CA2690488C - Pharmaceutical formulations of naproxen for soft gel encapsulation and combinations thereof - Google Patents

Pharmaceutical formulations of naproxen for soft gel encapsulation and combinations thereof Download PDF

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Publication number
CA2690488C
CA2690488C CA2690488A CA2690488A CA2690488C CA 2690488 C CA2690488 C CA 2690488C CA 2690488 A CA2690488 A CA 2690488A CA 2690488 A CA2690488 A CA 2690488A CA 2690488 C CA2690488 C CA 2690488C
Authority
CA
Canada
Prior art keywords
ranges
naproxen
weight
amount
formulation
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
CA2690488A
Other languages
English (en)
French (fr)
Other versions
CA2690488A1 (en
Inventor
John Lopez
Peter Draper
Sankalp Vashishtha
Nancy Klassen
Christina Armstrong
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.)
Catalent Ontario Ltd
Original Assignee
Accucaps Industries Ltd
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
Priority to CA2690488A priority Critical patent/CA2690488C/en
Application filed by Accucaps Industries Ltd filed Critical Accucaps Industries Ltd
Priority to MX2012008300A priority patent/MX358636B/es
Priority to EP11734283.2A priority patent/EP2525789B1/en
Priority to US13/574,159 priority patent/US9480667B2/en
Priority to PCT/CA2011/000059 priority patent/WO2011088553A1/en
Priority to PT117342832T priority patent/PT2525789T/pt
Priority to DK11734283.2T priority patent/DK2525789T3/da
Priority to ES11734283T priority patent/ES2880813T3/es
Priority to JP2012549215A priority patent/JP5975884B2/ja
Priority to EP21177143.1A priority patent/EP3909567A1/en
Priority to AU2011207061A priority patent/AU2011207061B2/en
Priority to HUE11734283A priority patent/HUE055771T2/hu
Priority to PL11734283T priority patent/PL2525789T3/pl
Priority to SI201131992T priority patent/SI2525789T1/sl
Publication of CA2690488A1 publication Critical patent/CA2690488A1/en
Application granted granted Critical
Publication of CA2690488C publication Critical patent/CA2690488C/en
Priority to JP2016007253A priority patent/JP2016094462A/ja
Priority to US15/285,968 priority patent/US10463637B2/en
Priority to US16/583,903 priority patent/US11896566B2/en
Priority to US18/400,069 priority patent/US20240139132A1/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
    • A61K31/185—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
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4833—Encapsulating processes; Filling of capsules
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds
    • 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)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Rheumatology (AREA)
  • Pain & Pain Management (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
CA2690488A 2010-01-19 2010-01-19 Pharmaceutical formulations of naproxen for soft gel encapsulation and combinations thereof Active CA2690488C (en)

Priority Applications (18)

