CA2923811C - Sublingual buprenorphine spray - Google Patents

Sublingual buprenorphine spray Download PDF

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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)
  • 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)
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)

Families Citing this family (25)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
WO2016007245A1 (en) * 2014-07-08 2016-01-14 Insys Pharma, Inc. Sublingual 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

Family Cites Families (27)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
WO2001097780A2 (en) 2000-06-22 2001-12-27 Pharmasol Ltd 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
WO2004018312A1 (en) * 2002-08-21 2004-03-04 Pharmacia Corporation Injectable pharmaceutical suspension in a two-chamber vial
AU2003285934A1 (en) * 2002-10-25 2004-05-25 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
WO2007070632A2 (en) 2005-12-13 2007-06-21 Biodelivery Sciences International, Inc. Abuse resistant transmucosal drug delivery device
AU2007208229B2 (en) * 2006-01-25 2009-11-05 Insys Therapeutics Inc. Sublingual fentanyl spray
WO2007123955A2 (en) * 2006-04-19 2007-11-01 Novadel Pharma Inc. 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
AU2007275581B2 (en) 2006-07-21 2011-09-08 Biodelivery Sciences International, Inc. Transmucosal delivery devices with enhanced uptake
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
AU2008282743B2 (en) * 2007-08-02 2012-11-29 Insys Therapeutics Inc. Sublingual fentanyl spray
EP2254561A2 (en) 2008-03-26 2010-12-01 AllTranz Inc. Abuse deterrent transdermal formulations of opiate agonists and agonist-antagonists
AU2009271271A1 (en) 2008-06-23 2010-01-21 Biodelivery Sciences International, Inc. Multidirectional mucosal delivery devices and methods of use
US8475832B2 (en) * 2009-08-07 2013-07-02 Rb Pharmaceuticals Limited Sublingual and buccal film compositions
JP5941038B2 (ja) * 2010-04-02 2016-06-29 ジネルバ ファーマシューティカルズ， 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

Also Published As

Publication number Publication date
WO2015038327A1 (en) 2015-03-19
JP2016529328A (ja) 2016-09-23
EP3043777B1 (en) 2020-04-22
DK3043777T3 (da) 2020-07-20
EP3043777A1 (en) 2016-07-20
ES2802976T3 (es) 2021-01-22
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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