JP6410408B2 - ロキソプロフェンナトリウム含有経口カプセル剤 - Google Patents
ロキソプロフェンナトリウム含有経口カプセル剤 Download PDFInfo
- Publication number
- JP6410408B2 JP6410408B2 JP2013108736A JP2013108736A JP6410408B2 JP 6410408 B2 JP6410408 B2 JP 6410408B2 JP 2013108736 A JP2013108736 A JP 2013108736A JP 2013108736 A JP2013108736 A JP 2013108736A JP 6410408 B2 JP6410408 B2 JP 6410408B2
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- JP
- Japan
- Prior art keywords
- capsule
- propylene glycol
- solution
- loxoprofen
- polyethylene glycol
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
- YMBXTVYHTMGZDW-UHFFFAOYSA-N loxoprofen Chemical compound C1=CC(C(C(O)=O)C)=CC=C1CC1C(=O)CCC1 YMBXTVYHTMGZDW-UHFFFAOYSA-N 0.000 title claims description 26
- 229960002373 loxoprofen Drugs 0.000 title claims description 26
- 229940100691 oral capsule Drugs 0.000 title 1
- DNIAPMSPPWPWGF-UHFFFAOYSA-N monopropylene glycol Natural products CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims description 81
- 239000002775 capsule Substances 0.000 claims description 28
- 239000000203 mixture Substances 0.000 claims description 21
- 239000002202 Polyethylene glycol Substances 0.000 claims description 18
- 229920001223 polyethylene glycol Polymers 0.000 claims description 18
- 239000007901 soft capsule Substances 0.000 claims description 16
- 238000011049 filling Methods 0.000 claims description 14
- 235000014113 dietary fatty acids Nutrition 0.000 claims description 10
- 239000000194 fatty acid Substances 0.000 claims description 10
- 229930195729 fatty acid Natural products 0.000 claims description 10
- -1 propylene glycol fatty acid ester Chemical class 0.000 claims description 9
- DOOTYTYQINUNNV-UHFFFAOYSA-N Triethyl citrate Chemical compound CCOC(=O)CC(O)(C(=O)OCC)CC(=O)OCC DOOTYTYQINUNNV-UHFFFAOYSA-N 0.000 claims description 8
- 238000000034 method Methods 0.000 claims description 8
- 239000001069 triethyl citrate Substances 0.000 claims description 7
- VMYFZRTXGLUXMZ-UHFFFAOYSA-N triethyl citrate Natural products CCOC(=O)C(O)(C(=O)OCC)C(=O)OCC VMYFZRTXGLUXMZ-UHFFFAOYSA-N 0.000 claims description 7
- 235000013769 triethyl citrate Nutrition 0.000 claims description 7
- 108010010803 Gelatin Proteins 0.000 claims description 3
- 229920000159 gelatin Polymers 0.000 claims description 3
- 239000008273 gelatin Substances 0.000 claims description 3
- 235000019322 gelatine Nutrition 0.000 claims description 3
- 235000011852 gelatine desserts Nutrition 0.000 claims description 3
- 150000004676 glycans Chemical class 0.000 claims description 2
- 229920001282 polysaccharide Polymers 0.000 claims description 2
- 239000005017 polysaccharide Substances 0.000 claims description 2
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 description 6
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 6
- 239000007788 liquid Substances 0.000 description 6
- 229940079593 drug Drugs 0.000 description 4
- 239000003814 drug Substances 0.000 description 4
- 238000009472 formulation Methods 0.000 description 4
- 239000004094 surface-active agent Substances 0.000 description 4
- 230000003110 anti-inflammatory effect Effects 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 235000011187 glycerol Nutrition 0.000 description 3
- 229960003511 macrogol Drugs 0.000 description 3
- 238000002360 preparation method Methods 0.000 description 3
- 239000000047 product Substances 0.000 description 3
- GHHURQMJLARIDK-UHFFFAOYSA-N 2-hydroxypropyl octanoate Chemical compound CCCCCCCC(=O)OCC(C)O GHHURQMJLARIDK-UHFFFAOYSA-N 0.000 description 2
- 208000002193 Pain Diseases 0.000 description 2
- 239000004480 active ingredient Substances 0.000 description 2
