JP2009203218A - イブプロフェン及びトラネキサム酸含有固形製剤 - Google Patents
イブプロフェン及びトラネキサム酸含有固形製剤 Download PDFInfo
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- JP2009203218A JP2009203218A JP2008191552A JP2008191552A JP2009203218A JP 2009203218 A JP2009203218 A JP 2009203218A JP 2008191552 A JP2008191552 A JP 2008191552A JP 2008191552 A JP2008191552 A JP 2008191552A JP 2009203218 A JP2009203218 A JP 2009203218A
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- acid
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- 238000002360 preparation method Methods 0.000 title claims abstract description 69
- 239000007787 solid Substances 0.000 title claims abstract description 68
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- 229960001680 ibuprofen Drugs 0.000 title claims abstract description 59
- GYDJEQRTZSCIOI-LJGSYFOKSA-N tranexamic acid Chemical compound NC[C@H]1CC[C@H](C(O)=O)CC1 GYDJEQRTZSCIOI-LJGSYFOKSA-N 0.000 title claims abstract description 51
- 229960000401 tranexamic acid Drugs 0.000 title claims abstract description 51
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- 150000003839 salts Chemical class 0.000 claims abstract description 41
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- BJEPYKJPYRNKOW-UHFFFAOYSA-N alpha-hydroxysuccinic acid Natural products OC(=O)C(O)CC(O)=O BJEPYKJPYRNKOW-UHFFFAOYSA-N 0.000 claims description 26
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- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 claims description 25
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- BEFDCLMNVWHSGT-UHFFFAOYSA-N ethenylcyclopentane Chemical compound C=CC1CCCC1 BEFDCLMNVWHSGT-UHFFFAOYSA-N 0.000 claims description 7
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- VZCYOOQTPOCHFL-UPHRSURJSA-N maleic acid Chemical compound OC(=O)\C=C/C(O)=O VZCYOOQTPOCHFL-UPHRSURJSA-N 0.000 claims description 7
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- 125000004432 carbon atom Chemical group C* 0.000 description 70
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- 125000002887 hydroxy group Chemical group [H]O* 0.000 description 37
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- PHTQWCKDNZKARW-UHFFFAOYSA-N isoamylol Chemical compound CC(C)CCO PHTQWCKDNZKARW-UHFFFAOYSA-N 0.000 description 16
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 15
- 230000008961 swelling Effects 0.000 description 15
- 229940093915 gynecological organic acid Drugs 0.000 description 14
- 235000005985 organic acids Nutrition 0.000 description 14
- VFPFQHQNJCMNBZ-UHFFFAOYSA-N ethyl gallate Chemical compound CCOC(=O)C1=CC(O)=C(O)C(O)=C1 VFPFQHQNJCMNBZ-UHFFFAOYSA-N 0.000 description 12
