JP2012526140A5 - - Google Patents
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- JP2012526140A5 JP2012526140A5 JP2012509968A JP2012509968A JP2012526140A5 JP 2012526140 A5 JP2012526140 A5 JP 2012526140A5 JP 2012509968 A JP2012509968 A JP 2012509968A JP 2012509968 A JP2012509968 A JP 2012509968A JP 2012526140 A5 JP2012526140 A5 JP 2012526140A5
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- JP
- Japan
- Prior art keywords
- package
- storage
- less
- pharmaceutical product
- storage method
- 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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- 238000000034 method Methods 0.000 claims description 47
- 239000000825 pharmaceutical preparation Substances 0.000 claims description 34
- 229940127557 pharmaceutical product Drugs 0.000 claims description 34
- 238000009472 formulation Methods 0.000 claims description 25
- 239000000203 mixture Substances 0.000 claims description 25
- 239000007787 solid Substances 0.000 claims description 23
- 239000002274 desiccant Substances 0.000 claims description 20
- 239000013543 active substance Substances 0.000 claims description 16
- 239000000546 pharmaceutical excipient Substances 0.000 claims description 16
- 238000002360 preparation method Methods 0.000 claims description 16
- 229920002774 Maltodextrin Polymers 0.000 claims description 8
- 239000005913 Maltodextrin Substances 0.000 claims description 8
- TVXBFESIOXBWNM-UHFFFAOYSA-N Xylitol Natural products OCCC(O)C(O)C(O)CCO TVXBFESIOXBWNM-UHFFFAOYSA-N 0.000 claims description 8
- 229940035034 maltodextrin Drugs 0.000 claims description 8
- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 claims description 8
- 238000004321 preservation Methods 0.000 claims description 8
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 claims description 8
- 229960002675 xylitol Drugs 0.000 claims description 8
- 235000010447 xylitol Nutrition 0.000 claims description 8
- 239000000811 xylitol Substances 0.000 claims description 8
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 6
- 238000009512 pharmaceutical packaging Methods 0.000 claims description 4
- RHWRWEUCEXUUAV-ZSESPEEFSA-N 2-[[(1r,2r,3as,9as)-2-hydroxy-1-[(3s)-3-hydroxyoctyl]-2,3,3a,4,9,9a-hexahydro-1h-cyclopenta[g]naphthalen-5-yl]oxy]acetic acid;2-(2-hydroxyethylamino)ethanol Chemical group OCCNCCO.C1=CC=C(OCC(O)=O)C2=C1C[C@@H]1[C@@H](CC[C@@H](O)CCCCC)[C@H](O)C[C@@H]1C2 RHWRWEUCEXUUAV-ZSESPEEFSA-N 0.000 claims 4
- 239000003814 drug Substances 0.000 claims 1
- 238000004806 packaging method and process Methods 0.000 claims 1
- PAJMKGZZBBTTOY-ZFORQUDYSA-N treprostinil Chemical compound C1=CC=C(OCC(O)=O)C2=C1C[C@@H]1[C@@H](CC[C@@H](O)CCCCC)[C@H](O)C[C@@H]1C2 PAJMKGZZBBTTOY-ZFORQUDYSA-N 0.000 description 20
- 229960005032 treprostinil Drugs 0.000 description 16
- 150000003839 salts Chemical class 0.000 description 12
- 229910019142 PO4 Inorganic materials 0.000 description 4
- 150000001413 amino acids Chemical class 0.000 description 4
- 125000001797 benzyl group Chemical group [H]C1=C([H])C([H])=C(C([H])=C1[H])C([H])([H])* 0.000 description 4
