AU2020301401B2 - Novel ibuprofen and acetaminophen composition - Google Patents

Novel ibuprofen and acetaminophen composition Download PDF

Info

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
Authority
AU
Australia
Prior art keywords
ibu
apap
fdc
study
placebo
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
AU2020301401A
Other languages
English (en)
Other versions
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
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=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
Application granted granted Critical
Publication of AU2020301401B2 publication Critical patent/AU2020301401B2/en
Priority to AU2024200875A priority Critical patent/AU2024200875A1/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

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
    • A61K9/20—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)
  • Chemical Kinetics & Catalysis (AREA)
  • Rheumatology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (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 (enExample)
EP (1) EP3989944A1 (enExample)
JP (2) JP7703220B2 (enExample)
KR (1) KR20220027194A (enExample)
CN (1) CN114173767A (enExample)
AU (2) AU2020301401B2 (enExample)
BR (1) BR112021026407A8 (enExample)
CA (1) CA3143724A1 (enExample)
CO (1) CO2021017722A2 (enExample)
IL (1) IL288989A (enExample)
MX (1) MX2021016089A (enExample)
PH (1) PH12021553169A1 (enExample)
WO (1) WO2020263947A1 (enExample)

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
WO2025212048A1 (en) * 2024-03-30 2025-10-09 Humanis Sağlik A.Ş. Pharmaceutical compositions comprising ibuprofen and paracetamol and relevant excipients
WO2025212049A1 (en) * 2024-03-30 2025-10-09 Humanis Sağlik A.Ş. Solid pharmaceutical compositions comprising ibuprofen and paracetamol

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
BRPI0512756A (pt) * 2004-07-07 2008-04-08 Aft Pharmaceuticals Ltd composição farmacêutica de combinação para o tratamento de dor, método de controle de dor, uso de uma composição e embalagem farmacêutica incluindo comprimidos ou cápsulas
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
EP4480495A3 (en) * 2017-07-10 2025-06-18 Gel Cap Technologies, LLC Dual release dosage form capsule and methods, devices and systems for making same
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
JP2025134843A (ja) 2025-09-17
AU2020301401A1 (en) 2022-01-27
US20200405645A1 (en) 2020-12-31
KR20220027194A (ko) 2022-03-07
CN114173767A (zh) 2022-03-11
US11918693B2 (en) 2024-03-05
IL288989A (en) 2022-02-01
MX2021016089A (es) 2022-04-25
BR112021026407A2 (pt) 2022-02-08
BR112021026407A8 (pt) 2022-11-22
JP2022540348A (ja) 2022-09-15
US20250302754A1 (en) 2025-10-02
WO2020263947A1 (en) 2020-12-30
PH12021553169A1 (en) 2022-08-15
US20240156740A1 (en) 2024-05-16
EP3989944A1 (en) 2022-05-04
CA3143724A1 (en) 2020-12-30
CO2021017722A2 (es) 2022-01-17
JP7703220B2 (ja) 2025-07-07
AU2024200875A1 (en) 2024-02-29

Similar Documents

Publication Publication Date Title
JP6325627B2 (ja) 口腔内崩壊錠及びその製造方法
US20250302754A1 (en) Novel ibuprofen and acetaminophen composition
DK2510950T3 (en) DRY-COATED ORALT-DISINTEGRATING TABLE
KR101400064B1 (ko) 건식 직타 속붕괴성 정제
CN101257800B (zh) 包含法莫替丁和布洛芬的药物
CN103402497A (zh) 快速分散颗粒、口腔崩解片以及方法
CA2685184A1 (en) Solid dosage forms
BG64165B1 (bg) Дозирана лекарствена форма на ибупрофен
JPH10182436A (ja) 固形医薬製剤
JP5630943B2 (ja) 複合剤組成物
JP2009502807A (ja) 薬剤含有率の高い製剤および投与量形態
KR102431738B1 (ko) 초고속 붕해 정제 및 그 제조 방법
JP6341196B2 (ja) 固形製剤
JP2012046454A (ja) 内服用錠剤およびその製造方法
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
JP5226732B2 (ja) 催眠用圧縮成型製剤
JP2025091085A (ja) 錠剤及び錠剤の製造方法
JP2025081930A (ja) 錠剤、造粒粒子、造粒粒子の製造方法及び錠剤の製造方法
JP2004107258A (ja) 催眠用圧縮成型製剤
HU231592B1 (hu) Favipiravir tartalmú gyógyszerkészítmény, ennek előállítása és alkalmazása
JP2005194225A (ja) 胃内崩壊性錠剤
TW201729798A (zh) 口腔內保持型崩解性固形製劑、其製造方法、及用於該製造方法之粉體組成物
CN101190206A (zh) 减少了对消化管的刺激性的口服固形组合物

Legal Events

Date Code Title Description
PC1 Assignment before grant (sect. 113)

Owner name: GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC

Free format text: FORMER APPLICANT(S): PF CONSUMER HEALTHCARE 1 LLC

FGA Letters patent sealed or granted (standard patent)