- 229960004543 anhydrous citric acid Drugs 0.000 description 11
- RYYVLZVUVIJVGH-UHFFFAOYSA-N caffeine Chemical compound CN1C(=O)N(C)C(=O)C2=C1N=CN2C RYYVLZVUVIJVGH-UHFFFAOYSA-N 0.000 description 11
- ZGTMUACCHSMWAC-UHFFFAOYSA-L EDTA disodium salt (anhydrous) Chemical compound [Na+].[Na+].OC(=O)CN(CC([O-])=O)CCN(CC(O)=O)CC([O-])=O ZGTMUACCHSMWAC-UHFFFAOYSA-L 0.000 description 10
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- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 description 9
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- 235000016337 monopotassium tartrate Nutrition 0.000 description 6
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- 229960002392 diphenylpyraline hydrochloride Drugs 0.000 description 1
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- SRRLDCNCJFKVFJ-UHFFFAOYSA-J disodium;2-[2-[bis(carboxylatomethyl)amino]ethyl-(carboxylatomethyl)amino]acetate;cobalt(2+) Chemical compound [Na+].[Na+].[Co+2].[O-]C(=O)CN(CC([O-])=O)CCN(CC([O-])=O)CC([O-])=O SRRLDCNCJFKVFJ-UHFFFAOYSA-J 0.000 description 1
- 238000009826 distribution Methods 0.000 description 1
- 229940005636 dl- methylephedrine Drugs 0.000 description 1
- 229940073563 dl- methylephedrine hydrochloride Drugs 0.000 description 1
- DLNKOYKMWOXYQA-UHFFFAOYSA-N dl-pseudophenylpropanolamine Natural products CC(N)C(O)C1=CC=CC=C1 DLNKOYKMWOXYQA-UHFFFAOYSA-N 0.000 description 1
- 229940126534 drug product Drugs 0.000 description 1
- DZYNKLUGCOSVKS-UHFFFAOYSA-N epigallocatechin Natural products OC1Cc2cc(O)cc(O)c2OC1c3cc(O)c(O)c(O)c3 DZYNKLUGCOSVKS-UHFFFAOYSA-N 0.000 description 1
- 229960000514 ethenzamide Drugs 0.000 description 1
- SBNKFTQSBPKMBZ-UHFFFAOYSA-N ethenzamide Chemical compound CCOC1=CC=CC=C1C(N)=O SBNKFTQSBPKMBZ-UHFFFAOYSA-N 0.000 description 1
- MVPICKVDHDWCJQ-UHFFFAOYSA-N ethyl 3-pyrrolidin-1-ylpropanoate Chemical compound CCOC(=O)CCN1CCCC1 MVPICKVDHDWCJQ-UHFFFAOYSA-N 0.000 description 1
- 238000011156 evaluation Methods 0.000 description 1
- 229930003935 flavonoid Natural products 0.000 description 1
- 235000017173 flavonoids Nutrition 0.000 description 1
- 150000002215 flavonoids Chemical class 0.000 description 1
- 235000013373 food additive Nutrition 0.000 description 1
- 239000002778 food additive Substances 0.000 description 1
- 235000019253 formic acid Nutrition 0.000 description 1
- 235000004611 garlic Nutrition 0.000 description 1
- 230000002496 gastric effect Effects 0.000 description 1
- 210000001156 gastric mucosa Anatomy 0.000 description 1
- 239000000499 gel Substances 0.000 description 1
- 239000008273 gelatin Substances 0.000 description 1
- 229920000159 gelatin Polymers 0.000 description 1
