CN113747882A - 甲基纳曲酮的液体口服剂量制剂 - Google Patents

甲基纳曲酮的液体口服剂量制剂 Download PDF

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Publication number
CN113747882A
CN113747882A CN202080033965.4A CN202080033965A CN113747882A CN 113747882 A CN113747882 A CN 113747882A CN 202080033965 A CN202080033965 A CN 202080033965A CN 113747882 A CN113747882 A CN 113747882A
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CN
China
Prior art keywords
pharmaceutical composition
methylnaltrexone
oil
surfactant
docusate
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.)
Pending
Application number
CN202080033965.4A
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English (en)
Chinese (zh)
Inventor
B·R·罗尔斯
D·J·施泰因
V·库马
E·菲利普斯
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.)
Doctor Medical Ireland Ltd
Original Assignee
Doctor Medical 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 Doctor Medical Ireland Ltd filed Critical Doctor Medical Ireland Ltd
Publication of CN113747882A publication Critical patent/CN113747882A/zh
Pending legal-status Critical Current

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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
    • A61K9/0012—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
    • 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
    • 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

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  • 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)
CN202080033965.4A 2019-05-07 2020-05-07 甲基纳曲酮的液体口服剂量制剂 Pending CN113747882A (zh)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201962844613P 2019-05-07 2019-05-07
US62/844613 2019-05-07
US202063010528P 2020-04-15 2020-04-15
US63/010528 2020-04-15
PCT/EP2020/062794 WO2020225395A1 (en) 2019-05-07 2020-05-07 Liquid oral dosage formulations of methylnaltrexone

Publications (1)

Publication Number Publication Date
CN113747882A true CN113747882A (zh) 2021-12-03

Family

ID=70802839

Family Applications (1)

Application Number Title Priority Date Filing Date
CN202080033965.4A Pending CN113747882A (zh) 2019-05-07 2020-05-07 甲基纳曲酮的液体口服剂量制剂

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

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120070495A1 (en) * 2010-03-11 2012-03-22 Wyeth Llc Oral formulations and lipophilic salts of methylnaltrexone
US20140057934A1 (en) * 2012-08-22 2014-02-27 Aptapharma Inc. Methylnaltrexone nasal formulations, methods of making, and use thereof
CN107249327A (zh) * 2014-10-17 2017-10-13 萨利克斯药品公司 使用甲基纳曲酮减缓肿瘤进展

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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
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

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120070495A1 (en) * 2010-03-11 2012-03-22 Wyeth Llc Oral formulations and lipophilic salts of methylnaltrexone
CN102918039A (zh) * 2010-03-11 2013-02-06 惠氏有限责任公司 甲基纳曲酮的口服制剂和亲脂盐
US20140057934A1 (en) * 2012-08-22 2014-02-27 Aptapharma Inc. Methylnaltrexone nasal formulations, methods of making, and use thereof
CN107249327A (zh) * 2014-10-17 2017-10-13 萨利克斯药品公司 使用甲基纳曲酮减缓肿瘤进展

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
LI-FANG YU ET AL: "Enhancing Oral Bioavailability of Methylnaltrexone Using an Emulsion Formulation", 《LETTERS IN DRUG DESIGN & DISCOVERY》, vol. 8, 31 January 2011 (2011-01-31), pages 88 *
徐元贞等主编: "《新全实用药物手册》", 31 August 2018, 河南科学技术出版社, pages: 844 *
李新岗;: "用HPLC法分析软明胶胶囊中的多库酯钠", 国外医学.药学分册, no. 01 *

Also Published As

Publication number Publication date
AU2020268767B1 (en) 2025-07-17
CA3137488C (en) 2023-10-31
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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