- 230000000202 analgesic effect Effects 0.000 description 2
- 239000002221 antipyretic Substances 0.000 description 2
- 230000000052 comparative effect Effects 0.000 description 2
- 230000001079 digestive effect Effects 0.000 description 2
- 238000004090 dissolution Methods 0.000 description 2
- 239000003925 fat Substances 0.000 description 2
- 239000012530 fluid Substances 0.000 description 2
- 239000007902 hard capsule Substances 0.000 description 2
- 238000002156 mixing Methods 0.000 description 2
- 239000003921 oil Substances 0.000 description 2
- 230000036407 pain Effects 0.000 description 2
- 239000000546 pharmaceutical excipient Substances 0.000 description 2
- 238000001556 precipitation Methods 0.000 description 2
- 238000011160 research Methods 0.000 description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 2
- 208000008035 Back Pain Diseases 0.000 description 1
- 235000004035 Cryptotaenia japonica Nutrition 0.000 description 1
- 244000146493 Cryptotaenia japonica Species 0.000 description 1
- 241000196324 Embryophyta Species 0.000 description 1
- 208000018522 Gastrointestinal disease Diseases 0.000 description 1
- HEFNNWSXXWATRW-UHFFFAOYSA-N Ibuprofen Chemical compound CC(C)CC1=CC=C(C(C)C(O)=O)C=C1 HEFNNWSXXWATRW-UHFFFAOYSA-N 0.000 description 1
- 206010061218 Inflammation Diseases 0.000 description 1
- 208000008930 Low Back Pain Diseases 0.000 description 1
- 206010034464 Periarthritis Diseases 0.000 description 1
- 239000004373 Pullulan Substances 0.000 description 1
- 229920001218 Pullulan Polymers 0.000 description 1
- 206010037660 Pyrexia Diseases 0.000 description 1
- 230000005856 abnormality Effects 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 239000012190 activator Substances 0.000 description 1
- 230000001154 acute effect Effects 0.000 description 1
- 230000001464 adherent effect Effects 0.000 description 1
- 125000005907 alkyl ester group Chemical group 0.000 description 1
- 230000036592 analgesia Effects 0.000 description 1
- 229940035676 analgesics Drugs 0.000 description 1
- 239000000730 antalgic agent Substances 0.000 description 1
- 239000002260 anti-inflammatory agent Substances 0.000 description 1
- 229940121363 anti-inflammatory agent Drugs 0.000 description 1
- 230000001754 anti-pyretic effect Effects 0.000 description 1
- 229940125716 antipyretic agent Drugs 0.000 description 1
- 239000012298 atmosphere Substances 0.000 description 1
- 239000003054 catalyst Substances 0.000 description 1
- 239000011248 coating agent Substances 0.000 description 1
- 239000013065 commercial product Substances 0.000 description 1
- 238000007796 conventional method Methods 0.000 description 1
- 238000005336 cracking Methods 0.000 description 1
- 230000003111 delayed effect Effects 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 230000032050 esterification Effects 0.000 description 1
- 238000005886 esterification reaction Methods 0.000 description 1
- 238000000605 extraction Methods 0.000 description 1
- 150000004665 fatty acids Chemical class 0.000 description 1
- 230000007160 gastrointestinal dysfunction Effects 0.000 description 1
- 239000007903 gelatin capsule Substances 0.000 description 1
- 239000011521 glass Substances 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
- 229960003943 hypromellose Drugs 0.000 description 1
- 229960001680 ibuprofen Drugs 0.000 description 1
- 230000001771 impaired effect Effects 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 230000004054 inflammatory process Effects 0.000 description 1
- 239000000314 lubricant Substances 0.000 description 1
- 238000013508 migration Methods 0.000 description 1
- 230000005012 migration Effects 0.000 description 1