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- 235000011852 gelatine desserts Nutrition 0.000 description 1
- 235000008397 ginger Nutrition 0.000 description 1
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- 235000019410 glycyrrhizin Nutrition 0.000 description 1
- LPLVUJXQOOQHMX-QWBHMCJMSA-N glycyrrhizinic acid Chemical compound O([C@@H]1[C@@H](O)[C@H](O)[C@H](O[C@@H]1O[C@@H]1C([C@H]2[C@]([C@@H]3[C@@]([C@@]4(CC[C@@]5(C)CC[C@@](C)(C[C@H]5C4=CC3=O)C(O)=O)C)(C)CC2)(C)CC1)(C)C)C(O)=O)[C@@H]1O[C@H](C(O)=O)[C@@H](O)[C@H](O)[C@H]1O LPLVUJXQOOQHMX-QWBHMCJMSA-N 0.000 description 1
- 239000008187 granular material Substances 0.000 description 1
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- VUYDGVRIQRPHFX-UHFFFAOYSA-N hesperidin Natural products COc1cc(ccc1O)C2CC(=O)c3c(O)cc(OC4OC(COC5OC(O)C(O)C(O)C5O)C(O)C(O)C4O)cc3O2 VUYDGVRIQRPHFX-UHFFFAOYSA-N 0.000 description 1
- OROGSEYTTFOCAN-UHFFFAOYSA-N hydrocodone Natural products C1C(N(CCC234)C)C2C=CC(O)C3OC2=C4C1=CC=C2OC OROGSEYTTFOCAN-UHFFFAOYSA-N 0.000 description 1
- 229960001545 hydrotalcite Drugs 0.000 description 1
- 229910001701 hydrotalcite Inorganic materials 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
- 230000000147 hypnotic effect Effects 0.000 description 1
- 239000005554 hypnotics and sedatives Substances 0.000 description 1
- 230000004054 inflammatory process Effects 0.000 description 1
- YNQQEYBLVYAWNX-WLHGVMLRSA-N ketotifen fumarate Chemical compound OC(=O)\C=C\C(O)=O.C1CN(C)CCC1=C1C2=CC=CC=C2CC(=O)C2=C1C=CS2 YNQQEYBLVYAWNX-WLHGVMLRSA-N 0.000 description 1
- 229960003630 ketotifen fumarate Drugs 0.000 description 1
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- 239000007942 layered tablet Substances 0.000 description 1
- 229940031703 low substituted hydroxypropyl cellulose Drugs 0.000 description 1
- VTHJTEIRLNZDEV-UHFFFAOYSA-L magnesium dihydroxide Chemical compound [OH-].[OH-].[Mg+2] VTHJTEIRLNZDEV-UHFFFAOYSA-L 0.000 description 1
- 239000000347 magnesium hydroxide Substances 0.000 description 1
- 229910001862 magnesium hydroxide Inorganic materials 0.000 description 1
- JFQQIWNDAXACSR-UHFFFAOYSA-L magnesium malate Chemical compound [Mg+2].[O-]C(=O)C(O)CC([O-])=O JFQQIWNDAXACSR-UHFFFAOYSA-L 0.000 description 1
- 229940096424 magnesium malate Drugs 0.000 description 1
- 239000000395 magnesium oxide Substances 0.000 description 1
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- 229960000869 magnesium oxide Drugs 0.000 description 1
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- ZADYMNAVLSWLEQ-UHFFFAOYSA-N magnesium;oxygen(2-);silicon(4+) Chemical compound [O-2].[O-2].[O-2].[Mg+2].[Si+4] ZADYMNAVLSWLEQ-UHFFFAOYSA-N 0.000 description 1
- 229940049920 malate Drugs 0.000 description 1
