US20150320087A1 - Trace Element Solution - Google Patents

Trace Element Solution Download PDF

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Publication number
US20150320087A1
US20150320087A1 US14/400,902 US201214400902A US2015320087A1 US 20150320087 A1 US20150320087 A1 US 20150320087A1 US 201214400902 A US201214400902 A US 201214400902A US 2015320087 A1 US2015320087 A1 US 2015320087A1
Authority
US
United States
Prior art keywords
solution
vitamin
zinc
manganese
trace element
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.)
Abandoned
Application number
US14/400,902
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English (en)
Inventor
William Alfred Smith
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.)
Warburton Technology Ltd
US Bank Trust Co NA
Original Assignee
Warburton Technology Ltd
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 Warburton Technology Ltd filed Critical Warburton Technology Ltd
Assigned to WARBURTON TECHNOLOGY LIMITED reassignment WARBURTON TECHNOLOGY LIMITED ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: SMITH, WILLIAM ALFRED
Publication of US20150320087A1 publication Critical patent/US20150320087A1/en
Assigned to U.S. BANK NATIONAL ASSOCIATION reassignment U.S. BANK NATIONAL ASSOCIATION SECURITY INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: WARBURTON TECHNOLOGY LIMITED
Assigned to U.S. BANK TRUST COMPANY, NATIONAL ASSOCIATION reassignment U.S. BANK TRUST COMPANY, NATIONAL ASSOCIATION ASSIGNMENT AND ASSUMPTION AGREEMENT Assignors: U.S. BANK NATIONAL ASSOCIATION
Abandoned legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/24—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
    • A23K1/1753—
    • A23K1/1603—
    • A23K1/175—
    • A23K1/1813—
    • 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
    • A23K20/30—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
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7135—Compounds containing heavy metals
    • A61K31/714—Cobalamins, e.g. cyanocobalamin, i.e. vitamin B12
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/04—Sulfur, selenium or tellurium; Compounds thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/18—Iodine; Compounds thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/24—Heavy metals; Compounds thereof
    • 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
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/24—Heavy metals; Compounds thereof
    • A61K33/32—Manganese; Compounds thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/24—Heavy metals; Compounds thereof
    • A61K33/34—Copper; Compounds thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner

