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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Links
- 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 (enExample) | 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 (enExample) |
| EP (1) | EP2427054A4 (enExample) |
| JP (1) | JP5649645B2 (enExample) |
| KR (1) | KR101544246B1 (enExample) |
| CN (1) | CN102421288B (enExample) |
| CA (1) | CA2760499C (enExample) |
| WO (1) | WO2010129757A1 (enExample) |
Families Citing this family (35)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102697790A (zh) | 2003-05-22 | 2012-10-03 | 联合治疗公司 | 化合物和释放前列环素类似物的方法 |
| DE602005020269D1 (de) * | 2004-04-12 | 2010-05-12 | United Therapeutics Corp | Verwendung von treprostinil zur behandlung von neuropathischen diabetischen fussgeschwüren |
| CA2654492C (en) | 2006-05-15 | 2017-06-27 | United Therapeutics Corporation | Treprostinil administration using a metered dose inhaler |
| DE102006026786A1 (de) | 2006-06-07 | 2007-12-13 | Joachim Kern | Dosierinhalator |
| WO2009078965A1 (en) | 2007-12-17 | 2009-06-25 | United Therapeutics Corporation | An improved process to prepare treprostinil, the active ingredient in remodulin |
| KR20160132501A (ko) | 2010-03-15 | 2016-11-18 | 유나이티드 세러퓨틱스 코오포레이션 | 폐고혈압의 치료 |
| CN103261142B (zh) | 2010-06-03 | 2014-12-10 | 联合治疗公司 | 曲前列环素的制备 |
| WO2011159693A2 (en) * | 2010-06-15 | 2011-12-22 | United Therapeutics Corporation | Oral treatment of digital ischemic lesions |
| ES2581762T3 (es) | 2011-03-02 | 2016-09-07 | United Therapeutics Corporation | Síntesis de producto intermedio para la producción de treprostinil |
| 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 |
| US9505737B2 (en) | 2013-01-11 | 2016-11-29 | Corsair Pharma, Inc. | Treprostinil derivative compounds and methods of using same |
| EP3712142B1 (en) | 2013-01-11 | 2022-07-06 | Corsair Pharma, Inc. | Prodrugs of treprostinil |
| WO2014159050A1 (en) | 2013-03-14 | 2014-10-02 | United Therapeutics Corporation | Solid forms of treprostinil |
| EP2970081A4 (en) | 2013-03-15 | 2016-10-12 | United Therapeutics Corp | SALTS OF TREPROSTINIL |
| WO2014160638A1 (en) | 2013-03-25 | 2014-10-02 | United Therapeutics Corporation | Process of making prostacyclin compounds with linker thiol and pegylated forms |
| US9469600B2 (en) | 2013-10-25 | 2016-10-18 | Insmed Incorporated | Prostacyclin compounds, compositions and methods of use thereof |
| ES2908142T3 (es) | 2014-06-13 | 2022-04-27 | United Therapeutics Corp | Formulaciones de treprostinil |
| CN107108427A (zh) | 2014-10-20 | 2017-08-29 | 联合治疗学有限公司 | 用于制备前列环素衍生物的中间体的合成 |
| US10343979B2 (en) | 2014-11-18 | 2019-07-09 | 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 |
| WO2018058124A1 (en) | 2016-09-26 | 2018-03-29 | United Therapeutics Corporation | Treprostinil prodrugs |
| US10799653B2 (en) | 2017-01-09 | 2020-10-13 | United Therapeutics Corporation | Aerosol delivery device and method for manufacturing and operating the same |
| CN112739679B (zh) | 2018-09-18 | 2024-03-12 | 伊莱利利公司 | 曲前列环素的特丁胺盐 |
| CN119632930A (zh) | 2019-04-29 | 2025-03-18 | 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 |
| CN114616225A (zh) | 2019-08-23 | 2022-06-10 | 联合治疗公司 | 曲前列环素前药 |
| IL296567A (en) | 2020-04-17 | 2022-11-01 | United Therapeutics Corp | Terfostinil for use in the treatment of interstitial lung disease |
