JP2009235073A5 - - Google Patents
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- Publication number
- JP2009235073A5 JP2009235073A5 JP2009112258A JP2009112258A JP2009235073A5 JP 2009235073 A5 JP2009235073 A5 JP 2009235073A5 JP 2009112258 A JP2009112258 A JP 2009112258A JP 2009112258 A JP2009112258 A JP 2009112258A JP 2009235073 A5 JP2009235073 A5 JP 2009235073A5
- Authority
- JP
- Japan
- Prior art keywords
- pharmaceutical composition
- composition according
- polysorbate
- sodium starch
- starch glycolate
- 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
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 6
- 150000001875 compounds Chemical class 0.000 claims description 4
- 235000019359 magnesium stearate Nutrition 0.000 claims description 3
- 239000008194 pharmaceutical composition Substances 0.000 claims 9
- 229920000136 polysorbate Polymers 0.000 claims 3
- 229950008882 polysorbate Drugs 0.000 claims 3
- 229940079832 sodium starch glycolate Drugs 0.000 claims 2
- 239000008109 sodium starch glycolate Substances 0.000 claims 2
- 229920003109 sodium starch glycolate Polymers 0.000 claims 2
- 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 1
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims 1
- 206010064911 Pulmonary arterial hypertension Diseases 0.000 claims 1
- 239000002775 capsule Substances 0.000 claims 1
- 239000007884 disintegrant Substances 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 239000000945 filler Substances 0.000 claims 1
- 229960001021 lactose monohydrate Drugs 0.000 claims 1
- 239000000314 lubricant Substances 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 229940016286 microcrystalline cellulose Drugs 0.000 claims 1
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims 1
- 239000008108 microcrystalline cellulose Substances 0.000 claims 1
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims 1
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims 1
- 229940068968 polysorbate 80 Drugs 0.000 claims 1
- 229920000053 polysorbate 80 Polymers 0.000 claims 1
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims 1
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims 1
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims 1
- 150000003839 salts Chemical class 0.000 claims 1
- 239000012453 solvate Substances 0.000 claims 1
- 239000004094 surface-active agent Substances 0.000 claims 1
- 239000011236 particulate material Substances 0.000 description 6
- 238000001035 drying Methods 0.000 description 4
- 239000008187 granular material Substances 0.000 description 4
- 238000000034 method Methods 0.000 description 4
- 239000000203 mixture Substances 0.000 description 4
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 4
- 239000012530 fluid Substances 0.000 description 2
- 241000237942 Conidae Species 0.000 description 1
- 238000007907 direct compression Methods 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 238000005550 wet granulation Methods 0.000 description 1
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EPPCT/EP2005/009775 | 2005-09-12 | ||
