AU2011263478B2 - Injectable flowable composition comprising buprenorphine - Google Patents

Injectable flowable composition comprising buprenorphine Download PDF

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Publication number
AU2011263478B2
AU2011263478B2 AU2011263478A AU2011263478A AU2011263478B2 AU 2011263478 B2 AU2011263478 B2 AU 2011263478B2 AU 2011263478 A AU2011263478 A AU 2011263478A AU 2011263478 A AU2011263478 A AU 2011263478A AU 2011263478 B2 AU2011263478 B2 AU 2011263478B2
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AU
Australia
Prior art keywords
buprenorphine
flowable composition
implant
metabolite
prodrug
Prior art date
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Active
Application number
AU2011263478A
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English (en)
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AU2011263478A1 (en
Inventor
Richard L. Norton
Andrew Watkins
Mingxing Zhou
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Indivior UK Ltd
Original Assignee
Indivior UK Ltd
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Application filed by Indivior UK Ltd filed Critical Indivior UK Ltd
Publication of AU2011263478A1 publication Critical patent/AU2011263478A1/en
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Publication of AU2011263478B2 publication Critical patent/AU2011263478B2/en
Assigned to INDIVIOR UK LIMITED reassignment INDIVIOR UK LIMITED Request to Amend Deed and Register Assignors: RB PHARMACEUTICALS LIMITED
Active legal-status Critical Current
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Classifications

    • 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
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0024—Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
    • 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
    • A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • 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
    • A61K9/08—Solutions
    • 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
    • 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
    • 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
    • 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
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • 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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • 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
    • 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
    • A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Inorganic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Emergency Medicine (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Neurology (AREA)
  • Addiction (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Psychiatry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Materials For Medical Uses (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
AU2011263478A 2010-06-08 2011-06-06 Injectable flowable composition comprising buprenorphine Active AU2011263478B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GB1009549.5 2010-06-08
GB1009549.5A GB2481018B (en) 2010-06-08 2010-06-08 Injectable flowable composition comprising buprenorphine
PCT/GB2011/051057 WO2011154724A2 (en) 2010-06-08 2011-06-06 Compositions

Publications (2)

Publication Number Publication Date
AU2011263478A1 AU2011263478A1 (en) 2013-01-10
AU2011263478B2 true AU2011263478B2 (en) 2015-01-22

Family

ID=42471306

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2011263478A Active AU2011263478B2 (en) 2010-06-08 2011-06-06 Injectable flowable composition comprising buprenorphine

Country Status (32)

Country Link
US (1) US8921387B2 (OSRAM)
EP (3) EP3360538B1 (OSRAM)
JP (2) JP5986072B2 (OSRAM)
KR (1) KR101865689B1 (OSRAM)
CN (1) CN103079544B (OSRAM)
AU (1) AU2011263478B2 (OSRAM)
BR (1) BR112012031290A2 (OSRAM)
CA (1) CA2801676C (OSRAM)
CL (1) CL2012003462A1 (OSRAM)
CO (1) CO6670529A2 (OSRAM)
CY (1) CY1120761T1 (OSRAM)
DK (2) DK3360538T3 (OSRAM)
ES (2) ES2939612T3 (OSRAM)
FI (1) FI3360538T3 (OSRAM)
GB (2) GB2513267B (OSRAM)
HR (1) HRP20180118T1 (OSRAM)
HU (1) HUE038275T2 (OSRAM)
IL (2) IL223488A (OSRAM)
LT (1) LT2579874T (OSRAM)
MX (1) MX339209B (OSRAM)
MY (1) MY171625A (OSRAM)
NO (1) NO2579874T3 (OSRAM)
NZ (1) NZ604026A (OSRAM)
PL (1) PL2579874T3 (OSRAM)
PT (1) PT2579874T (OSRAM)
RS (1) RS56820B1 (OSRAM)
RU (1) RU2607498C2 (OSRAM)
SG (1) SG186200A1 (OSRAM)
SI (1) SI2579874T1 (OSRAM)
SM (1) SMT201800038T1 (OSRAM)
WO (1) WO2011154724A2 (OSRAM)
ZA (1) ZA201209233B (OSRAM)