| AU2021289336B2 (en) | 2020-06-09 | 2025-08-28 | Mannkind Corporation | Fumaryl diketopiperidine prodrugs of treprostinil |
| KR102849520B1 (ko) | 2020-12-14 | 2025-08-25 | 유나이티드 쎄러퓨틱스 코포레이션 | 트레프로스티닐 프로드러그로 질환을 치료하는 방법 |
| WO2022187352A1 (en) | 2021-03-03 | 2022-09-09 | United Therapeutics Corporation | A dry powder composition of trestinil and its prodrug thereof and further comprising comprising (e)-3,6-bis[4-(n-carbonyl-2-propenyl)amidobutyl]-2,5-diketopiperazine (fdkp) |
| 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 |
| CN121241041A (zh) | 2023-01-19 | 2025-12-30 | 联合治疗公司 | 曲前列尼尔类似物及相关制备和使用方法 |
| 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 |
| US20260166056A1 (en) | 2024-12-13 | 2026-06-18 | United Therapeutics Corporation | Treprostinil formulations and their uses |
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 |
| ES2214753T3 (es) * | 1997-11-14 | 2004-09-16 | United Therapeutics Corporation | Uso de 9-desoxi-2',9-alfa-metano-3-oxa-4,5,6-trinor-3,7-(1',3'-interfenilen)-13,14-dihidro-prostaglandina f1 para tratar la enfermedad vascular periferica. |
| 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 |
| CA2473162A1 (en) * | 2002-01-30 | 2003-08-07 | Kissei Pharmaceutical Co., Ltd. | Novel thyroid hormone receptor ligand, medicinal compositions containing the same and use thereof |
| CN102697790A (zh) * | 2003-05-22 | 2012-10-03 | 联合治疗公司 | 化合物和释放前列环素类似物的方法 |
| 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 |
| CN1917866B (zh) * | 2003-12-16 | 2010-12-15 | 联合治疗公司 | 曲前列环素或它的衍生物,或其药学上可接受的盐在制备治疗和预防缺血性损害的药物中的用途 |
| US7199157B2 (en) * | 2003-12-16 | 2007-04-03 | United Therapeutics Corporation | Use of treprostinil to improve kidney functions |
| DE602005020269D1 (de) * | 2004-04-12 | 2010-05-12 | United Therapeutics Corp | Verwendung von treprostinil zur behandlung von neuropathischen diabetischen fussgeschwüren |
| AU2006217534B8 (en) * | 2005-02-22 | 2011-12-08 | Pfizer Inc. | Oxyindole derivatives as 5HT4 receptor agonists |
| 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 |
| US20090281129A1 (en) * | 2006-05-15 | 2009-11-12 | Senex Biotechnology, Inc. | Cdki pathway inhibitors and uses thereof |
| CA2654492C (en) * | 2006-05-15 | 2017-06-27 | United Therapeutics Corporation | Treprostinil administration using a metered dose inhaler |
| KR20090101276A (ko) * | 2006-12-21 | 2009-09-24 | 콘서트 파마슈티컬즈, 인크. | 프로스타시클린 유도체 |
| CA2678258A1 (en) * | 2007-02-09 | 2008-08-14 | United Therapeutics Corporation | Treprostinil treatment for interstitial lung disease and asthma |
| PT2079445E (pt) * | 2007-02-20 | 2016-02-29 | Allergan Pharmaceuticals Internat Ltd | Composições de enzimas digestivas estáveis |
| WO2009078965A1 (en) * | 2007-12-17 | 2009-06-25 | United Therapeutics Corporation | An improved process to prepare treprostinil, the active ingredient in remodulin |
-
2010
- 2010-05-06 CN CN201080019951.3A patent/CN102421288B/zh active Active
- 2010-05-06 WO PCT/US2010/033852 patent/WO2010129757A1/en not_active Ceased
- 2010-05-06 US US12/775,102 patent/US8349892B2/en active Active
- 2010-05-06 EP EP10772819.8A patent/EP2427054A4/en not_active Withdrawn
- 2010-05-06 KR KR1020117028834A patent/KR101544246B1/ko active Active
- 2010-05-06 CA CA2760499A patent/CA2760499C/en active Active
- 2010-05-06 JP JP2012509968A patent/JP5649645B2/ja active Active
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