| EP2005009775 | 2005-09-12 |
Related Parent Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2008529767A Division JP4955685B2 (ja) | 2005-09-12 | 2006-09-11 | ピリミジン−スルファミドを含む安定な医薬組成物 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2009235073A JP2009235073A (ja) | 2009-10-15 |
| JP2009235073A5 true JP2009235073A5 (https=) | 2012-03-29 |
| JP5054061B2 JP5054061B2 (ja) | 2012-10-24 |
Family
ID=37865339
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2008529767A Active JP4955685B2 (ja) | 2005-09-12 | 2006-09-11 | ピリミジン−スルファミドを含む安定な医薬組成物 |
| JP2009112258A Active JP5054061B2 (ja) | 2005-09-12 | 2009-05-01 | ピリミジン−スルファミドを含む安定な医薬組成物 |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2008529767A Active JP4955685B2 (ja) | 2005-09-12 | 2006-09-11 | ピリミジン−スルファミドを含む安定な医薬組成物 |
Country Status (23)
| Country | Link |
|---|---|
| US (6) | US20080233188A1 (https=) |
| EP (2) | EP1928409B1 (https=) |
| JP (2) | JP4955685B2 (https=) |
| KR (1) | KR101313395B1 (https=) |
| CN (1) | CN101262847B (https=) |
| AU (1) | AU2006290309B2 (https=) |
| BR (1) | BRPI0615898B8 (https=) |
| CA (1) | CA2621273C (https=) |
| CY (1) | CY1113395T1 (https=) |
| DK (1) | DK1928409T3 (https=) |
| ES (1) | ES2393117T3 (https=) |
| HR (1) | HRP20120957T1 (https=) |
| IL (1) | IL190072A (https=) |
| MY (1) | MY151003A (https=) |
| NO (1) | NO341325B1 (https=) |
| NZ (1) | NZ567188A (https=) |
| PL (1) | PL1928409T3 (https=) |
| PT (1) | PT1928409E (https=) |
| RU (1) | RU2424805C2 (https=) |
| SI (1) | SI1928409T1 (https=) |
| TW (1) | TWI323661B (https=) |
| WO (1) | WO2007031933A2 (https=) |
| ZA (1) | ZA200802947B (https=) |
Families Citing this family (27)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| PT1928409E (pt) | 2005-09-12 | 2012-11-27 | Actelion Pharmaceuticals Ltd | Composição farmacêutica estável que compreende uma pirimidina-sulfamida |
| AR062501A1 (es) * | 2006-08-29 | 2008-11-12 | Actelion Pharmaceuticals Ltd | Composiciones terapeuticas |
| TWI399223B (zh) * | 2006-09-15 | 2013-06-21 | Daiichi Sankyo Co Ltd | 奧美沙坦酯及氨氯地平之固體劑型 |
| MX2010001837A (es) | 2007-08-17 | 2010-03-10 | Actelion Pharmaceuticals Ltd | Derivados de 4-pirimidinasulfamida. |
| US8541433B2 (en) * | 2008-02-20 | 2013-09-24 | Actelion Pharmaceuticals, Ltd. | Combination comprising macitentan and paclitaxel for treating multi-drug resistant ovarian cancer |
| LT2315587T (lt) | 2008-08-13 | 2018-01-10 | Actelion Pharmaceuticals Ltd. | Terapinės kompozicijos, turinčios macitentano |
| ES2543280T3 (es) * | 2009-08-10 | 2015-08-17 | Board Of Regents, The University Of Texas System | Tratamiento de metástasis cerebrales con inhibidores de los receptores de endotelina en combinación con un agente quimioterapéutico citotóxico |
| JP5714600B2 (ja) | 2009-12-18 | 2015-05-07 | フリースランドカンピナ・ネーデルランド・ホールディング・ビー．ブイ．ＦｒｉｅｓｌａｎｄＣａｍｐｉｎａ Ｎｅｄｅｒｌａｎｄ Ｈｏｌｄｉｎｇ Ｂ．Ｖ． | 共加工された錠用賦形剤混合物、その調製及び使用 |
| IT1403248B1 (it) * | 2010-11-12 | 2013-10-17 | Scharper Therapeutics Srl | Composizione per il trattamento di disfunzioni degli apparati fonatorio ed olfattorio |
