CA2923811C - Sublingual buprenorphine spray - Google Patents

Sublingual buprenorphine spray Download PDF

Info

Publication number
CA2923811C
CA2923811C CA2923811A CA2923811A CA2923811C CA 2923811 C CA2923811 C CA 2923811C CA 2923811 A CA2923811 A CA 2923811A CA 2923811 A CA2923811 A CA 2923811A CA 2923811 C CA2923811 C CA 2923811C
Authority
CA
Canada
Prior art keywords
amount
buprenorphine
sublingual spray
sublingual
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
CA2923811A
Other languages
English (en)
French (fr)
Other versions
CA2923811A1 (en
Inventor
Kiran P. Amancha
Chandeshwari S. Chilampalli
Venkat R. Goskonda
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.)
Benuvia Operations Inc
Original Assignee
Benuvia Therapeutics Inc
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 Benuvia Therapeutics Inc filed Critical Benuvia Therapeutics Inc
Publication of CA2923811A1 publication Critical patent/CA2923811A1/en
Application granted granted Critical
Publication of CA2923811C publication Critical patent/CA2923811C/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
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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

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)
  • Emergency Medicine (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Addiction (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)
CA2923811A 2013-09-10 2014-08-26 Sublingual buprenorphine spray Active CA2923811C (en)

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
CA2923811A1 CA2923811A1 (en) 2015-03-19
CA2923811C true CA2923811C (en) 2021-07-27

Family

ID=52625856

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2923811A Active CA2923811C (en) 2013-09-10 2014-08-26 Sublingual buprenorphine spray

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)

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KR20220054908A (ko) 2014-04-04 2022-05-03 인트라-셀룰라 써래피스, 인코퍼레이티드. 유기 화합물
US10722510B2 (en) * 2014-07-08 2020-07-28 Hikma Pharmaceuticals Usa Inc. Liquid naloxone spray
EP3177146A4 (en) * 2014-07-08 2018-01-03 Insys Pharma, Inc. Sublingual naloxone spray
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
DK3277283T3 (da) * 2015-04-03 2021-04-12 Benuvia Therapeutics Llc Sublinguale sildenafilsprayformuerlinger
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
RU2743513C2 (ru) 2016-01-26 2021-02-19 Интра-Селлулар Терапиз, Инк. Органические соединения
IL281050B2 (en) 2016-03-25 2023-04-01 Intra Cellular Therapies Inc A controlled or delayed release pharmaceutical preparation containing a deuterated compound
WO2018034920A1 (en) * 2016-08-17 2018-02-22 Insys Development Company, Inc. Liquid naloxone spray
PT3548091T (pt) 2016-11-29 2022-01-21 Oculis SA Preparação de complexos sólidos de ciclodextrina para administração oftálmica de ingrediente farmacêutico ativo
EP3562484B1 (en) 2016-12-29 2021-08-25 Intra-Cellular Therapies, Inc. Pyrido[3',4':4,5]pyrrolo[1,2,3-de]quinoxaline derivatives useful in the treatment of cns disorders
WO2018126140A1 (en) 2016-12-29 2018-07-05 Intra-Cellular Therapies, Inc. Organic compounds
EP3600325A4 (en) 2017-03-24 2021-01-06 Intra-Cellular Therapies, Inc. UNIQUE COMPOSITIONS AND PROCESSES
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
WO2019178484A1 (en) 2018-03-16 2019-09-19 Intra-Cellular Therapies, Inc. Novel methods
SMT202600133T1 (it) 2018-03-23 2026-05-12 Intra Cellular Therapies Inc Composti organici
AU2019240226B2 (en) 2018-03-23 2024-11-28 Intra-Cellular Therapies, Inc. Organic compounds
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
WO2020047408A1 (en) 2018-08-31 2020-03-05 Intra-Cellular Therapies, Inc. Novel methods
WO2021001366A1 (en) * 2019-07-01 2021-01-07 Oculis SA Method for stabilizing the ph of an aqueous composition comprising a drug
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
JP2024536239A (ja) * 2021-09-30 2024-10-04 エランコ・ユーエス・インコーポレイテッド ブプレノルフィンの安定な製剤
US12414948B2 (en) 2022-05-18 2025-09-16 Intra-Cellular Therapies, Inc. Methods

