ECSP19072294A - Composición farmacéutica que comprende selexipag - Google Patents
Composición farmacéutica que comprende selexipagInfo
- Publication number
- ECSP19072294A ECSP19072294A ECSENADI201972294A ECDI201972294A ECSP19072294A EC SP19072294 A ECSP19072294 A EC SP19072294A EC SENADI201972294 A ECSENADI201972294 A EC SENADI201972294A EC DI201972294 A ECDI201972294 A EC DI201972294A EC SP19072294 A ECSP19072294 A EC SP19072294A
- Authority
- EC
- Ecuador
- Prior art keywords
- compositions
- pharmaceutical composition
- aqueous
- selexipag
- composition including
- Prior art date
Links
- 239000008194 pharmaceutical composition Substances 0.000 title abstract 4
- QXWZQTURMXZVHJ-UHFFFAOYSA-N selexipag Chemical compound C=1C=CC=CC=1C1=NC(N(CCCCOCC(=O)NS(C)(=O)=O)C(C)C)=CN=C1C1=CC=CC=C1 QXWZQTURMXZVHJ-UHFFFAOYSA-N 0.000 title abstract 2
- 229960003841 selexipag Drugs 0.000 title 1
- 239000000203 mixture Substances 0.000 abstract 3
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 abstract 1
- 229920001213 Polysorbate 20 Polymers 0.000 abstract 1
- 108091006335 Prostaglandin I receptors Proteins 0.000 abstract 1
- 150000001875 compounds Chemical class 0.000 abstract 1
- 208000037765 diseases and disorders Diseases 0.000 abstract 1
- 238000000034 method Methods 0.000 abstract 1
- 239000008363 phosphate buffer Substances 0.000 abstract 1
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 abstract 1
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 abstract 1
- 229940068977 polysorbate 20 Drugs 0.000 abstract 1
Classifications
-
- 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
- A61K9/08—Solutions
-
- 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
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/4965—Non-condensed pyrazines
-
- 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
- A61K47/02—Inorganic compounds
-
- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
-
- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
- A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/12—Antihypertensives
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Dermatology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Heart & Thoracic Surgery (AREA)
- Cardiology (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Inorganic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
La invención se relaciona con composiciones farmacéuticas acuosas que comprenden el compuesto 2-{4-[N-(5,6-difenilpirazin-2-il)-N-isopropilamino]butiloxi}-N-(metilsulfonil) acetamida; glicina; polisorbato 20; y un regulador de fosfato acuoso, en donde las cantidades relativas son como se describió en la descripción, en donde el pH de dicha composición farmacéutica está entre aproximadamente 7 y 8; con composiciones farmacéuticas liofilizadas preparadas a partir de dichas composiciones acuosas, y con composiciones acuosas reconstituidas de estas que son adecuadas para administración i.v. La invención se relaciona, además, con procesos para la preparación de dichas composiciones, y con su uso para el tratamiento de enfermedades y trastornos relacionados con el receptor IP.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP2017055406 | 2017-03-08 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ECSP19072294A true ECSP19072294A (es) | 2019-11-30 |
Family
ID=61655736
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ECSENADI201972294A ECSP19072294A (es) | 2017-03-08 | 2019-10-04 | Composición farmacéutica que comprende selexipag |
Country Status (27)
| Country | Link |
|---|---|
