JP7646646B2 - セレキシパグを含む医薬組成物 - Google Patents

セレキシパグを含む医薬組成物 Download PDF

Info

Publication number
JP7646646B2
JP7646646B2 JP2022523448A JP2022523448A JP7646646B2 JP 7646646 B2 JP7646646 B2 JP 7646646B2 JP 2022523448 A JP2022523448 A JP 2022523448A JP 2022523448 A JP2022523448 A JP 2022523448A JP 7646646 B2 JP7646646 B2 JP 7646646B2
Authority
JP
Japan
Prior art keywords
pharmaceutical composition
composition according
amount
tablet
content
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.)
Active
Application number
JP2022523448A
Other languages
English (en)
Japanese (ja)
Other versions
JP2022553313A (ja
JP2022553313A5 (https=
Inventor
パトリック シュレイダー マーク
シュリッカー-スペイン アレクサンドラ
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Nippon Shinyaku Co Ltd
Original Assignee
Nippon Shinyaku Co Ltd
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Nippon Shinyaku Co Ltd filed Critical Nippon Shinyaku Co Ltd
Publication of JP2022553313A publication Critical patent/JP2022553313A/ja
Publication of JP2022553313A5 publication Critical patent/JP2022553313A5/ja
Priority to JP2025033867A priority Critical patent/JP2025074286A/ja
Application granted granted Critical
Publication of JP7646646B2 publication Critical patent/JP7646646B2/ja
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic 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
    • A61K31/4965Non-condensed pyrazines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/286Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/12Drugs for disorders of the urinary system of the kidneys
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/02Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/10Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/12Antihypertensives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/14Vasoprotectives; Antihaemorrhoidals; Drugs for varicose therapy; Capillary stabilisers

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Urology & Nephrology (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Pulmonology (AREA)
  • Diabetes (AREA)
  • Emergency Medicine (AREA)
  • Endocrinology (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Dermatology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
JP2022523448A 2019-10-23 2020-10-22 セレキシパグを含む医薬組成物 Active JP7646646B2 (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2025033867A JP2025074286A (ja) 2019-10-23 2025-03-04 セレキシパグを含む医薬組成物

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EPPCT/EP2019/078905 2019-10-23
EP2019078905 2019-10-23
PCT/EP2020/079698 WO2021078835A1 (en) 2019-10-23 2020-10-22 Pharmaceutical composition comprising selexipag

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2025033867A Division JP2025074286A (ja) 2019-10-23 2025-03-04 セレキシパグを含む医薬組成物

Publications (3)

Publication Number Publication Date
JP2022553313A JP2022553313A (ja) 2022-12-22
JP2022553313A5 JP2022553313A5 (https=) 2023-10-30
JP7646646B2 true JP7646646B2 (ja) 2025-03-17

Family

ID=75620412

Family Applications (2)

Application Number Title Priority Date Filing Date
JP2022523448A Active JP7646646B2 (ja) 2019-10-23 2020-10-22 セレキシパグを含む医薬組成物
JP2025033867A Pending JP2025074286A (ja) 2019-10-23 2025-03-04 セレキシパグを含む医薬組成物

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2025033867A Pending JP2025074286A (ja) 2019-10-23 2025-03-04 セレキシパグを含む医薬組成物

Country Status (15)

Country Link
US (1) US20220401441A1 (https=)
EP (1) EP4048235A1 (https=)
JP (2) JP7646646B2 (https=)
KR (1) KR20220087443A (https=)
CN (1) CN114555088A (https=)
AU (1) AU2020369912A1 (https=)
BR (1) BR112022007207A2 (https=)
CA (1) CA3154802A1 (https=)
EC (1) ECSP22040921A (https=)
IL (1) IL292354A (https=)
JO (1) JOP20220093A1 (https=)
MX (1) MX2022004882A (https=)
PE (1) PE20221455A1 (https=)
PH (1) PH12022550937A1 (https=)
WO (1) WO2021078835A1 (https=)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TR2022005274A1 (tr) * 2022-04-05 2023-10-23 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi Seleksi̇pag'in bi̇r kati di̇spersi̇yonunu i̇çeren bi̇r fi̇lm kapli tablet
TR2022005277A2 (tr) * 2022-04-05 2023-10-23 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi Yaş granülasyon i̇le i̇şlenmi̇ş seleksi̇pag i̇çeren bi̇r fi̇lm kapli tablet
TR2022005273A2 (tr) * 2022-04-05 2023-10-23 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi Seleksi̇pag i̇çeren bi̇r fi̇lm kapli tablet
TR2022020995A1 (tr) * 2022-12-28 2024-07-22 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi Seleksi̇pag i̇çeren bi̇r tablet formülasyonu
CN116392491A (zh) * 2023-04-11 2023-07-07 广东省实验动物监测所 司来帕格的药物组合物及其制备方法

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2017098998A1 (ja) 2015-12-02 2017-06-15 日本新薬株式会社 2-{4-[n-(5,6-ジフェニルピラジン-2-イル)-n-イソプロピルアミノ]ブチルオキシ}-n-(メチルスルホニル)アセトアミドを含有する医薬組成物
WO2019163822A1 (ja) 2018-02-21 2019-08-29 日本新薬株式会社 粒状組成物、粒状組成物の製造方法、および粒状組成物の溶出性改善方法

