AU2017326519B2 - Formulations containing acetaminophen and sulfoalkyl ether cyclodextrin - Google Patents

Formulations containing acetaminophen and sulfoalkyl ether cyclodextrin Download PDF

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Publication number
AU2017326519B2
AU2017326519B2 AU2017326519A AU2017326519A AU2017326519B2 AU 2017326519 B2 AU2017326519 B2 AU 2017326519B2 AU 2017326519 A AU2017326519 A AU 2017326519A AU 2017326519 A AU2017326519 A AU 2017326519A AU 2017326519 B2 AU2017326519 B2 AU 2017326519B2
Authority
AU
Australia
Prior art keywords
formulation
acetaminophen
sulfoalkyl ether
ether cyclodextrin
range
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
AU2017326519A
Other languages
English (en)
Other versions
AU2017326519A1 (en
Inventor
Gerold L. Mosher
James D. Pipkin
Roger Rajewski
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.)
Cydex Pharmaceuticals Inc
Original Assignee
Cydex Pharmaceuticals 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 Cydex Pharmaceuticals Inc filed Critical Cydex Pharmaceuticals Inc
Publication of AU2017326519A1 publication Critical patent/AU2017326519A1/en
Application granted granted Critical
Publication of AU2017326519B2 publication Critical patent/AU2017326519B2/en
Priority to AU2023203660A priority Critical patent/AU2023203660A1/en
Priority to AU2025204233A priority patent/AU2025204233A1/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
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61K9/08—Solutions
    • 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
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular 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
    • A61K9/14—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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/04—Centrally acting analgesics, e.g. opioids
    • 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
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/40—Cyclodextrins; Derivatives thereof

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth 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)
  • Pain & Pain Management (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Dermatology (AREA)
  • Rheumatology (AREA)
  • Inorganic Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
AU2017326519A 2016-09-16 2017-09-15 Formulations containing acetaminophen and sulfoalkyl ether cyclodextrin Active AU2017326519B2 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
AU2023203660A AU2023203660A1 (en) 2016-09-16 2023-06-13 Formulations containing acetaminophen and sulfoalkyl ether cyclodextrin
AU2025204233A AU2025204233A1 (en) 2016-09-16 2025-06-06 Formulations containing acetaminophen and sulfoalkyl ether cyclodextrin

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201662395794P 2016-09-16 2016-09-16
US62/395,794 2016-09-16
PCT/US2017/051919 WO2018053358A1 (en) 2016-09-16 2017-09-15 Formulations containing acetaminophen and sulfoalkyl ether cyclodextrin

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2023203660A Division AU2023203660A1 (en) 2016-09-16 2023-06-13 Formulations containing acetaminophen and sulfoalkyl ether cyclodextrin

Publications (2)

Publication Number Publication Date
AU2017326519A1 AU2017326519A1 (en) 2019-04-11
AU2017326519B2 true AU2017326519B2 (en) 2023-03-16

Family

ID=61619250

Family Applications (3)

Application Number Title Priority Date Filing Date
AU2017326519A Active AU2017326519B2 (en) 2016-09-16 2017-09-15 Formulations containing acetaminophen and sulfoalkyl ether cyclodextrin
AU2023203660A Abandoned AU2023203660A1 (en) 2016-09-16 2023-06-13 Formulations containing acetaminophen and sulfoalkyl ether cyclodextrin
AU2025204233A Pending AU2025204233A1 (en) 2016-09-16 2025-06-06 Formulations containing acetaminophen and sulfoalkyl ether cyclodextrin

Family Applications After (2)

Application Number Title Priority Date Filing Date
AU2023203660A Abandoned AU2023203660A1 (en) 2016-09-16 2023-06-13 Formulations containing acetaminophen and sulfoalkyl ether cyclodextrin
AU2025204233A Pending AU2025204233A1 (en) 2016-09-16 2025-06-06 Formulations containing acetaminophen and sulfoalkyl ether cyclodextrin

Country Status (9)

Country Link
US (1) US20190255000A1 (enExample)
EP (1) EP3512511A4 (enExample)
JP (3) JP7181185B2 (enExample)
KR (2) KR20240005122A (enExample)
CN (2) CN110167543A (enExample)
AU (3) AU2017326519B2 (enExample)
CA (1) CA3036989A1 (enExample)
MX (2) MX2019002976A (enExample)
WO (1) WO2018053358A1 (enExample)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN119233815A (zh) * 2022-05-20 2024-12-31 株式会社大赛璐 液态医药组合物