- WPBNNNQJVZRUHP-UHFFFAOYSA-L manganese(2+);methyl n-[[2-(methoxycarbonylcarbamothioylamino)phenyl]carbamothioyl]carbamate;n-[2-(sulfidocarbothioylamino)ethyl]carbamodithioate Chemical compound [Mn+2].[S-]C(=S)NCCNC([S-])=S.COC(=O)NC(=S)NC1=CC=CC=C1NC(=S)NC(=O)OC WPBNNNQJVZRUHP-UHFFFAOYSA-L 0.000 description 1
- 230000007721 medicinal effect Effects 0.000 description 1
- 229960005042 mequitazine Drugs 0.000 description 1
- 229910052751 metal Inorganic materials 0.000 description 1
- 239000002184 metal Substances 0.000 description 1
- 229930182817 methionine Natural products 0.000 description 1
- 125000002496 methyl group Chemical group [H]C([H])([H])* 0.000 description 1
- 201000009240 nasopharyngitis Diseases 0.000 description 1
- ARGKVCXINMKCAZ-UHFFFAOYSA-N neohesperidine Natural products C1=C(O)C(OC)=CC=C1C1OC2=CC(OC3C(C(O)C(O)C(CO)O3)OC3C(C(O)C(O)C(C)O3)O)=CC(O)=C2C(=O)C1 ARGKVCXINMKCAZ-UHFFFAOYSA-N 0.000 description 1
- 208000004296 neuralgia Diseases 0.000 description 1
- 229910052759 nickel Inorganic materials 0.000 description 1
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 description 1
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 description 1
- 239000003921 oil Substances 0.000 description 1
- 235000019198 oils Nutrition 0.000 description 1
- 229960003104 ornithine Drugs 0.000 description 1
- 235000006408 oxalic acid Nutrition 0.000 description 1
- GHZNWXGYWUBLLI-UHFFFAOYSA-N p-Lactophenetide Chemical compound CCOC1=CC=C(NC(=O)C(C)O)C=C1 GHZNWXGYWUBLLI-UHFFFAOYSA-N 0.000 description 1
- AQIXEPGDORPWBJ-UHFFFAOYSA-N pentan-3-ol Chemical compound CCC(O)CC AQIXEPGDORPWBJ-UHFFFAOYSA-N 0.000 description 1
- 150000002989 phenols Chemical class 0.000 description 1
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- SONNWYBIRXJNDC-VIFPVBQESA-N phenylephrine Chemical compound CNC[C@H](O)C1=CC=CC(O)=C1 SONNWYBIRXJNDC-VIFPVBQESA-N 0.000 description 1
- 229960001802 phenylephrine Drugs 0.000 description 1
- DLNKOYKMWOXYQA-APPZFPTMSA-N phenylpropanolamine Chemical compound C[C@@H](N)[C@H](O)C1=CC=CC=C1 DLNKOYKMWOXYQA-APPZFPTMSA-N 0.000 description 1
- 229960000395 phenylpropanolamine Drugs 0.000 description 1
- 239000006187 pill Substances 0.000 description 1
- 229920002451 polyvinyl alcohol Polymers 0.000 description 1
- 235000019422 polyvinyl alcohol Nutrition 0.000 description 1
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 description 1
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 description 1
- 239000001267 polyvinylpyrrolidone Substances 0.000 description 1
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 1
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 1
- 239000011591 potassium Substances 0.000 description 1
