CA3137488C - Liquid oral dosage formulations of methylnaltrexone - Google Patents

Liquid oral dosage formulations of methylnaltrexone Download PDF

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Publication number
CA3137488C
CA3137488C CA3137488A CA3137488A CA3137488C CA 3137488 C CA3137488 C CA 3137488C CA 3137488 A CA3137488 A CA 3137488A CA 3137488 A CA3137488 A CA 3137488A CA 3137488 C CA3137488 C CA 3137488C
Authority
CA
Canada
Prior art keywords
pharmaceutical composition
methylnaltrexone
composition
surfactant
oil
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
CA3137488A
Other languages
English (en)
French (fr)
Other versions
CA3137488A1 (en
Inventor
Brian Robert ROHRS
Daniel Jason STEIN
Vijay Kumar
Eric Phillips
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.)
Bausch Health Ireland Ltd
Original Assignee
Bausch Health Ireland 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
Application filed by Bausch Health Ireland Ltd filed Critical Bausch Health Ireland Ltd
Publication of CA3137488A1 publication Critical patent/CA3137488A1/en
Application granted granted Critical
Publication of CA3137488C publication Critical patent/CA3137488C/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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/485—Morphinan derivatives, e.g. morphine, codeine
    • 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
    • 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
    • A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/10—Laxatives

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Emergency Medicine (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Physiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nutrition Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
CA3137488A 2019-05-07 2020-05-07 Liquid oral dosage formulations of methylnaltrexone Active CA3137488C (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201962844613P 2019-05-07 2019-05-07
US62/844,613 2019-05-07
US202063010528P 2020-04-15 2020-04-15
US63/010,528 2020-04-15
PCT/EP2020/062794 WO2020225395A1 (en) 2019-05-07 2020-05-07 Liquid oral dosage formulations of methylnaltrexone

Publications (2)

Publication Number Publication Date
CA3137488A1 CA3137488A1 (en) 2020-11-12
CA3137488C true CA3137488C (en) 2023-10-31

Family

ID=70802839

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3137488A Active CA3137488C (en) 2019-05-07 2020-05-07 Liquid oral dosage formulations of methylnaltrexone

Country Status (9)

Country Link
US (1) US20220096461A1 (enExample)
EP (1) EP3965731A1 (enExample)
JP (1) JP7692366B2 (enExample)
CN (1) CN113747882A (enExample)
AU (1) AU2020268767B8 (enExample)
BR (1) BR112021022194A2 (enExample)
CA (1) CA3137488C (enExample)
MX (1) MX2021013488A (enExample)
WO (1) WO2020225395A1 (enExample)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TWI489984B (zh) 2006-08-04 2015-07-01 Wyeth Corp 用於非經腸道傳輸化合物之配方及其用途
WO2021224138A1 (en) 2020-05-02 2021-11-11 Bausch Health Ireland Limited Methods of reducing mortality risk in subjects suffering from an underlying disease or condition by administration of methylnaltrexone
AU2022248850A1 (en) * 2021-03-27 2023-11-09 TRx Biosciences Limited Compositions having improved bioavailability of therapeutics
WO2025177181A1 (en) * 2024-02-19 2025-08-28 Nanoprime Labs Corp Self-assembling microemulsions carrying nutraceuticals and methods for use thereof

Family Cites Families (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4518433A (en) 1982-11-08 1985-05-21 Fmc Corporation Enteric coating for pharmaceutical dosage forms
US4719215A (en) 1986-03-07 1988-01-12 University Of Chicago Quaternary derivatives of noroxymorphone which relieve nausea and emesis
US4861781A (en) 1986-03-07 1989-08-29 The University Of Chicago Quaternary derivatives of noroxymorphone which relieve nausea and emesis
US4816259A (en) 1987-02-12 1989-03-28 Chase Chemical Company, L.P. Process for coating gelatin capsules
US5102887A (en) 1989-02-17 1992-04-07 Arch Development Corporation Method for reducing emesis and nausea induced by the administration of an emesis causing agent
US5330759A (en) 1992-08-26 1994-07-19 Sterling Winthrop Inc. Enteric coated soft capsules and method of preparation thereof
DE19651551C2 (de) 1996-12-11 2000-02-03 Klinge Co Chem Pharm Fab Opioidantagonisthaltige galenische Formulierung
US5972954A (en) 1997-11-03 1999-10-26 Arch Development Corporation Use of methylnaltrexone and related compounds
US6559158B1 (en) 1997-11-03 2003-05-06 Ur Labs, Inc. Use of methylnaltrexone and related compounds to treat chronic opioid use side affects
US6274591B1 (en) 1997-11-03 2001-08-14 Joseph F. Foss Use of methylnaltrexone and related compounds
CN1688294A (zh) 2002-10-01 2005-10-26 旗帜药物胶囊公司 用于制备软胶囊壁的肠溶组合物
MXPA05010821A (es) 2003-04-08 2006-03-30 Progenics Pharm Inc Terapia de combinacion para constipacion que comprende un laxante y un antagonista opioide periferico.
JP2006522817A (ja) 2003-04-08 2006-10-05 プロジェニックス ファーマシューティカルズ，インコーポレーテッド 過敏性腸症候群を処置するための末梢オピオイドアンタゴニスト、特にメチルナルトレキソンの使用
US8946262B2 (en) 2003-12-04 2015-02-03 Adolor Corporation Methods of preventing and treating gastrointestinal dysfunction
AR057035A1 (es) 2005-05-25 2007-11-14 Progenics Pharm Inc SíNTESIS DE (R)-N-METILNALTREXONA, COMPOSICIONES FARMACÉUTICAS Y USOS
TWI605814B (zh) * 2010-03-11 2017-11-21 惠氏有限責任公司 甲基拿淬松（ｍｅｔｈｙｌｎａｌｔｒｅｘｏｎｅ）之口服製劑及親脂性鹽
JP6397813B2 (ja) 2012-05-02 2018-09-26 キャプシュゲル・ベルジウム・エヌ・ヴィ ヒドロキシプロピルメチルセルロースアセテートスクシネート（ｈｐｍｃａｓ）の水性分散液
US10485798B2 (en) * 2012-08-22 2019-11-26 Aptapharma Inc. Methylnaltrexone nasal formulations, methods of making, and use thereof
EP3206491B1 (en) * 2014-10-17 2019-11-27 Salix Pharmaceuticals, Inc. Use of methylnaltrexone to attenuate tumor progression

Also Published As

Publication number Publication date
AU2020268767B1 (en) 2025-07-17
CN113747882A (zh) 2021-12-03
WO2020225395A1 (en) 2020-11-12
JP7692366B2 (ja) 2025-06-13
AU2020268767A1 (en) 2021-10-28
MX2021013488A (es) 2021-12-10
AU2020268767B8 (en) 2025-08-07
JP2022531685A (ja) 2022-07-08
BR112021022194A2 (pt) 2021-12-28
EP3965731A1 (en) 2022-03-16
CA3137488A1 (en) 2020-11-12
US20220096461A1 (en) 2022-03-31

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