- ZBCBWPMODOFKDW-UHFFFAOYSA-N diethanolamine Chemical compound OCCNCCO ZBCBWPMODOFKDW-UHFFFAOYSA-N 0.000 description 4
- 150000002148 esters Chemical class 0.000 description 4
- -1 glycolamide ester Chemical class 0.000 description 4
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 description 4
- 239000010452 phosphate Substances 0.000 description 4
- 102000004169 proteins and genes Human genes 0.000 description 4
- 108090000623 proteins and genes Proteins 0.000 description 4
- 0 CCCCC[C@](*)CC[C@]1[C@](*)CC(C2)C1Cc1c2c(*)ccc1 Chemical compound CCCCC[C@](*)CC[C@]1[C@](*)CC(C2)C1Cc1c2c(*)ccc1 0.000 description 1
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US17626809P | 2009-05-07 | 2009-05-07 | |
| US61/176,268 | 2009-05-07 | ||
| PCT/US2010/033852 WO2010129757A1 (en) | 2009-05-07 | 2010-05-06 | Solid formulations of prostacyclin analogs |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2012526140A JP2012526140A (ja) | 2012-10-25 |
| JP2012526140A5 true JP2012526140A5 (https=) | 2014-05-01 |
| JP5649645B2 JP5649645B2 (ja) | 2015-01-07 |
Family
ID=43050464
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2012509968A Active JP5649645B2 (ja) | 2009-05-07 | 2010-05-06 | プロスタサイクリンアナログの固形製剤 |
Country Status (7)
| Country | Link |
|---|---|
| US (1) | US8349892B2 (https=) |
| EP (1) | EP2427054A4 (https=) |
| JP (1) | JP5649645B2 (https=) |
| KR (1) | KR101544246B1 (https=) |
| CN (1) | CN102421288B (https=) |
| CA (1) | CA2760499C (https=) |
| WO (1) | WO2010129757A1 (https=) |
Families Citing this family (34)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ES2622471T5 (es) | 2003-05-22 | 2020-07-23 | United Therapeutics Corp | Compuestos y procedimientos para la administración de análogos de prostaciclina |
| WO2005099680A2 (en) * | 2004-04-12 | 2005-10-27 | United Therapeutics, Inc. | Use of treprostinil to treat neuropathic diabetic foot ulcers |
| EP2026816B1 (en) | 2006-05-15 | 2018-10-24 | United Therapeutics Corporation | Treprostinil administration using a metered dose inhaler |
| DE102006026786A1 (de) | 2006-06-07 | 2007-12-13 | Joachim Kern | Dosierinhalator |
| CN101903324B (zh) | 2007-12-17 | 2013-07-03 | 联合治疗公司 | 一种制备Remodulin中的活性成分曲前列素的改良方法 |
| ES2611187T3 (es) | 2010-03-15 | 2017-05-05 | United Therapeutics Corporation | Tratamiento para hipertensión pulmonar |
| JP6046034B2 (ja) | 2010-06-03 | 2016-12-14 | ユナイテッド セラピューティクス コーポレイション | トレプロスチニルの製造 |
| US20120004307A1 (en) * | 2010-06-15 | 2012-01-05 | United Therapeutics Corporation | Oral treatment of digital ischemic lesions |
| US20130345471A1 (en) | 2011-03-02 | 2013-12-26 | United Therapeutics Corporation | Synthesis of intermediate for treprostinil production |
| CN103193627B (zh) * | 2012-01-10 | 2016-04-20 | 上海天伟生物制药有限公司 | 一种前列腺素类似物的晶型及其制备方法和用途 |
| EP3712142B1 (en) | 2013-01-11 | 2022-07-06 | Corsair Pharma, Inc. | Prodrugs of treprostinil |
| US9505737B2 (en) | 2013-01-11 | 2016-11-29 | Corsair Pharma, Inc. | Treprostinil derivative compounds and methods of using same |
| JP2016517410A (ja) | 2013-03-14 | 2016-06-16 | ユナイテッド セラピューティクス コーポレイション | トレプロスチニルの固体形態 |