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20110015273A1 (en) * 2008-01-17 2011-01-20 Rajnarayana Kandhagatla Stable pharmaceutical aqueous compositions
EP2277546A1 (en) * 2009-07-23 2011-01-26 Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A. Stable ready to use injectable paracetamol formulation
WO2012037117A1 (en) * 2010-09-13 2012-03-22 Bev-Rx, Inc. Aqueous drug delivery system comprising off - flavor masking agent
EP2918291A2 (en) * 2014-03-13 2015-09-16 Bio Biologica Industria Farmaceutica Ltda. Pharmaceutical composition of stabilized paracetamol, plastic bags and use of the pharmaceutical composition

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6046177A (en) * 1997-05-05 2000-04-04 Cydex, Inc. Sulfoalkyl ether cyclodextrin based controlled release solid pharmaceutical formulations
US7034013B2 (en) * 2001-03-20 2006-04-25 Cydex, Inc. Formulations containing propofol and a sulfoalkyl ether cyclodextrin
KR20160033795A (ko) * 2012-02-28 2016-03-28 사이덱스 파마슈티칼스, 인크. 알킬화된 시클로덱스트린 조성물 및 이의 제조 및 사용 방법
CN102871994B (zh) * 2012-09-29 2015-07-29 中国科学院大连化学物理研究所 氟比洛芬对乙酰氨基酚酯环糊精包合物及其制备方法
SMT202100404T1 (it) * 2016-02-04 2021-09-14 Czap Research And Development Llc Veicoli di complessi di inclusione di ciclodestrine stratificati e rilascio controllato

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20110015273A1 (en) * 2008-01-17 2011-01-20 Rajnarayana Kandhagatla Stable pharmaceutical aqueous compositions
EP2277546A1 (en) * 2009-07-23 2011-01-26 Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A. Stable ready to use injectable paracetamol formulation
WO2012037117A1 (en) * 2010-09-13 2012-03-22 Bev-Rx, Inc. Aqueous drug delivery system comprising off - flavor masking agent
EP2918291A2 (en) * 2014-03-13 2015-09-16 Bio Biologica Industria Farmaceutica Ltda. Pharmaceutical composition of stabilized paracetamol, plastic bags and use of the pharmaceutical composition

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
JARUNEE KAULPIBOON, PRAKARN RUDEEKULTHAMRONG: "Correspondence to: Effect of Temperature on Cyclodextrin Production and Characterization of Paracetamol/Cyclodextrin Complexes", J MED ASSOC THAI J MED ASSOC THAI, vol. 93, no. 6, 1 January 2010 (2010-01-01), pages S160 - S165, XP055500009 *
LIN ET AL.: "Kinetic Determinations Of Stability Of Acetaminophen With Cyclodextrins And Glucose In Aqueous Solution", INTERNATIONAL JOURNAL OF PHARMACEUTICAL TECHNOLOGY AND PRODUCTMANUFACTURE, CHILDWALL UNIVERSITY PRESS, LONDON, GB, vol. 5, no. 4, 1 January 1984 (1984-01-01), GB , pages 19 - 24, XP009514077, ISSN: 0260-6267 *

Also Published As

Publication number Publication date
WO2018053358A1 (en) 2018-03-22
EP3512511A1 (en) 2019-07-24
US20190255000A1 (en) 2019-08-22
KR20190065296A (ko) 2019-06-11
CN110167543A (zh) 2019-08-23
JP2024051102A (ja) 2024-04-10
MX2019002976A (es) 2019-07-10
AU2025204233A1 (en) 2025-06-26
JP2022140780A (ja) 2022-09-27
EP3512511A4 (en) 2020-05-20
JP2019532927A (ja) 2019-11-14
MX2023003761A (es) 2023-04-26
AU2023203660A1 (en) 2023-07-06
JP7181185B2 (ja) 2022-11-30
CN116869983A (zh) 2023-10-13
RU2019107764A3 (enExample) 2021-01-15
RU2019107764A (ru) 2020-10-16
CA3036989A1 (en) 2018-03-22
KR20240005122A (ko) 2024-01-11
AU2017326519A1 (en) 2019-04-11

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