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TWI316055B (https=) 2001-04-26 2009-10-21 Nippon Shinyaku Co Ltd
CN104761509A (zh) 2008-02-28 2015-07-08 日本新药株式会社 纤维化抑制剂
WO2009154246A1 (ja) 2008-06-19 2009-12-23 日本新薬株式会社 勃起不全治療剤
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
HRP20151443T1 (hr) 2008-06-23 2016-01-29 Nippon Shinyaku Co., Ltd. Terapijsko sredstvo protiv stenoze kralježniäśnog kanala
CN102065864B (zh) 2008-06-23 2012-11-21 日本新药株式会社 炎性肠病治疗剂
LT2447254T (lt) 2009-06-26 2018-01-10 Nippon Shinyaku Co., Ltd. Kristalai
WO2011024874A1 (ja) 2009-08-26 2011-03-03 日本新薬株式会社 塩基付加塩
HK1198358A1 (en) 2011-08-12 2015-04-10 Ascendis Pharma A/S Sustained release composition of prostacyclin
EP2913047B1 (en) 2012-10-29 2019-05-08 Cardio Incorporated Pulmonary disease-specific therapeutic agent
JOP20190204A1 (ar) 2017-03-08 2019-09-05 Actelion Pharmaceuticals Ltd تركيبة صيدلانية تشتمل على سيليكسيباغ
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

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2017098998A1 (ja) 2015-12-02 2017-06-15 日本新薬株式会社 2-{4-[n-(5,6-ジフェニルピラジン-2-イル)-n-イソプロピルアミノ]ブチルオキシ}-n-(メチルスルホニル)アセトアミドを含有する医薬組成物
WO2019163822A1 (ja) 2018-02-21 2019-08-29 日本新薬株式会社 粒状組成物、粒状組成物の製造方法、および粒状組成物の溶出性改善方法

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
European Journal of Drug Metabolism and Pharmacokinetics,2018年,Vol.43, No.1,p.115-120

Also Published As

Publication number Publication date
EP4048235A1 (en) 2022-08-31
ECSP22040921A (es) 2022-06-30
PH12022550937A1 (en) 2023-06-14
BR112022007207A2 (pt) 2022-07-26
JP2022553313A (ja) 2022-12-22
WO2021078835A1 (en) 2021-04-29
MX2022004882A (es) 2022-08-04
CA3154802A1 (en) 2021-04-29
CN114555088A (zh) 2022-05-27
KR20220087443A (ko) 2022-06-24
PE20221455A1 (es) 2022-09-21
JP2025074286A (ja) 2025-05-13
JOP20220093A1 (ar) 2023-01-30
AU2020369912A1 (en) 2022-04-14
US20220401441A1 (en) 2022-12-22
IL292354A (en) 2022-06-01

Similar Documents

Publication Publication Date Title
JP7646646B2 (ja) セレキシパグを含む医薬組成物
JP4463875B2 (ja) 医薬組成物
TWI702953B (zh) 包含azd9291之醫藥組合物及錠劑以及其用途
JPWO2002024166A1 (ja) 崩壊性が良好な経口製剤
JPWO2013022059A1 (ja) ジアミン誘導体含有医薬組成物
US11382912B2 (en) Controlled-release preparation
US10888524B2 (en) Immediate release tablet of dofetilide
JPWO2010147169A1 (ja) 溶出性の改善された医薬組成物
JP5417662B2 (ja) ネビラピンの徐放性製剤
WO2011102504A1 (ja) 経口用徐放性固形製剤
JP5714562B2 (ja) 経口用徐放性固形製剤
JP5318400B2 (ja) レボフロキサシン含有錠剤
JP5295506B2 (ja) レボフロキサシン含有錠剤
WO2016012898A1 (en) Oral pharmaceutical composition of lurasidone
WO2019131891A1 (ja) 苦味がマスキングされた薬物含有粒子及び該薬物含有粒子を含む製剤
ES2963886T3 (es) Comprimidos que contienen tamsulosina y solifenacina
EP4552633A1 (en) Pharmaceutical compositions comprising amorphous solid solutions of rivaroxaban and copovidone and preparation methods thereof
JP2026509613A (ja) (4s)-24-クロロ-4-エチル-73-フルオロ-35-メトキシ-32,5-ジオキソ-14-(トリフルオロメチル)-32h-6-アザ-3(4,1)-ピリジナ-1(1)-[1,2,3]トリアゾラ-2(1,2),7(1)-ジベンゼナヘプタファン-74-カルボキサミドを含む医薬剤形
KR20160059442A (ko) 말초혈관병 환자의 간헐성 파행 증상을 경감하기 위해 사용되는 퀴놀리논-유도체인 실로스타졸의 신규 제형
HK40036074A (en) Controlled release formulation
HK1198466B (en) Prasugrel-containing immediate release stable oral pharmaceutical compositions
HK1198466A1 (en) Prasugrel-containing immediate release stable oral pharmaceutical compositions

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20231019

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20231019

A977 Report on retrieval

Free format text: JAPANESE INTERMEDIATE CODE: A971007

Effective date: 20240920

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20240924

A711 Notification of change in applicant

Free format text: JAPANESE INTERMEDIATE CODE: A711

Effective date: 20241106

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A821

Effective date: 20241111

RD04 Notification of resignation of power of attorney

Free format text: JAPANESE INTERMEDIATE CODE: A7424

Effective date: 20241111

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A821

Effective date: 20241106

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20241223

TRDD Decision of grant or rejection written
A01 Written decision to grant a patent or to grant a registration (utility model)

Free format text: JAPANESE INTERMEDIATE CODE: A01

Effective date: 20250204

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20250305

R150 Certificate of patent or registration of utility model

Ref document number: 7646646

Country of ref document: JP

Free format text: JAPANESE INTERMEDIATE CODE: R150