JP7703220B2 - 新規なイブプロフェン及びアセトアミノフェン組成物 - Google Patents

新規なイブプロフェン及びアセトアミノフェン組成物 Download PDF

Info

Publication number
JP7703220B2
JP7703220B2 JP2021577292A JP2021577292A JP7703220B2 JP 7703220 B2 JP7703220 B2 JP 7703220B2 JP 2021577292 A JP2021577292 A JP 2021577292A JP 2021577292 A JP2021577292 A JP 2021577292A JP 7703220 B2 JP7703220 B2 JP 7703220B2
Authority
JP
Japan
Prior art keywords
ibu
apap
fdc
study
weight
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
JP2021577292A
Other languages
English (en)
Japanese (ja)
Other versions
JP2022540348A5 (https=
JP2022540348A (ja
Inventor
アンドリューズ,クリスティーン,ドラムヘラー
ケルステイン,デビッド,エリス
キンター,ケビン,スコット
ショー,ボニー,ルネ
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.)
Haleon US Holdings LLC
Original Assignee
Haleon US Holdings LLC
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=73543315&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=JP7703220(B2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Haleon US Holdings LLC filed Critical Haleon US Holdings LLC
Publication of JP2022540348A publication Critical patent/JP2022540348A/ja
Publication of JP2022540348A5 publication Critical patent/JP2022540348A5/ja
Priority to JP2025102400A priority Critical patent/JP2025134843A/ja
Application granted granted Critical
Publication of JP7703220B2 publication Critical patent/JP7703220B2/ja
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

Classifications

    • 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
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/16Amides, e.g. hydroxamic acids
    • A61K31/165Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/192Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid 
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic 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
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A61K9/2009Inorganic compounds
    • 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
    • A61K9/2059Starch, 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
    • A61K9/2072Pills, 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
    • A61K9/2077Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • 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
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2121/00Preparations for use in therapy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
    • 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

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)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Pain & Pain Management (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Rheumatology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Inorganic Chemistry (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
JP2021577292A 2019-06-27 2020-06-24 新規なイブプロフェン及びアセトアミノフェン組成物 Active JP7703220B2 (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2025102400A JP2025134843A (ja) 2019-06-27 2025-06-18 新規なイブプロフェン及びアセトアミノフェン組成物

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201962867683P 2019-06-27 2019-06-27
US62/867,683 2019-06-27
PCT/US2020/039321 WO2020263947A1 (en) 2019-06-27 2020-06-24 Novel ibuprofen and acetaminophen composition

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2025102400A Division JP2025134843A (ja) 2019-06-27 2025-06-18 新規なイブプロフェン及びアセトアミノフェン組成物

Publications (3)

Publication Number Publication Date
JP2022540348A JP2022540348A (ja) 2022-09-15
JP2022540348A5 JP2022540348A5 (https=) 2023-06-29
JP7703220B2 true JP7703220B2 (ja) 2025-07-07

Family

ID=73543315

Family Applications (2)

Application Number Title Priority Date Filing Date
JP2021577292A Active JP7703220B2 (ja) 2019-06-27 2020-06-24 新規なイブプロフェン及びアセトアミノフェン組成物
JP2025102400A Pending JP2025134843A (ja) 2019-06-27 2025-06-18 新規なイブプロフェン及びアセトアミノフェン組成物

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2025102400A Pending JP2025134843A (ja) 2019-06-27 2025-06-18 新規なイブプロフェン及びアセトアミノフェン組成物

Country Status (13)

Country Link
US (3) US11918693B2 (https=)
EP (1) EP3989944A1 (https=)
JP (2) JP7703220B2 (https=)
KR (1) KR20220027194A (https=)
CN (1) CN114173767A (https=)
AU (2) AU2020301401B2 (https=)
BR (1) BR112021026407A8 (https=)
CA (1) CA3143724A1 (https=)
CO (1) CO2021017722A2 (https=)
IL (1) IL288989A (https=)
MX (1) MX2021016089A (https=)
PH (1) PH12021553169A1 (https=)
WO (1) WO2020263947A1 (https=)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP7750663B2 (ja) * 2021-03-19 2025-10-07 エスエス製薬株式会社 被覆固形医薬製剤
WO2025212049A1 (en) * 2024-03-30 2025-10-09 Humanis Sağlik A.Ş. Solid pharmaceutical compositions comprising ibuprofen and paracetamol
WO2025212048A1 (en) * 2024-03-30 2025-10-09 Humanis Sağlik A.Ş. Pharmaceutical compositions comprising ibuprofen and paracetamol and relevant excipients

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PL195966B1 (pl) 2001-02-23 2007-11-30 Zaklady Farmaceutyczne Polfa L Preparat farmaceutyczny przeciwbólowy
JP2008505889A (ja) 2004-07-07 2008-02-28 エイ・エフ・ティ・ファーマスーティカルズ・リミテッド 複合剤組成物
JP2009508916A (ja) 2005-09-22 2009-03-05 レキット ベンキサー ヘルスケア (ユーケイ) リミテッド Nsaidとパラセタモールを含んだ組成物
WO2019108147A1 (en) 2017-11-29 2019-06-06 İlko İlaç Sanayi̇ Ve Ti̇caret A.Ş. Color stable fixed dose tablet combination of ibuprofen and paracetamol