| US (1) | US12121516B2 (es) |
| EP (1) | EP3592391B1 (es) |
| JP (1) | JP6964679B2 (es) |
| KR (1) | KR102593075B1 (es) |
| CN (1) | CN110430900B (es) |
| AR (1) | AR111570A1 (es) |
| AU (1) | AU2018229750B2 (es) |
| BR (1) | BR112019018420A2 (es) |
| CA (1) | CA3055010A1 (es) |
| CL (1) | CL2019002511A1 (es) |
| CO (1) | CO2019009221A2 (es) |
| CR (1) | CR20190455A (es) |
| DO (1) | DOP2019000250A (es) |
| EA (1) | EA201992074A1 (es) |
| EC (1) | ECSP19072294A (es) |
| ES (1) | ES2880009T3 (es) |
| IL (1) | IL269061A (es) |
| JO (1) | JOP20190204A1 (es) |
| MA (1) | MA47816A (es) |
| MX (1) | MX391339B (es) |
| NI (1) | NI201900090A (es) |
| PE (1) | PE20191492A1 (es) |
| PH (1) | PH12019502033A1 (es) |
| PL (1) | PL3592391T3 (es) |
| SG (1) | SG11201907804QA (es) |
| TW (1) | TWI764996B (es) |
| WO (1) | WO2018162527A1 (es) |
Families Citing this family (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2022532076A (ja) * | 2019-05-06 | 2022-07-13 | アクテリオン ファーマシューティカルズ リミテッド | サルコイドーシス関連肺高血圧症の治療方法 |
| WO2020249602A1 (en) * | 2019-06-11 | 2020-12-17 | Actelion Pharmaceuticals Ltd | Methods for treating pulmonary arterial hypertension |
| PH12022550937A1 (en) | 2019-10-23 | 2023-06-14 | Actelion Pharmaceuticals Ltd | Pharmaceutical composition comprising selexipag |
| US20230113077A1 (en) | 2020-01-31 | 2023-04-13 | Actelion Pharmaceuticals Ltd | Controlled release selexipag composition |
| TW202239408A (zh) * | 2021-01-29 | 2022-10-16 | 瑞士商艾克泰聯製藥有限公司 | 包含二苯基吡𠯤衍生物的醫藥組成物 |
| WO2022215045A1 (en) * | 2021-04-08 | 2022-10-13 | Glenmark Pharmaceutical Limited | Lyophilized composition comprising selexipag |
| WO2023131608A1 (en) | 2022-01-04 | 2023-07-13 | Actelion Pharmaceuticals Ltd | Controlled release compositions |
| WO2023209731A1 (en) * | 2022-04-25 | 2023-11-02 | Msn Laboratories Private Limited, R&D Center | Injectable liquid or lyophilized powder dosage forms of selexipag and their method of preparation |
| WO2023214059A1 (en) | 2022-05-06 | 2023-11-09 | Actelion Pharmaceuticals Ltd | Diphenylpyrazine compounds as prodrugs |
| JP2025114012A (ja) * | 2022-06-10 | 2025-08-05 | 日本新薬株式会社 | 持続型注射剤 |
| WO2024017964A1 (en) | 2022-07-20 | 2024-01-25 | Actelion Pharmaceuticals Ltd | Injectable pharmaceutical composition comprising a diphenylpyrazine derivative |
| WO2024133620A1 (en) | 2022-12-22 | 2024-06-27 | Actelion Pharmaceuticals Ltd | In vitro dissolution test |
| WO2024194449A1 (en) | 2023-03-23 | 2024-09-26 | Actelion Pharmaceuticals Ltd | Pharmaceutical composition comprising a diphenylpyrazine derivative |
| WO2025009945A1 (ko) * | 2023-07-06 | 2025-01-09 | 재단법인대구경북과학기술원 | 셀렉시팍을 포함하는 퇴행성 뇌질환의 예방 또는 치료용 약학 조성물 |
| EP4595961A1 (en) * | 2024-02-01 | 2025-08-06 | Sorbonne Universite | Selexipag for use in the treatment and/or prevention of atherosclerosis |
| WO2025196095A1 (en) | 2024-03-20 | 2025-09-25 | Actelion Pharmaceuticals Ltd | Injectable pharmaceutical composition for treating pulmonary hypertension |
Family Cites Families (18)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| TWI316055B (es) | 2001-04-26 | 2009-10-21 | Nippon Shinyaku Co Ltd | |
| ATE397440T1 (de) * | 2002-02-22 | 2008-06-15 | Schering Corp | Pharmazeutische zubereitungen von antineoplastischen wirkstoffen, insbesondere temozolomid, verfahren zu ihrer herstellung und deren verwendung |
| ES2817557T3 (es) | 2008-02-28 | 2021-04-07 | Nippon Shinyaku Co Ltd | Inhibidor de fibrosis |
| WO2009154246A1 (ja) | 2008-06-19 | 2009-12-23 | 日本新薬株式会社 | 勃起不全治療剤 |
| CN102065864B (zh) | 2008-06-23 | 2012-11-21 | 日本新药株式会社 | 炎性肠病治疗剂 |
