WO2007027076A1 - Formula estabilizadora de vacunas con antígenos vivos para su uso en sistemas de vacunación masiva - Google Patents
Formula estabilizadora de vacunas con antígenos vivos para su uso en sistemas de vacunación masiva Download PDFInfo
- Publication number
- WO2007027076A1 WO2007027076A1 PCT/MX2005/000073 MX2005000073W WO2007027076A1 WO 2007027076 A1 WO2007027076 A1 WO 2007027076A1 MX 2005000073 W MX2005000073 W MX 2005000073W WO 2007027076 A1 WO2007027076 A1 WO 2007027076A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- vaccine
- ppm
- sample
- edta
- water
- Prior art date
Links
- 229960005486 vaccine Drugs 0.000 title claims abstract description 140
- 239000000427 antigen Substances 0.000 title claims abstract description 20
- 102000036639 antigens Human genes 0.000 title claims abstract description 20
- 108091007433 antigens Proteins 0.000 title claims abstract description 20
- 238000012768 mass vaccination Methods 0.000 title claims description 11
- 230000003019 stabilising effect Effects 0.000 title abstract 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 73
- 150000001875 compounds Chemical class 0.000 claims abstract 5
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 44
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 42
- 239000000203 mixture Substances 0.000 claims description 36
- KCXVZYZYPLLWCC-UHFFFAOYSA-N EDTA Chemical compound OC(=O)CN(CC(O)=O)CCN(CC(O)=O)CC(O)=O KCXVZYZYPLLWCC-UHFFFAOYSA-N 0.000 claims description 34
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims description 24
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 24
- 239000008101 lactose Substances 0.000 claims description 23
- 239000000377 silicon dioxide Substances 0.000 claims description 22
- 235000012239 silicon dioxide Nutrition 0.000 claims description 22
- AKHNMLFCWUSKQB-UHFFFAOYSA-L sodium thiosulfate Chemical compound [Na+].[Na+].[O-]S([O-])(=O)=S AKHNMLFCWUSKQB-UHFFFAOYSA-L 0.000 claims description 22
- 235000019345 sodium thiosulphate Nutrition 0.000 claims description 22
- 239000011780 sodium chloride Substances 0.000 claims description 21
- 229910019142 PO4 Inorganic materials 0.000 claims description 19
- ZPWVASYFFYYZEW-UHFFFAOYSA-L dipotassium hydrogen phosphate Chemical compound [K+].[K+].OP([O-])([O-])=O ZPWVASYFFYYZEW-UHFFFAOYSA-L 0.000 claims description 19
- 235000021317 phosphate Nutrition 0.000 claims description 19
- 239000000975 dye Substances 0.000 claims description 17
- 241000700605 Viruses Species 0.000 claims description 14
- 241001465754 Metazoa Species 0.000 claims description 13
- 230000000087 stabilizing effect Effects 0.000 claims description 13
- 241000894006 Bacteria Species 0.000 claims description 12
- 235000019359 magnesium stearate Nutrition 0.000 claims description 11
- 239000003381 stabilizer Substances 0.000 claims description 9
- QXNVGIXVLWOKEQ-UHFFFAOYSA-N Disodium Chemical compound [Na][Na] QXNVGIXVLWOKEQ-UHFFFAOYSA-N 0.000 claims description 7
- 150000003839 salts Chemical class 0.000 claims description 7
- 230000002411 adverse Effects 0.000 claims description 6
- 229940111685 dibasic potassium phosphate Drugs 0.000 claims description 5
- 235000013305 food Nutrition 0.000 claims description 5
- 229940111688 monobasic potassium phosphate Drugs 0.000 claims description 5
- 235000019796 monopotassium phosphate Nutrition 0.000 claims description 5
- GNSKLFRGEWLPPA-UHFFFAOYSA-M potassium dihydrogen phosphate Chemical compound [K+].OP(O)([O-])=O GNSKLFRGEWLPPA-UHFFFAOYSA-M 0.000 claims description 5
- BVKZGUZCCUSVTD-UHFFFAOYSA-M Bicarbonate Chemical class OC([O-])=O BVKZGUZCCUSVTD-UHFFFAOYSA-M 0.000 claims description 4
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims description 4
- RAHZWNYVWXNFOC-UHFFFAOYSA-N Sulphur dioxide Chemical compound O=S=O RAHZWNYVWXNFOC-UHFFFAOYSA-N 0.000 claims description 4
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 claims description 4
- 150000003013 phosphoric acid derivatives Chemical class 0.000 claims description 4
- 239000003352 sequestering agent Substances 0.000 claims description 4
- GEHJYWRUCIMESM-UHFFFAOYSA-L sodium sulfite Chemical compound [Na+].[Na+].[O-]S([O-])=O GEHJYWRUCIMESM-UHFFFAOYSA-L 0.000 claims description 4
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 claims description 3
- BPQQTUXANYXVAA-UHFFFAOYSA-N Orthosilicate Chemical compound [O-][Si]([O-])([O-])[O-] BPQQTUXANYXVAA-UHFFFAOYSA-N 0.000 claims description 3
- 239000001045 blue dye Substances 0.000 claims description 3
