parasitic infection and/or viral infection in a subject comprising administering to the subject the composition according to any one of claims 1 to 12 a daily dose in the range from 25 to 500 mg dry weight / kg body weight of the subject.
24 A composition comprising one or more C1-C12 organic acid and/or its salt, an iron component, and B-vitamins for use in reducing the risk of and/or treatment of a parasitic infection and/or viral infection in a subject, wherein the B-vitamins is in an amount of 0-200 mg/g dry weight of the composition and the amount of B- vitamins corresponding to at least that which theoretically can be consumed during metabolism of the COOH-groups of the organic acid and wherein the organic acid is a carboxylic acid wherein the organic acid is a carboxylic acid with acidic properties according Bronsted definition of an acid which is a molecule that can donate a proton to another molecule.
25. The composition for use according to any one of claims 24, wherein the composition is administration by inhalation or intranasal application in the state of powder, suspension, gel-suspension, supplemented directly to food/feed or is swallowed as a tablet or capsule.
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EP1691626B1 (en) 2003-12-05 2009-02-25 Vitality Innovation AS Food and feed supplement and its use
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