JP2009507051A - セルチンドールの安定な固形製剤 - Google Patents
セルチンドールの安定な固形製剤 Download PDFInfo
- Publication number
- JP2009507051A JP2009507051A JP2008529472A JP2008529472A JP2009507051A JP 2009507051 A JP2009507051 A JP 2009507051A JP 2008529472 A JP2008529472 A JP 2008529472A JP 2008529472 A JP2008529472 A JP 2008529472A JP 2009507051 A JP2009507051 A JP 2009507051A
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- JP
- Japan
- Prior art keywords
- pharmaceutical formulation
- solid pharmaceutical
- iron oxide
- coating layer
- less
- 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.)
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- GZKLJWGUPQBVJQ-UHFFFAOYSA-N sertindole Chemical compound C1=CC(F)=CC=C1N1C2=CC=C(Cl)C=C2C(C2CCN(CCN3C(NCC3)=O)CC2)=C1 GZKLJWGUPQBVJQ-UHFFFAOYSA-N 0.000 title claims abstract description 61
- 229960000652 sertindole Drugs 0.000 title claims abstract description 57
- 239000007787 solid Substances 0.000 title claims description 43
- 239000000203 mixture Substances 0.000 title claims description 39
- 238000009472 formulation Methods 0.000 title claims description 18
- UQSXHKLRYXJYBZ-UHFFFAOYSA-N Iron oxide Chemical compound [Fe]=O UQSXHKLRYXJYBZ-UHFFFAOYSA-N 0.000 claims abstract description 103
- 239000008194 pharmaceutical composition Substances 0.000 claims abstract description 47
- 239000003223 protective agent Substances 0.000 claims abstract description 34
- 230000005855 radiation Effects 0.000 claims abstract description 30
- 238000000034 method Methods 0.000 claims abstract description 12
- 238000004519 manufacturing process Methods 0.000 claims abstract description 10
- 201000000980 schizophrenia Diseases 0.000 claims abstract description 6
- 235000013980 iron oxide Nutrition 0.000 claims description 50
- 239000011247 coating layer Substances 0.000 claims description 36
- 239000010410 layer Substances 0.000 claims description 29
- 238000000576 coating method Methods 0.000 claims description 26
- GWEVSGVZZGPLCZ-UHFFFAOYSA-N Titan oxide Chemical compound O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 claims description 24
- 239000007888 film coating Substances 0.000 claims description 22
- 238000009501 film coating Methods 0.000 claims description 22
- 239000002775 capsule Substances 0.000 claims description 19
- 150000003839 salts Chemical class 0.000 claims description 17
- 239000011248 coating agent Substances 0.000 claims description 16
- 229910052751 metal Inorganic materials 0.000 claims description 16
- 239000002184 metal Substances 0.000 claims description 16
- -1 yellow iron oxide Chemical class 0.000 claims description 13
- 239000004408 titanium dioxide Substances 0.000 claims description 12
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- 229960003988 indigo carmine Drugs 0.000 claims description 10
- KHLVKKOJDHCJMG-QDBORUFSSA-L indigo carmine Chemical compound [Na+].[Na+].N/1C2=CC=C(S([O-])(=O)=O)C=C2C(=O)C\1=C1/NC2=CC=C(S(=O)(=O)[O-])C=C2C1=O KHLVKKOJDHCJMG-QDBORUFSSA-L 0.000 claims description 10
- 239000004179 indigotine Substances 0.000 claims description 10
- 235000012738 indigotine Nutrition 0.000 claims description 10
