JP2016523846A5 - - Google Patents
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- Publication number
- JP2016523846A5 JP2016523846A5 JP2016517984A JP2016517984A JP2016523846A5 JP 2016523846 A5 JP2016523846 A5 JP 2016523846A5 JP 2016517984 A JP2016517984 A JP 2016517984A JP 2016517984 A JP2016517984 A JP 2016517984A JP 2016523846 A5 JP2016523846 A5 JP 2016523846A5
- Authority
- JP
- Japan
- Prior art keywords
- iron oxide
- dosage form
- solid dosage
- light stabilizer
- titanium dioxide
- 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.)
- Granted
Links
- UQSXHKLRYXJYBZ-UHFFFAOYSA-N Iron oxide Chemical compound [Fe]=O UQSXHKLRYXJYBZ-UHFFFAOYSA-N 0.000 claims description 132
- GWEVSGVZZGPLCZ-UHFFFAOYSA-N Titan oxide Chemical compound O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 claims description 122
- 239000002775 capsule Substances 0.000 claims description 105
- 239000004611 light stabiliser Substances 0.000 claims description 70
- 239000004408 titanium dioxide Substances 0.000 claims description 61
- 235000010215 titanium dioxide Nutrition 0.000 claims description 61
- 239000003826 tablet Substances 0.000 claims description 56
- CEZCCHQBSQPRMU-LLIZZRELSA-L Allura red AC Chemical compound [Na+].[Na+].COC1=CC(S([O-])(=O)=O)=C(C)C=C1\N=N\C1=C(O)C=CC2=CC(S([O-])(=O)=O)=CC=C12 CEZCCHQBSQPRMU-LLIZZRELSA-L 0.000 claims description 49
- 239000004191 allura red AC Substances 0.000 claims description 49
- 235000012741 allura red AC Nutrition 0.000 claims description 49
- YOZBGTLTNGAVFU-UHFFFAOYSA-N roxadustat Chemical compound C1=C2C(C)=NC(C(=O)NCC(O)=O)=C(O)C2=CC=C1OC1=CC=CC=C1 YOZBGTLTNGAVFU-UHFFFAOYSA-N 0.000 claims description 44
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 40
- 239000007909 solid dosage form Substances 0.000 claims description 40
- 239000000654 additive Substances 0.000 claims description 33
- 230000000996 additive effect Effects 0.000 claims description 31
- 239000008194 pharmaceutical composition Substances 0.000 claims description 27
- PNEYBMLMFCGWSK-UHFFFAOYSA-N Alumina Chemical compound [O-2].[O-2].[O-2].[Al+3].[Al+3] PNEYBMLMFCGWSK-UHFFFAOYSA-N 0.000 claims description 24
- WSVLPVUVIUVCRA-KPKNDVKVSA-N Alpha-lactose monohydrate Chemical compound O.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 WSVLPVUVIUVCRA-KPKNDVKVSA-N 0.000 claims description 20
- 229920002785 Croscarmellose sodium Polymers 0.000 claims description 20
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 20
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims description 20
- OIQPTROHQCGFEF-QIKYXUGXSA-L Sunset Yellow FCF Chemical compound [Na+].[Na+].OC1=CC=C2C=C(S([O-])(=O)=O)C=CC2=C1\N=N\C1=CC=C(S([O-])(=O)=O)C=C1 OIQPTROHQCGFEF-QIKYXUGXSA-L 0.000 claims description 20
- 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 claims description 20
- 229960001681 croscarmellose sodium Drugs 0.000 claims description 20
- 235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 claims description 20
- 229960001021 lactose monohydrate Drugs 0.000 claims description 20
- 235000019359 magnesium stearate Nutrition 0.000 claims description 20
- 229940057948 magnesium stearate Drugs 0.000 claims description 20
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims description 20
- 239000008108 microcrystalline cellulose Substances 0.000 claims description 20
- 229940016286 microcrystalline cellulose Drugs 0.000 claims description 20
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims description 20
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims description 20
- 229940069328 povidone Drugs 0.000 claims description 20
- 239000004173 sunset yellow FCF Substances 0.000 claims description 20
- 235000012751 sunset yellow FCF Nutrition 0.000 claims description 20