- 229960003975 potassium Drugs 0.000 description 1
- 229910052700 potassium Inorganic materials 0.000 description 1
- QFRKWSPTCBGLSU-UHFFFAOYSA-M potassium 4-hydroxy-3-methoxybenzene-1-sulfonate Chemical compound [K+].COC1=CC(S([O-])(=O)=O)=CC=C1O QFRKWSPTCBGLSU-UHFFFAOYSA-M 0.000 description 1
- GRLPQNLYRHEGIJ-UHFFFAOYSA-J potassium aluminium sulfate Chemical compound [Al+3].[K+].[O-]S([O-])(=O)=O.[O-]S([O-])(=O)=O GRLPQNLYRHEGIJ-UHFFFAOYSA-J 0.000 description 1
- 229940069505 potassium guaiacolsulfonate Drugs 0.000 description 1
- 239000001415 potassium malate Substances 0.000 description 1
- SVICABYXKQIXBM-UHFFFAOYSA-L potassium malate Chemical compound [K+].[K+].[O-]C(=O)C(O)CC([O-])=O SVICABYXKQIXBM-UHFFFAOYSA-L 0.000 description 1
- 235000011033 potassium malate Nutrition 0.000 description 1
- 235000010241 potassium sorbate Nutrition 0.000 description 1
- 239000004302 potassium sorbate Substances 0.000 description 1
- 229940069338 potassium sorbate Drugs 0.000 description 1
- 239000003755 preservative agent Substances 0.000 description 1
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- 235000019260 propionic acid Nutrition 0.000 description 1
- 235000019423 pullulan Nutrition 0.000 description 1
- IUVKMZGDUIUOCP-BTNSXGMBSA-N quinbolone Chemical compound O([C@H]1CC[C@H]2[C@H]3[C@@H]([C@]4(C=CC(=O)C=C4CC3)C)CC[C@@]21C)C1=CCCC1 IUVKMZGDUIUOCP-BTNSXGMBSA-N 0.000 description 1
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- 239000000932 sedative agent Substances 0.000 description 1
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- 229960001153 serine Drugs 0.000 description 1
- 235000015170 shellfish Nutrition 0.000 description 1
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- WXMKPNITSTVMEF-UHFFFAOYSA-M sodium benzoate Chemical compound [Na+].[O-]C(=O)C1=CC=CC=C1 WXMKPNITSTVMEF-UHFFFAOYSA-M 0.000 description 1
- 239000004299 sodium benzoate Substances 0.000 description 1
- 235000010234 sodium benzoate Nutrition 0.000 description 1
- 229960003885 sodium benzoate Drugs 0.000 description 1
- JWBPVFVNISJVEM-UHFFFAOYSA-M sodium caffeine benzoate Chemical compound [Na+].[O-]C(=O)C1=CC=CC=C1.CN1C(=O)N(C)C(=O)C2=C1N=CN2C JWBPVFVNISJVEM-UHFFFAOYSA-M 0.000 description 1
- 239000004320 sodium erythorbate Substances 0.000 description 1
- 235000010352 sodium erythorbate Nutrition 0.000 description 1
- DVQHRBFGRZHMSR-UHFFFAOYSA-N sodium methyl 2,2-dimethyl-4,6-dioxo-5-(N-prop-2-enoxy-C-propylcarbonimidoyl)cyclohexane-1-carboxylate Chemical compound [Na+].C=CCON=C(CCC)[C-]1C(=O)CC(C)(C)C(C(=O)OC)C1=O DVQHRBFGRZHMSR-UHFFFAOYSA-N 0.000 description 1
- 229940045902 sodium stearyl fumarate Drugs 0.000 description 1