- 229920001223 polyethylene glycol Polymers 0.000 claims description 9
- 239000002202 Polyethylene glycol Substances 0.000 claims description 8
- ZFOZVQLOBQUTQQ-UHFFFAOYSA-N Tributyl citrate Chemical compound CCCCOC(=O)CC(O)(C(=O)OCCCC)CC(=O)OCCCC ZFOZVQLOBQUTQQ-UHFFFAOYSA-N 0.000 claims description 6
- DOIRQSBPFJWKBE-UHFFFAOYSA-N dibutyl phthalate Chemical compound CCCCOC(=O)C1=CC=CC=C1C(=O)OCCCC DOIRQSBPFJWKBE-UHFFFAOYSA-N 0.000 claims description 6
- FLKPEMZONWLCSK-UHFFFAOYSA-N diethyl phthalate Chemical compound CCOC(=O)C1=CC=CC=C1C(=O)OCC FLKPEMZONWLCSK-UHFFFAOYSA-N 0.000 claims description 6
- WTFXARWRTYJXII-UHFFFAOYSA-N iron(2+);iron(3+);oxygen(2-) Chemical compound [O-2].[O-2].[O-2].[O-2].[Fe+2].[Fe+3].[Fe+3] WTFXARWRTYJXII-UHFFFAOYSA-N 0.000 claims description 6
- SZVJSHCCFOBDDC-UHFFFAOYSA-N iron(II,III) oxide Inorganic materials O=[Fe]O[Fe]O[Fe]=O SZVJSHCCFOBDDC-UHFFFAOYSA-N 0.000 claims description 6
- JEIPFZHSYJVQDO-UHFFFAOYSA-N iron(III) oxide Inorganic materials O=[Fe]O[Fe]=O JEIPFZHSYJVQDO-UHFFFAOYSA-N 0.000 claims description 6
- 239000000126 substance Substances 0.000 claims description 6
- URAYPUMNDPQOKB-UHFFFAOYSA-N triacetin Chemical compound CC(=O)OCC(OC(C)=O)COC(C)=O URAYPUMNDPQOKB-UHFFFAOYSA-N 0.000 claims description 6
- 239000000654 additive Substances 0.000 claims description 5
- 239000006229 carbon black Substances 0.000 claims description 5
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- 235000000177 Indigofera tinctoria Nutrition 0.000 claims description 4
- 235000019241 carbon black Nutrition 0.000 claims description 4
- 229940097275 indigo Drugs 0.000 claims description 4
- COHYTHOBJLSHDF-UHFFFAOYSA-N indigo powder Natural products N1C2=CC=CC=C2C(=O)C1=C1C(=O)C2=CC=CC=C2N1 COHYTHOBJLSHDF-UHFFFAOYSA-N 0.000 claims description 4
- 239000011833 salt mixture Substances 0.000 claims description 4
- QZCLKYGREBVARF-UHFFFAOYSA-N Acetyl tributyl citrate Chemical compound CCCCOC(=O)CC(C(=O)OCCCC)(OC(C)=O)CC(=O)OCCCC QZCLKYGREBVARF-UHFFFAOYSA-N 0.000 claims description 3
- PYGXAGIECVVIOZ-UHFFFAOYSA-N Dibutyl decanedioate Chemical compound CCCCOC(=O)CCCCCCCCC(=O)OCCCC PYGXAGIECVVIOZ-UHFFFAOYSA-N 0.000 claims description 3
- DOOTYTYQINUNNV-UHFFFAOYSA-N Triethyl citrate Chemical compound CCOC(=O)CC(O)(C(=O)OCC)CC(=O)OCC DOOTYTYQINUNNV-UHFFFAOYSA-N 0.000 claims description 3
- 239000001087 glyceryl triacetate Substances 0.000 claims description 3
- 235000013773 glyceryl triacetate Nutrition 0.000 claims description 3
- VBMVTYDPPZVILR-UHFFFAOYSA-N iron(2+);oxygen(2-) Chemical class [O-2].[Fe+2] VBMVTYDPPZVILR-UHFFFAOYSA-N 0.000 claims description 3
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- 239000001069 triethyl citrate Substances 0.000 claims description 3
- VMYFZRTXGLUXMZ-UHFFFAOYSA-N triethyl citrate Natural products CCOC(=O)C(O)(C(=O)OCC)C(=O)OCC VMYFZRTXGLUXMZ-UHFFFAOYSA-N 0.000 claims description 3
- 235000013769 triethyl citrate Nutrition 0.000 claims description 3
- 238000001782 photodegradation Methods 0.000 claims description 2
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- 150000002739 metals Chemical class 0.000 claims 2
