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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US10077267B2 (en) 2014-04-04 2018-09-18 Intra-Cellular Therapies, Inc. Organic compounds
WO2016007245A1 (en) * 2014-07-08 2016-01-14 Insys Pharma, Inc. Sublingual naloxone spray
US10722510B2 (en) * 2014-07-08 2020-07-28 Hikma Pharmaceuticals Usa Inc. Liquid 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
CN108367010A (zh) * 2015-04-03 2018-08-03 因塞斯发展股份有限公司 西地那非舌下喷雾制剂
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
PL3838274T3 (pl) 2016-01-26 2024-04-02 Intra-Cellular Therapies, Inc. Pochodna pirydo[3',4':4,5]pirolo[1,2,3-DE]chinoksaliny do zastosowania w leczeniu zaburzeń OUN
DK3407889T3 (da) 2016-03-25 2021-08-09 Intra Cellular Therapies Inc Organiske forbindelser og deres anvendelse til behandling og forebyggelse af lidelser i centralnervesystemet
WO2018034920A1 (en) * 2016-08-17 2018-02-22 Insys Development Company, Inc. Liquid naloxone spray
PL3548091T3 (pl) 2016-11-29 2022-03-28 Oculis SA Otrzymywanie stałych kompleksów cyklodekstryny do dostarczenia czynnego składnika farmaceutycznego do oczu
WO2018126140A1 (en) 2016-12-29 2018-07-05 Intra-Cellular Therapies, Inc. Organic compounds
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
RU2767410C2 (ru) 2017-03-24 2022-03-17 Интра-Селлулар Терапиз, Инк. Новые композиции и способы
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
CN112040940A (zh) 2018-03-23 2020-12-04 细胞内治疗公司 有机化合物
US12144808B2 (en) 2018-08-29 2024-11-19 Intra-Cellular Therapies, Inc. Compositions and methods
WO2020047408A1 (en) 2018-08-31 2020-03-05 Intra-Cellular Therapies, Inc. Novel methods
BR112021003655A2 (pt) 2018-08-31 2021-05-18 Intra-Cellular Therapies, Inc. métodos novos
DK3993807T3 (da) 2019-07-01 2026-01-19 Oculis Operations Sarl Fremgangsmåde til stabilisering af ph-værden i en vandig sammensætning, der indeholder et lægemiddel
US12478623B2 (en) 2019-09-25 2025-11-25 Intra-Cellular Therapies, Inc. Methods of treating central nervous system disorders comprising administering lumateperone and a nitric oxide donor
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
WO2001097780A2 (en) 2000-06-22 2001-12-27 Pharmasol Ltd Pharmaceutical compositions comprising an opioid analgesic
WO2003002071A2 (en) * 2001-06-29 2003-01-09 Lewandowski Leon J Individualized addiction cessation 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
US7387623B2 (en) * 2002-08-21 2008-06-17 Pfizer Inc. Injectable pharmaceutical suspension in a two-chamber vial
EP1554290B1 (en) 2002-10-25 2009-09-30 Euro-Celtique S.A. Analogs and prodrugs of buprenorphine
AU2003297087B2 (en) 2003-02-04 2009-06-11 Philip Morris Products S.A. Aerosol formulations and aerosol delivery of buspirone, buprenorphine, triazolam, cyclobenzaprine and zolpidem
WO2006105205A1 (en) 2005-03-29 2006-10-05 University Of Kentucky Research Foundation Sublingual spray for the treatment of pain
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EP2015632B1 (en) 2006-04-19 2015-12-02 Mist Pharmaceuticals, LLC Stable hydroalcoholic oral spray formulations and methods
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PT2180844T (pt) * 2007-08-02 2018-04-06 Insys Dev Co Inc Nebulizador sub-lingual de fentanilo
JP2011515495A (ja) 2008-03-26 2011-05-19 オールトランツ インコーポレイティド オピエートアゴニスト及びアゴニスト−アンタゴニストの乱用抑制経皮製剤
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CA2795156C (en) * 2010-04-02 2019-05-14 Alltranz Inc. Transdermally deliverable opioid prodrugs, abuse-resistant compositions and methods of using opioid prodrugs

Also Published As

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

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