HRP940267A2 - Veterinary composition - Google Patents
Veterinary composition Download PDFInfo
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- HRP940267A2 HRP940267A2 HR9301489-2A HRP940267A HRP940267A2 HR P940267 A2 HRP940267 A2 HR P940267A2 HR P940267 A HRP940267 A HR P940267A HR P940267 A2 HRP940267 A2 HR P940267A2
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- ingredients
- pharmaceutical preparation
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- tablets
- small intestine
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- 239000000203 mixture Substances 0.000 title claims abstract description 16
- 229940126409 proton pump inhibitor Drugs 0.000 claims abstract description 22
- 239000000612 proton pump inhibitor Substances 0.000 claims abstract description 22
- 241001465754 Metazoa Species 0.000 claims abstract description 17
- 238000002360 preparation method Methods 0.000 claims abstract description 16
- 201000010099 disease Diseases 0.000 claims abstract description 7
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims abstract description 7
- 210000004211 gastric acid Anatomy 0.000 claims abstract description 6
- 238000000034 method Methods 0.000 claims abstract description 6
- 238000000576 coating method Methods 0.000 claims description 25
- 239000004615 ingredient Substances 0.000 claims description 25
- 210000000813 small intestine Anatomy 0.000 claims description 21
- 239000000825 pharmaceutical preparation Substances 0.000 claims description 20
- 239000011248 coating agent Substances 0.000 claims description 18
- 239000003795 chemical substances by application Substances 0.000 claims description 16
- SUBDBMMJDZJVOS-UHFFFAOYSA-N 5-methoxy-2-{[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl}-1H-benzimidazole Chemical compound N=1C2=CC(OC)=CC=C2NC=1S(=O)CC1=NC=C(C)C(OC)=C1C SUBDBMMJDZJVOS-UHFFFAOYSA-N 0.000 claims description 15
- 239000000126 substance Substances 0.000 claims description 15
- 229960000381 omeprazole Drugs 0.000 claims description 14
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 13
- 239000003112 inhibitor Substances 0.000 claims description 11
- 239000006071 cream Substances 0.000 claims description 9
- 241000283086 Equidae Species 0.000 claims description 7
- 239000006179 pH buffering agent Substances 0.000 claims description 7
- 239000008188 pellet Substances 0.000 claims description 7
- 239000007864 aqueous solution Substances 0.000 claims description 6
- 238000005086 pumping Methods 0.000 claims description 6
- 239000011324 bead Substances 0.000 claims description 5
- MJIHNNLFOKEZEW-UHFFFAOYSA-N lansoprazole Chemical compound CC1=C(OCC(F)(F)F)C=CN=C1CS(=O)C1=NC2=CC=CC=C2N1 MJIHNNLFOKEZEW-UHFFFAOYSA-N 0.000 claims description 5
- IQPSEEYGBUAQFF-UHFFFAOYSA-N Pantoprazole Chemical group COC1=CC=NC(CS(=O)C=2NC3=CC=C(OC(F)F)C=C3N=2)=C1OC IQPSEEYGBUAQFF-UHFFFAOYSA-N 0.000 claims description 4
- ZLMJMSJWJFRBEC-UHFFFAOYSA-N Potassium Chemical compound [K] ZLMJMSJWJFRBEC-UHFFFAOYSA-N 0.000 claims description 4
- 229960003174 lansoprazole Drugs 0.000 claims description 4
- 229960005019 pantoprazole Drugs 0.000 claims description 4
- 239000011591 potassium Substances 0.000 claims description 4
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 claims description 3
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 claims description 3
- 239000011575 calcium Substances 0.000 claims description 3
- 229910052791 calcium Inorganic materials 0.000 claims description 3
- 239000011777 magnesium Substances 0.000 claims description 3
- 229910052749 magnesium Inorganic materials 0.000 claims description 3
- 229910052700 potassium Inorganic materials 0.000 claims description 3
- PSIREIZGKQBEEO-UHFFFAOYSA-N 2-(1h-benzimidazol-2-ylsulfinylmethyl)-n-methyl-n-(2-methylpropyl)aniline Chemical group CC(C)CN(C)C1=CC=CC=C1CS(=O)C1=NC2=CC=CC=C2N1 PSIREIZGKQBEEO-UHFFFAOYSA-N 0.000 claims description 2
- 229910052782 aluminium Inorganic materials 0.000 claims description 2
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 claims description 2
- 238000010438 heat treatment Methods 0.000 claims description 2
- 229950007395 leminoprazole Drugs 0.000 claims description 2
- 229910017053 inorganic salt Inorganic materials 0.000 claims 2
- 239000002552 dosage form Substances 0.000 claims 1