- 239000000378 calcium silicate Substances 0.000 claims description 3
- 229910052918 calcium silicate Inorganic materials 0.000 claims description 3
- 235000012241 calcium silicate Nutrition 0.000 claims description 3
- OYACROKNLOSFPA-UHFFFAOYSA-N calcium;dioxido(oxo)silane Chemical compound [Ca+2].[O-][Si]([O-])=O OYACROKNLOSFPA-UHFFFAOYSA-N 0.000 claims description 3
- 239000003638 chemical reducing agent Substances 0.000 claims description 3
- 210000001035 gastrointestinal tract Anatomy 0.000 claims description 3
- 230000003204 osmotic effect Effects 0.000 claims description 3
- 238000009736 wetting Methods 0.000 claims description 3
- AOSFMYBATFLTAQ-UHFFFAOYSA-N 1-amino-3-(benzimidazol-1-yl)propan-2-ol Chemical compound C1=CC=C2N(CC(O)CN)C=NC2=C1 AOSFMYBATFLTAQ-UHFFFAOYSA-N 0.000 claims description 2
- XTEGARKTQYYJKE-UHFFFAOYSA-M Chlorate Chemical class [O-]Cl(=O)=O XTEGARKTQYYJKE-UHFFFAOYSA-M 0.000 claims description 2
- WQZGKKKJIJFFOK-QTVWNMPRSA-N D-mannopyranose Chemical compound OC[C@H]1OC(O)[C@@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-QTVWNMPRSA-N 0.000 claims description 2
- 229930091371 Fructose Natural products 0.000 claims description 2
- 239000005715 Fructose Substances 0.000 claims description 2
- RFSUNEUAIZKAJO-ARQDHWQXSA-N Fructose Chemical compound OC[C@H]1O[C@](O)(CO)[C@@H](O)[C@@H]1O RFSUNEUAIZKAJO-ARQDHWQXSA-N 0.000 claims description 2
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 claims description 2
- 239000004115 Sodium Silicate Substances 0.000 claims description 2
- DWAQJAXMDSEUJJ-UHFFFAOYSA-M Sodium bisulfite Chemical compound [Na+].OS([O-])=O DWAQJAXMDSEUJJ-UHFFFAOYSA-M 0.000 claims description 2
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- 229930006000 Sucrose Natural products 0.000 claims description 2
- LSNNMFCWUKXFEE-UHFFFAOYSA-N Sulfurous acid Chemical class OS(O)=O LSNNMFCWUKXFEE-UHFFFAOYSA-N 0.000 claims description 2
- XYXNTHIYBIDHGM-UHFFFAOYSA-N ammonium thiosulfate Chemical compound [NH4+].[NH4+].[O-]S([O-])(=O)=S XYXNTHIYBIDHGM-UHFFFAOYSA-N 0.000 claims description 2
- SXDBWCPKPHAZSM-UHFFFAOYSA-M bromate Chemical class [O-]Br(=O)=O SXDBWCPKPHAZSM-UHFFFAOYSA-M 0.000 claims description 2
- 150000001649 bromium compounds Chemical class 0.000 claims description 2
- CJZGTCYPCWQAJB-UHFFFAOYSA-L calcium stearate Chemical compound [Ca+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O CJZGTCYPCWQAJB-UHFFFAOYSA-L 0.000 claims description 2
- 239000008116 calcium stearate Substances 0.000 claims description 2
- 235000013539 calcium stearate Nutrition 0.000 claims description 2
- 150000001720 carbohydrates Chemical class 0.000 claims description 2
- 150000004649 carbonic acid derivatives Chemical class 0.000 claims description 2
- 150000001805 chlorine compounds Chemical class 0.000 claims description 2
- 239000008121 dextrose Substances 0.000 claims description 2
- 150000004673 fluoride salts Chemical class 0.000 claims description 2
- 239000008103 glucose Substances 0.000 claims description 2
- ICIWUVCWSCSTAQ-UHFFFAOYSA-N iodic acid Chemical class OI(=O)=O ICIWUVCWSCSTAQ-UHFFFAOYSA-N 0.000 claims description 2
- 150000004694 iodide salts Chemical class 0.000 claims description 2
- 150000003893 lactate salts Chemical class 0.000 claims description 2
- 239000011777 magnesium Substances 0.000 claims description 2
- 229910052749 magnesium Inorganic materials 0.000 claims description 2
- 239000000395 magnesium oxide Substances 0.000 claims description 2
- CPLXHLVBOLITMK-UHFFFAOYSA-N magnesium oxide Inorganic materials [Mg]=O CPLXHLVBOLITMK-UHFFFAOYSA-N 0.000 claims description 2
- 235000012245 magnesium oxide Nutrition 0.000 claims description 2
- GVALZJMUIHGIMD-UHFFFAOYSA-H magnesium phosphate Chemical compound [Mg+2].[Mg+2].[Mg+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O GVALZJMUIHGIMD-UHFFFAOYSA-H 0.000 claims description 2
- 239000000391 magnesium silicate Substances 0.000 claims description 2
- 229910052919 magnesium silicate Inorganic materials 0.000 claims description 2
- 235000019792 magnesium silicate Nutrition 0.000 claims description 2
- AXZKOIWUVFPNLO-UHFFFAOYSA-N magnesium;oxygen(2-) Chemical compound [O-2].[Mg+2] AXZKOIWUVFPNLO-UHFFFAOYSA-N 0.000 claims description 2
- 150000002823 nitrates Chemical class 0.000 claims description 2
- 150000002826 nitrites Chemical class 0.000 claims description 2
- XYJRXVWERLGGKC-UHFFFAOYSA-D pentacalcium;hydroxide;triphosphate Chemical compound [OH-].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O XYJRXVWERLGGKC-UHFFFAOYSA-D 0.000 claims description 2