- 108010010803 Gelatin Proteins 0.000 claims description 16
- 229920000159 gelatin Polymers 0.000 claims description 16
- 239000008273 gelatin Substances 0.000 claims description 16
- 235000019322 gelatine Nutrition 0.000 claims description 16
- 235000011852 gelatine desserts Nutrition 0.000 claims description 16
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 claims description 15
- 229910052782 aluminium Inorganic materials 0.000 claims description 15
- COHYTHOBJLSHDF-BUHFOSPRSA-N indigo dye Chemical compound N\1C2=CC=CC=C2C(=O)C/1=C1/C(=O)C2=CC=CC=C2N1 COHYTHOBJLSHDF-BUHFOSPRSA-N 0.000 claims description 12
- 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 12
- 239000011248 coating agent Substances 0.000 claims description 11
- 238000000576 coating method Methods 0.000 claims description 11
- QTBSBXVTEAMEQO-UHFFFAOYSA-N acetic acid Substances CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 claims description 10
- 238000000034 method Methods 0.000 claims description 10
- 239000000049 pigment Substances 0.000 claims description 8
- -1 methyl-7-phenoxy-isoquinoline-3-carbonyl Chemical group 0.000 claims description 7
- 239000000825 pharmaceutical preparation Substances 0.000 claims description 7
- 208000007502 anemia Diseases 0.000 claims description 4
- 235000013980 iron oxide Nutrition 0.000 claims description 4
- LDHBWEYLDHLIBQ-UHFFFAOYSA-M iron(3+);oxygen(2-);hydroxide;hydrate Chemical compound O.[OH-].[O-2].[Fe+3] LDHBWEYLDHLIBQ-UHFFFAOYSA-M 0.000 claims description 4
- JEIPFZHSYJVQDO-UHFFFAOYSA-N iron(III) oxide Inorganic materials O=[Fe]O[Fe]=O JEIPFZHSYJVQDO-UHFFFAOYSA-N 0.000 claims description 4
- 239000001053 orange pigment Substances 0.000 claims description 4
- 238000006303 photolysis reaction Methods 0.000 claims description 4
- 230000015843 photosynthesis, light reaction Effects 0.000 claims description 4
- 239000001054 red pigment Substances 0.000 claims description 4
- 239000001052 yellow pigment Substances 0.000 claims description 4
- 239000003795 chemical substances by application Substances 0.000 claims description 3
- 206010021143 Hypoxia Diseases 0.000 claims description 2
- 239000011324 bead Substances 0.000 claims description 2
- 239000001055 blue pigment Substances 0.000 claims description 2
- 239000008187 granular material Substances 0.000 claims description 2
- 239000001056 green pigment Substances 0.000 claims description 2
- 230000002401 inhibitory effect Effects 0.000 claims description 2
- 239000007937 lozenge Substances 0.000 claims description 2
- 230000001404 mediated effect Effects 0.000 claims description 2
- 239000008188 pellet Substances 0.000 claims description 2
- 239000006187 pill Substances 0.000 claims description 2
- 230000000087 stabilizing effect Effects 0.000 claims description 2
- 239000000203 mixture Substances 0.000 claims 4
- RTAQQCXQSZGOHL-UHFFFAOYSA-N Titanium Chemical compound [Ti] RTAQQCXQSZGOHL-UHFFFAOYSA-N 0.000 claims 1
- 239000002253 acid Substances 0.000 claims 1
- 230000007954 hypoxia Effects 0.000 claims 1
- 230000001939 inductive effect Effects 0.000 claims 1
- 239000010936 titanium Substances 0.000 claims 1
- 229910052719 titanium Inorganic materials 0.000 claims 1
- 239000000945 filler Substances 0.000 description 2
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201361831909P | 2013-06-06 | 2013-06-06 | |
| US61/831,909 | 2013-06-06 | ||
| PCT/US2014/041021 WO2014197660A1 (en) | 2013-06-06 | 2014-06-05 | Pharmaceutical formulations of a hif hydroxylase inhibitor |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2019104562A Division JP6861758B2 (ja) | 2013-06-06 | 2019-06-04 | Ｈｉｆプロリルヒドロキシラーゼ阻害剤の医薬製剤 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2016523846A JP2016523846A (ja) | 2016-08-12 |