- 239000000796 flavoring agent Substances 0.000 claims 1
- 235000019634 flavors Nutrition 0.000 claims 1
- 239000003349 gelling agent Substances 0.000 abstract description 4
- 239000008203 oral pharmaceutical composition Substances 0.000 abstract 1
- 239000002245 particle Substances 0.000 description 18
- 239000000499 gel Substances 0.000 description 16
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 12
- 150000001875 compounds Chemical class 0.000 description 9
- 125000003545 alkoxy group Chemical group 0.000 description 7
- 239000007931 coated granule Substances 0.000 description 7
- 125000000217 alkyl group Chemical group 0.000 description 6
- 238000002156 mixing Methods 0.000 description 6
- 239000000230 xanthan gum Substances 0.000 description 6
- 229920001285 xanthan gum Polymers 0.000 description 6
- 235000010493 xanthan gum Nutrition 0.000 description 6
- 229940082509 xanthan gum Drugs 0.000 description 6
- 230000027119 gastric acid secretion Effects 0.000 description 5
- 229920000642 polymer Polymers 0.000 description 5
- 239000000243 solution Substances 0.000 description 5
- -1 for example Chemical class 0.000 description 4
- 229920000896 Ethulose Polymers 0.000 description 3
- 239000001859 Ethyl hydroxyethyl cellulose Substances 0.000 description 3
- 235000019326 ethyl hydroxyethyl cellulose Nutrition 0.000 description 3
- 150000002431 hydrogen Chemical class 0.000 description 3
- 229910052739 hydrogen Inorganic materials 0.000 description 3
- 239000001257 hydrogen Substances 0.000 description 3
- 150000003839 salts Chemical class 0.000 description 3
- BHPQYMZQTOCNFJ-UHFFFAOYSA-N Calcium cation Chemical compound [Ca+2] BHPQYMZQTOCNFJ-UHFFFAOYSA-N 0.000 description 2
- 235000010643 Leucaena leucocephala Nutrition 0.000 description 2
- 240000007472 Leucaena leucocephala Species 0.000 description 2
- 208000008469 Peptic Ulcer Diseases 0.000 description 2
- WCUXLLCKKVVCTQ-UHFFFAOYSA-M Potassium chloride Chemical compound [Cl-].[K+] WCUXLLCKKVVCTQ-UHFFFAOYSA-M 0.000 description 2
- 208000007107 Stomach Ulcer Diseases 0.000 description 2
- 208000025865 Ulcer Diseases 0.000 description 2
- ZNOZWUKQPJXOIG-XSBHQQIPSA-L [(2r,3s,4r,5r,6s)-6-[[(1r,3s,4r,5r,8s)-3,4-dihydroxy-2,6-dioxabicyclo[3.2.1]octan-8-yl]oxy]-4-[[(1r,3r,4r,5r,8s)-8-[(2s,3r,4r,5r,6r)-3,4-dihydroxy-6-(hydroxymethyl)-5-sulfonatooxyoxan-2-yl]oxy-4-hydroxy-2,6-dioxabicyclo[3.2.1]octan-3-yl]oxy]-5-hydroxy-2-( Chemical compound O[C@@H]1[C@@H](O)[C@@H](OS([O-])(=O)=O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H]2OC[C@H]1O[C@H](O[C@H]1[C@H]([C@@H](CO)O[C@@H](O[C@@H]3[C@@H]4OC[C@H]3O[C@H](O)[C@@H]4O)[C@@H]1O)OS([O-])(=O)=O)[C@@H]2O ZNOZWUKQPJXOIG-XSBHQQIPSA-L 0.000 description 2
- 239000002253 acid Substances 0.000 description 2
- WPYMKLBDIGXBTP-UHFFFAOYSA-N benzoic acid Chemical compound OC(=O)C1=CC=CC=C1 WPYMKLBDIGXBTP-UHFFFAOYSA-N 0.000 description 2
- 229910001424 calcium ion Inorganic materials 0.000 description 2
- 125000004432 carbon atom Chemical group C* 0.000 description 2
- 229920002678 cellulose Polymers 0.000 description 2
- 239000001913 cellulose Substances 0.000 description 2
- 208000000718 duodenal ulcer Diseases 0.000 description 2
- 125000004428 fluoroalkoxy group Chemical group 0.000 description 2
- 230000002496 gastric effect Effects 0.000 description 2
- 229910052736 halogen Inorganic materials 0.000 description 2
- 150000002367 halogens Chemical class 0.000 description 2
- 238000011065 in-situ storage Methods 0.000 description 2
- 150000002500 ions Chemical class 0.000 description 2
- JVTAAEKCZFNVCJ-UHFFFAOYSA-N lactic acid Chemical compound CC(O)C(O)=O JVTAAEKCZFNVCJ-UHFFFAOYSA-N 0.000 description 2
- 230000007774 longterm Effects 0.000 description 2
- 238000004519 manufacturing process Methods 0.000 description 2
- 230000007935 neutral effect Effects 0.000 description 2
- 239000006174 pH buffer Substances 0.000 description 2
- 208000011906 peptic ulcer disease Diseases 0.000 description 2
- 230000003389 potentiating effect Effects 0.000 description 2
- 210000002784 stomach Anatomy 0.000 description 2
- 238000003860 storage Methods 0.000 description 2
- 231100000397 ulcer Toxicity 0.000 description 2
- 239000011240 wet gel Substances 0.000 description 2
- BJEPYKJPYRNKOW-REOHCLBHSA-N (S)-malic acid Chemical compound OC(=O)[C@@H](O)CC(O)=O BJEPYKJPYRNKOW-REOHCLBHSA-N 0.000 description 1