- HRZFUMHJMZEROT-UHFFFAOYSA-L sodium disulfite Chemical compound [Na+].[Na+].[O-]S(=O)S([O-])(=O)=O HRZFUMHJMZEROT-UHFFFAOYSA-L 0.000 claims description 2
- 235000010267 sodium hydrogen sulphite Nutrition 0.000 claims description 2
- 229940001584 sodium metabisulfite Drugs 0.000 claims description 2
- 235000010262 sodium metabisulphite Nutrition 0.000 claims description 2
- 229910052911 sodium silicate Inorganic materials 0.000 claims description 2
- 235000019794 sodium silicate Nutrition 0.000 claims description 2
- 235000010265 sodium sulphite Nutrition 0.000 claims description 2
- 150000003890 succinate salts Chemical class 0.000 claims description 2
- 239000005720 sucrose Substances 0.000 claims description 2
- 150000004763 sulfides Chemical class 0.000 claims description 2
- 150000003467 sulfuric acid derivatives Chemical class 0.000 claims description 2
- 235000010269 sulphur dioxide Nutrition 0.000 claims description 2
- 235000019731 tricalcium phosphate Nutrition 0.000 claims description 2
- 238000012795 verification Methods 0.000 claims description 2
- 239000007853 buffer solution Substances 0.000 claims 2
- QZKRHPLGUJDVAR-UHFFFAOYSA-K EDTA trisodium salt Chemical compound [Na+].[Na+].[Na+].OC(=O)CN(CC([O-])=O)CCN(CC([O-])=O)CC([O-])=O QZKRHPLGUJDVAR-UHFFFAOYSA-K 0.000 claims 1
- 150000001242 acetic acid derivatives Chemical class 0.000 claims 1
- XFWJKVMFIVXPKK-UHFFFAOYSA-N calcium;oxido(oxo)alumane Chemical compound [Ca+2].[O-][Al]=O.[O-][Al]=O XFWJKVMFIVXPKK-UHFFFAOYSA-N 0.000 claims 1
- HCWCAKKEBCNQJP-UHFFFAOYSA-N magnesium orthosilicate Chemical compound [Mg+2].[Mg+2].[O-][Si]([O-])([O-])[O-] HCWCAKKEBCNQJP-UHFFFAOYSA-N 0.000 claims 1
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 claims 1
- NTHWMYGWWRZVTN-UHFFFAOYSA-N sodium silicate Chemical compound [Na+].[Na+].[O-][Si]([O-])=O NTHWMYGWWRZVTN-UHFFFAOYSA-N 0.000 claims 1
- HLWRUJAIJJEZDL-UHFFFAOYSA-M sodium;2-[2-[bis(carboxymethyl)amino]ethyl-(carboxymethyl)amino]acetate Chemical compound [Na+].OC(=O)CN(CC(O)=O)CCN(CC(O)=O)CC([O-])=O HLWRUJAIJJEZDL-UHFFFAOYSA-M 0.000 claims 1
- 239000000080 wetting agent Substances 0.000 claims 1
- 239000000843 powder Substances 0.000 abstract description 16
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- ZAMOUSCENKQFHK-UHFFFAOYSA-N Chlorine atom Chemical compound [Cl] ZAMOUSCENKQFHK-UHFFFAOYSA-N 0.000 description 49
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- 230000000694 effects Effects 0.000 description 34
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- 241000287828 Gallus gallus Species 0.000 description 15
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- 238000004458 analytical method Methods 0.000 description 15
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- 230000003247 decreasing effect Effects 0.000 description 15
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- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 description 15
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- 238000012360 testing method Methods 0.000 description 15
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- DEWPTISPUKDSLQ-UHFFFAOYSA-K magnesium potassium octadecanoate Chemical compound [Mg++].[K+].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O DEWPTISPUKDSLQ-UHFFFAOYSA-K 0.000 description 9
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- 229910052736 halogen Inorganic materials 0.000 description 4
- 150000002367 halogens Chemical class 0.000 description 4
- LWIHDJKSTIGBAC-UHFFFAOYSA-K potassium phosphate Substances [K+].[K+].[K+].[O-]P([O-])([O-])=O LWIHDJKSTIGBAC-UHFFFAOYSA-K 0.000 description 4
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Classifications
-
- 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
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
-
- 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
- A61K47/02—Inorganic compounds
-
- 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
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
Definitions
- VACCINE STABILIZING FORMULA WITH LIVING ANTIGENS FOR USE IN MASS VACCINATION SYSTEMS VACCINE STABILIZING FORMULA WITH LIVING ANTIGENS FOR USE IN MASS VACCINATION SYSTEMS
- the invention mentioned herein is a stabilizing formula for live vaccines to increase the viability in solution thereof and thus ensure the correct immunization of animals. This also mentions the method of preparation and application.