Application Number Priority Date Filing Date Title
CA2690488A CA2690488C (en) 2010-01-19 2010-01-19 Pharmaceutical formulations of naproxen for soft gel encapsulation and combinations thereof
HUE11734283A HUE055771T2 (hu) 2010-01-19 2011-01-19 Naproxén gyógyászati kiszerelései lágy gél kapszulázáshoz, és ezek kombinációi
US13/574,159 US9480667B2 (en) 2010-01-19 2011-01-19 Pharmaceutical formulations of naproxen for soft gel encapsulation and combinations thereof
PCT/CA2011/000059 WO2011088553A1 (en) 2010-01-19 2011-01-19 Pharmaceutical formulations of naproxen for soft gel encapsulation and combinations thereof
PT117342832T PT2525789T (pt) 2010-01-19 2011-01-19 Formulações farmacêuticas de naproxeno para encapsulação de gel mole e combinações das mesmas
DK11734283.2T DK2525789T3 (da) 2010-01-19 2011-01-19 Farmaceutiske formuleringer af naproxen til softgel-indkapsling og kombinationer deraf
ES11734283T ES2880813T3 (es) 2010-01-19 2011-01-19 Formulaciones farmacéuticas de naproxeno para encapsulación en gel blando y combinaciones de las mismas
JP2012549215A JP5975884B2 (ja) 2010-01-19 2011-01-19 ソフトゲルカプセル化のためのナプロキセンの医薬処方およびその組合せ
EP21177143.1A EP3909567A1 (en) 2010-01-19 2011-01-19 Pharmaceutical formulations of naproxen for soft gel encapsulation and combinations thereof
SI201131992T SI2525789T1 (sl) 2010-01-19 2011-01-19 Farmacevtske formulacije naproksena za enkapsulacijo v mehko želatino in njihove kombinacije
MX2012008300A MX358636B (es) 2010-01-19 2011-01-19 Formulaciones farmacéuticas de naproxeno para la encapsulación en gel blando y combinaciones de las mismas.
EP11734283.2A EP2525789B1 (en) 2010-01-19 2011-01-19 Pharmaceutical formulations of naproxen for soft gel encapsulation and combinations thereof
AU2011207061A AU2011207061B2 (en) 2010-01-19 2011-01-19 Pharmaceutical formulations of naproxen for soft gel encapsulation and combinations thereof
PL11734283T PL2525789T3 (pl) 2010-01-19 2011-01-19 Farmaceutyczne formulacje naproksenu do kapsułkowania w miękkich kapsułkach żelowych i ich kombinacje
JP2016007253A JP2016094462A (ja) 2010-01-19 2016-01-18 ソフトゲルカプセル化のためのナプロキセンの医薬処方およびその組合せ
US15/285,968 US10463637B2 (en) 2010-01-19 2016-10-05 Pharmaceutical formulations of naproxen for soft gel encapsulation and combinations thereof
US16/583,903 US11896566B2 (en) 2010-01-19 2019-09-26 Pharmaceutical formulations of naproxen for soft gel encapsulation and combinations thereof
US18/400,069 US20240139132A1 (en) 2010-01-19 2023-12-29 Pharmaceutical formulations of naproxen for soft gel encapsulation and combinations thereof

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CA2690488A CA2690488C (en) 2010-01-19 2010-01-19 Pharmaceutical formulations of naproxen for soft gel encapsulation and combinations thereof

Publications (2)

Publication Number Publication Date
CA2690488A1 CA2690488A1 (en) 2011-07-19
CA2690488C true CA2690488C (en) 2013-06-11

Family

ID=44303618

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2690488A Active CA2690488C (en) 2010-01-19 2010-01-19 Pharmaceutical formulations of naproxen for soft gel encapsulation and combinations thereof

Country Status (13)

Country Link
US (4) US9480667B2 (OSRAM)
EP (2) EP2525789B1 (OSRAM)
JP (2) JP5975884B2 (OSRAM)
AU (1) AU2011207061B2 (OSRAM)
CA (1) CA2690488C (OSRAM)
DK (1) DK2525789T3 (OSRAM)
ES (1) ES2880813T3 (OSRAM)
HU (1) HUE055771T2 (OSRAM)
MX (1) MX358636B (OSRAM)
PL (1) PL2525789T3 (OSRAM)
PT (1) PT2525789T (OSRAM)
SI (1) SI2525789T1 (OSRAM)
WO (1) WO2011088553A1 (OSRAM)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB201301626D0 (en) 2013-01-30 2013-03-13 Dignity Sciences Ltd Composition comprising 15-OHEPA and methods of using the same
JP2017516823A (ja) * 2014-06-04 2017-06-22 ディグニティ サイエンシス リミテッド Ｄｇｌａを含む薬学的組成物及びその使用
CN104083339A (zh) * 2014-08-04 2014-10-08 人福普克药业（武汉）有限公司 萘普生钠软胶囊及其制备方法
US10368284B2 (en) * 2014-11-12 2019-07-30 T-Mobile Usa, Inc. Quality of experience-based handover management
WO2016181221A1 (en) 2015-05-13 2016-11-17 Dignity Sciences Limited Compositions comprising 15-oxo-epa or 15-oxo-dgla and methods of making and using same
JP2018520197A (ja) 2015-07-21 2018-07-26 アフィミューン リミテッド 癌及び神経疾患の治療または予防において使用するための、１５−ｈｅｐｅを含む組成物
CA3008774C (en) 2015-12-18 2021-10-12 Afimmune Limited Compositions comprising 15-hepe and methods of using the same
US11911517B2 (en) 2018-05-16 2024-02-27 Bayer Healthcare Llc High concentration suspension formulation for cold and flu soft gel capsule medications
CN109692127A (zh) * 2019-03-15 2019-04-30 王征 一种密封小胶囊的制备方法
CN113950324A (zh) * 2019-04-26 2022-01-18 R.P.谢勒技术有限公司 微型软胶囊萘普生组合物
US20210315851A1 (en) 2020-04-03 2021-10-14 Afimmune Limited Compositions comprising 15-hepe and methods of treating or preventing hematologic disorders, and/or related diseases
US20220233452A1 (en) * 2021-01-25 2022-07-28 R.P. Scherer Technologies, Llc Mini softgel naproxen composition