- 239000000820 nonprescription drug Substances 0.000 description 1
- 201000008482 osteoarthritis Diseases 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 239000004014 plasticizer Substances 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 239000000651 prodrug Substances 0.000 description 1
- 229940002612 prodrug Drugs 0.000 description 1
- 235000019423 pullulan Nutrition 0.000 description 1
- 210000002345 respiratory system Anatomy 0.000 description 1
- 206010039073 rheumatoid arthritis Diseases 0.000 description 1
- 230000003637 steroidlike Effects 0.000 description 1
- 210000002784 stomach Anatomy 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 108010013480 succinylated gelatin Proteins 0.000 description 1
- 229940007079 succinylated gelatin Drugs 0.000 description 1
- 150000005846 sugar alcohols Polymers 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 150000003505 terpenes Chemical class 0.000 description 1
- 235000007586 terpenes Nutrition 0.000 description 1
- 208000004371 toothache Diseases 0.000 description 1
- 238000005809 transesterification reaction Methods 0.000 description 1
- 238000012546 transfer Methods 0.000 description 1
- 230000007704 transition Effects 0.000 description 1
- 238000005550 wet granulation Methods 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Description
A ≦ 2×B + C/4
を満たし、且つ、(B)が溶液の10%以下となる組成物を充填して成る軟カプセル剤により達成することが可能となった。
A ≦ D/2 + C/4
を満たし、且つ、(D)が溶液の85%以下となる組成物を充填して成る軟カプセル剤でも同様の効果が得られることが判明した。
A ≦ 2×B + D/2 + C/4
を満たし、且つ、(B)が溶液の10%以下となる組成物を充填して成る軟カプセル剤でも同様の効果が得られることが判明した。
Claims (2)
- ロキソプロフェンナトリウム(A)、ポリエチレングリコール(D)及びプロピレングリコール脂肪酸エステルからなる室温で澄明な溶液であり、任意にクエン酸トリエチル(C)を含み、このとき、溶液の重量基準による組成比が
A ≦ D/2 + C/4
を満たし、且つ、(D)が溶液の38.9%以下となる組成物を充填して成る軟カプセル剤。 - 軟カプセル剤が、ロータリーダイ法または滴下法で製造され、カプセル剤皮の主構成成分がゼラチン、コハク化ゼラチン及び/又は植物由来多糖類から選択される請求項1に記載の軟カプセル剤。
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2013108736A JP6410408B2 (ja) | 2013-05-23 | 2013-05-23 | ロキソプロフェンナトリウム含有経口カプセル剤 |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2013108736A JP6410408B2 (ja) | 2013-05-23 | 2013-05-23 | ロキソプロフェンナトリウム含有経口カプセル剤 |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2014227381A JP2014227381A (ja) | 2014-12-08 |
JP6410408B2 true JP6410408B2 (ja) | 2018-10-24 |
Family
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Application Number | Title | Priority Date | Filing Date |
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JP2013108736A Active JP6410408B2 (ja) | 2013-05-23 | 2013-05-23 | ロキソプロフェンナトリウム含有経口カプセル剤 |
Country Status (1)
Country | Link |
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JP (1) | JP6410408B2 (ja) |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN115531305B (zh) * | 2022-10-21 | 2023-11-07 | 福建汇天生物药业有限公司 | 一种洛索洛芬钠口服溶液剂及其制备方法 |
Family Cites Families (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2001031565A (ja) * | 1999-07-19 | 2001-02-06 | Nisshin Flour Milling Co Ltd | ロキソプロフェンナトリウム含有カプセル製剤 |
JP2003055254A (ja) * | 2001-08-17 | 2003-02-26 | Toyo Capsule Kk | 経口投与用シクロスポリン製剤 |
JP5503939B2 (ja) * | 2009-10-16 | 2014-05-28 | 東洋カプセル株式会社 | アゼラスチン塩酸塩含有カプセル剤 |
JP5715400B2 (ja) * | 2009-12-08 | 2015-05-07 | 興和株式会社 | ロキソプロフェン含有医薬組成物 |
JP5567909B2 (ja) * | 2010-06-17 | 2014-08-06 | 東洋カプセル株式会社 | タクロリムス含有カプセル剤 |
JP5750278B2 (ja) * | 2011-02-28 | 2015-07-15 | 東洋カプセル株式会社 | カンデサルタンシレキセチルのカプセル充填用組成物 |
-
2013
- 2013-05-23 JP JP2013108736A patent/JP6410408B2/ja active Active
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Publication number | Publication date |
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JP2014227381A (ja) | 2014-12-08 |
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