| EP2670405B1 (en) | 2011-02-04 | 2015-09-02 | Actelion Pharmaceuticals Ltd. | Combinations comprising macitentan for the treatment of glioblastoma multiforme |
| DE14721256T1 (de) * | 2013-04-22 | 2017-03-16 | Sandoz Ag | Pharmazeutische zusammensetzungen mit kristallinem macitentan |
| SG10201910773VA (en) | 2013-06-13 | 2020-01-30 | Akebia Therapeutics Inc | Compositions and methods for treating anemia |
| CN104411691B (zh) * | 2013-06-14 | 2016-05-25 | 杭州普晒医药科技有限公司 | 马西替坦晶体及其制备方法、其药物组合物和用途 |
| US20170158645A1 (en) * | 2014-07-15 | 2017-06-08 | Olon S.P.A. | Amorphous form and new crystalline forms of macitentan |
| US10085993B2 (en) | 2014-07-25 | 2018-10-02 | Novartis Ag | Tablet formulation of 2-fluoro-N-methyl-4-[ 7-( quinolin-6-ylmethyl) imidazo [1,2-B] [1,2,4] triazin-2-yl] benzamide |
| CN105388244B (zh) * | 2015-12-10 | 2017-03-08 | 合肥久诺医药科技有限公司 | 一种马西替坦有关物质的高效液相色谱分析方法 |
| WO2018153925A1 (en) | 2017-02-22 | 2018-08-30 | Amneal Pharmaceuticals Company Gmbh | Stable pharmaceutical compositions comprising macitentan |
| CA3123990A1 (en) | 2018-12-21 | 2020-06-25 | Actelion Pharmaceuticals Ltd | Pharmaceutical composition for the treatment of pulmonary arterial hypertension |
| TW202042818A (zh) * | 2019-01-25 | 2020-12-01 | 瑞士商艾克泰聯製藥有限公司 | 用於治療慢性血栓性肺高血壓之醫藥組成物 |
| AU2020277546B2 (en) | 2019-05-22 | 2025-07-03 | Wuxi Biocity Biopharmaceutics Co., Ltd. | Crystal form of pyrimidine sulfonamide compound and preparation method therefor |
| MX2022000267A (es) * | 2019-07-05 | 2022-02-03 | Tecnimede Sociedade Tecnico Medicinal Sa | Composiciones comprimidas de macitentan, metodos y usos de las mismas. |
| CN114728002A (zh) | 2019-11-29 | 2022-07-08 | 埃科特莱茵药品有限公司 | 治疗肺动脉高血压的方法 |
| WO2022238375A1 (en) | 2021-05-11 | 2022-11-17 | Actelion Pharmaceuticals Ltd | Methods of treating pulmonary hypertension |
| TW202317119A (zh) * | 2021-06-11 | 2023-05-01 | 瑞士商艾克泰聯製藥有限公司 | 用於口服投予之分散錠 |
| EP4392024A1 (en) | 2021-08-25 | 2024-07-03 | Basf Se | Direct tableting auxiliary composition |
| TR2021013983A1 (tr) * | 2021-09-07 | 2023-03-21 | Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi | Masi̇tentan i̇çeren bi̇r kapsül formülasyonu |
| EP4154873A1 (en) | 2021-09-22 | 2023-03-29 | Sanovel Ilac Sanayi Ve Ticaret A.S. | The tablet comprising macitentan |
Family Cites Families (35)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5945098A (en) | 1990-02-01 | 1999-08-31 | Baxter International Inc. | Stable intravenously-administrable immune globulin preparation |
| JPH04103525A (ja) | 1990-08-22 | 1992-04-06 | Sanwa Kagaku Kenkyusho Co Ltd | 難水溶性薬物の持続性製剤化方法 |
| RU2086544C1 (ru) * | 1991-06-13 | 1997-08-10 | Хоффманн-Ля Рош АГ | Бензолсульфонамидные производные пиримидина или их соли, фармацевтическая композиция для лечения заболеваний, связанных с активностью эндотелина |
| DE69329795T2 (de) | 1992-10-02 | 2001-07-05 | Genetics Institute, Inc. | Zusammensetzung, welche den koagulationsfaktor viii beinhaltet; verfahren zu deren herstellung und die benutzung eines oberflächenaktiven stoffes als stabilisator |