- 229920001817 Agar Polymers 0.000 description 1
- 235000002198 Annona diversifolia Nutrition 0.000 description 1
- 241000416162 Astragalus gummifer Species 0.000 description 1
- 239000005711 Benzoic acid Substances 0.000 description 1
- 241000282832 Camelidae Species 0.000 description 1
- 241000282472 Canis lupus familiaris Species 0.000 description 1
- 241001125840 Coryphaenidae Species 0.000 description 1
- FEWJPZIEWOKRBE-JCYAYHJZSA-N Dextrotartaric acid Chemical compound OC(=O)[C@H](O)[C@@H](O)C(O)=O FEWJPZIEWOKRBE-JCYAYHJZSA-N 0.000 description 1
- 102000004190 Enzymes Human genes 0.000 description 1
- 108090000790 Enzymes Proteins 0.000 description 1
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 1
- 241000282326 Felis catus Species 0.000 description 1
- 229920000855 Fucoidan Polymers 0.000 description 1
- 229920002907 Guar gum Polymers 0.000 description 1
- 229940122957 Histamine H2 receptor antagonist Drugs 0.000 description 1
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 description 1
- 241000282838 Lama Species 0.000 description 1
- 229920001543 Laminarin Polymers 0.000 description 1
- 241000283201 Odobenidae Species 0.000 description 1
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 description 1
- KDYFGRWQOYBRFD-UHFFFAOYSA-N Succinic acid Natural products OC(=O)CCC(O)=O KDYFGRWQOYBRFD-UHFFFAOYSA-N 0.000 description 1
- 241000282887 Suidae Species 0.000 description 1
- FEWJPZIEWOKRBE-UHFFFAOYSA-N Tartaric acid Natural products [H+].[H+].[O-]C(=O)C(O)C(O)C([O-])=O FEWJPZIEWOKRBE-UHFFFAOYSA-N 0.000 description 1
- 229920001615 Tragacanth Polymers 0.000 description 1
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 description 1
- 230000002378 acidificating effect Effects 0.000 description 1
- 239000013543 active substance Substances 0.000 description 1
- 239000008272 agar Substances 0.000 description 1
- 235000010419 agar Nutrition 0.000 description 1
- 235000010443 alginic acid Nutrition 0.000 description 1
- 239000000783 alginic acid Substances 0.000 description 1
- 229920000615 alginic acid Polymers 0.000 description 1
- 229960001126 alginic acid Drugs 0.000 description 1
- 150000004781 alginic acids Chemical class 0.000 description 1
- BJEPYKJPYRNKOW-UHFFFAOYSA-N alpha-hydroxysuccinic acid Natural products OC(=O)C(O)CC(O)=O BJEPYKJPYRNKOW-UHFFFAOYSA-N 0.000 description 1
- 230000000767 anti-ulcer Effects 0.000 description 1
- 235000010233 benzoic acid Nutrition 0.000 description 1
- KDYFGRWQOYBRFD-NUQCWPJISA-N butanedioic acid Chemical compound O[14C](=O)CC[14C](O)=O KDYFGRWQOYBRFD-NUQCWPJISA-N 0.000 description 1
- 235000014121 butter Nutrition 0.000 description 1
- 239000001768 carboxy methyl cellulose Substances 0.000 description 1
- 235000015165 citric acid Nutrition 0.000 description 1
- 210000001072 colon Anatomy 0.000 description 1
- 229920001577 copolymer Polymers 0.000 description 1
- 238000002425 crystallisation Methods 0.000 description 1
- 230000008025 crystallization Effects 0.000 description 1
- 238000000354 decomposition reaction Methods 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 210000001198 duodenum Anatomy 0.000 description 1
- 210000003238 esophagus Anatomy 0.000 description 1
- BEFDCLMNVWHSGT-UHFFFAOYSA-N ethenylcyclopentane Chemical compound C=CC1CCCC1 BEFDCLMNVWHSGT-UHFFFAOYSA-N 0.000 description 1
- 238000001125 extrusion Methods 0.000 description 1
- 210000004907 gland Anatomy 0.000 description 1
- 239000008187 granular material Substances 0.000 description 1
- 159000000011 group IA salts Chemical class 0.000 description 1
- 239000000665 guar gum Substances 0.000 description 1
- 235000010417 guar gum Nutrition 0.000 description 1
- 229960002154 guar gum Drugs 0.000 description 1
- GPRLSGONYQIRFK-UHFFFAOYSA-N hydron Chemical compound [H+] GPRLSGONYQIRFK-UHFFFAOYSA-N 0.000 description 1
- 239000001863 hydroxypropyl cellulose Substances 0.000 description 1
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 description 1
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 description 1
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 description 1
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 description 1
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 description 1