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- 230000000694 effects Effects 0.000 description 8
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 8
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Classifications
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- A61K9/00—Medicinal preparations characterised by special physical form
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- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2813—Inorganic compounds
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- 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
- A61K31/445—Non condensed piperidines, e.g. piperocaine
- A61K31/4523—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
- A61K31/454—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. pimozide, domperidone
-
- 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
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
-
- 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)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Inorganic Chemistry (AREA)
- Psychiatry (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DKPA200501255 | 2005-09-08 | ||
| PCT/DK2006/050038 WO2007065448A1 (en) | 2005-09-08 | 2006-09-06 | Stable solid formulation of sertindole |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| JP2009507051A true JP2009507051A (ja) | 2009-02-19 |
Family
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2008529472A Withdrawn JP2009507051A (ja) | 2005-09-08 | 2006-09-06 | セルチンドールの安定な固形製剤 |
Country Status (17)
| Country | Link |
|---|---|
| EP (1) | EP1924261A1 (ru) |
| JP (1) | JP2009507051A (ru) |
| KR (1) | KR20080042102A (ru) |
| CN (1) | CN101257906A (ru) |
| AR (1) | AR056475A1 (ru) |
| AU (1) | AU2006322460A1 (ru) |
| BR (1) | BRPI0615630A2 (ru) |
| CA (1) | CA2621866A1 (ru) |
| EA (1) | EA013167B1 (ru) |
| IL (1) | IL189541A0 (ru) |
| MX (1) | MX2008002290A (ru) |
| NO (1) | NO20081721L (ru) |
| NZ (1) | NZ565330A (ru) |
| TW (1) | TW200738239A (ru) |
| UA (1) | UA97349C2 (ru) |
| WO (1) | WO2007065448A1 (ru) |
| ZA (1) | ZA200801169B (ru) |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2016523846A (ja) * | 2013-06-06 | 2016-08-12 | フィブロジェン インコーポレイテッド | Ｈｉｆプロリルヒドロキシラーゼ阻害剤の医薬製剤 |
| JP2016537318A (ja) * | 2013-11-19 | 2016-12-01 | シガ・テクノロジーズ・インコーポレーテッド | 微粒子化テコビリマット一水和物の再水和 |
| JP2018172361A (ja) * | 2016-10-14 | 2018-11-08 | 大原薬品工業株式会社 | 光安定性を改善した、デュロキセチンを含有する固形製剤 |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| TWI320783B (en) | 2005-04-14 | 2010-02-21 | Otsuka Pharma Co Ltd | Heterocyclic compound |
| JP5591128B2 (ja) * | 2009-01-29 | 2014-09-17 | 大日本住友製薬株式会社 | 内核を有する口腔内崩壊錠 |
| FR2943061B1 (fr) * | 2009-03-13 | 2011-02-25 | Rhodia Operations | Composes organophosphores, systemes catalytiques comprenant ces composes et procede d'hydrocyanation ou d'hydroformylation utilisant ces systemes catalytiques |
| US8883823B2 (en) | 2012-07-16 | 2014-11-11 | Fibrogen, Inc. | Crystalline forms of a prolyl hydroxylase inhibitor |
| CN104684897A (zh) | 2012-07-16 | 2015-06-03 | 菲布罗根有限公司 | 脯氨酰羟化酶抑制剂的晶体形态 |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH04346929A (ja) * | 1991-05-22 | 1992-12-02 | Takada Seiyaku Kk | 光に安定なメシル酸ブロモクリプチン製剤 |