| CN109608326A (zh) | 2013-03-15 | 2019-04-12 | 联合治疗公司 | 曲前列环素的盐 |
| JP6263604B2 (ja) | 2013-03-25 | 2018-01-17 | ユナイテッド セラピューティクス コーポレイション | チオールリンカーを持つ、ペグ化型のプロスタサイクリン化合物の製造方法 |
| ES2860975T3 (es) | 2013-10-25 | 2021-10-05 | Insmed Inc | Compuestos de prostaciclina |
| ES2908142T3 (es) | 2014-06-13 | 2022-04-27 | United Therapeutics Corp | Formulaciones de treprostinil |
| US9593061B2 (en) | 2014-10-20 | 2017-03-14 | United Therapeutics Corporation | Synthesis of intermediates for producing prostacyclin derivatives |
| AU2015349969B2 (en) | 2014-11-18 | 2020-02-06 | Insmed Incorporated | Methods of manufacturing treprostinil and treprostinil derivative prodrugs |
| US9394227B1 (en) | 2015-06-17 | 2016-07-19 | Corsair Pharma, Inc. | Treprostinil derivatives and compositions and uses thereof |
| US9643911B2 (en) | 2015-06-17 | 2017-05-09 | Corsair Pharma, Inc. | Treprostinil derivatives and compositions and uses thereof |
| JP7220650B2 (ja) | 2016-09-26 | 2023-02-10 | ユナイテッド セラピューティクス コーポレイション | トレプロスチニルプロドラッグ |
| US10799653B2 (en) | 2017-01-09 | 2020-10-13 | United Therapeutics Corporation | Aerosol delivery device and method for manufacturing and operating the same |
| ES2976468T3 (es) | 2018-09-18 | 2024-08-01 | Lilly Co Eli | Sal de treprostinil erbumina |
| CN114072136B (zh) | 2019-04-29 | 2024-11-29 | 英斯梅德股份有限公司 | 曲前列素前药的干粉组合物及其使用方法 |
| EP4017588A1 (en) | 2019-08-23 | 2022-06-29 | United Therapeutics Corporation | Treprostinil prodrugs |
| JP2023523557A (ja) | 2020-04-17 | 2023-06-06 | ユナイテッド セラピューティクス コーポレイション | 間質性肺疾患の治療における使用のためのトレプロスチニル |
| IL298591A (en) | 2020-06-09 | 2023-01-01 | United Therapeutics Corp | Pomeryl dictopiperidine prodrugs of treprostinil |
| KR20250133451A (ko) | 2020-12-14 | 2025-09-05 | 유나이티드 쎄러퓨틱스 코포레이션 | 트레프로스티닐 프로드러그로 질환을 치료하는 방법 |
| JP2024510930A (ja) | 2021-03-03 | 2024-03-12 | ユナイテッド セラピューティクス コーポレイション | トレプロスチニル及びそのプロドラッグの乾燥粉末組成物、及び、さらに(e)-3,6-ビス[4-(n-カルボニル-2-プロペニル)アミドブチル]-2,5-ジケトピペラジン(fdkp)を含む乾燥粉末組成物 |
| WO2023154705A1 (en) | 2022-02-08 | 2023-08-17 | United Therapeutics Corporation | Treprostinil iloprost combination therapy |
| EP4516297A4 (en) | 2022-04-29 | 2026-02-25 | Zhaoke pharmaceutical guangzhou co ltd | Treprostinil Gentle Inhalation Mist |
| EP4652151A1 (en) | 2023-01-19 | 2025-11-26 | United Therapeutics Corporation | Treprostinil analogs |
| CN117800845B (zh) * | 2023-03-28 | 2026-04-14 | 广州楷石医药有限公司 | 一种羟基取代曲前列尼尔衍生物、合成方法及其应用 |
Family Cites Families (24)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4306075A (en) * | 1980-03-28 | 1981-12-15 | The Upjohn Company | Composition and process |
| GB8814438D0 (en) * | 1988-06-17 | 1988-07-20 | Wellcome Found | Compounds for use in medicine |
| GB9011588D0 (en) * | 1990-05-24 | 1990-07-11 | Wellcome Found | Prostaglandin analogues for use in medicine |
| US6441245B1 (en) * | 1997-10-24 | 2002-08-27 | United Therapeutics Corporation | Process for stereoselective synthesis of prostacyclin derivatives |
| KR100638684B1 (ko) * | 1997-11-14 | 2006-10-27 | 유나이티드 세러퓨틱스 코오포레이션 | 말초 혈관 질환의 치료를 위한 9-데옥시-2',9-알파-메타노-3-옥사-4,5,6-트리노르-3,7-(1',3'-인터페닐렌)-13,14-디하이드로-프로스타글란딘 에프1의 용도 |
