JP6448096B2 - 舌下及び頬用フィルム組成物 - Google Patents

舌下及び頬用フィルム組成物 Download PDF

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Publication number
JP6448096B2
JP6448096B2 JP2016502836A JP2016502836A JP6448096B2 JP 6448096 B2 JP6448096 B2 JP 6448096B2 JP 2016502836 A JP2016502836 A JP 2016502836A JP 2016502836 A JP2016502836 A JP 2016502836A JP 6448096 B2 JP6448096 B2 JP 6448096B2
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JP
Japan
Prior art keywords
composition
pharmaceutically acceptable
acceptable salt
naloxone
film
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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.)
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JP2016502836A
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English (en)
Japanese (ja)
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JP2016513736A5 (enExample
JP2016513736A (ja
Inventor
ゲイリー エル マイヤーズ
ゲイリー エル マイヤーズ
エリック ダデイ
エリック ダデイ
Original Assignee
アクエスティブ セラピューティクス インコーポレイテッド
アクエスティブ セラピューティクス インコーポレイテッド
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Publication of JP2016513736A publication Critical patent/JP2016513736A/ja
Publication of JP2016513736A5 publication Critical patent/JP2016513736A5/ja
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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
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7007—Drug-containing films, membranes or sheets
    • 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
    • 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
    • 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
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • 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
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
    • A61P25/36—Opioid-abuse
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Emergency Medicine (AREA)
  • Nutrition Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Physiology (AREA)
  • Biomedical Technology (AREA)
  • Addiction (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Pain & Pain Management (AREA)
  • Psychiatry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
JP2016502836A 2013-03-15 2014-03-14 舌下及び頬用フィルム組成物 Active JP6448096B2 (ja)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US13/842,543 2013-03-15
US13/842,543 US20140271788A1 (en) 2013-03-15 2013-03-15 Sublingual and buccal film compositions
US14/196,082 2014-03-04
US14/196,082 US9511033B2 (en) 2013-03-15 2014-03-04 Sublingual and buccal film compositions
PCT/US2014/028568 WO2014144241A1 (en) 2013-03-15 2014-03-14 Sublingual and buccal film compositions

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2018225191A Division JP2019048882A (ja) 2013-03-15 2018-11-30 舌下及び頬用フィルム組成物

Publications (3)

Publication Number Publication Date
JP2016513736A JP2016513736A (ja) 2016-05-16
JP2016513736A5 JP2016513736A5 (enExample) 2018-07-05
JP6448096B2 true JP6448096B2 (ja) 2019-01-09

Family

ID=51528033

Family Applications (2)

Application Number Title Priority Date Filing Date
JP2016502836A Active JP6448096B2 (ja) 2013-03-15 2014-03-14 舌下及び頬用フィルム組成物
JP2018225191A Abandoned JP2019048882A (ja) 2013-03-15 2018-11-30 舌下及び頬用フィルム組成物

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2018225191A Abandoned JP2019048882A (ja) 2013-03-15 2018-11-30 舌下及び頬用フィルム組成物

Country Status (15)

Country Link
US (5) US20140271788A1 (enExample)
EP (1) EP2968121B1 (enExample)
JP (2) JP6448096B2 (enExample)
KR (1) KR20160029730A (enExample)
CN (1) CN105491997B (enExample)
AU (1) AU2014227693B2 (enExample)
BR (1) BR112015023725A2 (enExample)
CA (1) CA2906773C (enExample)
DK (1) DK2968121T3 (enExample)
IL (1) IL241441B (enExample)
MX (1) MX2015013184A (enExample)
MY (1) MY181159A (enExample)
RU (1) RU2015143647A (enExample)
WO (1) WO2014144241A1 (enExample)
ZA (1) ZA201507685B (enExample)