- 230000002401 inhibitory effect Effects 0.000 description 1
- 230000000968 intestinal effect Effects 0.000 description 1
- 239000004310 lactic acid Substances 0.000 description 1
- 235000014655 lactic acid Nutrition 0.000 description 1
- DBTMGCOVALSLOR-VPNXCSTESA-N laminarin Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)OC1O[C@@H]1[C@@H](O)C(O[C@H]2[C@@H]([C@@H](CO)OC(O)[C@@H]2O)O)O[C@H](CO)[C@H]1O DBTMGCOVALSLOR-VPNXCSTESA-N 0.000 description 1
- 239000001630 malic acid Substances 0.000 description 1
- 235000011090 malic acid Nutrition 0.000 description 1
- 229910021645 metal ion Inorganic materials 0.000 description 1
- 210000004877 mucosa Anatomy 0.000 description 1
- 239000008183 oral pharmaceutical preparation Substances 0.000 description 1
- 210000001711 oxyntic cell Anatomy 0.000 description 1
- 239000001814 pectin Substances 0.000 description 1
- 235000010987 pectin Nutrition 0.000 description 1
- 229920001277 pectin Polymers 0.000 description 1
- 229920001451 polypropylene glycol Polymers 0.000 description 1
- 239000001103 potassium chloride Substances 0.000 description 1
- 235000011164 potassium chloride Nutrition 0.000 description 1
- 229910001414 potassium ion Inorganic materials 0.000 description 1
- 238000003825 pressing Methods 0.000 description 1
- 229940044551 receptor antagonist Drugs 0.000 description 1
- 239000002464 receptor antagonist Substances 0.000 description 1
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 description 1
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 description 1
- 235000019333 sodium laurylsulphate Nutrition 0.000 description 1
- 239000004334 sorbic acid Substances 0.000 description 1
- 235000010199 sorbic acid Nutrition 0.000 description 1
- 229940075582 sorbic acid Drugs 0.000 description 1
- 230000001629 suppression Effects 0.000 description 1
- 239000000725 suspension Substances 0.000 description 1
- 239000011975 tartaric acid Substances 0.000 description 1
- 235000002906 tartaric acid Nutrition 0.000 description 1
- 235000010487 tragacanth Nutrition 0.000 description 1
- 239000000196 tragacanth Substances 0.000 description 1
- 229940116362 tragacanth Drugs 0.000 description 1
- 230000009466 transformation Effects 0.000 description 1
- 230000000472 traumatic effect Effects 0.000 description 1
Classifications
-
- 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
- A61K31/415—1,2-Diazoles
-
- 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
-
- 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
- A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
- A61K9/5078—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings with drug-free core
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
Landscapes
- Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
Description
Izum se odnosi na jedan farmaceutski oralni pripravak koji sadrži inhibitor pumpanja protona (PPI) i namjenjen je liječenju oboljenja u svezi s želučanom kiselinom kod životinja.
Inhibitori pumpanja protona su moćni inhibitori izlučivanja želučane kiseline i upotrebljavaju se za liječenje oboljenja povezanih s želučanom kiselinom kod ljudi, kao što je, npr., čir na želucu i na dvanaestercu. Ove tvari su podložne raspadanju/pretvorbi uz djelovanje kiselih i neutralnih sredina. Farmaceutski pripravci za oralno davanje ljudima su preporučljivo zaštićeni oblogom koja se topi u tankom crijevu. Ovi pripravci su osjetljivi na vlagu i trebaju se čuvati u dobro zatvorenim hermetičkim posudama kod dužeg skladištenja.
Oboljenja tipa peptičkog ulkusa su uobičajena kod nekih životinja,posebno kod konja i deva. Ostale životinje koje su zanimljive za liječenje oboljenja tipa peptičkog ulkusa su, na primjer, delfini, morževi,ljame, psi, mačke i svinje. Gastro-endoskopskim pregledom konja, nađeni su ulkusi na pločastoj mukozi, fundusu bez žlijezda i na dvanaestercu. Etiologija čira na želucu i dvanaestercu kod konja uglavnom je nepoznata, ali se čini da stres igra važnu ulogu u nekim slučajevima.
Postoje podaci da su spojevi koji djeluju protiv ulkusa, kao što su antagonisti histamin-2-receptora, davani jednom konju nekoliko puta dnevno uz pomoć cijevi kroz grlo ili kroz nos do želuca. Ovaj postupak može biti traumatičan i može zahtjevati lagano uspavljivanje konja. Za davanje lijeka su potrebne kvalificirane osobe.