Family Cites Families (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4443428A (en) * 1982-06-21 1984-04-17 Euroceltique, S.A. Extended action controlled release compositions
US5071643A (en) * 1986-10-17 1991-12-10 R. P. Scherer Corporation Solvent system enhancing the solubility of pharmaceuticals for encapsulation
CN1130354A (zh) 1993-09-07 1996-09-04 普罗克特和廿保尔公司 含有丙酸类非甾体消炎药氨基酸盐和减充血药、祛痰药、抗组胺药和镇咳药中至少一种的组合物
US5484606A (en) * 1994-01-24 1996-01-16 The Procter & Gamble Company Process for reducing the precipitation of difficulty soluble pharmaceutical actives
SK96196A3 (en) * 1994-01-24 1997-03-05 Procter & Gamble Process for solubilizing difficultly soluble pharmaceutical actives
US5641512A (en) * 1995-03-29 1997-06-24 The Procter & Gamble Company Soft gelatin capsule compositions
CA2318128C (en) * 1998-01-20 2008-10-14 Applied Analytical Industries, Inc. Oral liquid compositions
US6383515B2 (en) * 1999-05-28 2002-05-07 Sawyer Maryjean Solvent system for enhancing solubility
US6387400B1 (en) 2000-08-29 2002-05-14 R.P. Scherer Technologies, Inc. Process for preparing pharmaceutical compositions for use with soft gelatin formulations
WO2004071490A1 (en) * 2003-02-12 2004-08-26 R & P Korea Co., Ltd. Solvent system of hardly soluble drug with improved elution rate
US20090318558A1 (en) * 2003-02-12 2009-12-24 Jae-Hwan Kim Solvent system of hardly soluble drug with improved dissolution rate
US20070053868A1 (en) * 2005-03-08 2007-03-08 Banner Pharmacaps, Inc. Solvent system for enhancing the solubility of pharmaceutical agents
US7582679B2 (en) 2006-02-03 2009-09-01 Pharmaceutics International Incorporated Compositions containing solid ibuprofen concentrates and methods of making solid ibuprofen concentrates
US20080014274A1 (en) * 2006-07-14 2008-01-17 Wyeth Enhanced stability phenylephrine liquid compositions
US20110052679A1 (en) * 2009-08-25 2011-03-03 Pharmaceutics International, Inc. Solid naproxen concentrates and related dosage forms

Also Published As

Publication number Publication date
EP2525789B1 (en) 2021-06-02
MX358636B (es) 2018-08-29
US20170020832A1 (en) 2017-01-26
US11896566B2 (en) 2024-02-13
HUE055771T2 (hu) 2021-12-28
PT2525789T (pt) 2021-07-19
JP5975884B2 (ja) 2016-08-23
EP3909567A1 (en) 2021-11-17
CA2690488A1 (en) 2011-07-19
JP2016094462A (ja) 2016-05-26
AU2011207061B2 (en) 2015-05-28
DK2525789T3 (da) 2021-07-19
MX2012008300A (es) 2012-11-23
US20130011470A1 (en) 2013-01-10
AU2011207061A1 (en) 2012-07-26
WO2011088553A1 (en) 2011-07-28
EP2525789A1 (en) 2012-11-28
PL2525789T3 (pl) 2022-01-03
ES2880813T3 (es) 2021-11-25
EP2525789A4 (en) 2014-04-30
US20240139132A1 (en) 2024-05-02
US9480667B2 (en) 2016-11-01
US20200046662A1 (en) 2020-02-13
JP2013517304A (ja) 2013-05-16
SI2525789T1 (sl) 2021-12-31
US10463637B2 (en) 2019-11-05

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