- Vaccination as a prophylactic measure, is part of a series of activities aimed at ensuring the health and welfare of animals in modern production systems. Together with biosafety systems and proper food, it allows the producer to ensure a correct performance of the productive system throughout the cycle and therefore a greater economic gain. The importance of an adequate vaccination program is manifested by observing the significant economic losses due to an infectious outbreak caused by a low capacity of animals to control a field challenge.
- the route of application and the technique with which it is to be applied are of the utmost importance, since its execution directly defines the possible success or failure of the operation.
- the vaccine itself does not represent one of the highest costs within an operation, however, it is one of the activities that requires more attention, logistics and supervision.
- the cost of labor related to this activity is high and the chances of error, deviations or low uniformity also.
- the management and care that must be taken for a successful vaccination are especially critical.
- Current intensive production systems require massive vaccination and medication techniques that allow the producer to immunize a large number of birds in a short time, with little labor, in order to reduce associated costs and increase profit margins.
- the quality of the water used in the production farms is difficult to assure, due to the presence of pathogenic microorganisms and adverse physicochemical conditions.
- it may have varying hardness conditions (calcium and mineral magnesium), pH ranges away from the neutral and presence of halogens, chlorine and iodine, coming from treatment systems to eliminate pathogens from water.
- Vaccinate and medicate are two procedures that require very specific water conditions: a neutral pH, absence of chlorine and iodine, low hardness, and therefore rarely optimal results can be achieved under normal field conditions.
- the pH is a determining factor in the efficiency of the vaccination and medication processes. In the case of the former, viruses and bacteria are very sensitive to denaturation or inactivation by ranges of acidity or alkalinity higher than neutral.
- the ideal pH to vaccinate or medicate is pH 7.
- the hardness in the water is the presence of calcium or magnesium ions, mainly from mineral deposits in the subsoil. These ions have chelating or agglutination functions of viruses, bacteria and active ingredients that are used in prophylaxis.
- the ideal condition is the absence or the minimum possible concentration of these ions in the water when vaccinating or medicating.
- All living microorganisms whether viruses or bacteria, have a spatial structure, or tertiary structure, which is modified by the osmotic pressure of the solution, which when altered can cause ruptures of the outer walls of the bacteria or cause denaturation of the majority of viruses. This It is ideal that the vaccine solution has the minimum isoelectric potential to keep the living antigens stable.
- skim milk as a stabilizer for live antigen vaccines. Due to the slightly basic characteristics of milk, neutralizing characteristics are attributed to the pH.
- milk as a stabilizer is not very convenient since in many cases the same milk contains iodine residues that damage the vaccine, therefore the use of only milk that can be certified as free of this or commercial stabilizing preparations should be considered. Even so, the milk's ability to stabilize the pH and the presence of halogens in the water is very limited, almost nil.
- the field of application of the invention is in the systems of vaccination and medication in drinking water and vaccination and medication in spray for vaccines with live antigens.
- the means of distribution of the vaccine is usually water, but is not limited to it, so that the vaccine can be applied in another means of distribution, while in a liquid medium.
- the stabilizing formula of vaccines with live antigens for use in mass vaccination systems comprises a mixture of ingredients formulated to confer extended stability to live antigens (virus vaccines or live bacteria) used in the vaccination of animals in animal production processes .
- the invention consists of a product that can be in liquid or solid presentation for mixing in the water used for the vaccination of farm animals.
- a pH stabilizing agent will be used in order to stabilize the pH of the vaccine solution in a range of 6.5 to 7.5, a range in which most bacteria and viruses are viable.
- the pH stabilizing agents can be phosphates, succinates, bicarbonates and lactates.
- the use of potassium phosphates is preferred due to their low irritation capacity and because they are considered safe for use in animals and humans.
- a water hardness sequestering agent will be used to remove dissolved minerals in the water that can cause inactivation of the viruses and bacteria present in the vaccine.
- sequestering agents are the salts of ethylenediaminetetraacetic acid.
- the use of ethylenediaminetetraacetic acid in its disodium salt (disodium EDTA) is preferred because it is considered safe for use, does not significantly modify the pH of the solution and does not cause irritation in living tissues.
- a reducing agent is used to neutralize the sanitizers present in the water of the locality where the application will be carried out.
- sanitizers can be based on chlorine, iodine, peroxide, bromine, fluorine, ozone, permanganate. All of these can be considered as oxidizing agents that can be neutralized through, but not limited to, sodium thiosulfate, sodium metabisulfite, sodium bisulfite, sodium sulphite, sulfur dioxide, ammonium bisulfite, and ammonium thiosulfate. The use of sodium thiosulfate is preferred since it has a high neutralization capacity and is considered safe and non-corrosive.