- RBWSWDPRDBEWCR-RKJRWTFHSA-N sodium;(2r)-2-[(2r)-3,4-dihydroxy-5-oxo-2h-furan-2-yl]-2-hydroxyethanolate Chemical compound [Na+].[O-]C[C@@H](O)[C@H]1OC(=O)C(O)=C1O RBWSWDPRDBEWCR-RKJRWTFHSA-N 0.000 description 1
- KZQSXALQTHVPDQ-UHFFFAOYSA-M sodium;butanedioate;hydron Chemical compound [Na+].OC(=O)CCC([O-])=O KZQSXALQTHVPDQ-UHFFFAOYSA-M 0.000 description 1
- 235000019698 starch Nutrition 0.000 description 1
- 239000008117 stearic acid Substances 0.000 description 1
- 239000004575 stone Substances 0.000 description 1
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- 229910052623 talc Inorganic materials 0.000 description 1
- 235000012222 talc Nutrition 0.000 description 1
- JZRWCGZRTZMZEH-UHFFFAOYSA-N thiamine Chemical compound CC1=C(CCO)SC=[N+]1CC1=CN=C(C)N=C1N JZRWCGZRTZMZEH-UHFFFAOYSA-N 0.000 description 1
- 229960002898 threonine Drugs 0.000 description 1
- JWIXXNLOKOAAQT-UHFFFAOYSA-N tipepidine Chemical compound C1N(C)CCCC1=C(C=1SC=CC=1)C1=CC=CS1 JWIXXNLOKOAAQT-UHFFFAOYSA-N 0.000 description 1
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- 239000004474 valine Substances 0.000 description 1
- 235000019154 vitamin C Nutrition 0.000 description 1
- 239000011718 vitamin C Substances 0.000 description 1
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid
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- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
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- A61K9/00—Medicinal preparations characterised by special physical form
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
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- A—HUMAN NECESSITIES
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- Oil, Petroleum & Natural Gas (AREA)
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Abstract
イブプロフェン及びトラネキサム酸を含有する固形製剤であって、高温保存条件下における膨張が抑制された固形製剤を提供すること。
【解決手段】
イブプロフェン及びトラネキサム酸を含有する固形製剤であって、有機酸若しくはそのエステル又はそれらの塩を含有する固形製剤。
【選択図】 なし
Description
[1] イブプロフェン及びトラネキサム酸を含有する固形製剤であって、有機酸若しくはそのエステル又はそれらの塩を含有する固形製剤。
[2] 有機酸若しくはそのエステル又はそれらの塩を含有してなる、イブプロフェン及びトラネキサム酸を含有する固形製剤のための膨張抑制剤。
[3] イブプロフェン及びトラネキサム酸を含有する固形製剤であって、膨張抑制成分として、有機酸若しくはそのエステル又はそれらの塩を含有する固形製剤。
[4] イブプロフェン及びトラネキサム酸を含有する固形製剤を製造する方法であって、
有機酸若しくはそのエステル又はそれらの塩を添加する工程、
を含むことを特徴とする製造方法。
[5] イブプロフェン及びトラネキサム酸を含有する固形製剤を製造する方法であって、
膨張抑制成分として、有機酸若しくはそのエステル又はそれらの塩を添加する工程、
を含むことを特徴とする製造方法。
[6] イブプロフェン及びトラネキサム酸を含有する固形製剤を製造するための、有機酸若しくはそのエステル又はそれらの塩の使用(use)。
[7] 膨張抑制された、イブプロフェン及びトラネキサム酸を含有する固形製剤を製造するための、有機酸若しくはそのエステル又はそれらの塩の使用(use)。
[8] イブプロフェン及びトラネキサム酸を含有する固形製剤の膨張を抑制するための、有機酸若しくはそのエステル又はそれらの塩の使用(use)。
[9] 有機酸若しくはそのエステル又はそれらの塩を添加することによって、イブプロフェン及びトラネキサム酸を含有する固形製剤の膨張を抑制する方法(method)。
[10] イブプロフェン及びトラネキサム酸を含有する固形製剤であって、
