JP2016529328A - 舌下ブプレノルフィンスプレー - Google Patents

舌下ブプレノルフィンスプレー Download PDF

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Publication number
JP2016529328A
JP2016529328A JP2016541991A JP2016541991A JP2016529328A JP 2016529328 A JP2016529328 A JP 2016529328A JP 2016541991 A JP2016541991 A JP 2016541991A JP 2016541991 A JP2016541991 A JP 2016541991A JP 2016529328 A JP2016529328 A JP 2016529328A
Authority
JP
Japan
Prior art keywords
amount
spray formulation
sublingual spray
buprenorphine
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.)
Pending
Application number
JP2016541991A
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English (en)
Japanese (ja)
Other versions
JP2016529328A5 (enExample
Inventor
アマンチャ,キラン・ピー
チラムパリ,チャンデスワリ・エス
ゴスコンダ,ベンカット・アール
Original Assignee
インシス・ファーマ・インコーポレーテッド
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 インシス・ファーマ・インコーポレーテッド filed Critical インシス・ファーマ・インコーポレーテッド
Publication of JP2016529328A publication Critical patent/JP2016529328A/ja
Publication of JP2016529328A5 publication Critical patent/JP2016529328A5/ja
Pending legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic 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
    • A61K31/47Quinolines; Isoquinolines
    • A61K31/485Morphinan derivatives, e.g. morphine, codeine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/04Centrally acting analgesics, e.g. opioids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/30Drugs for disorders of the nervous system for treating abuse or dependence
    • A61P25/36Opioid-abuse

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Emergency Medicine (AREA)
  • Addiction (AREA)
  • Biomedical Technology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Neurology (AREA)
  • Organic Chemistry (AREA)
  • Neurosurgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pain & Pain Management (AREA)
  • Psychiatry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
JP2016541991A 2013-09-10 2014-08-26 舌下ブプレノルフィンスプレー Pending JP2016529328A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201361875837P 2013-09-10 2013-09-10
US61/875,837 2013-09-10
PCT/US2014/052699 WO2015038327A1 (en) 2013-09-10 2014-08-26 Sublingual buprenorphine spray

Publications (2)

Publication Number Publication Date
JP2016529328A true JP2016529328A (ja) 2016-09-23
JP2016529328A5 JP2016529328A5 (enExample) 2017-11-16

Family

ID=52625856

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2016541991A Pending JP2016529328A (ja) 2013-09-10 2014-08-26 舌下ブプレノルフィンスプレー

Country Status (7)

Country Link
US (1) US9216175B2 (enExample)
EP (1) EP3043777B1 (enExample)
JP (1) JP2016529328A (enExample)
CA (1) CA2923811C (enExample)
DK (1) DK3043777T3 (enExample)
ES (1) ES2802976T3 (enExample)
WO (1) WO2015038327A1 (enExample)

Cited By (1)

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JP2017519803A (ja) * 2014-07-08 2017-07-20 インシス・ファーマ・インコーポレーテッド 舌下ナロキソンスプレー