- a water soluble salt will be used in order to provide an osmotic pressure necessary to keep the tertiary structure of the virus stable and the outer wall of the bacteria present in the vaccine intact.
- these are the salts of chlorides, iodides, carbonates, bicarbonates, phosphates, iodates, chlorates, bromides, bromates, fluorides, nitrates, nitrites, sulphides, sulfates and sulphites.
- sodium chloride is preferred due to its zero toxicity, irritability and because it is considered safe for consumption.
- a carbohydrate will be used to protect the structure of the virus or bacteria from the attack of the adverse conditions of the digestive tract of the bird, and this can be among others, glucose, dextrose, lactose, sucrose, mannose and fructose.
- lactose is preferred since it has a high solubility due to the size of its powdered particle and because it does not have a negative interaction with the normal metabolism of birds.
- a food grade dye will be used to provide a means of visual verification for the vaccinator, which will allow the user of the stabilizer to know when the protector has been applied to the water, and at a given time, that the animal has already received carrier water of the vaccine.
- these are the colors and preparations of colors blue, red, green, violet, orange, etc. Of these, the use of blue color is preferred due to the contrast it exerts on the color of living tissues.
- a food grade anti-humectant agent will be used to prevent the wetting of the mixture since it has hygroscopic properties in some of its salts. These agents do not modify the physicochemical functioning of the product and only work to decrease the wetting of the mixture.
- magnesium stearate examples include silicon dioxide, calcium stearate, magnesium stearate, tribasic calcium phosphate, tribasic magnesium phosphate, magnesium oxide, calcium silicate, magnesium silicate, sodium silicate aluminate, calcium silicate silicate, etc. .
- silicon dioxide calcium stearate, magnesium stearate, tribasic calcium phosphate, tribasic magnesium phosphate, magnesium oxide, calcium silicate, magnesium silicate, sodium silicate aluminate, calcium silicate silicate, etc.
- silicon dioxide examples include silicon dioxide, calcium stearate, magnesium stearate, tribasic calcium phosphate, tribasic magnesium phosphate, magnesium oxide, calcium silicate, magnesium silicate, sodium silicate aluminate, calcium silicate silicate, etc.
- magnesium stearate and silicon dioxide is preferred due to its zero toxicity, irritability and because it is considered safe for consumption.
- the formulation is given as follows: Disodium salt of ethylenediaminetetraacetic acid (EDTA) in a range of 0.03% to 34.19% with an optimal concentration of 3.75%, monobasic potassium phosphate in a range of 0.03% to 34.48% with a concentration optimal 5% dibasic potassium phosphate in a range of 0.03% to 56.07% with an optimum concentration of 41.25% thiosulfate 'sodium in a range of 0.03% to 33.73% with an optimum concentration of 1.75% sodium chloride in a range of 0.03% to 35.91% with an optimal concentration of 10.75%, lactose in a range of 0.03% to 51.02% with an optimal concentration of 28%, silicon dioxide in a range of 0.03% to 5% with an optimal concentration 1%, magnesium stearate in a range of 0.03% to 5% with an optimal concentration of 1% and bright blue dye in a range of 0.03% to 44.25% with an optimal concentration of 7.50%.
- the manufacturing process is formed by the progressive mixing of these raw materials under constant stirring for 15 minutes between each addition, at a maximum relative humidity of 30% and a temperature in a range of 15 0 C to 35 ° C, in Ia following sequence: dibasic potassium phosphate, lactose, monobasic potassium phosphate, disodium salt of ethylenediaminetetraacetic acid (EDTA), sodium thiosulfate, sodium chloride, magnesium stearate, silicon dioxide and bright blue color.
- EDTA ethylenediaminetetraacetic acid
- the vaccine When the vaccine is mixed with the stabilizing solution at a concentration of between 2.85 g / L and 5.93 g / L of solution to be prepared at a temperature between 15 ° C and 35 ° C, the virus or the drug is not exposed to adverse conditions Therefore, its viability is maintained for long periods.
- the lactose functions as a protector on the outer surface of the virus, preventing it from being damaged during the journey until it reaches the lower digestive system, where the vaccine passes into the bloodstream through the membranes of the intestine and the immunogenic reaction begins.
- the use procedure is defined as follows: for each liter of vaccine solution to be prepared, depending on the composition, an amount in the range 2.85 to 5.93 g / L of the stabilizer for live vaccines will be added, gradually adding in agitation keep going. Once the required amount is solubilized, the vaccine is added and applied to the animals to be vaccinated.
- Example A A laboratory-level test was carried out where, at a white water solution with a pH of 6, 100 ppm of total hardness and 5 ppm of free chlorine, the product was applied at the aforementioned concentration and at five minutes a vial with 1000 doses with a 3.7 log TM titer of vaccine against avian infectious bronchitis disease that was used as a biological model (sample A) and a duplicate sample with the white solution without the product (sample B).