Omeprazol i ostali inhibitori protonskog pumpanja su moćni inhibitori izlučivanja želučane kiseline kod životinja. Oni blokiraju proizvodnju želučane kiseline inhibicijom H+K+-ATPaze, enzima odgovornog za produkciju vodikovog iona u parietalnim stanicama. Inhibitori pumpanja protona izazivaju temeljno suzbijanje kiseline, i, za razliku od većine protivulkusnih spojeva, kao što su, na primjer, H2-blokeri, omeprazol se može davati samo jedanput dnevno. Prema prikazanom izumu, kuglice prevučene ohlogom koja se topi u tankom crijevu, a koje sadrže omeprazol, stavljene u neki gel pripravak, mogu se lagano nanijeti na gornji dio jezika konja i u poljskim uvjetima, a konji to dobro prihvaćaju.
Takav vlažni gel koji sadrži kuglice inhibitora pumpanja protona s oblogom topivom u tankom crijevu, nije stabilan kod dugotrajnog skladištenja na sobnoj temperaturi, pa se mora pripravljati neposredno prije davanja. Do danas ne postoji takav pripravak na tržištu.
Omeprazol, 5-metoksi-2-(((4-metoksi-3,5-dimietil-2-piridinil)metil)sulfinil)-1H-benzimidazol, prikazanje u europskom patentu br. 5129 kao moćan inhibitor izlučivanja želučane kiseline.
Lansoprazol, 2-[[[3-metil-4-(2,2,2-trifluoretoksi)-2-piridil]metil]sulfinil]-1H-benzimidazol, opisan je u europskom
patentu br. 174 726 kao moćan inhibitor izlučivanja želučane kiseline.
Pantoprazol je prikazan u europskom patentu br. 166 287 kao moćan inhibitor izlučivanja želučane kiseline.
Leminoprazol je prikazan u britanskom patentu br. 2 163 747.
Cilj prikazanog izuma je ostvarenje oralnih farmaceutskih pripravaka koji će se lagano davati konjima i ostalim životinjama. Inhibitor pumpanja protona je u vidu suhih čestica, kao što su kuglice ili tablete, koje su prevučene s jednom ili više obloga, od kojih je jedna topiva u tankom crijevu. Kuglice ili tablete se mogu pripremati prešanjem, kristalizacijom, nanošenjem otopine ili suspenzije inhibitora pumpanja protona na inertne jezgre, istiskivanjem i oblikovanjem kuglica ili sličnim postupcima. Kuglice ili tablete topive u tankom crijevu, miješaju se sa suhim sredstvom, ili sredstvima za želatiranje kao što je, na primjer, ksantan smola, guar smola, smola bagremovog sjemena, tragakant, modificirani derivati celuloze ili slični spojevi koji stvaraju gel. Po dodatku vode, nastaje gel sličan kremi. Taj se gel, na primjer, nanosi na gornju stranu jezika životinje kao sto je konj, a uz pomoć prigodne naprave za nanošenje.
Inhibitori pumpanja protona koji se upotrebljavaju u pripravcima prema izumu su spojevi općenite formule I
[image]
gdje je R,
[image]
R1 i R3 su neovisno odabrani između vodika, nižeg alkila, nižeg alkoksi i halogena, R2je odabran između vodika, nižeg alkila, nižeg alkoksi, niži alkoksi-nižeg alkoksi, nižeg fluoralkoksi i
[image]
R4 i R5 su neovisno odabrani između nižih alkila, A je
[image]
R6 i R7 su neovisno odabrani između vodika, nižeg alkila, nižeg alkoksi, nižeg fluoralkoksi, halogena,
[image]
kod čega je R8 niži alkohol ili niži alkoksi.
Pod nižim alkilom u prikazanom izumu podrazumijeva se alkilna skupina koja ima 1-5 ugljikovih atoma.
Pod nižim alkoksi u prikazanom izumu podrazumijeva se alkoksi skupina koja ima 1-5 ugljikovih atoma.
Primjeri inhibitora pumpanja protona prema formuli I su
[image]
[image]
Inhibitori pumpanja protona koji se upotrebljavaju u pripravcima prema izumu mogu se upotrebljavati kao neutralni ili kao lužnate soli, kao što su, na primjer, Mg2+, Ca2+, Na+ ili K+ soli, preporučivo Mg2+ ili Na+ soli. Tamo gdje je to primjenjljivo, naprijed navedeni spojevi mogu se upotrebljavati racemični ili kao jedan u biti čisti enantiomer.
Kod jedne izvedbe izuma, čestice s oblogom topivim u tankom crijevu (dalje :crijevno obložene čestice), pomiješane su s prigodnim tvarima kao što su, na primjer, anorganske ili organske soli kalija, kalcija, magnezija ili aluminija topive u vodi. Kada se vodena otopina prigodnog, ili prigodnih polimernih spojeva, kao što je, na primjer, kapa-karaginan, pektin, neionski polimeri za koje se zna da stvaraju gel s pozitivno nabijenim kovinskim ionima ili slični spojevi, doda smjesi, nastaje gel kao krema uzajamnim djelovanjem iona i polimera.