有機酸若しくはそのエステル又はそれらの塩を含有する固形製剤。
[11] 有機酸が、
酢酸、酪酸、ソルビン酸、安息香酸、フタル酸、サリチル酸、マロン酸、コハク酸、アジピン酸、マレイン酸、フマル酸、クエン酸、エチレンジアミン四酢酸、乳酸、リンゴ酸、酒石酸、アスコルビン酸、エリソルビン酸、没食子酸、及びアミノ酸からなる群から選択された1種以上である、[10]記載の固形製剤。
[12] 有機酸が、
クエン酸、リンゴ酸、没食子酸、酒石酸、及びエチレンジアミン四酢酸からなる群から選択された1種以上である、[10]記載の固形製剤。
[13] 有機酸がクエン酸である、[10]に記載の固形製剤。
[14] 有機酸がリンゴ酸である、[10]に記載の固形製剤。
[15] 有機酸が没食子酸である、[10]に記載の固形製剤。
[16] 有機酸がエチレンジアミン四酢酸である、[10]に記載の固形製剤。
[17] 有機酸若しくはそのエステル又はそれらの塩として、
クエン酸、クエン酸カルシウム、クエン酸トリエチル、クエン酸ナトリウム、クエン酸二ナトリウム、無水クエン酸、無水クエン酸ナトリウム、リンゴ酸、リンゴ酸ナトリウム、酒石酸、酒石酸水素カリウム、酒石酸ナトリウム、酒石酸ナトリウムカリウム、没食子酸、没食子酸エチル、没食子酸プロピル、没食子酸イソアミル、エチレンジアミン四酢酸カルシウム二ナトリウム、及びエチレンジアミン四酢酸二ナトリウムからなる群から選択された1種以上を含有する、[10]記載の固形製剤。
[18] 有機酸若しくはそのエステル又はそれらの塩を含有してなる、イブプロフェン及びトラネキサム酸を含有する固形製剤のための膨張抑制剤。
[19] 有機酸が、
酢酸、酪酸、ソルビン酸、安息香酸、フタル酸、サリチル酸、マロン酸、コハク酸、アジピン酸、マレイン酸、フマル酸、クエン酸、エチレンジアミン四酢酸、乳酸、リンゴ酸、酒石酸、アスコルビン酸、エリソルビン酸、没食子酸、及びアミノ酸からなる群から選択された1種以上である、[18]に記載の膨張抑制剤。
[20] 有機酸が、
クエン酸、リンゴ酸、没食子酸、酒石酸、及びエチレンジアミン四酢酸からなる群から選択された1種以上である、[18]に記載の膨張抑制剤。
[21] 有機酸がクエン酸である、[18]に記載の膨張抑制剤。
[22] 有機酸がリンゴ酸である、[18]に記載の膨張抑制剤。
[23] 有機酸が没食子酸である、[18]に記載の膨張抑制剤。
[24] 有機酸がエチレンジアミン四酢酸である、[18]に記載の膨張抑制剤。
[25] 有機酸若しくはそのエステル又はそれらの塩として、
クエン酸、クエン酸カルシウム、クエン酸トリエチル、クエン酸ナトリウム、クエン酸二ナトリウム、無水クエン酸、無水クエン酸ナトリウム、リンゴ酸、リンゴ酸ナトリウム、酒石酸、酒石酸水素カリウム、酒石酸ナトリウム、酒石酸ナトリウムカリウム、没食子酸、没食子酸エチル、没食子酸プロピル、没食子酸イソアミル、エチレンジアミン四酢酸カルシウム二ナトリウム、及びエチレンジアミン四酢酸二ナトリウムからなる群から選択された1種以上を含有する、[18]記載の膨張抑制剤。
催眠鎮静剤としては、ブロムワレリル尿素やアリルイソプロピルアセチル尿素等が挙げられる。
イブプロフェン900g(米沢浜理製:商品名 日本薬局方イブプロフェン)、トラネキサム酸1499.4g(第一三共プロファーマ製:商品名 日本薬局方トラネキサム酸)、無水クエン酸106.2g(小松屋化学製:商品名 日本薬局方無水クエン酸)、カルメロースカルシウム360g(五徳薬品製:商品名 ECG505)、乳糖水和物1897.2g(DMV INTERNATIONAL製:商品名 乳糖200M)を高速攪拌造粒機(深江工業製:FS−10型)に投入して混合後、精製水466gを添加して練合した。この造粒物を流動層乾燥機(フロイント産業製:FLO−5型)に投入して乾燥後、整粒機(岡田精工製:ND−10型)を用いて整粒した。この整粒物4762.8g及びステアリン酸マグネシウム97.2gを混合機(コトブキ製:PM50型)に投入して混合した後、直径8.5mmの杵を取り付けた打錠機(畑鉄工所製:HT−AP18SS型)を用いて打錠し、1錠の質量が270mgの錠剤18000錠を得た。
イブプロフェン900g(米沢浜理製:商品名 日本薬局方イブプロフェン)、トラネキサム酸1499.4g(第一三共プロファーマ製:商品名 日本薬局方トラネキサム酸)、ヒドロキシプロピルセルロース106.2g(日本曹達製:商品名 HPC−L)、クロスカルメロースナトリウム360g(ニチリン化学工業製:商品名 キッコレートND−2HS)、結晶セルロース1897.2g(旭化成ケミカルズ製:商品名 セオラスPH−101)を高速攪拌造粒機(深江工業製:FS−10型)に投入して混合後、精製水466gを添加して練合した。この造粒物を流動層乾燥機(フロイント産業製:FLO−5型)に投入して乾燥後、整粒機(岡田精工製:ND−10型)を用いて整粒した。この整粒物4762.8g及びステアリン酸マグネシウム97.2gを混合機(コトブキ製:PM50型)に投入して混合した後、直径8.5mmの杵を取り付けた打錠機(畑鉄工所製:HT−AP18SS型)を用いて打錠し、1錠の質量が270mgの錠剤18000錠を得た。
実施例1および比較例1で得た錠剤1錠を各々ガラス瓶(2K規格)に入れ、密栓した後、40℃の恒温容器に、1ヶ月間、2ヶ月間および3ヶ月間保存した。デジタルマイクロメーターで測定した製造直後の錠剤の厚みと保存後の錠剤の厚みから、以下の式(1)で定義される膨張率(%)を算出した。
式中、Dは保存後の錠剤の厚みであり、D0は製造直後の錠剤の厚みである。
無水クエン酸をリンゴ酸(川崎化成工業製:商品名 リンゴ酸 食添用40M)に変更した以外は、実施例1と同様にして、錠剤を得た。
保存期間を1ヵ月とし、試験例1と同様にして、実施例2で得られた錠剤について試験を実施した。その結果、40℃1ヶ月間保存後の膨張率は0.1%であり、顕著な膨張抑制効果を認めた。また、本発明の錠剤(実施例2)は、保存後でも錠剤の割れや欠けが認められず、安定な錠剤であることがわかった。
無水クエン酸を没食子酸プロピル(和光純薬工業製:商品名 没食子酸プロピル)に変更した以外は、実施例1と同様にして、錠剤を得た。