| JP2016523846A5 true JP2016523846A5 (https=) | 2017-07-13 |
| JP6604941B2 JP6604941B2 (ja) | 2019-11-13 |
Family
ID=51063834
Family Applications (4)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2016517984A Active JP6604941B2 (ja) | 2013-06-06 | 2014-06-05 | Ｈｉｆプロリルヒドロキシラーゼ阻害剤の医薬製剤 |
| JP2019104562A Active JP6861758B2 (ja) | 2013-06-06 | 2019-06-04 | Ｈｉｆプロリルヒドロキシラーゼ阻害剤の医薬製剤 |
| JP2021057424A Withdrawn JP2021100971A (ja) | 2013-06-06 | 2021-03-30 | Ｈｉｆプロリルヒドロキシラーゼ阻害剤の医薬製剤 |
| JP2023049709A Pending JP2023068197A (ja) | 2013-06-06 | 2023-03-27 | Ｈｉｆプロリルヒドロキシラーゼ阻害剤の医薬製剤 |
Family Applications After (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2019104562A Active JP6861758B2 (ja) | 2013-06-06 | 2019-06-04 | Ｈｉｆプロリルヒドロキシラーゼ阻害剤の医薬製剤 |
| JP2021057424A Withdrawn JP2021100971A (ja) | 2013-06-06 | 2021-03-30 | Ｈｉｆプロリルヒドロキシラーゼ阻害剤の医薬製剤 |
| JP2023049709A Pending JP2023068197A (ja) | 2013-06-06 | 2023-03-27 | Ｈｉｆプロリルヒドロキシラーゼ阻害剤の医薬製剤 |
Country Status (24)
| Country | Link |
|---|---|
| US (3) | US20160120859A1 (https=) |
| EP (2) | EP3708154A1 (https=) |
| JP (4) | JP6604941B2 (https=) |
| KR (3) | KR20210104173A (https=) |
| CN (5) | CN105377242A (https=) |
| AU (1) | AU2014274890B2 (https=) |
| CA (1) | CA2914049C (https=) |
| CY (1) | CY1122951T1 (https=) |
| DK (1) | DK3003284T3 (https=) |
| ES (1) | ES2786924T3 (https=) |
| HR (1) | HRP20200615T1 (https=) |
| HU (1) | HUE049623T2 (https=) |
| IL (3) | IL296484B2 (https=) |
| LT (1) | LT3003284T (https=) |
| ME (1) | ME03777B (https=) |
| MX (3) | MX2015016536A (https=) |
| PL (1) | PL3003284T3 (https=) |
| PT (1) | PT3003284T (https=) |
| RS (1) | RS60464B1 (https=) |
| SG (1) | SG11201509764RA (https=) |
| SI (1) | SI3003284T1 (https=) |
| SM (1) | SMT202000190T1 (https=) |
| WO (1) | WO2014197660A1 (https=) |
| ZA (1) | ZA201508712B (https=) |
Families Citing this family (18)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CA2528232C (en) | 2003-06-06 | 2010-05-25 | Fibrogen, Inc. | Novel nitrogen-containing heteroaryl compounds and their use in increasing endogenous erythropoietin |
| WO2010056767A1 (en) | 2008-11-14 | 2010-05-20 | Fibrogen, Inc. | Thiochromene derivatives as hip hydroxylase inhibitors |
| US8883823B2 (en) | 2012-07-16 | 2014-11-11 | Fibrogen, Inc. | Crystalline forms of a prolyl hydroxylase inhibitor |
| KR20210130849A (ko) | 2012-07-16 | 2021-11-01 | 피브로겐, 인크. | 프롤릴 하이드록실라제 억제제 [(4-하이드록시-1-메틸-7-페녹시-아이소퀴놀린-3-카보닐)-아미노]-아세트산의 결정형 |
| EP2872487B1 (en) | 2012-07-16 | 2017-04-26 | Fibrogen, Inc. | Process for making isoquinoline compounds |
| KR20210104173A (ko) | 2013-06-06 | 2021-08-24 | 피브로겐, 인크. | Hif 하이드록실라제 억제자의 약학적 제형 |
| US11324734B2 (en) | 2015-04-01 | 2022-05-10 | Akebia Therapeutics, Inc. | Compositions and methods for treating anemia |
| WO2019042485A1 (en) | 2017-08-30 | 2019-03-07 | Zentiva, K.S. | FORMS IN THE STRONG STATE OF ROXADUSTAT |
| US11192860B2 (en) | 2017-09-04 | 2021-12-07 | Sandoz Ag | Co-crystal of an orally available HIF prolyl hydroxylase inhibitor |
| CN110664814A (zh) * | 2019-10-24 | 2020-01-10 | 上海长海医院 | Fg-4592在制备治疗炎性肠病药物中的用途 |
| CN110934833B (zh) * | 2019-12-17 | 2022-08-19 | 河北长天药业有限公司 | 一种复方氨酚那敏颗粒 |
| WO2021186356A1 (en) * | 2020-03-17 | 2021-09-23 | Cadila Healthcare Limited | Formulation comprising hif prolyl hydroxylase inhibitors |
| WO2022192097A1 (en) * | 2021-03-06 | 2022-09-15 | Mind Medicine, Inc. | Formulations of psilocin that have enhanced stability |
| CN116832005A (zh) * | 2022-03-23 | 2023-10-03 | 石药集团中奇制药技术（石家庄）有限公司 | 一种罗沙司他胶囊 |
| CN114796280B (zh) * | 2022-06-15 | 2024-06-25 | 河北长天药业有限公司 | 一种复方氨酚那敏颗粒及其制备工艺 |
| EP4321155A1 (en) | 2022-08-08 | 2024-02-14 | Sanovel Ilac Sanayi Ve Ticaret A.S. | An oral pharmaceutical composition comprising roxadustat |
