JP2024501051A - 持続放出ウパダシチニブ配合物 - Google Patents

持続放出ウパダシチニブ配合物 Download PDF

Info

Publication number
JP2024501051A
JP2024501051A JP2023539796A JP2023539796A JP2024501051A JP 2024501051 A JP2024501051 A JP 2024501051A JP 2023539796 A JP2023539796 A JP 2023539796A JP 2023539796 A JP2023539796 A JP 2023539796A JP 2024501051 A JP2024501051 A JP 2024501051A
Authority
JP
Japan
Prior art keywords
dosage form
solid dosage
upadacitinib
sustained release
hours
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.)
Pending
Application number
JP2023539796A
Other languages
English (en)
Japanese (ja)
Other versions
JP2024501051A5 (enExample
Inventor
チウ，イーホン
ホワン，イエ
ジョウ，ドーリャン
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.)
AbbVie Inc
Original Assignee
AbbVie Inc
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 AbbVie Inc filed Critical AbbVie Inc
Publication of JP2024501051A publication Critical patent/JP2024501051A/ja
Publication of JP2024501051A5 publication Critical patent/JP2024501051A5/ja
Pending legal-status Critical Current

Links

Images

Classifications

    • 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
    • A61K31/4985—Pyrazines or piperazines ortho- or peri-condensed with heterocyclic ring systems
    • 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
    • A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A61K9/0004—Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
    • 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
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2009—Inorganic compounds
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/2853—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Rheumatology (AREA)
  • Inorganic Chemistry (AREA)
  • Pain & Pain Management (AREA)
  • Immunology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
JP2023539796A 2020-12-29 2021-12-29 持続放出ウパダシチニブ配合物 Pending JP2024501051A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202063131564P 2020-12-29 2020-12-29
US63/131,564 2020-12-29
PCT/US2021/065443 WO2022147073A1 (en) 2020-12-29 2021-12-29 Extended release upadacitinib formulations

Publications (2)

Publication Number Publication Date
JP2024501051A true JP2024501051A (ja) 2024-01-10
JP2024501051A5 JP2024501051A5 (enExample) 2025-01-07

Family

ID=82261098

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2023539796A Pending JP2024501051A (ja) 2020-12-29 2021-12-29 持続放出ウパダシチニブ配合物

Country Status (8)

Country Link
US (3) US20240316040A1 (enExample)
EP (1) EP4271380A4 (enExample)
JP (1) JP2024501051A (enExample)
KR (1) KR20230127266A (enExample)
AU (1) AU2021411506A1 (enExample)
CA (1) CA3206839A1 (enExample)
MX (1) MX2023007741A (enExample)
WO (1) WO2022147073A1 (enExample)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111909160B (zh) * 2019-05-09 2024-05-28 苏州鹏旭医药科技有限公司 一种乌帕替尼盐类化合物及其制备方法
CA3248817A1 (en) * 2022-01-20 2023-07-27 Renata Pharmaceutical (Ireland) Limited Extended-release pharmaceutical composition of Upadacitinib
EP4583877A1 (en) * 2022-09-09 2025-07-16 Intas Pharmaceuticals Ltd. Upadacitinib formulation
CN117357492A (zh) * 2023-10-31 2024-01-09 苏州天马医药集团天吉生物制药有限公司 一种乌帕替尼缓释片剂及其制备方法

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2009500318A (ja) * 2005-06-29 2009-01-08 パナセア バイオテック リミテッド 新規な徐放性医薬組成物とその製法
JP2015034168A (ja) * 2003-09-26 2015-02-19 アルザ・コーポレーシヨン 有効成分の制御送達のためのｏｒｏｓプッシュ−スティック
JP2016512250A (ja) * 2013-03-15 2016-04-25 ジョンソン・アンド・ジョンソン・コンシューマー・インコーポレイテッドＪｏｈｎｓｏｎ ＆ Ｊｏｈｎｓｏｎ Ｃｏｎｓｕｍｅｒ Ｉｎｃ． 樹脂酸フェニレフリン粒子
JP2020510016A (ja) * 2017-03-09 2020-04-02 アッヴィ・インコーポレイテッド クローン病及び潰瘍性大腸炎を処置する方法
JP2020529987A (ja) * 2017-08-01 2020-10-15 セラヴァンス バイオファーマ アール＆ディー アイピー， エルエルシー Ｊａｋキナーゼ阻害剤としてのピラゾロおよびトリアゾロ二環式化合物

