AU2020301401B2 - Novel ibuprofen and acetaminophen composition - Google Patents

Novel ibuprofen and acetaminophen composition Download PDF

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Publication number
AU2020301401B2
AU2020301401B2 AU2020301401A AU2020301401A AU2020301401B2 AU 2020301401 B2 AU2020301401 B2 AU 2020301401B2 AU 2020301401 A AU2020301401 A AU 2020301401A AU 2020301401 A AU2020301401 A AU 2020301401A AU 2020301401 B2 AU2020301401 B2 AU 2020301401B2
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AU
Australia
Prior art keywords
ibu
apap
fdc
study
placebo
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AU2020301401A
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English (en)
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AU2020301401A1 (en
Inventor
Christine Drumheller ANDREWS
David Ellis KELLSTEIN
Kevin Scott KINTER
Bonny Rene Shaw
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
GlaxoSmithKline Consumer Healthcare Holdings US LLC
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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=AU2020301401(B2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by GlaxoSmithKline Consumer Healthcare Holdings US LLC filed Critical GlaxoSmithKline Consumer Healthcare Holdings US LLC
Publication of AU2020301401A1 publication Critical patent/AU2020301401A1/en
Assigned to GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC reassignment GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC Request for Assignment Assignors: PF CONSUMER HEALTHCARE 1 LLC
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Publication of AU2020301401B2 publication Critical patent/AU2020301401B2/en
Priority to AU2024200875A priority Critical patent/AU2024200875A1/en
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    • 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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167—Amides, 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
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid 
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—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
    • A61K9/2009—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
    • 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
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • 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
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • 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]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2121/00—Preparations for use in therapy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

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)
AU2020301401A 2019-06-27 2020-06-24 Novel ibuprofen and acetaminophen composition Active AU2020301401B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2024200875A AU2024200875A1 (en) 2019-06-27 2024-02-12 Novel ibuprofen and acetaminophen composition

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
AU2024200875A Division AU2024200875A1 (en) 2019-06-27 2024-02-12 Novel ibuprofen and acetaminophen composition

Publications (2)

Publication Number Publication Date
AU2020301401A1 AU2020301401A1 (en) 2022-01-27
AU2020301401B2 true AU2020301401B2 (en) 2023-12-21

Family

ID=73543315

Family Applications (2)

Application Number Title Priority Date Filing Date
AU2020301401A Active AU2020301401B2 (en) 2019-06-27 2020-06-24 Novel ibuprofen and acetaminophen composition
AU2024200875A Abandoned AU2024200875A1 (en) 2019-06-27 2024-02-12 Novel ibuprofen and acetaminophen composition

Family Applications After (1)

Application Number Title Priority Date Filing Date
AU2024200875A Abandoned AU2024200875A1 (en) 2019-06-27 2024-02-12 Novel ibuprofen and acetaminophen composition

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 (1)

* 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

Family Cites Families (12)

* 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
ATE543491T1 (de) * 2004-07-07 2012-02-15 Aft Pharmaceuticals Ltd Kombinationspräparat enthaltend ibuprofen und paracetamol
US20080166407A1 (en) * 2005-07-29 2008-07-10 Shalaby Shalaby W Solid oral formulations for combination therapy
GB0519350D0 (en) * 2005-09-22 2005-11-02 Boots Healthcare Int Ltd Therapeutic agents
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
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
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 (1)

* 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

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
JP2025134843A (ja) 2025-09-17
IL288989A (en) 2022-02-01
JP7703220B2 (ja) 2025-07-07
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

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