Kod druge izvedbe izuma, crijevno obložene čestice miješaju se s prigodnim sastojcima. Kada se doda otopina malog viskoziteta nekog polimera osjetljivog na temperaturu, kao što je, na primjer, etilhidroksietilceluloza (EHEC) ili polietilenpolipropilen-glikoli ili slične tvari, pa se sustav zagrije do temperature 33-35°C ili više, nastaje viskozni gel sličan kremi.
Kod još jedne izvedbe izuma crijevno obložene čestice se miješaju s prigodnim tvarima u vidu sredstava za želatinizaciju.Takvi agensi su akacija, agar, alginska kiselina, natrij-karboksimetil-celuloza, hidroksipropil-celuloza, hidroksipropilmetil-celuloza ili ostali slični derivati celuloze, fukoidan, ksantanska smola, furcelaranm laminaran ili slična sredstva za želatinizaciju.
Kod jedne preporučive izvedbe izuma, inhibitor pumpanja iona je omeprazol. Količina pojedinih sastojaka pripravka može se mijenjati i ovisit će od raznih čimbenika kao što je, na primjer, pojedinačna potreba životinjekoja se liječi.
Količina sredstava za želatinaciju može se mijenjati, ali je u granicama 0,02 do 20% težinski, računato na količinu vlažnog gela, poželjno u rasponu od 0,2 do 20%, a naročito 0,5 do 5% težinski.
Količina aktivne tvari, tj. crijevno obloženih čestica ovisit će o pojedinačnom doziranju po životinji.Tako je, na primjer, količina čestica s oblogom topivom u tankom crijevu obično u rasponu od 0,1 do 20 g, preporučivo 0,2 do 10 grama po dozi kod konja. Ukupni volumen gotovog gela koji se daje konjima je u rasponu od 5 do 50 mL.
Pogodne tvari se mogu dodati crijevno obloženim česticama inhibitora pumpanja protona miješanjem različitih tvari s crijevno obloženim česticama u jednu smjesu ili u prepisanu smjesu. Prepisana smjesa se može načiniti, na primjer, adhezijom čestica ili postupcima oblaganja.
Smjese crijevno obloženih čestica inhibitora pumpanja protona i prigodnih sastojaka suše se prije ili poslije miješanja, do razine vlažnosti na kojoj inhibitor pumpanja protona ima dobru vremensku stabilnost. Smjesa se poželjno stavlja u hermetičku spravu za nanošenje, najbolje u vidu brizgalice.
Smjesa crijevno obloženih kuglica ili tableta inhibitora pumpanja protona i ostalih sastojaka može također sadržavati i neku prigodnu pH-pufersku tvar koja će poboljšati funkcionalnu stabilnost pripravka tijekom njegovog prolaza kroz jednjak i želudac prije nego što stigne do tankog crijeva gdje se inhibitor pumpanja protona otapa i apsorbira. Prigodne puterske tvari su limunska kiselina, vinska kiselina, jantarna kiselina, jabučna kiselina, mliječna kiselina, benzojeva kiselina, sorbinska kiselina i asorbinska kiselina i ostale tvari. Ove će tvari smanjiti pH-vrijednost dobivenog gela na vrijednost nižu od 5,5, čime se štiti obloga kuglica ili tableta koja se otapa u tankom crijevu.
Osim toga, smjesa crijevno obloženih čestica i prigodnih sastojaka može sadržavati i inertne čestice kao što su kuglice, radi olakšavanja miješanja različitih sastojaka s crijevno obloženim česticama. Takve inertne kuglice su, na primjer, šećerne kuglice stvrdnute kore ili bilo koja druga vrsta kuglica koje nisu opasne za životinju.
Crijevno obložene kuglice ili tablete mogu se pripravljati uobičajenim postupcima. Crijevno obložena zrnca omeprazola mogu se pripravljati kako je opisano u europskom patentu br. 247 983. Ova crijevno obložena zrnca ili kuglice omeprazola obložene su s najmanje dvije obloge od kojih je jedna izolacijska obloga/donja obloga, a druga je obloga topiva u debelom crijevu.
Priprava stabilnog farmaceutskog pripravka prema izumu obavlja se uključivanjem inhibitora pumpanja protona u obliku kuglica ili tableta, koje su prevučene s jednom ili više obloga od kojih je jedna topiva u tankom crijevu, u gel u vidu kreme.