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP5052051B2 (ja) * 2006-06-16 2012-10-17 トーアエイヨー株式会社 腸溶性顆粒剤及びその製造方法
WO2020115212A1 (en) * 2018-12-05 2020-06-11 Lek Pharmaceuticals D.D. Crystalline phosphate salt of selective jak1 inhibitor upadacitinib

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2015034168A (ja) * 2003-09-26 2015-02-19 アルザ・コーポレーシヨン 有効成分の制御送達のためのｏｒｏｓプッシュ−スティック
JP2009500318A (ja) * 2005-06-29 2009-01-08 パナセア バイオテック リミテッド 新規な徐放性医薬組成物とその製法
JP2016512250A (ja) * 2013-03-15 2016-04-25 ジョンソン・アンド・ジョンソン・コンシューマー・インコーポレイテッドＪｏｈｎｓｏｎ ＆ Ｊｏｈｎｓｏｎ Ｃｏｎｓｕｍｅｒ Ｉｎｃ． 樹脂酸フェニレフリン粒子
JP2020510016A (ja) * 2017-03-09 2020-04-02 アッヴィ・インコーポレイテッド クローン病及び潰瘍性大腸炎を処置する方法
JP2020529987A (ja) * 2017-08-01 2020-10-15 セラヴァンス バイオファーマ アール＆ディー アイピー， エルエルシー Ｊａｋキナーゼ阻害剤としてのピラゾロおよびトリアゾロ二環式化合物

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
MOHAMED, MOHAMED-ESLAM F. ET AL.: "Pharmacokinetics of Upadacitinib With the Clinical Regimens of the Extended-Release Formulation", CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT, vol. 8, no. 2, JPN6025050913, 2019, pages 2085 - 216, ISSN: 0005753976 *

Also Published As

Publication number Publication date
WO2022147073A1 (en) 2022-07-07
AU2021411506A9 (en) 2024-09-26
MX2023007741A (es) 2023-09-15
KR20230127266A (ko) 2023-08-31
US20240316040A1 (en) 2024-09-26
US20250161302A1 (en) 2025-05-22
CA3206839A1 (en) 2022-07-07
EP4271380A4 (en) 2025-01-22
US20260007661A1 (en) 2026-01-08
AU2021411506A1 (en) 2023-07-13
EP4271380A1 (en) 2023-11-08

Similar Documents

Publication Publication Date Title
US20260007661A1 (en) Extended release upadacitinib formulations
JP4072597B2 (ja) 持続性製剤
CN103458901B (zh) 用于改进释放的含他索西替尼的口服剂型
US20040052844A1 (en) Time-controlled, sustained release, pharmaceutical composition containing water-soluble resins
US20070275061A1 (en) Pharmaceutical compositions and formulations of metformin extended release tablets
CA2616081C (en) Gastroretentive formulations and manufacturing process thereof
JP2007517050A (ja) アトモキセチン製剤
CN113476421B (zh) 一种非布司他的控释组合物及其制备方法
AU2004258732A1 (en) Sustained release formulation for venlafaxine hydrochloride
CN115297848B (zh) 一种非布司他片
EP2435029B1 (en) Pharmaceutical composition comprising tamsulosin
US20220016058A1 (en) Pharmaceutical composition containing tamsulosin hydrochloride with excellent acid resistance and preparation method therefor
KR20130121717A (ko) 위체류 약물전달 시스템을 이용한 서방성 제제
JP2023071921A (ja) 様々な用量のレナリドミドの経口用錠剤組成物
EP3764983B1 (en) A sustained release formulation comprising acemetacin with bimodal in vitro release
KR20110130382A (ko) 생체접착성 컴팩트 매트릭스의 제조방법
ES2973959T3 (es) Composición de liberación sostenida que comprende oxalato de tapentadol y método de preparación de la misma
JP2008546830A (ja) ｐＨ依存性の溶解度を有する有効成分の持続放出製剤
HK1122729B (en) Gastroretentive formulations and manufacturing process thereof

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20241223

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20241223

A977 Report on retrieval

Free format text: JAPANESE INTERMEDIATE CODE: A971007

Effective date: 20251112

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20251216

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20260306