| WO2009157397A1 (ja) | 2008-06-23 | 2009-12-30 | 日本新薬株式会社 | 非ステロイド性抗炎症剤投与に伴う腸管傷害治療剤 |
| PL2292231T3 (pl) | 2008-06-23 | 2016-03-31 | Nippon Shinyaku Co Ltd | Środek terapeutyczny przeciw zwężeniu kanału kręgowego |
| MX346318B (es) | 2009-06-26 | 2017-03-15 | Nippon Shinyaku Co Ltd | Cristales. |
| WO2011024874A1 (ja) | 2009-08-26 | 2011-03-03 | 日本新薬株式会社 | 塩基付加塩 |
| BR112013027009A2 (pt) * | 2011-04-19 | 2016-12-27 | Rigshospitalet | prostaciclina e análogos da mesa administrada durante cirurgia para prevenção e tratamento de derrame capilar |
| US9872864B2 (en) | 2011-08-12 | 2018-01-23 | Ascendis Pharma A/S | Sustained release composition of prostacyclin |
| ES2733998T3 (es) | 2012-10-29 | 2019-12-03 | Cardio Incorporated | Agente terapéutico específico de enfermedad pulmonar |
| IL312865B2 (en) | 2013-09-11 | 2025-06-01 | Eagle Biologics Inc | Liquid protein formulations containing viscosity-lowering agents |
| GB201400412D0 (en) * | 2014-01-10 | 2014-02-26 | Heart Biotech Ltd | Pharmaceutical formulations for the treatment of pulmonary arterial hypertension |
| WO2017029594A1 (en) * | 2015-08-17 | 2017-02-23 | Dr. Reddy's Laboratories Limited | Processes for preparation of selexipag and its amorphous form |
| WO2017040872A1 (en) * | 2015-09-03 | 2017-03-09 | Teva Pharmaceuticals International Gmbh | Solid state forms of selexipag |
| DK4331607T3 (da) | 2015-12-02 | 2025-05-19 | Nippon Shinyaku Co Ltd | Fast farmaceutisk sammensætning indeholdende 2-{4-[n-(5,6-diphenylpyrazin-2-yl)-n-isopropylamino]butyloxy}-n-(methylsulfonyl)acetamid |
| EP3192502A1 (en) | 2016-01-15 | 2017-07-19 | Sandoz Ag | Pharmaceutical composition of selexipag |
-
2017
- 2017-06-16 JO JOP/2019/0204A patent/JOP20190204A1/ar unknown
-
2018
- 2018-03-06 TW TW107107374A patent/TWI764996B/zh not_active IP Right Cessation
- 2018-03-07 CA CA3055010A patent/CA3055010A1/en active Pending
- 2018-03-07 CN CN201880016540.5A patent/CN110430900B/zh not_active Expired - Fee Related
- 2018-03-07 AR ARP180100522A patent/AR111570A1/es unknown
- 2018-03-07 ES ES18711258T patent/ES2880009T3/es active Active
- 2018-03-07 CR CR20190455A patent/CR20190455A/es unknown
- 2018-03-07 WO PCT/EP2018/055551 patent/WO2018162527A1/en not_active Ceased
- 2018-03-07 EA EA201992074A patent/EA201992074A1/ru unknown
- 2018-03-07 KR KR1020197029059A patent/KR102593075B1/ko active Active
- 2018-03-07 PE PE2019001788A patent/PE20191492A1/es unknown
- 2018-03-07 BR BR112019018420A patent/BR112019018420A2/pt not_active IP Right Cessation
- 2018-03-07 US US16/491,854 patent/US12121516B2/en active Active
- 2018-03-07 JP JP2019548608A patent/JP6964679B2/ja not_active Expired - Fee Related
- 2018-03-07 AU AU2018229750A patent/AU2018229750B2/en not_active Expired - Fee Related
- 2018-03-07 MX MX2019010598A patent/MX391339B/es unknown
- 2018-03-07 MA MA047816A patent/MA47816A/fr unknown
- 2018-03-07 EP EP18711258.6A patent/EP3592391B1/en active Active
- 2018-03-07 SG SG11201907804QA patent/SG11201907804QA/en unknown
- 2018-03-07 PL PL18711258T patent/PL3592391T3/pl unknown
-
2019
- 2019-08-27 CO CONC2019/0009221A patent/CO2019009221A2/es unknown
- 2019-09-02 IL IL26906119A patent/IL269061A/en unknown
- 2019-09-02 CL CL2019002511A patent/CL2019002511A1/es unknown
- 2019-09-06 NI NI201900090A patent/NI201900090A/es unknown
- 2019-09-06 PH PH12019502033A patent/PH12019502033A1/en unknown
- 2019-10-02 DO DO2019000250A patent/DOP2019000250A/es unknown
- 2019-10-04 EC ECSENADI201972294A patent/ECSP19072294A/es unknown
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