保存期間を1ヵ月とし、試験例1と同様にして、実施例3で得られた錠剤について試験を実施した。その結果、40℃1ヶ月間保存後の膨張率は0.1%であり、顕著な膨張抑制効果を認めた。また、本発明の錠剤(実施例3)は、保存後でも錠剤の割れや欠けが認められず、安定な錠剤であることがわかった。
無水クエン酸を酒石酸(関東化学製:商品名 L(+)−酒石酸)に変更した以外は、実施例1と同様にして、錠剤を得た。
保存期間を1ヵ月とした以外は、試験例1と同様にして、実施例4で得られた錠剤について試験を実施した。その結果、40℃1ヶ月間保存後の膨張率は0.5%であり、顕著な膨張抑制効果を認めた。また、本発明の錠剤(実施例4)は、保存後でも錠剤の割れや欠けが認められず、安定な錠剤であることがわかった。
無水クエン酸をエデト酸ナトリウム(関東化学製:商品名 EDTA2Na)にかえる以外は、実施例1と同様にして、錠剤を得た。
保存期間を1ヵ月とした以外は、試験例1と同様にして、実施例5で得られた錠剤について試験を実施した。その結果、40℃1ヶ月間保存後の膨張率は0.6%であり、顕著な膨張抑制効果を認めた。また、本発明の錠剤(実施例5)は、保存後でも錠剤の割れや欠けが認められず、安定な錠剤であることがわかった。
Claims (6)
- イブプロフェン及びトラネキサム酸を含有する固形製剤であって、
有機酸若しくはそのエステル又はそれらの塩を含有する固形製剤。 - 有機酸が、
酢酸、酪酸、ソルビン酸、安息香酸、フタル酸、サリチル酸、マロン酸、コハク酸、アジピン酸、マレイン酸、フマル酸、クエン酸、エチレンジアミン四酢酸、乳酸、リンゴ酸、酒石酸、アスコルビン酸、エリソルビン酸、没食子酸、及びアミノ酸からなる群から選択された1種以上である、請求項1記載の固形製剤。 - 有機酸が、
クエン酸、リンゴ酸、没食子酸、酒石酸、及びエチレンジアミン四酢酸からなる群から選択された1種以上である、請求項1記載の固形製剤。 - 有機酸若しくはそのエステル又はそれらの塩を含有してなる、イブプロフェン及びトラネキサム酸を含有する固形製剤のための膨張抑制剤。
- 有機酸が、
酢酸、酪酸、ソルビン酸、安息香酸、フタル酸、サリチル酸、マロン酸、コハク酸、アジピン酸、マレイン酸、フマル酸、クエン酸、エチレンジアミン四酢酸、乳酸、リンゴ酸、酒石酸、アスコルビン酸、エリソルビン酸、没食子酸、及びアミノ酸からなる群から選択された1種以上である、請求項4に記載の膨張抑制剤。 - 有機酸が、
クエン酸、リンゴ酸、没食子酸、酒石酸、及びエチレンジアミン四酢酸からなる群から選択された1種以上である、請求項4に記載の膨張抑制剤。
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JP2009179613A (ja) * | 2008-01-31 | 2009-08-13 | Kowa Co | イブプロフェン及びトラネキサム酸を含有する固形製剤 |
JP2011231105A (ja) * | 2010-04-07 | 2011-11-17 | Taisho Pharmaceutical Co Ltd | イブプロフェンの昇華抑制方法 |
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JPH11209305A (ja) * | 1998-01-21 | 1999-08-03 | Taisho Pharmaceut Co Ltd | メキタジン配合固形製剤 |
JP2003055217A (ja) * | 2001-08-10 | 2003-02-26 | Taiyo Yakuhin Kogyo Kk | 医薬組成物 |
JP2005187328A (ja) * | 2003-12-24 | 2005-07-14 | Lion Corp | イブプロフェン含有解熱鎮痛組成物、及び感冒薬 |
JP2006096771A (ja) * | 1992-07-29 | 2006-04-13 | Gacell Lab Ab | 制御放出モルヒネ製剤 |
JP2007091633A (ja) * | 2005-09-28 | 2007-04-12 | Rohto Pharmaceut Co Ltd | メキタジン、イブプロフェン及びトラネキサム酸含有医薬組成物 |
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JP2006096771A (ja) * | 1992-07-29 | 2006-04-13 | Gacell Lab Ab | 制御放出モルヒネ製剤 |
JPH11209305A (ja) * | 1998-01-21 | 1999-08-03 | Taisho Pharmaceut Co Ltd | メキタジン配合固形製剤 |
JP2003055217A (ja) * | 2001-08-10 | 2003-02-26 | Taiyo Yakuhin Kogyo Kk | 医薬組成物 |
JP2005187328A (ja) * | 2003-12-24 | 2005-07-14 | Lion Corp | イブプロフェン含有解熱鎮痛組成物、及び感冒薬 |
JP2007091633A (ja) * | 2005-09-28 | 2007-04-12 | Rohto Pharmaceut Co Ltd | メキタジン、イブプロフェン及びトラネキサム酸含有医薬組成物 |
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JP2009179613A (ja) * | 2008-01-31 | 2009-08-13 | Kowa Co | イブプロフェン及びトラネキサム酸を含有する固形製剤 |
JP2011231105A (ja) * | 2010-04-07 | 2011-11-17 | Taisho Pharmaceutical Co Ltd | イブプロフェンの昇華抑制方法 |
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