- Sample A the water hardness of 55 ppm of total hardness, a pH of 7.1 and a zero free chlorine titration. It was observed that the vaccine title was maintained at a concentration of 94% of the initial concentration of the vaccine applied, so there was only a 6% loss of activity of the vaccine.
- Sample B a hardness of 115 ppm, pH of 6.1 and 4 ppm of free chlorine were obtained. It was observed that the titre of the vaccine decreased to 30% of the initial concentration of the vaccine applied so that there was a 70% loss of vaccine activity.
- Sample A The water hardness of 0 ppm of total hardness, a pH of 7.0 and a zero free chlorine titration. It was observed that the vaccine titer was maintained at a concentration of 97% of the initial applied concentration of the vaccine, so there was only a 3% loss of vaccine activity.
- Sample B obtained a hardness of 105 ppm, pH of 5.9 and 5 ppm of free chlorine. It was observed that the titre of the vaccine decreased to 25% of the initial concentration of the vaccine applied, so there was 75% of loss of vaccine activity.
- Sample A The water hardness of 0 ppm of total hardness, a pH of 7.0 and a zero free chlorine titration. It was observed that the vaccine titer was maintained at a concentration of 97% of the initial applied concentration of the vaccine, so there was only a 3% loss of vaccine activity.
- Sample B a hardness of 110 ppm, pH of 6.0 and 4 ppm of free chlorine were obtained. It was observed that the titre of the vaccine decreased to 30% of the initial concentration of the vaccine applied so that there was a 70% loss of vaccine activity.
- Sample A Water hardness of 0 ppm of total hardness, a pH of 7.6 and a zero free chlorine titration. It was observed that the vaccine titer was maintained at a concentration of 93% of the initial applied concentration of the vaccine, so there was only a 7% loss of vaccine activity.
- a laboratory-level test was carried out where, at a white water solution with a pH of 6, 100 ppm of total hardness and 5 ppm of free chlorine, the product was applied at the aforementioned concentration and at five minutes a vial with 1000 doses with a 3.7 log 10 titer of vaccine against avian infectious bronchitis disease that was used as a biological model (sample A) and a duplicate sample with the white solution without the product (sample B).
- Sample A the water hardness of 4 ppm of total hardness, a pH of 6.2 and a zero free chlorine titration. It was observed that the titre of the vaccine was maintained at a concentration of 83% of the initial applied concentration of the vaccine, so there was only a 17% loss of vaccine activity.
- Sample B a hardness of 104 ppm, pH of 6.0 and 5 ppm of free chlorine were obtained. . It was observed that the titre of the vaccine decreased to 33% of the initial concentration of the vaccine applied, so there was a 67% loss of vaccine activity.
- Example 7 Example 7
- a laboratory-level test was carried out where, at a white water solution with a pH of 6, 100 ppm of total hardness and 5 ppm of free chlorine, the product was applied at the aforementioned concentration and at five minutes a vial with 1000 doses with a 3.7 log 10 titer of vaccine against avian infectious bronchitis disease that was used as a biological model (sample A) and a duplicate sample with the white solution without the product (sample B).
- Sample A the water hardness of 2 ppm of total hardness, a pH of 5.8 and a zero free chlorine titration. It was observed that the vaccine titer was maintained at a concentration of 73% of the initial applied concentration of the vaccine, so there was only a 27% loss of vaccine activity.
- Sample B a hardness of 100 ppm, pH of 5.9 and 4 ppm of free chlorine were obtained. It was observed that the titre of the vaccine decreased to 29% of the initial concentration of the vaccine applied, so there was a 71% loss of vaccine activity.
- Example 8 A powder mixture containing 2.80% EDTA, 3.74% potassium monobasic phosphate, 56.07% potassium dibasic phosphate, 1.31% sodium thiosulfate, 8.04% sodium chloride, 20.93% lactose, 0.75% magnesium stearate, 0.75% silicon dioxide and 5.61% dye. This mixture is dosed at a rate of 5.35 g per liter of water to be prepared.
- Example A A laboratory-level test was carried out where, at a white water solution with a pH of 6, 100 ppm of total hardness and 5 ppm of free chlorine, the product was applied at the aforementioned concentration and at five minutes a vial with 1000 doses with a title of 3.7 log-io vaccine against avian infectious bronchitis disease that it was used as a biological model (sample A) and a sample in duplicate with the white solution without the product (sample B).
- Sample A The water hardness of 3 ppm total hardness, a pH of 7.6 and a zero free chlorine titration. It was observed that the vaccine titre was maintained at a concentration of 91% of the initial applied concentration of the vaccine, so there was only a 9% loss of. vaccine activity.
- Sample B a hardness of 108 ppm, pH of 6.1 and 5 ppm of free chlorine were obtained. It was observed that the titre of the vaccine decreased to 36% of the initial concentration of the vaccine applied, so there was a 64% loss of vaccine activity.
- Example 9 A powder mixture containing 3.82% EDTA, 5.09% potassium monobasic phosphate, 41.97% potassium dibasic phosphate, 0.03% sodium thiosulfate, 10.94% sodium chloride, 28.49% lactose, 1.02% magnesium stearate, 1.02% silicon dioxide and 7.63% dye. This mixture is dosed at a rate of 3.93 g per liter of water to be prepared.