Točnije, priprava pripravka u vidu gela sličnog kremi obavlja se bilo I) miješanjem obloženih čestica inhibitora pumpanja protona s nekim sredstvom za želatinizaciju i, eventualno, s nekim pH-puferskim sustavom koji štiti obložene čestice, nakon čega se voda dodaje na licu mjesta, neposredno prije davanja životinji, ili II) miješanjem obloženih čestica s nekom soli koja sadrži kalij ili kalcij ion i, eventualno, neki pH-puferski sustav, a zatim na licu mjesta, neposredno prije davanja životinji, s vodenom otopinom malog viskoziteta nekog sredstva za želatizaciju kao što je neki kopolimerni spoj ili spojevi, ili III) miješanjem obloženih čestica na licu mjesta, neposredno prije davanja životinji, s otopinom malog viskoziteta nekog sredstva za želatinizaciju u vidu polimera osjetljivog na temperaturu i, eventualno, nekim pH-puferskim sustavom, i izlaganje smjese laganom zagrijavanju.
Radni primjeri
Zrnca omeprazola s oblogom topivom u tankom crijevu pripravljena su prema primjeru 2 iz europskog patenta broj 247 983. EP 247 983 uključen je ovdje kao literatura.
Primjer 1
Crijevno obložena zrnca omeprazola 7 g
(odgovara oko 600 mg omeprazola)
Ksantanska smola 0,3 g
pomiješani su u jednoj brizgalici.
Kada se doda 10 mL vode, nastaje viskozan gel.
Primjer 2
Crijevno obložena zrnca omeprazola 7 g
Ksantanska smola 0,3 g
Limunska kiselina 60 mg
pomiješani su u jednoj brizgalici.
Kada se doda 10 mL vode, nastaje viskozan gel.
Primjer 3
Crijevno obložena zrnca omeprazola 7 g
Kalij-klorid 30 mg
pomiješani su u jednoj brizgalici.
Kada se doda 10 mL l%-tne otopine kapa-karaginana, nastaje viskozan gel.
Primjer 4
Crijevno obložena zrnca omeprazola 7 g
pomiješane su u jednoj brizgalici.
Kada se doda 10 mL otopine EHEC 1,25% i natrij-lauril sulfata
0,1% i zagrije do 35 °C, nastaje viskozni gel.
Primjer 5
Crijevno obložena zrnca lansoprazola 10 g
(pripravljena prema primjerima 1 i 2
iz EP 277 741)
(odgovara oko 900 mg lansoprazola)
Ksantanska smola 0,45 g
Limunska kiselina 80 mg
Kada se doda 15 mL vode nastaje viskozni gel.
Prinijer 6
Crijevno obložena zrnca pantoprazola 10 g
(pripravljena prema primjeru 2 iz
EP 519 365)
(odgovara oko 1200 mg pantoprazola)
Ksantanska smola 0,3 g
Limunska kiselina 50 mg
Kada se doda 10 mL vode nastaje viskozni gel.
Trenutno najbolji poznati način izvedbe izuma je primjena pripravka opisanog u primjeru 2.
Claims (20)
1. Farmaceutski pripravak za oralno davanje životinjama, naznačen time, što obuhvaća jedan inhibitor pumpanja protona u obliku kuglica ili tableta, koje su prevučene s jednom ili više obloga od kojih je jedna topiva u tankom crijevu, uključen u gel u vidu kreme.
2. Farmaceutski pripravak prema zahtjevu 1, naznačen time, što su kuglice ili tablete prekrivene s najmanje dvije obloge od kojih je jedna donja obloga, a druga obloga je topiva u tankom crijevu.
3. Farmaceutski pripravak prema zahtjevu 1 ili 2, naznačen time, što su životinje konji.
4. Farmaceutski pripravak prema zahtjevu 1 ili 2, naznačen time, što obuhvaća sastojke koji su suhe tablete ili tablete s oblogom topivom u tankom crijevu, eventualno miješane sa suhim sastojcima, koji sastojci po dodatku vode ili neke vodene otopine daju gel u vidu kreme.
5. Farmaceutski pripravak prema bilo kojem od zahtjeva od 1 do 4, naznačen time, što obuhvaća sastojke koji su suhe kuglice ili tablete s oblogom topivom u tankom crijevu, suho sredstvo ili sredstva za želatinizacijui eventualno pH-pufersku tvar i/iii tvari za davanje okusa, a koji sastojci dodatkom vode daju gel kao kremu.
6. Farmaceutski pripravak prema bilo kojem od zahtjeva od 1 do 5, naznačen time, što su suhe kuglice ili tablete s oblogom topivom u tankom crijevu, suho sredstvo ili sredstva za želatinizaciju i eventualno pH-puferska tvar i/ili tvari za davanje okusa pomiješani u jednu smjesu.
7. Farmaceutski pripravak prema zahtjevu 6, naznačen time, što je smjesa jedna prepisana smjesa.
8. Farmaceutski pripravak prema bilo kojem od zahtjeva od 1 do 4, naznačen time, što obuhvaća prvu skupinu sastojaka koju čine suhe kuglice ili tablete s oblogom topivom u tankom crijevu, organsku ili anorgansku sol kalija, kalcija, magnezija ili aluminija topivu u vodi, i eventualno pH-puferske tvari i/ili tvari za davanje okusa, i drugu skupinu sastojaka koja je vodena otopina nekog sredstva za želatinizaciju, a koje skupine sastojaka kada se pomiješaju daju gel u vidu kreme.