Definitions

  • the present invention relates to a trace element solution.
  • the present invention relates to a trace element solution supplemented with Vitamin B12.
  • ZA 1982/6778 discloses a trace element solution and a method of providing the trace elements to livestock.
  • These trace element solutions include ethylene diamino tetra acetic acid complex of the required mineral in suitable quantities.
  • the trace element solution includes no selenium or selenite compound.
  • EDTA refers to ethylene diaminotetraacetic acid (C 10 H 16 O 8 N 2 or (HO 2 CH 2 C) 2 NCH 2 CH 2 N—(CH 2 CO 2 H) 2 ).
  • U.S. Pat. No. 4,335,116 (Howard) discloses mineral-containing therapeutic compositions containing EDTA complexes of trace elements.
  • U.S. Pat. No. 4,335,116 utilises tetra-sodium EDTA, a selenium glycine complex, and metal chlorides for the preparation of the EDTA complexes.
  • the chloride ions cause contamination and each complex solution is to be made individually.
  • overnight time is required for complexing and heating up afterward to speed up the process, requires extra apparatus.
  • mixtures are required, the individual solutions are to be blended.
  • various concentrations as well as compositions are to be made, it can only be done in a cumbersome way, requiring extra apparatus.
  • a further problem arises when mixtures of high concentration are needed. In certain cases it would be impossible to deliver them, because mixing is always accompanied by dilution.
  • the maximum concentration achieved with this method was 13.5 mg/ml.
  • U.S. Pat. No. 6,638,539 discloses a method of preparing a trace element solution, which includes the steps of providing at least one EDTA-complex, of providing a sodium selenite solution, and of combining the EDTA-complexes and the sodium selenite solution.
  • the method enables production of a trace element solution of only about 55 mg/ml.
  • U.S. Pat. No. 7,285,292 discloses a trace element solution, which comprises at least one metal selected from the group comprising selenium, copper, zinc, manganese and chromium and which comprises a concentration of the metal(s) of at least 60 mg/ml.
  • the solution further comprises at least one compound selected from the group comprising iodine, potassium iodide, sodium iodide, iron, iron chloride, zinc oxide, manganese sulphate, sodium selenite, copper carbonate, sodium carbonate, anhydrous disodium EDTA and sodium hydroxide.
  • the trace element solution is prepared by a method consisting essentially of the steps of preparing a MnCO 3 mixture in a container; adding an EDTA/NaOH mixture to the container and subsequently adding at least one metal compound; and adding Na 2 SeO 3 to the container to obtain the trace element solution.
  • the method also comprises the step of adding CrCl 3 .6H 2 O to the trace element solution.
  • a trace element solution comprises at least the following metals:
  • the ratio of zinc to manganese may be at least 2:1.
  • the ratio of zinc to manganese may be at least 4:1.
  • the ratio of zinc to copper may be at least 2:1 or 4:1.
  • the ratio of zinc to selenium may be at least 4:1 or 12:1.
  • the concentration of the metals may be at least 36 mg/ml.
  • the trace element solution may comprise the following concentrations:
  • the concentration of the metals may be at least 90 mg/ml.
  • the solution may comprise chromium and/or iodine.
  • the solution may comprise butaphosphan to stabilize the Vitamin B12.
  • butaphosphan may enable the Vitamin B12 to remain more stable.
  • butaphosphan may have synergistic activity with the minerals.
  • the solution may be an injectable trace element solution.
  • the solution may be visually stable.
  • the invention also extends to a method of preparing a trace element solution as described herein.
  • the example relates to a trace element solution predominantly to be used for cattle and includes the mineral elements zinc, manganese, selenium and copper and Vitamin B12.
  • a trace element solution comprises the following metals:
  • the ratio of zinc to manganese can be at least 2:1.
  • the ratio of zinc to manganese can be at least 4:1.
  • the ratio of zinc to copper can be at least 2:1 or 4:1.
  • the ratio of zinc to selenium can be at least 4:1 or 12:1.
  • the concentration of the metals is at least 36 mg/ml.
  • the trace element solution comprises the following concentrations:
  • the concentration of the metals can be at least 90 mg/ml.
  • the solution can comprise chromium and/or iodine.
  • the solution comprises butaphosphan to stabilize the Vitamin B12.
  • butaphosphan may have synergistic activity with the minerals
  • the solution is generally an injectable trace element solution.
  • the solution is visually stable.
  • the objective of the study is to develop a new formulation of an injectable trace element solution supplemented with Vitamin B12.
  • the formulation plan consisted of performing two consecutive phases with the aim to select at the end one of several formulation candidates.
  • salts of zinc, copper and manganese were dissolved in water and complexed with EDTA, and then salt of selenium is added.
  • Vitamin B12 is a water-soluble vitamin available as a dietary supplement. Vitamin B12 exists in several forms. Vitamin B12 cyanocobalamin is used for this study.
  • a vitamin B12 conforming to EP monograph was screened and received.
  • vitamins, and especially vitamin B12 are not very stable in solution and degradation is observed on storage.
  • Butaphosphan is a phosphonic derivative acid.
  • Butanol described in US2011/0065665A1 has been replaced by use of benzyl alcohol (1%).
  • butaphosphan is used with vitamin B12 in Catosal® formulation, from Bayer, and alone in Calphone® formulation, from Bayer.
  • Glycine is an aminoacid.
  • Biodyl® formula glycine (5.0 g), vitamin B12 (0.050 g), selenium (0.045 g)/100 ml Glycine has been tried during development: 0.01% to 1% w/v.
  • antioxidant Use of antioxidant is evaluated, with butylhydroxyanisole BHA and butylhydroxytoluene BHT.
  • Other antioxidants have used: propyl gallate, ascorbic acid, rongalite, sodium metabisulphate.
  • Manganese Manganese Carboante
  • Zinc Zinc Oxide
  • Copper Copper Sulphate Pentahydrate
  • Selenite Sodium Selenite Anhydrous
  • Butaphosphan 100.0 Vitamin B12 1.5
  • Manganese Manganese Carbonate
  • Zinc Zinc Oxide
  • Copper Copper Sulphate Pentahydrate
  • Selenite Sodium Selenite Anhydrous
  • Butaphosphan 100.0 Vitamin B12 1.5
  • the aim of this study was to screen the formulations stable under ambient and accelerated conditions.
  • a visual inspection will be checked at different periods in order to control the absence of precipitation in the formulations: at 5° C., 25° C./60% RH and 40° C./75% RH: T0, T1, T2 and T3 months.
  • Vitamin B12 Assays of Vitamin B12 were evaluated: follow up on stability at 25° C./60% RH and 40° C./75% RH: T0, T3 and T6 months.
  • the method of preparing a trace element solution in accordance with the invention thus enables the production of an injectable solution comprising an adequate trace mineral concentration and Vitamin B12 so that a 5 to 10 millilitre injection can make a significant impact on the trace mineral status of the animal and an injection is provided at a rate of between 1 ml per 50 kg bodyweight (BW) and 1 ml per 100 kg BW, i.e. a practically applicable injectable supplement and a product that can improve the trace mineral status of an animal is provided.
  • BW bodyweight
  • the subcutaneous injection is the preferred route to minimize tissue damage, but intra-muscular injection can also be used.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Inorganic Chemistry (AREA)
  • Polymers & Plastics (AREA)
  • Engineering & Computer Science (AREA)
  • Food Science & Technology (AREA)
  • Zoology (AREA)
  • Animal Husbandry (AREA)
  • Molecular Biology (AREA)
  • Dermatology (AREA)
  • Birds (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biophysics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Coloring Foods And Improving Nutritive Qualities (AREA)
  • Saccharide Compounds (AREA)
  • Investigating Or Analysing Materials By Optical Means (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
US14/400,902 2012-05-14 2012-05-14 Trace Element Solution Abandoned US20150320087A1 (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/IB2012/052389 WO2013171538A1 (en) 2012-05-14 2012-05-14 Trace element solution

