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)
  • Emergency Medicine (AREA)
  • Nutrition Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Physiology (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 (https=)
EP (1) EP3043777B1 (https=)
JP (1) JP2016529328A (https=)
CA (1) CA2923811C (https=)
DK (1) DK3043777T3 (https=)
ES (1) ES2802976T3 (https=)
WO (1) WO2015038327A1 (https=)

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MX365969B (es) 2014-04-04 2019-06-21 Intra Cellular Therapies Inc Gamma-carbolinas fusionadas con heterociclos sustituidas con deuterio.
US10617686B2 (en) * 2014-07-08 2020-04-14 Hikma Pharmaceuticals Usa Inc. Liquid naloxone spray
US10722510B2 (en) * 2014-07-08 2020-07-28 Hikma Pharmaceuticals Usa Inc. Liquid naloxone spray
CA2954370A1 (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
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
CN108463214A (zh) * 2015-10-27 2018-08-28 因塞斯发展股份有限公司 液体丁丙诺啡制剂
CN108883111B (zh) 2016-01-26 2021-10-08 细胞内治疗公司 有机化合物
PL3407889T3 (pl) 2016-03-25 2021-11-22 Intra-Cellular Therapies, Inc. Związki organiczne i ich zastosowanie w leczeniu lub zapobieganiu zaburzeniom ośrodkowego układu nerwowego
JP7114570B2 (ja) * 2016-08-17 2022-08-08 ヒクマ・ファーマシューティカルズ・ユー・エス・エイ・インコーポレイテッド 液体ナロキソンスプレー
JP7138103B2 (ja) 2016-11-29 2022-09-15 オキュリス エスエー 眼科用活性医薬成分送達のためのシクロデキストリン固体複合体の製造
US10906906B2 (en) 2016-12-29 2021-02-02 Intra-Cellular Therapies, Inc. Organic compounds
US10961245B2 (en) 2016-12-29 2021-03-30 Intra-Cellular Therapies, Inc. Substituted heterocycle fused gamma-carbolines for treatment of central nervous system disorders
IL268970B2 (en) 2017-03-24 2023-12-01 Intra Cellular Therapies Inc Oral transmucosal formulations of substituted heterocycle fused gamma carbolines
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
AU2019240226B2 (en) 2018-03-23 2024-11-28 Intra-Cellular Therapies, Inc. Organic compounds
EP3843729A4 (en) 2018-08-29 2022-06-01 Intra-Cellular Therapies, Inc. NOVEL COMPOSITIONS AND PROCESSES
CA3108558A1 (en) 2018-08-31 2020-03-05 Intra-Cellular Therapies, Inc. Novel methods
CN112584837A (zh) 2018-08-31 2021-03-30 细胞内治疗公司 新方法
EP4670738A3 (en) 2019-07-01 2026-03-04 Oculis Operations Sàrl Method for stabilizing the ph of an aqueous composition comprising a drug
EP4034119A4 (en) 2019-09-25 2023-10-18 Intra-Cellular Therapies, Inc. NOVEL METHODS
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
US20030190290A1 (en) 2000-06-22 2003-10-09 Calvin Ross Pharmaceutical compositions
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
DE60329515D1 (de) 2002-10-25 2009-11-12 Euro Celtique Sa Analoga und prodrugs von buprenorphin
US7501113B2 (en) 2003-02-04 2009-03-10 Philip Morris Usa Inc. Aerosol formulations and aerosol delivery of buprenorphine
WO2006105205A1 (en) 2005-03-29 2006-10-05 University Of Kentucky Research Foundation Sublingual spray for the treatment of pain
BRPI0619806A2 (pt) 2005-12-13 2011-10-18 Biodelivery Sciences Int Inc dispositivo para fornecimento de fármacos transmucosal resistente ao abuso
RU2432950C2 (ru) * 2006-01-25 2011-11-10 Инсис Терапьютикс Инк. Подъязычный спрей на основе фентанила
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
RU2504377C2 (ru) 2006-07-21 2014-01-20 БайоДеливери Сайенсиз Интэнэшнл, Инк. Способ трансмукозальной доставки лекарства, средство трансмукозальной доставки лекарства (варианты) и способ лечения боли
EP1897543A1 (en) 2006-08-30 2008-03-12 Euro-Celtique S.A. Buprenorphine- wafer for drug substitution therapy
US20090270438A1 (en) 2006-10-18 2009-10-29 Clive Booles Novel compositions and formulations
GB2461681A (en) 2008-04-17 2010-01-13 Pharmasol Ltd Buprenorphine liquid spray formulation with solvent and antioxidant
GB2447014A (en) 2007-03-01 2008-09-03 Reckitt Benckiser Healthcare Analgesic composition comprising a specific ratio of buprenorphine and naltrexone
ES2668366T3 (es) 2007-08-02 2018-05-17 Insys Development Company, Inc. Pulverización sublingual de fentanilo
EP2254561A2 (en) 2008-03-26 2010-12-01 AllTranz Inc. Abuse deterrent transdermal formulations of opiate agonists and agonist-antagonists
EP2293751B1 (en) 2008-06-23 2018-01-10 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
EP2552924B1 (en) 2010-04-02 2015-09-16 Zynerba Pharmaceuticals, Inc. Transdermally deliverable opioid prodrugs, abuse-resistant compositions and methods of using opioid prodrugs

Also Published As

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

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