9. Farmaceutski pripravak prema bilo kojem od zahtjeva od 1 do 4, naznačen time, što obuhvaća prvu skupinu sastojaka koju čine suhe kuglice ili tablete s oblogom topivom u tankom crijevu, eventualno pomiješane s pH-puferskom tvari i/ili tvari za davanje okusa, i drugu skupinu sastojaka koja je vodena otopina nekog sredstva za želatinizaciju osjetljivog na temperaturu, a koje skupine sastojaka kada se pomiješaju i izlože laganom zagrijavanju daju gel u vidu kreme.
10. Farmaceutski pripravak prema bilo kojem od zahtjeva 1 do 9, naznačen time, što je inhibitor pumpanja protona omeprazol.
11. Farmaceutski pripravak prema bilo kojem od zahtjeva 1 do 9, naznačen time, što je inhibitor pumpanja protona lansoprazol.
12. Farmaceutski pripravak prema bilo kojem od zahtjeva 1 do 9, naznačen time, što je inhibitor pumpanja protona pantoprazol.
13. Farmaceutski pripravak prema bilo kojem od zahtjeva 1 do 9, naznačen time, što je inhibitor pumpanja protona leminoprazol.
14. Stabilan farmaceutski pripravak u vidu jednog kompleta koji sadrži suhe kuglice ili tablete inhibitora pumpanja protona s oblogom topivim u tankom crijevu, i suhe sastojke, a koji sastojci s dodatkom vode ili neke vodene otopine daju gel u vidu kreme.
15. Stabilan farmaceutski pripravak u vidu jednog kompleta koji sadrži prvu skupinu sastojaka koji su kuglice ili tablete inhibitora pumpanja protona s oblogom topivom u tankom crijevu, organsku ili anorgansku sol kalija, kalcija, magnezija ili akiininija topivu u vodi, i eventualno pH-puferske tvari i/ili tvari za davanje okusa, i drugu skupinu sastojaka koja je suho sredstvo ili sredstva za želatinizaciju, a koje skupine sastojaka kada se miješaju u nazočnosti vode daju gel u vidu kreme.
16. Stabilan farmaceutski pripravak u vidu jednog kompleta koji sadrži prvu skupinu sastojaka koji su kuglice ili tablete inhibitora pumpanja protona s oblogom topivom u tankom crijevu, eventualno miješane s pH-puferskim tvarima i/ili tvari za davanje okusa, i drugu skupinu sastojaka koja je sredstvo ili sredstva za želatinizaciju osjetljiva na temperaturu, a koje skupine sastojaka kada se miješaju u nazočnosti vode i lagano zagrijavaju daju gel u vidu kreme.
17. Farmaceutski pripravak prema bilo kojem od zahtjeva 1 do 16, naznačen time, što je pripravak u cjelosti ili njegovi djelovi smješten u spravu za nanošenje u obliku brizgalice.
18. Postupak za pripravu farmaceutskog pripravka prema bilo kojem od zahtjeva 1 do 13, naznačen time, što se jedan inhibitor pumpanja protona u vidu perli s jednom ili više obloga, od kojih je jedna topiva u tankom crijevu, uključuje u jedan gel u vidu kreme.
19. Primjena pripravka prema bilo kojem od zahtjeva 1 do 17 za pripravu aktivnog doznog oblika za liječenje oboljenja povezanih s želučanom kiselinom kod životinja.
20. Postuapk za liječenje oboljenja povezanih s želučanom kiselinom po kojem se jedna fiziološki aktivna količina pripravka prema zahtjevima 1 do 17 daje životinji kojoj je potrebno takvo liječenje.
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| SE19939301489A SE9301489D0 (sv) | 1993-04-30 | 1993-04-30 | Veterinary composition |
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|---|---|
| HRP940267A2 true HRP940267A2 (en) | 1996-10-31 |
Family
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| EP (1) | EP0696921B1 (hr) |
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| KR (1) | KR100324451B1 (hr) |
| CN (1) | CN1100570C (hr) |
| AT (1) | ATE199060T1 (hr) |
| AU (1) | AU678830B2 (hr) |
| BR (1) | BR9406363A (hr) |
| CZ (1) | CZ285191B6 (hr) |
| DE (1) | DE69426669T2 (hr) |
| DK (1) | DK0696921T3 (hr) |
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| EG (1) | EG20401A (hr) |
| ES (1) | ES2155473T3 (hr) |
| FI (1) | FI955124A0 (hr) |
| GR (1) | GR3035831T3 (hr) |
| HR (1) | HRP940267A2 (hr) |
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