- Example A A laboratory-level test was carried out where, at a white water solution with a pH of 6, 100 ppm of total hardness and 5 ppm of free chlorine, the product was applied at the aforementioned concentration and at five minutes a vial with 1000 doses with a 3.7 log TM titer of vaccine against avian infectious bronchitis disease that was used as a biological model (sample A) and a duplicate sample with the white solution without the product (sample B).
- Sample A the water hardness of 4 ppm of total hardness, a pH of 7.1 and a free chlorine titre of 2 ppm. It was observed that the vaccine titer was maintained at a concentration of 72% of the initial applied concentration of the vaccine, so there was only a 28% loss of vaccine activity.
- Sample B a hardness of 100 ppm, pH of 6.0 and 5 ppm of free chlorine were obtained. It was observed that the titre of the vaccine decreased to 35% of the initial concentration of the vaccine applied, so there was a 65% loss of vaccine activity.
- a laboratory-level test was carried out where, at a white water solution with a pH of 6, 100 ppm of total hardness and 5 ppm of free chlorine, the product was applied at the aforementioned concentration and at five minutes a vial with 1000 doses with a 3.7 log 10 titer of vaccine against avian infectious bronchitis disease that was used as a biological model (sample A) and a duplicate sample with the white solution without the product (sample B).
- Sample A The water hardness of 1 ppm of total hardness, a pH of 7.0 and a zero free chlorine titration. It was observed that the vaccine titre was maintained at a concentration of 96% of the initial applied concentration of the vaccine, so there was only a 4% loss of vaccine activity.
- Sample B a hardness of 107 ppm, pH of 6.1 and 5 ppm of free chlorine were obtained. It was observed that the titre of the vaccine decreased to 32% of the initial concentration of the vaccine applied, so there was a 68% loss of vaccine activity.
- Example 11 A powder mixture containing 4.20% EDTA, 5.60% potassium monobasic phosphate, 46.21% potassium dibasic phosphate, 1.96% sodium thiosulfate, 0.03% sodium chloride, 31.36% lactose, 1.12% magnesium stearate, 1.12% of silicon dioxide and 8.40% dye. This mixture is dosed at a rate of 3.57 g per liter of water to be prepared.
- Sample A The water hardness of 0 ppm of total hardness, a pH of 7.2 and a zero free chlorine titration. It was observed that the titre of the vaccine was maintained at a concentration of 96% of the initial applied concentration of the vaccine, so there was only a 4% loss of activity of the vaccine.
- Sample A Water hardness of 3 ppm of total hardness, a pH of 6.8 and a zero free chlorine titration. It was observed that the vaccine titre was maintained at a concentration of 91% of the initial applied concentration of the vaccine, so that there was only a 9% loss of vaccine activity.
- Sample B a hardness of 100 ppm, pH of 6.0 and 5 ppm of free chlorine were obtained. It was observed that the titre of the vaccine decreased to 31% of the initial concentration of the vaccine applied, so there was a 69% loss of vaccine activity.
- a laboratory-level test was carried out where, at a white water solution with a pH of 6, 100 ppm of total hardness and 5 ppm of free chlorine, the product was applied at the aforementioned concentration and at five minutes a vial with 1000 doses with a 3.7 log 10 titer of vaccine against avian infectious bronchitis disease that was used as a biological model (sample A) and a duplicate sample with the white solution without the product (sample B).
- Sample A Water hardness of 4 ppm of total hardness, a pH of 7.0 and a zero free chlorine titration. It was observed that the vaccine titer was maintained at a concentration of 93% of the initial applied concentration of the vaccine, so there was only a 7% loss of vaccine activity.
- Sample A The water hardness of 21 ppm of total hardness, a pH of 7.3 and a zero free chlorine titration. It was observed that the vaccine titre was maintained at a concentration of 95% of the initial applied concentration of the vaccine, so there was only a 5% loss of vaccine activity.
- Sample B a hardness of 107 ppm, pH of 6.0 and 5 ppm of free chlorine were obtained.
- Sample A the water hardness of 2 ppm of total hardness, a pH of 7.0 and a zero free chlorine titration. It was observed that the vaccine titer was maintained at a concentration of 97% of the initial applied concentration of the vaccine, so there was only a 3% loss of vaccine activity.
- Sample B a hardness of 100 ppm, pH of 6.0 and 5 ppm of free chlorine were obtained. It was observed that the titre of the vaccine decreased to 25% of the initial concentration of the vaccine applied, so there was a 75% loss of activity of the vaccine.
- a laboratory-level test was carried out where, at a white water solution with a pH of 6, 100 ppm of total hardness and 5 ppm of free chlorine, the product was applied at the aforementioned concentration and at five minutes a vial with 1000 doses with a 3.7-log titer of vaccine against the disease of avian infectious bronchitis that was used as a biological model (sample A) and a sample in duplicate with the white solution without the product (sample B).