| WO2025111214A1 (en) | 2023-11-22 | 2025-05-30 | Fibrogen, Inc. | [(4-hydroxy-1-methyl-7-phenoxyisoquinoline-3- carbonyl)amino]acetic acid (roxadustat) for the treatment of anemia in subjects with myelodysplastic syndrome (mds) |
| CN118436652A (zh) * | 2024-04-18 | 2024-08-06 | 南方医科大学顺德医院(佛山市顺德区第一人民医院) | 一种罗沙司他药物制剂及其应用 |
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| EP0650961B1 (de) | 1993-11-02 | 1997-03-05 | Hoechst Aktiengesellschaft | Substituierte heterocyclische Carbonsäureamide, ihre Herstellung und ihre Verwendung als Arzneimittel |
| DE19746287A1 (de) | 1997-10-20 | 1999-04-22 | Hoechst Marion Roussel De Gmbh | Substituierte Isochinolin-2-Carbonsäureamide, ihre Herstellung und ihre Verwendung als Arzneimittel |
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| KR20210130849A (ko) | 2012-07-16 | 2021-11-01 | 피브로겐, 인크. | 프롤릴 하이드록실라제 억제제 [(4-하이드록시-1-메틸-7-페녹시-아이소퀴놀린-3-카보닐)-아미노]-아세트산의 결정형 |
| US8883823B2 (en) | 2012-07-16 | 2014-11-11 | Fibrogen, Inc. | Crystalline forms of a prolyl hydroxylase inhibitor |
| EP2872487B1 (en) | 2012-07-16 | 2017-04-26 | Fibrogen, Inc. | Process for making isoquinoline compounds |
| CA2899024C (en) | 2013-01-24 | 2022-01-04 | Fibrogen, Inc. | Crystalline forms of {[1-cyano-5-(4-chlorophenoxy)-4-hydroxy-isoquinoline-3-carbonyl]-amino}-acetic acid |
| KR20210104173A (ko) | 2013-06-06 | 2021-08-24 | 피브로겐, 인크. | Hif 하이드록실라제 억제자의 약학적 제형 |
-
2014
- 2014-06-05 KR KR1020217025795A patent/KR20210104173A/ko not_active Ceased
- 2014-06-05 US US14/896,353 patent/US20160120859A1/en not_active Abandoned
- 2014-06-05 CN CN201480031209.2A patent/CN105377242A/zh active Pending
- 2014-06-05 CN CN202010591484.7A patent/CN111728952A/zh active Pending
- 2014-06-05 LT LTEP14735770.1T patent/LT3003284T/lt unknown
- 2014-06-05 CA CA2914049A patent/CA2914049C/en active Active
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- 2014-06-05 HU HUE14735770A patent/HUE049623T2/hu unknown
- 2014-06-05 WO PCT/US2014/041021 patent/WO2014197660A1/en not_active Ceased
- 2014-06-05 AU AU2014274890A patent/AU2014274890B2/en active Active
- 2014-06-05 JP JP2016517984A patent/JP6604941B2/ja active Active
- 2014-06-05 ES ES14735770T patent/ES2786924T3/es active Active
- 2014-06-05 SM SM20200190T patent/SMT202000190T1/it unknown
- 2014-06-05 EP EP20156653.6A patent/EP3708154A1/en not_active Withdrawn
- 2014-06-05 EP EP14735770.1A patent/EP3003284B1/en not_active Revoked
- 2014-06-05 ME MEP-2020-79A patent/ME03777B/me unknown
- 2014-06-05 PT PT147357701T patent/PT3003284T/pt unknown
- 2014-06-05 CN CN202010591474.3A patent/CN111728950A/zh active Pending
- 2014-06-05 DK DK14735770.1T patent/DK3003284T3/da active
- 2014-06-05 IL IL296484A patent/IL296484B2/en unknown
- 2014-06-05 SI SI201431529T patent/SI3003284T1/sl unknown
- 2014-06-05 KR KR1020227041268A patent/KR20220164069A/ko not_active Ceased
- 2014-06-05 CN CN202010591483.2A patent/CN111728951A/zh active Pending
- 2014-06-05 HR HRP20200615TT patent/HRP20200615T1/hr unknown
- 2014-06-05 IL IL298998A patent/IL298998B2/en unknown
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- 2014-06-05 PL PL14735770T patent/PL3003284T3/pl unknown
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2015
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2018
- 2018-07-13 US US16/035,503 patent/US10765672B2/en active Active
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2019
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2020
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2021
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- 2021-03-30 JP JP2021057424A patent/JP2021100971A/ja not_active Withdrawn
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2023
- 2023-03-27 JP JP2023049709A patent/JP2023068197A/ja active Pending
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