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PL104904B1 (pl) 1977-02-11 1979-09-29 Zaklady Radiowe Radmor Sposob wytwarzania anteny z izolacyjna oslona z tworzyw sztucznych
US4757090A (en) 1986-07-14 1988-07-12 Mallinckrodt, Inc. Direct tableting acetaminophen compositions
US20080166407A1 (en) * 2005-07-29 2008-07-10 Shalaby Shalaby W Solid oral formulations for combination therapy
CN101584673A (zh) * 2009-07-13 2009-11-25 浙江京新药业股份有限公司 一种左乙拉西坦片剂及其制备方法
CN102266301A (zh) * 2011-07-27 2011-12-07 蚌埠丰原涂山制药有限公司 一种非甾体抗炎药片及其制备方法
AU2016210691A1 (en) * 2015-08-05 2017-02-23 Beximco Pharmaceuticals Controlled release formulations of paracetamol
CN114681324B (zh) * 2017-07-10 2024-05-03 盖尔凯普科技有限公司 双释放剂型胶囊及其制备方法、装置和系统
US20190350883A1 (en) 2018-05-20 2019-11-21 Luan Chau Pharmaceutical Composition of Acetaminophen/Ibuprofen
US11197830B2 (en) * 2019-02-27 2021-12-14 Aft Pharmaceuticals Limited Pharmaceutical composition containing acetaminophen and ibuprofen

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PL195966B1 (pl) 2001-02-23 2007-11-30 Zaklady Farmaceutyczne Polfa L Preparat farmaceutyczny przeciwbólowy
JP2008505889A (ja) 2004-07-07 2008-02-28 エイ・エフ・ティ・ファーマスーティカルズ・リミテッド 複合剤組成物
JP2009508916A (ja) 2005-09-22 2009-03-05 レキット ベンキサー ヘルスケア (ユーケイ) リミテッド Nsaidとパラセタモールを含んだ組成物
WO2019108147A1 (en) 2017-11-29 2019-06-06 İlko İlaç Sanayi̇ Ve Ti̇caret A.Ş. Color stable fixed dose tablet combination of ibuprofen and paracetamol

Also Published As

Publication number Publication date
BR112021026407A8 (pt) 2022-11-22
CO2021017722A2 (es) 2022-01-17
CA3143724A1 (en) 2020-12-30
KR20220027194A (ko) 2022-03-07
AU2020301401A1 (en) 2022-01-27
US20240156740A1 (en) 2024-05-16
JP2022540348A (ja) 2022-09-15
PH12021553169A1 (en) 2022-08-15
BR112021026407A2 (pt) 2022-02-08
MX2021016089A (es) 2022-04-25
WO2020263947A1 (en) 2020-12-30
AU2020301401B2 (en) 2023-12-21
JP2025134843A (ja) 2025-09-17
IL288989A (en) 2022-02-01
US11918693B2 (en) 2024-03-05
CN114173767A (zh) 2022-03-11
US20250302754A1 (en) 2025-10-02
EP3989944A1 (en) 2022-05-04
AU2024200875A1 (en) 2024-02-29
US20200405645A1 (en) 2020-12-31

Similar Documents

Publication Publication Date Title
JP4989733B2 (ja) 口腔内崩壊錠
US20250302754A1 (en) Novel ibuprofen and acetaminophen composition
DK2510950T3 (en) DRY-COATED ORALT-DISINTEGRATING TABLE
CN101257800B (zh) 包含法莫替丁和布洛芬的药物
US8426470B2 (en) Method for alleviating signs and symptoms of spasticity
CN103402497A (zh) 快速分散颗粒、口腔崩解片以及方法
CN104244930A (zh) 口腔崩解片及其制造方法
JP2009502807A (ja) 薬剤含有率の高い製剤および投与量形態
JP5208729B2 (ja) 徐放性錠剤の製造方法
CN119587499A (zh) 一种包衣制剂及其制备方法
CN107080741A (zh) 吡非尼酮缓释制剂及制备方法
CN111759849B (zh) 一种抗心绞痛的药物组合物及其制备方法和应用
CN100448431C (zh) 一种用于治疗儿童感冒的氨酚麻美口腔崩解片及制备方法
TW201626990A (zh) 含有褪黑激素和舍曲林的口服複合錠劑
CN116869951A (zh) 萘普生钠的改性释放制剂
US20250205207A1 (en) Matrix tablets of dexpramipexole and methods of manufacturing and use thereof
JP5226732B2 (ja) 催眠用圧縮成型製剤
EP0975337A2 (en) Fast release compressed tablet of flurbiprofen
CN1706385B (zh) 治疗季节性和常年性过敏性鼻炎的新组合物
TWI810656B (zh) 二氟甲基鳥氨酸及舒林酸(sulindac),固定劑量組合調配物
HU231592B1 (hu) Favipiravir tartalmú gyógyszerkészítmény, ennek előállítása és alkalmazása
Zimmer et al. Superdisintegrants in new solid dosage forms–a review
JP2019206522A (ja) 固形状組成物
CN101190206A (zh) 减少了对消化管的刺激性的口服固形组合物
HK1118208B (en) Oral solid composition reduced in stimulation to the gastrointestinal tract

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A821

Effective date: 20220218

A711 Notification of change in applicant

Free format text: JAPANESE INTERMEDIATE CODE: A712

Effective date: 20220218

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20230621

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20230621

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20240702

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20240926

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20241106

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20250212

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20250507

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: 20250520

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20250618

R150 Certificate of patent or registration of utility model

Ref document number: 7703220

Country of ref document: JP

Free format text: JAPANESE INTERMEDIATE CODE: R150