- Sample A The water hardness of 35 ppm of total hardness, a pH of 6.9 and a zero free chlorine titration. It was observed that the vaccine title was maintained at a concentration of 92% of the initial concentration of the vaccine applied, so there was only 8% loss of vaccine activity.
- Sample B a hardness of 109 ppm, pH of 6.0 and 5 ppm of free chlorine were obtained. It was observed that the titre of the vaccine decreased to 33% of the initial concentration of the vaccine applied, so there was a 67% loss of vaccine activity.
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- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
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Abstract
Description
Claims
Priority Applications (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
BRPI0520505-0A BRPI0520505B1 (pt) | 2005-09-01 | 2005-09-01 | Fórmula estabilizadora de vacinas com antígenos vivos para uso em sistemas de vacinação em massa |
PCT/MX2005/000073 WO2007027076A1 (es) | 2005-09-01 | 2005-09-01 | Formula estabilizadora de vacunas con antígenos vivos para su uso en sistemas de vacunación masiva |
US12/065,216 US20080268000A1 (en) | 2005-09-01 | 2005-09-01 | Vaccine Stabilising Formula with Live Antigens for Use in Mass Vaccination Systems |
CN2005800518503A CN101291689B (zh) | 2005-09-01 | 2005-09-01 | 用于大规模接种系统的活抗原的疫苗稳定化制剂 |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
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PCT/MX2005/000073 WO2007027076A1 (es) | 2005-09-01 | 2005-09-01 | Formula estabilizadora de vacunas con antígenos vivos para su uso en sistemas de vacunación masiva |
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WO2007027076A1 true WO2007027076A1 (es) | 2007-03-08 |
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PCT/MX2005/000073 WO2007027076A1 (es) | 2005-09-01 | 2005-09-01 | Formula estabilizadora de vacunas con antígenos vivos para su uso en sistemas de vacunación masiva |
Country Status (4)
Country | Link |
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US (1) | US20080268000A1 (es) |
CN (1) | CN101291689B (es) |
BR (1) | BRPI0520505B1 (es) |
WO (1) | WO2007027076A1 (es) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN104023744A (zh) * | 2011-12-23 | 2014-09-03 | 诺华股份有限公司 | 用于针对金黄色葡萄球菌免疫的稳定组合物 |
Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO1993021951A1 (en) * | 1992-04-27 | 1993-11-11 | Michigan State University | Method for producing a bacterial vaccine and novel vaccines produced thereby |
WO1997023238A1 (fr) * | 1995-12-22 | 1997-07-03 | Pasteur Merieux Serums & Vaccins | Stabilisants pour vaccins vivants |
WO2000057906A1 (en) * | 1999-03-26 | 2000-10-05 | Merck & Co., Inc. | Human papillomavirus vaccine with disassembled and reassembled virus-like particles |
Family Cites Families (4)
Publication number | Priority date | Publication date | Assignee | Title |
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JPS6034925B2 (ja) * | 1979-07-31 | 1985-08-12 | 帝人株式会社 | 持続性鼻腔用製剤およびその製造法 |
US6051238A (en) * | 1996-12-20 | 2000-04-18 | Merck & Co., Inc. | Stabilizers for lyophilized mumps vaccines |
JP4427182B2 (ja) * | 1997-09-22 | 2010-03-03 | ノバルティス バクシンズ アンド ダイアグノスティックス,インコーポレーテッド | 抗原を安定化するための緩衝液 |
US6541606B2 (en) * | 1997-12-31 | 2003-04-01 | Altus Biologics Inc. | Stabilized protein crystals formulations containing them and methods of making them |
-
2005
- 2005-09-01 WO PCT/MX2005/000073 patent/WO2007027076A1/es active Application Filing
- 2005-09-01 US US12/065,216 patent/US20080268000A1/en not_active Abandoned
- 2005-09-01 BR BRPI0520505-0A patent/BRPI0520505B1/pt not_active IP Right Cessation
- 2005-09-01 CN CN2005800518503A patent/CN101291689B/zh not_active Expired - Fee Related
Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO1993021951A1 (en) * | 1992-04-27 | 1993-11-11 | Michigan State University | Method for producing a bacterial vaccine and novel vaccines produced thereby |
WO1997023238A1 (fr) * | 1995-12-22 | 1997-07-03 | Pasteur Merieux Serums & Vaccins | Stabilisants pour vaccins vivants |
WO2000057906A1 (en) * | 1999-03-26 | 2000-10-05 | Merck & Co., Inc. | Human papillomavirus vaccine with disassembled and reassembled virus-like particles |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN104023744A (zh) * | 2011-12-23 | 2014-09-03 | 诺华股份有限公司 | 用于针对金黄色葡萄球菌免疫的稳定组合物 |
Also Published As
Publication number | Publication date |
---|---|
BRPI0520505A2 (pt) | 2009-05-12 |
US20080268000A1 (en) | 2008-10-30 |
BRPI0520505B1 (pt) | 2015-03-31 |
CN101291689B (zh) | 2012-12-05 |
CN101291689A (zh) | 2008-10-22 |
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