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US20140271788A1 (en) * 2013-03-15 2014-09-18 Monosol Rx, Llc Sublingual and buccal film compositions
AU2015341490C1 (en) 2014-11-07 2021-03-11 Indivior Uk Limited Buprenorphine dosing regimens
US20160175296A1 (en) * 2014-12-23 2016-06-23 Arx, Llc Method of producing uniform buprenorphine-containing formulations
EP3281625B1 (en) * 2015-04-07 2020-02-26 Nipro Corporation Oral film preparation
KR102851614B1 (ko) 2016-02-04 2025-08-29 신돔 파마, 인크. 장애 치료를 위한 중수소화된 돔페리돈 조성물 및 방법
US11738036B2 (en) 2016-05-28 2023-08-29 Rajiv Gandhi Centre For Biotechnology, An Autonomous Institute Under The Department Of Biotechnology, Government Of India Uttroside B and derivatives thereof as therapeutics for hepatocellular carcinoma
JP2020500220A (ja) 2016-11-15 2020-01-09 クラリア ファーマ ホールディング エービー 医薬製剤
CA3045043A1 (en) 2016-12-31 2018-07-05 Bioxcel Therapeutics, Inc. Use of sublingual dexmedetomidine for the treatment of agitation
GB201709141D0 (en) 2017-06-08 2017-07-26 Klaria Pharma Holding Ab Pharmaceutical formulation
US10646484B2 (en) 2017-06-16 2020-05-12 Indivior Uk Limited Methods to treat opioid use disorder
KR20240125702A (ko) 2017-06-30 2024-08-19 신돔 파마, 인크. 중수소화 돔페리돈 조성물, 방법, 및 제조
US12478612B2 (en) 2017-06-30 2025-11-25 Cindome Pharma, Inc. Deuterated domperidone compositions, methods, and preparation
EP3473246A1 (en) 2017-10-19 2019-04-24 Capsugel Belgium NV Immediate release abuse deterrent formulations
GB201808462D0 (en) 2018-05-23 2018-07-11 Klaria Pharma Holding Ab Pharmaceutical formulation
WO2019240212A1 (ja) * 2018-06-14 2019-12-19 株式会社カネカ 薬学的活性成分を含む製剤
CN115154440A (zh) 2018-06-27 2022-10-11 比奥克斯塞尔医疗股份有限公司 含右美托咪定的膜制剂及其制造方法
US11648197B2 (en) * 2018-06-28 2023-05-16 Arx, Llc Dispensing method for producing dissolvable unit dose film constructs
GB201819978D0 (en) * 2018-12-11 2019-01-23 Univ Strathclyde Oral thin films
JP7287032B2 (ja) 2019-03-20 2023-06-06 株式会社リコー シート、シート積層体、医薬品、シートの製造方法、及びシート積層体の製造方法
WO2021016112A2 (en) 2019-07-19 2021-01-28 Bioxcel Therapeutics, Inc. Non-sedating dexmedetomidine treatment regimens
US11806320B2 (en) * 2020-02-19 2023-11-07 Endo Ventures Limited Isoproterenol compositions and methods
US11806334B1 (en) 2023-01-12 2023-11-07 Bioxcel Therapeutics, Inc. Non-sedating dexmedetomidine treatment regimens
WO2025147530A1 (en) * 2024-01-05 2025-07-10 Taho Pharmaceuticals Ltd. Naloxone buccal film product and uses thereof

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US4457933A (en) 1980-01-24 1984-07-03 Bristol-Myers Company Prevention of analgesic abuse
US4366159A (en) 1981-09-08 1982-12-28 Michael Richard Magruder Nalbuphine-narcotic analgesic composition and method of producing analgesia
GB8332556D0 (en) 1983-12-06 1984-01-11 Reckitt & Colmann Prod Ltd Analgesic compositions
US5225417A (en) 1992-01-21 1993-07-06 G. D. Searle & Co. Opioid agonist compounds
US5223507A (en) 1992-01-21 1993-06-29 G. D. Searle & Co. Method of using opioid compounds as delta opioid selective agonist analgesics
GB9202464D0 (en) 1992-02-05 1992-03-18 Danbiosyst Uk Composition for nasal administration
ATE214276T1 (de) 1994-09-19 2002-03-15 Du Pont Pharm Co Zusammensetzungen von opioid antagonisten mit selektiven serotonin-aufnahme inhibitoren, zur behandlung von alkoholismus und alkohoabhängigkeit
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AT403162B (de) 1995-10-11 1997-11-25 Nycomed Austria Gmbh Neue kristallform von morphin-6-glucuronid
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ATE210983T1 (de) 1997-11-03 2002-01-15 Stada Arzneimittel Ag Stabilisiertes kombinationsarzneimittel enthaltend naloxone und ein opiatanalgetikum
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Also Published As

Publication number Publication date
RU2015143647A (ru) 2017-04-21
IL241441B (en) 2019-07-31
EP2968121A1 (en) 2016-01-20
US20140271788A1 (en) 2014-09-18
CN105491997A (zh) 2016-04-13
IL241441A0 (en) 2015-11-30
WO2014144241A1 (en) 2014-09-18
KR20160029730A (ko) 2016-03-15
CA2906773C (en) 2023-12-12
US20200315984A1 (en) 2020-10-08
AU2014227693A1 (en) 2015-10-29
US9511033B2 (en) 2016-12-06
CN105491997B (zh) 2019-12-17
MY181159A (en) 2020-12-19
BR112015023725A2 (pt) 2017-07-18
DK2968121T3 (en) 2019-02-04
AU2014227693B2 (en) 2018-06-21
MX2015013184A (es) 2016-04-07
ZA201507685B (en) 2017-06-28
EP2968121B1 (en) 2018-12-19
US20170296482A1 (en) 2017-10-19
US20140271789A1 (en) 2014-09-18
JP2019048882A (ja) 2019-03-28
CA2906773A1 (en) 2014-09-18
US20190038570A1 (en) 2019-02-07
JP2016513736A (ja) 2016-05-16

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