| AU2587297A (en) * | 1996-03-25 | 1997-10-17 | Eli Lilly And Company | Method for treating pain |
| ZA973433B (en) * | 1996-04-24 | 1997-12-10 | Shionogi & Co | A sertindole-containing preparation and a method for producing the same. |
| ZA977967B (en) * | 1996-09-23 | 1999-03-04 | Lilly Co Eli | Combination therapy for treatment of psychoses |
-
2006
- 2006-06-09 UA UAA200803569A patent/UA97349C2/ru unknown
- 2006-08-17 TW TW095130202A patent/TW200738239A/zh unknown
- 2006-08-29 AR ARP060103764A patent/AR056475A1/es not_active Application Discontinuation
- 2006-09-06 BR BRPI0615630A patent/BRPI0615630A2/pt not_active IP Right Cessation
- 2006-09-06 AU AU2006322460A patent/AU2006322460A1/en not_active Abandoned
- 2006-09-06 WO PCT/DK2006/050038 patent/WO2007065448A1/en active Application Filing
- 2006-09-06 CN CNA2006800323410A patent/CN101257906A/zh active Pending
- 2006-09-06 CA CA002621866A patent/CA2621866A1/en not_active Abandoned
- 2006-09-06 KR KR1020087004910A patent/KR20080042102A/ko not_active Withdrawn
- 2006-09-06 MX MX2008002290A patent/MX2008002290A/es not_active Application Discontinuation
- 2006-09-06 EP EP06846966A patent/EP1924261A1/en not_active Withdrawn
- 2006-09-06 EA EA200800774A patent/EA013167B1/ru not_active IP Right Cessation
- 2006-09-06 NZ NZ565330A patent/NZ565330A/en not_active IP Right Cessation
- 2006-09-06 ZA ZA200801169A patent/ZA200801169B/xx unknown
- 2006-09-06 JP JP2008529472A patent/JP2009507051A/ja not_active Withdrawn
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2008
- 2008-02-14 IL IL189541A patent/IL189541A0/en unknown
- 2008-04-08 NO NO20081721A patent/NO20081721L/no not_active Application Discontinuation
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2016523846A (ja) * | 2013-06-06 | 2016-08-12 | フィブロジェン インコーポレイテッド | Ｈｉｆプロリルヒドロキシラーゼ阻害剤の医薬製剤 |
| JP2019137703A (ja) * | 2013-06-06 | 2019-08-22 | フィブロジェン インコーポレイテッド | Ｈｉｆプロリルヒドロキシラーゼ阻害剤の医薬製剤 |
| JP2016537318A (ja) * | 2013-11-19 | 2016-12-01 | シガ・テクノロジーズ・インコーポレーテッド | 微粒子化テコビリマット一水和物の再水和 |
| US10406103B2 (en) | 2013-11-19 | 2019-09-10 | Siga Technologies Inc. | Rehydration of micronized tecovirmimat monohydrate |
| US10716759B2 (en) | 2013-11-19 | 2020-07-21 | Siga Technologies Inc. | Rehydration of micronized tecovirimat monohydrate |
| JP2018172361A (ja) * | 2016-10-14 | 2018-11-08 | 大原薬品工業株式会社 | 光安定性を改善した、デュロキセチンを含有する固形製剤 |
Also Published As
| Publication number | Publication date |
|---|---|
| TW200738239A (en) | 2007-10-16 |
| CA2621866A1 (en) | 2007-06-14 |
| KR20080042102A (ko) | 2008-05-14 |
| UA97349C2 (ru) | 2012-02-10 |
| NO20081721L (no) | 2008-04-08 |
| WO2007065448A1 (en) | 2007-06-14 |
| ZA200801169B (en) | 2010-07-28 |
| EP1924261A1 (en) | 2008-05-28 |
| EA200800774A1 (ru) | 2008-06-30 |
| AR056475A1 (es) | 2007-10-10 |
| AU2006322460A1 (en) | 2007-06-14 |
| CN101257906A (zh) | 2008-09-03 |
| IL189541A0 (en) | 2008-08-07 |
| MX2008002290A (es) | 2008-03-14 |
| EA013167B1 (ru) | 2010-02-26 |
| NZ565330A (en) | 2011-06-30 |
| BRPI0615630A2 (pt) | 2016-11-16 |
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