| US6521212B1 (en) * | 1999-03-18 | 2003-02-18 | United Therapeutics Corporation | Method for treating peripheral vascular disease by administering benzindene prostaglandins by inhalation |
| US6700025B2 (en) * | 2001-01-05 | 2004-03-02 | United Therapeutics Corporation | Process for stereoselective synthesis of prostacyclin derivatives |
| US6803386B2 (en) * | 2002-01-16 | 2004-10-12 | United Therapeutics Corporation | Prostacyclin derivative containing compositions and methods of using the same for the treatment of cancer |
| EP1471049A4 (en) * | 2002-01-30 | 2006-08-16 | Kissei Pharmaceutical | NEW THYROIDIAN HORMONE RECEPTOR LIGAND, MEDICINAL PREPARATIONS CONTAINING THE SAME AND USE THEREOF |
| ES2622471T5 (es) * | 2003-05-22 | 2020-07-23 | United Therapeutics Corp | Compuestos y procedimientos para la administración de análogos de prostaciclina |
| US20040265238A1 (en) * | 2003-06-27 | 2004-12-30 | Imtiaz Chaudry | Inhalable formulations for treating pulmonary hypertension and methods of using same |
| US20050101608A1 (en) * | 2003-09-24 | 2005-05-12 | Santel Donald J. | Iloprost in combination therapies for the treatment of pulmonary arterial hypertension |
| ATE441418T1 (de) * | 2003-12-16 | 2009-09-15 | United Therapeutics Corp | Verwendung von treprostinil zur verbesserung der nierenfunktion |
| DE602004028155D1 (de) * | 2003-12-16 | 2010-08-26 | United Therapeutics Corp | Verwendung von treprostinil zur behandlung von ischämischen läsionen |
| WO2005099680A2 (en) * | 2004-04-12 | 2005-10-27 | United Therapeutics, Inc. | Use of treprostinil to treat neuropathic diabetic foot ulcers |
| KR100908547B1 (ko) * | 2005-02-22 | 2009-07-20 | 화이자 인코포레이티드 | 5ht4 수용체 작용제로서의 옥시인돌 유도체 |
| US20060222792A1 (en) * | 2006-04-21 | 2006-10-05 | Chemagis Ltd. | Temozolomide storage system |
| US8747897B2 (en) * | 2006-04-27 | 2014-06-10 | Supernus Pharmaceuticals, Inc. | Osmotic drug delivery system |
| EP2026816B1 (en) * | 2006-05-15 | 2018-10-24 | United Therapeutics Corporation | Treprostinil administration using a metered dose inhaler |
| US20090281129A1 (en) * | 2006-05-15 | 2009-11-12 | Senex Biotechnology, Inc. | Cdki pathway inhibitors and uses thereof |
| KR20090101276A (ko) * | 2006-12-21 | 2009-09-24 | 콘서트 파마슈티컬즈, 인크. | 프로스타시클린 유도체 |
| JP2010518122A (ja) * | 2007-02-09 | 2010-05-27 | ユナイテッド セラピューティクス コーポレーション | 間質性肺疾患および喘息のためのトレプロスチニル処置 |
| US8246950B2 (en) * | 2007-02-20 | 2012-08-21 | Aptalis Pharma Limited | Stable digestive enzyme compositions |
| CN101903324B (zh) * | 2007-12-17 | 2013-07-03 | 联合治疗公司 | 一种制备Remodulin中的活性成分曲前列素的改良方法 |
-
2010
- 2010-05-06 US US12/775,102 patent/US8349892B2/en active Active
- 2010-05-06 KR KR1020117028834A patent/KR101544246B1/ko active Active
- 2010-05-06 CA CA2760499A patent/CA2760499C/en active Active
- 2010-05-06 EP EP10772819.8A patent/EP2427054A4/en not_active Withdrawn
- 2010-05-06 JP JP2012509968A patent/JP5649645B2/ja active Active
- 2010-05-06 CN CN201080019951.3A patent/CN102421288B/zh active Active
- 2010-05-06 WO PCT/US2010/033852 patent/WO2010129757A1/en not_active Ceased
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