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2012/052389 A-371-Of-International WO2013171538A1 (en) 2012-05-14 2012-05-14 Trace element solution

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US17/355,791 Continuation US20210315997A1 (en) 2012-05-14 2021-06-23 Trace element solution

Publications (1)

Publication Number Publication Date
US20150320087A1 true US20150320087A1 (en) 2015-11-12

Family

ID=49583206

Family Applications (2)

Application Number Title Priority Date Filing Date
US14/400,902 Abandoned US20150320087A1 (en) 2012-05-14 2012-05-14 Trace Element Solution
US17/355,791 Pending US20210315997A1 (en) 2012-05-14 2021-06-23 Trace element solution

Family Applications After (1)

Application Number Title Priority Date Filing Date
US17/355,791 Pending US20210315997A1 (en) 2012-05-14 2021-06-23 Trace element solution

Country Status (17)

Country Link
US (2) US20150320087A1 (pt)
EP (4) EP3566708B1 (pt)
AU (1) AU2012379964B2 (pt)
BR (1) BR112014027576B1 (pt)
CA (1) CA2871991C (pt)
DK (3) DK2849764T3 (pt)
ES (3) ES2742812T3 (pt)
FI (1) FI3915569T3 (pt)
HR (1) HRP20211302T1 (pt)
HU (2) HUE056783T2 (pt)
LT (2) LT3915569T (pt)
MX (1) MX360934B (pt)
PL (3) PL3915569T3 (pt)
PT (2) PT3566708T (pt)
SI (2) SI3566708T1 (pt)
WO (1) WO2013171538A1 (pt)
ZA (1) ZA201409093B (pt)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR102058133B1 (ko) 2019-02-22 2019-12-20 우진 비앤지 주식회사 혼합제제 내 항생제 용해도를 향상시킬 수 있는 면역 증강용 조성물 및 이의 용도
US10799531B2 (en) 2015-10-09 2020-10-13 Warburton Technology Limited Trace element solution

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2020312430B9 (en) * 2019-07-12 2022-02-17 Chemvet Australia Pty Ltd Injectable nutritional supplement

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008113483A2 (de) * 2007-03-16 2008-09-25 Bayer Animal Health Gmbh Stabilisierung von vitamin b12

Family Cites Families (16)