| US5811120A (en) | 1994-03-02 | 1998-09-22 | Eli Lilly And Company | Solid orally administerable raloxifene hydrochloride pharmaceutical formulation |
| TW442301B (en) * | 1995-06-07 | 2001-06-23 | Sanofi Synthelabo | Pharmaceutical compositions containing irbesartan |
| WO1997022595A1 (en) | 1995-12-20 | 1997-06-26 | Yamanouchi Pharmaceutical Co., Ltd. | Arylethenesulfonamide derivatives and drug composition containing the same |
| JPH103525A (ja) | 1996-06-14 | 1998-01-06 | Dainippon Printing Co Ltd | Ｉｃカード、命令コード格納方法及び命令コード実行方法 |
| AR017426A1 (es) | 1997-12-08 | 2001-09-05 | Smithkline Beecham Corp | Sal de monoargininilo del acido (e)-3-[1-n-butil-5-[2-(2-carboxifenil)metoxi-4-clorofenil]-1h-pirazol-4-il]-2-[(5-metoxi-2,3-dihidrobenzofuran-6-il)metil]-prop-2-enoico, composicion farmaceutica que la contiene, su uso para la manufactura de un medicamento y procedimiento para su preparacion |
| CA2322315C (en) | 1998-03-06 | 2008-09-16 | Eurand International S.P.A. | Fast disintegrating tablets |
| US20010014352A1 (en) * | 1998-05-27 | 2001-08-16 | Udit Batra | Compressed tablet formulation |
| US20040062803A1 (en) * | 1999-12-22 | 2004-04-01 | Hedden David B. | Sustained-release formulation of a cyclooxygenase-2 inhibitor |
| HUP0203935A3 (en) * | 1999-12-31 | 2006-02-28 | Encysive Pharmaceuticals Inc H | Sulfonamides and derivatives thereof that modulate the activity of endothelin, pharmaceutical compositions containing them and their use |
| GB0001621D0 (en) | 2000-01-26 | 2000-03-15 | Astrazeneca Ab | Pharmaceutical compositions |
| JP2001335469A (ja) | 2000-05-26 | 2001-12-04 | Lion Corp | 固体製剤の製造方法 |
| JP2004501191A (ja) | 2000-06-28 | 2004-01-15 | テバ ファーマシューティカル インダストリーズ リミティド | カルベジロール |
| WO2002043704A1 (fr) | 2000-12-01 | 2002-06-06 | Kyowa Hakko Kogyo Co., Ltd. | Composition a solubilite ou absorbabilite orale amelioree |
| IL156315A0 (en) | 2000-12-07 | 2004-01-04 | Cv Therapeutics Inc | Abca-1 elevating compounds |
| HU229403B1 (en) * | 2000-12-18 | 2013-12-30 | Actelion Pharmaceuticals Ltd | Novel sulfamides and their use as endothelin receptor antagonists |
| FR2819720B1 (fr) * | 2001-01-22 | 2004-03-12 | Fournier Lab Sa | Nouveaux comprimes de fenofibrate |
| JP3930290B2 (ja) | 2001-09-12 | 2007-06-13 | 富士フイルム株式会社 | 熱現像感光材料及びそれを用いた熱現像方法 |
| KR20030041577A (ko) | 2001-11-20 | 2003-05-27 | 디디에스텍주식회사 | 난용성 약물과 치환된 시클로덱스트린을 함유하는고체분산체 및 이를 함유하는 약제학적 조성물 |
| WO2003057166A2 (en) * | 2002-01-07 | 2003-07-17 | Pharmacia Corporation | Treatment of pain, inflammation, and inflammation-related disorders with a combination of a cyclooxygenase-2 selective inhibitor and aspirin |
| KR100698982B1 (ko) | 2002-02-11 | 2007-03-26 | 화이자 인코포레이티드 | Ｐｄｅ4 억제제로서 유용한 니코틴아미드 유도체 |
| KR20100090726A (ko) * | 2002-02-26 | 2010-08-16 | 아스트라제네카 아베 | 수용성 셀룰로스 유도체를 포함하는 이레사의 약학 조제물 |
| GB0204771D0 (en) | 2002-02-28 | 2002-04-17 | Phoqus Ltd | Fast disintegrating tablets |
| US7625887B2 (en) | 2003-01-28 | 2009-12-01 | Takeda Pharmaceutical Company Limited | Receptor agonists |
| HRP20050675A2 (en) | 2003-02-25 | 2005-10-31 | Eli Lilly And Company | Crystalline non-solavated 1-(4-(2-piperidinylethoxy)phenoxy)-2-(4-methanesulfonylphenyl)-6-hydroxynaphthalene hydrochloride |