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US6512010B1 (en) * 1996-07-15 2003-01-28 Alza Corporation Formulations for the administration of fluoxetine
US6413496B1 (en) 1996-12-04 2002-07-02 Biogland Ireland (R&D) Limited Pharmaceutical compositions and devices for their administration
IT1302682B1 (it) 1998-10-16 2000-09-29 Formenti Farmaceutici Spa Composizioni farmaceutiche orali contenenti buprenorfina
KR100383252B1 (ko) * 1998-12-17 2003-07-16 주식회사 삼양사 부프레놀핀을함유하는경피투여조성물및이를포함하는패취
AR031682A1 (es) 1999-11-19 2003-10-01 Reckitt Benckiser Helthcare Uk Composiciones farmaceuticas
EP1296649A2 (en) 2000-06-22 2003-04-02 Pharmasol Limited Pharmaceutical compositions comprising an opioid analgesic
EP1418862A4 (en) * 2001-06-29 2010-06-09 Leon J Lewandowski INDIVIDUALIZED SEARCH THERAPY
US7666876B2 (en) 2002-03-19 2010-02-23 Vernalis (R&D) Limited Buprenorphine formulations for intranasal delivery
US6946150B2 (en) 2002-08-14 2005-09-20 Gw Pharma Limited Pharmaceutical formulation
JP4416653B2 (ja) * 2002-08-21 2010-02-17 ファルマシア コーポレーション ２つのチャンバーを有するバイアルに収容された注射用医薬懸濁液
EP1554290B1 (en) * 2002-10-25 2009-09-30 Euro-Celtique S.A. Analogs and prodrugs of buprenorphine
WO2004071491A1 (en) 2003-02-04 2004-08-26 Chrysalis Technologies Incorporated Aerosol formulations and aerosol delivery of buspirone, buprenorphine, triazolam, cyclobenzaprine and zolpidem
US20090117054A1 (en) * 2005-03-29 2009-05-07 University Of Kentucky Research Foundation Sublingual spray for the treatment of pain
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SI1976521T1 (sl) * 2006-01-25 2015-06-30 Insys Therapeutics, Inc. Podjezično fentanilno pršilo
EP2015632B1 (en) 2006-04-19 2015-12-02 Mist Pharmaceuticals, LLC Stable hydroalcoholic oral spray formulations and methods
US20100233257A1 (en) * 2006-06-09 2010-09-16 Ethypharm Low dose sublingual tablets of opioid analgesics and preparation process
ES2577390T3 (es) 2006-07-21 2016-07-14 Biodelivery Sciences International, Inc. Dispositivos de administración transmucosa con mayor captación
EP1897543A1 (en) 2006-08-30 2008-03-12 Euro-Celtique S.A. Buprenorphine- wafer for drug substitution therapy
GB2461681A (en) 2008-04-17 2010-01-13 Pharmasol Ltd Buprenorphine liquid spray formulation with solvent and antioxidant
US20090270438A1 (en) 2006-10-18 2009-10-29 Clive Booles Novel compositions and formulations
GB2447014A (en) 2007-03-01 2008-09-03 Reckitt Benckiser Healthcare Analgesic composition comprising a specific ratio of buprenorphine and naltrexone
WO2009017837A2 (en) 2007-08-02 2009-02-05 Insys Therapeutics Inc. Sublingual fentanyl spray
CA2718943A1 (en) 2008-03-26 2009-10-01 Alltranz Inc. Abuse deterrent transdermal formulations of opiate agonists and agonist-antagonists
CN105833420A (zh) 2008-06-23 2016-08-10 生物递送科学国际公司 多向粘膜给药装置及使用方法
US8475832B2 (en) * 2009-08-07 2013-07-02 Rb Pharmaceuticals Limited Sublingual and buccal film compositions
ES2555258T3 (es) * 2010-04-02 2015-12-30 Zynerba Pharmaceuticals, Inc. Profármacos de opioides administrables por vía transdérmica, composiciones que no inducen al abuso y procedimientos de uso de los profármacos opioides

Also Published As

Publication number Publication date
WO2015038327A1 (en) 2015-03-19
HK1225653A1 (en) 2017-09-15
JP2016529328A (ja) 2016-09-23
EP3043777A1 (en) 2016-07-20
ES2802976T3 (es) 2021-01-22
EP3043777B1 (en) 2020-04-22
CA2923811A1 (en) 2015-03-19
US20150071971A1 (en) 2015-03-12
DK3043777T3 (da) 2020-07-20
EP3043777A4 (en) 2017-08-02
US9216175B2 (en) 2015-12-22

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