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US4335116A (en) 1980-10-07 1982-06-15 University Patents, Inc. Mineral-containing therapeutic compositions
ZA826778B (en) 1981-09-01 1983-07-27 Animalia Pty Ltd Trace elements
UY26194A1 (es) * 2000-06-06 2002-01-31 Atilio Patrone Belderrain Geor Nueva bebida canina
WO2002017933A1 (en) 2000-08-28 2002-03-07 Warburton Technology Limited Trace elements
AT502590A1 (de) * 2001-09-27 2007-04-15 Oekopharm Forschungs Und Entwi Basenhältige mikronährstoffmischung
UY27260A1 (es) * 2002-04-11 2003-11-28 Tredin S A Bebida alimento y sanitaria para perros
US6706697B1 (en) * 2002-09-19 2004-03-16 Jason Pharmaceuticals, Inc. Diabetic nutrition and weight loss drink compositions
US20040132689A1 (en) * 2002-12-27 2004-07-08 Seiji Nishida Aqueous preparation containing a shark-derived chondroitin iron sulfate colloid
CN1949987B (zh) * 2004-04-09 2010-06-09 努特里希亚公司 液体浓缩制剂
US7285292B2 (en) 2004-04-29 2007-10-23 Warburton Technology Limited Trace elements
SI3078274T1 (sl) * 2004-05-03 2022-06-30 Warburton Technology Limited Elementi v sledovih
WO2006108208A1 (en) * 2004-10-14 2006-10-19 Adventures Plus Pty Ltd A method for the treatment of gastrointestinal and other disorders with an admixture of vitamins and minerals
ES2387509T3 (es) * 2006-10-19 2012-09-25 Nestec S.A. Alimentación por vía entérica para mantenimiento a largo plazo
US20110076341A1 (en) * 2009-09-25 2011-03-31 William Alfred Smith Trace elements
US20110195158A1 (en) * 2010-02-10 2011-08-11 Fuhr David R Wildlife nutritional supplementation and methods for making the same
WO2011150395A2 (en) * 2010-05-28 2011-12-01 Bmg Hematology Llc Nutrient compositions

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008113483A2 (de) * 2007-03-16 2008-09-25 Bayer Animal Health Gmbh Stabilisierung von vitamin b12

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10799531B2 (en) 2015-10-09 2020-10-13 Warburton Technology Limited Trace element solution
KR102058133B1 (ko) 2019-02-22 2019-12-20 우진 비앤지 주식회사 혼합제제 내 항생제 용해도를 향상시킬 수 있는 면역 증강용 조성물 및 이의 용도

Also Published As

Publication number Publication date
PL2849764T3 (pl) 2020-03-31
DK3915569T3 (da) 2023-08-21
HRP20211302T1 (hr) 2021-11-12
AU2012379964A1 (en) 2015-01-22
ES2883802T3 (es) 2021-12-09
AU2012379964B2 (en) 2017-06-15
SI3915569T1 (sl) 2023-10-30
EP3566708B1 (en) 2021-07-28
ES2953691T3 (es) 2023-11-15
SI3566708T1 (sl) 2021-11-30
EP3566708A1 (en) 2019-11-13
EP3915569B8 (en) 2023-08-30
ZA201409093B (en) 2017-05-31
EP2849764A1 (en) 2015-03-25
LT3566708T (lt) 2021-08-25
MX360934B (es) 2018-11-22
HUE056783T2 (hu) 2022-03-28
EP4233881A2 (en) 2023-08-30
FI3915569T3 (fi) 2023-08-08
CA2871991C (en) 2019-02-26
HUE062949T2 (hu) 2023-12-28
US20210315997A1 (en) 2021-10-14
EP3915569A1 (en) 2021-12-01
WO2013171538A1 (en) 2013-11-21
CA2871991A1 (en) 2013-11-21
BR112014027576B1 (pt) 2020-06-30
ES2742812T3 (es) 2020-02-17
EP2849764B1 (en) 2019-07-31
PT3915569T (pt) 2023-08-17
PL3566708T3 (pl) 2021-11-22
EP2849764A4 (en) 2015-12-16
EP3915569B1 (en) 2023-07-26
BR112014027576A2 (pt) 2017-06-27
EP4233881A3 (en) 2023-10-04
DK2849764T3 (da) 2019-08-19
MX2014013792A (es) 2015-05-11
LT3915569T (lt) 2023-09-11
DK3566708T3 (da) 2021-08-23
PT3566708T (pt) 2021-08-19
PL3915569T3 (pl) 2023-09-18

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