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CA2944512C (en) 2014-04-04 2018-04-24 Intra-Cellular Therapies, Inc. Heterocycle fused gamma-carbolines for treatment of central nervous system disorders
US10617686B2 (en) * 2014-07-08 2020-04-14 Hikma Pharmaceuticals Usa Inc. Liquid naloxone spray
US11135155B2 (en) 2014-07-08 2021-10-05 Hikma Pharmaceuticals Usa Inc. Liquid naloxone spray
US10722510B2 (en) * 2014-07-08 2020-07-28 Hikma Pharmaceuticals Usa Inc. Liquid naloxone spray
EP3277283B8 (en) * 2015-04-03 2021-04-28 Benuvia Therapeutics, LLC Sildenafil sublingual spray formulations
WO2016164158A1 (en) * 2015-04-09 2016-10-13 Insys Development Company, Inc. Ketorolac sublingual spray formulations
JP2018531964A (ja) * 2015-10-27 2018-11-01 インシス・ディベロップメント・カンパニー・インコーポレイテッド 液体ブプレノルフィン製剤
PT3407888T (pt) 2016-01-26 2021-03-19 Intra Cellular Therapies Inc Compostos de piridopirroloquinoxalina, suas composições e utilizações
SI3407889T1 (sl) 2016-03-25 2021-09-30 Intra-Cellular Therapies, Inc. Organske spojine in njihova uporaba v zdravljenju ali preprečevanju motenj centralnega živčnega sistema
EP3500261A4 (en) * 2016-08-17 2020-05-06 Hikma Pharmaceuticals USA Inc. LIQUID NALOXONE SPRAYING
HUE057221T2 (hu) 2016-11-29 2022-04-28 Oculis SA Szilárd ciklodextrin komplexek készítményei szemészetileg aktív gyógyászati hatóanyag adagolásához
WO2018126140A1 (en) 2016-12-29 2018-07-05 Intra-Cellular Therapies, Inc. Organic compounds
WO2018126143A1 (en) 2016-12-29 2018-07-05 Intra-Cellular Therapies, Inc. Organic compounds
IL304026B2 (en) 2017-03-24 2024-11-01 Intra Cellular Therapies Inc A pharmaceutical preparation containing 1-(4-fluoro-phenyl)-4-((Sa10,Rb6)-3-D2-2,2-methyl-2, 3, a10, 10, 9, b6- hexahydro-H7, H1- Pyrido[3',4',:4,5]pyrrolo[3,2,1-de]quioxalin-8-yl)-butan-1-one and its uses
WO2019026085A1 (en) * 2017-08-04 2019-02-07 Alkem Laboratories Ltd. SUBLINGUAL FILM COMPOSITION
US20180193332A1 (en) * 2017-10-09 2018-07-12 Adapt Pharma Operations Limited Low-temperature stable opioid antagonist solutions
US11980617B2 (en) 2018-03-16 2024-05-14 Intra-Cellular Therapies, Inc. Methods of treating acute depression and/or acute anxiety
IL277504B1 (en) 2018-03-23 2026-02-01 Intra Cellular Therapies Inc Deuterium-converted ((sa10,rb6)-8-(3-(4-fluorophenoxy)propyl 6b, 7, 8, 9, 10, 10a-hexahydro-1h-pyrido[3',4':4,5]pyrrolo[1,2,3-de]quinoxalin-82(h3)-one compounds, pharmaceutical composition containing them and their uses
US12144808B2 (en) 2018-08-29 2024-11-19 Intra-Cellular Therapies, Inc. Compositions and methods
AU2019328528B2 (en) 2018-08-31 2025-01-23 Intra-Cellular Therapies, Inc. Novel methods
MX2021002321A (es) 2018-08-31 2021-04-28 Intra Cellular Therapies Inc Nuevos metodos.
SI3993807T1 (sl) 2019-07-01 2026-04-30 Oculis Operations Sarl Postopek za stabiliziranje ph vodnega sestavka, ki obsega zdravilo
JP2022549335A (ja) 2019-09-25 2022-11-24 イントラ-セルラー・セラピーズ・インコーポレイテッド 新規方法
US12414948B2 (en) 2022-05-18 2025-09-16 Intra-Cellular Therapies, Inc. Methods

Citations (3)

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JP2009528272A (ja) * 2006-01-25 2009-08-06 インシス セラピューティクス インコーポレイテッド 舌下フェンタニルスプレー
WO2009127878A1 (en) * 2008-04-17 2009-10-22 Pharmasol Limited A liquid spray solution comprising buprenorphine, ethanol and an antioxidant
JP2013523779A (ja) * 2010-04-02 2013-06-17 オールトランツ インコーポレイティド 経皮送達可能なオピオイドプロドラッグ、乱用抵抗性組成物及びオピオイドプロドラッグを使用する方法

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KR100383252B1 (ko) * 1998-12-17 2003-07-16 주식회사 삼양사 부프레놀핀을함유하는경피투여조성물및이를포함하는패취
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US20090117054A1 (en) * 2005-03-29 2009-05-07 University Of Kentucky Research Foundation Sublingual spray for the treatment of pain
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AU2008282743B2 (en) * 2007-08-02 2012-11-29 Insys Therapeutics Inc. Sublingual fentanyl spray
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Publication number Priority date Publication date Assignee Title
JP2009528272A (ja) * 2006-01-25 2009-08-06 インシス セラピューティクス インコーポレイテッド 舌下フェンタニルスプレー
WO2009127878A1 (en) * 2008-04-17 2009-10-22 Pharmasol Limited A liquid spray solution comprising buprenorphine, ethanol and an antioxidant
JP2013523779A (ja) * 2010-04-02 2013-06-17 オールトランツ インコーポレイティド 経皮送達可能なオピオイドプロドラッグ、乱用抵抗性組成物及びオピオイドプロドラッグを使用する方法

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2017519803A (ja) * 2014-07-08 2017-07-20 インシス・ファーマ・インコーポレーテッド 舌下ナロキソンスプレー

Also Published As

Publication number Publication date
WO2015038327A1 (en) 2015-03-19
EP3043777B1 (en) 2020-04-22
DK3043777T3 (da) 2020-07-20
EP3043777A1 (en) 2016-07-20
ES2802976T3 (es) 2021-01-22
CA2923811C (en) 2021-07-27
CA2923811A1 (en) 2015-03-19
EP3043777A4 (en) 2017-08-02
US20150071971A1 (en) 2015-03-12
HK1225653A1 (en) 2017-09-15
US9216175B2 (en) 2015-12-22

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