| EP1697382A4 (en) | 2003-12-10 | 2008-11-05 | Activbiotics Inc | ANALOGUES OF RIFAMYCIN AND USES THEREOF |
| US7094081B1 (en) * | 2005-03-24 | 2006-08-22 | Delphi Technologies, Inc. | Electrical connector assembly |
| PT1928409E (pt) | 2005-09-12 | 2012-11-27 | Actelion Pharmaceuticals Ltd | Composição farmacêutica estável que compreende uma pirimidina-sulfamida |
| AR062501A1 (es) | 2006-08-29 | 2008-11-12 | Actelion Pharmaceuticals Ltd | Composiciones terapeuticas |
| US8541433B2 (en) | 2008-02-20 | 2013-09-24 | Actelion Pharmaceuticals, Ltd. | Combination comprising macitentan and paclitaxel for treating multi-drug resistant ovarian cancer |
| LT2315587T (lt) | 2008-08-13 | 2018-01-10 | Actelion Pharmaceuticals Ltd. | Terapinės kompozicijos, turinčios macitentano |
| EP2670405B1 (en) | 2011-02-04 | 2015-09-02 | Actelion Pharmaceuticals Ltd. | Combinations comprising macitentan for the treatment of glioblastoma multiforme |
-
2006
- 2006-09-11 PT PT06809280T patent/PT1928409E/pt unknown
- 2006-09-11 BR BRPI0615898A patent/BRPI0615898B8/pt active IP Right Grant
- 2006-09-11 CN CN2006800333751A patent/CN101262847B/zh active Active
- 2006-09-11 EP EP06809280A patent/EP1928409B1/en active Active
- 2006-09-11 KR KR1020087008450A patent/KR101313395B1/ko active Active
- 2006-09-11 US US12/066,448 patent/US20080233188A1/en not_active Abandoned
- 2006-09-11 AU AU2006290309A patent/AU2006290309B2/en active Active
- 2006-09-11 WO PCT/IB2006/053210 patent/WO2007031933A2/en not_active Ceased
- 2006-09-11 EP EP10009910A patent/EP2292209A3/en not_active Withdrawn
- 2006-09-11 ES ES06809280T patent/ES2393117T3/es active Active
- 2006-09-11 RU RU2008113869/15A patent/RU2424805C2/ru active
- 2006-09-11 NZ NZ567188A patent/NZ567188A/en unknown
- 2006-09-11 HR HRP20120957TT patent/HRP20120957T1/hr unknown
- 2006-09-11 JP JP2008529767A patent/JP4955685B2/ja active Active
- 2006-09-11 MY MYPI20080524 patent/MY151003A/en unknown
- 2006-09-11 CA CA2621273A patent/CA2621273C/en active Active
- 2006-09-11 DK DK06809280.8T patent/DK1928409T3/da active
- 2006-09-11 PL PL06809280T patent/PL1928409T3/pl unknown
- 2006-09-11 SI SI200631471T patent/SI1928409T1/sl unknown
- 2006-09-12 TW TW095133695A patent/TWI323661B/zh active
-
2008
- 2008-03-11 IL IL190072A patent/IL190072A/en active IP Right Grant
- 2008-04-03 ZA ZA200802947A patent/ZA200802947B/xx unknown
- 2008-04-09 NO NO20081724A patent/NO341325B1/no unknown
-
2009
- 2009-02-18 US US12/388,142 patent/US8367685B2/en active Active
- 2009-05-01 JP JP2009112258A patent/JP5054061B2/ja active Active
-
2012
- 2012-11-21 CY CY20121101126T patent/CY1113395T1/el unknown
-
2013
- 2013-01-08 US US13/736,699 patent/US9265762B2/en active Active
-
2016
- 2016-01-20 US US15/002,255 patent/US10117870B2/en active Active
-
2018
- 2018-02-20 US US15/900,586 patent/US10946015B2/en active Active
-
2020
- 2020-12-09 US US17/116,983 patent/US11648249B2/en active Active
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