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US8470359B2 (en) * 2000-11-13 2013-06-25 Qlt Usa, Inc. Sustained release polymer
GB2513267B (en) 2010-06-08 2015-03-18 Rb Pharmaceuticals Ltd Injectable flowable composition comprising buprenorphine
GB2513060B (en) 2010-06-08 2015-01-07 Rb Pharmaceuticals Ltd Microparticle buprenorphine suspension
US9272044B2 (en) 2010-06-08 2016-03-01 Indivior Uk Limited Injectable flowable composition buprenorphine
WO2013126552A1 (en) * 2012-02-21 2013-08-29 Auburn University Buprenorphine nanoparticle composition and methods thereof
IN2014DN09238A (OSRAM) 2012-04-17 2015-07-10 Purdue Pharma Lp
MX387722B (es) * 2012-07-26 2025-03-18 Camurus Ab Formulaciones de opioides.
AU2013294915C1 (en) * 2012-07-26 2019-11-21 Camurus Ab Opioid formulations
EP2931253A1 (en) * 2012-12-13 2015-10-21 Heron Therapeutics, Inc. Pharmaceutical composition comprising antiemetic compounds and polyorthoester
MX352907B (es) * 2013-03-15 2017-12-13 Heron Therapeutics Inc Composiciones de un poliortoéster y un solvente aprótico.
US9636308B2 (en) 2013-03-15 2017-05-02 Oakwood Laboratories LLC High drug load buprenorphine microspheres and method of producing same
US9393211B2 (en) * 2013-03-15 2016-07-19 Oakwood Laboratories LLC High drug load buprenorphine microspheres and method of producing same
GB201404139D0 (en) * 2014-03-10 2014-04-23 Rb Pharmaceuticals Ltd Sustained release buprenorphine solution formulations
US11083730B2 (en) 2014-04-21 2021-08-10 Heron Therapeutics, Inc. Long-acting polymeric delivery systems
US9801945B2 (en) 2014-04-21 2017-10-31 Heron Therapeutics, Inc. Long-acting polymeric delivery systems
BR112016024665B1 (pt) 2014-04-21 2023-04-11 Heron Therapeutics, Inc Composição, composição semissólida e seu uso
EP3134070B1 (en) * 2014-04-21 2020-09-23 Heron Therapeutics, Inc. Compositions of a polyorthoester and an organic acid excipient
PT3137081T (pt) 2014-04-28 2018-02-08 Orphomed Inc Dímero de buprenorfina e o seu uso no tratamento de transtornos gastrointestinais
GB201419091D0 (en) 2014-10-27 2014-12-10 Camurus Ab Formulations
CA2965895C (en) * 2014-11-07 2019-08-06 Indivior Uk Limited The use of sustained-release buprenorphine formulations for the treatment of pain or opioid use disorders
ES2836805T3 (es) * 2015-08-03 2021-06-28 Tolmar International Ltd Sistema de administración de polímeros líquidos para la administración extendida de fármacos
FI3377041T3 (fi) 2015-11-16 2023-11-30 Medincell S A Menetelmä farmaseuttisesti aktiivisten pääainesosien morselloimiseksi ja/tai kohdentamiseksi synoviaalikudokseen
LT3512518T (lt) 2016-09-13 2023-02-10 Alar Pharmaceuticals Inc. Sulėtinto atpalaidavimo buprenorfino vaisto formos
AU2018283724B2 (en) 2017-06-16 2021-08-19 Indivior Uk Limited Methods to treat opioid use disorder
US10646484B2 (en) 2017-06-16 2020-05-12 Indivior Uk Limited Methods to treat opioid use disorder
CA3089114A1 (en) 2018-01-22 2019-07-25 Foresee Pharmaceuticals Co., Ltd. Pharmaceutical composition for sustained release delivery of buprenorphine
AU2019266795B2 (en) 2018-05-11 2023-02-09 Alar Pharmaceuticals Inc. Long-acting injectable formulations and crystalline forms of buprenorphine derivatives
US20210393618A1 (en) 2018-10-11 2021-12-23 Indivior Uk Limited Buprenorphine to treat respiratory depression
US12403291B2 (en) * 2019-08-30 2025-09-02 Intersect Ent, Inc. Submucosal bioresorbable drug eluting platform
CN118831057A (zh) * 2023-04-25 2024-10-25 深圳善康医药科技股份有限公司 丁丙诺啡植入剂及其制备方法

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Also Published As

Publication number Publication date
JP5986072B2 (ja) 2016-09-06
SG186200A1 (en) 2013-01-30
MY171625A (en) 2019-10-21
GB2481018B (en) 2015-03-18
CA2801676A1 (en) 2011-12-15
RU2607498C2 (ru) 2017-01-10
MX2012014335A (es) 2013-03-05
GB201009549D0 (en) 2010-07-21
HRP20180118T1 (hr) 2018-03-09
PT2579874T (pt) 2018-01-29
DK3360538T3 (da) 2023-03-06
EP3360538B1 (en) 2023-02-15
GB201413064D0 (en) 2014-09-03
IL254417A0 (en) 2017-11-30
ES2939612T3 (es) 2023-04-25
CN103079544B (zh) 2017-06-09
AU2011263478A1 (en) 2013-01-10
CL2012003462A1 (es) 2013-04-01
CN103079544A (zh) 2013-05-01
NO2579874T3 (OSRAM) 2018-06-09
EP4218720A1 (en) 2023-08-02
SI2579874T1 (en) 2018-03-30
RS56820B1 (sr) 2018-04-30
US20130210853A1 (en) 2013-08-15
CO6670529A2 (es) 2013-05-15
ZA201209233B (en) 2014-04-30
MX339209B (es) 2016-04-15
FI3360538T3 (fi) 2023-03-22
ES2656938T3 (es) 2018-03-01
GB2513267B (en) 2015-03-18
PL2579874T3 (pl) 2018-05-30
CA2801676C (en) 2018-08-07
WO2011154724A2 (en) 2011-12-15
JP2016155865A (ja) 2016-09-01
HUE038275T2 (hu) 2018-10-29
SMT201800038T1 (it) 2018-03-08
JP6251774B2 (ja) 2017-12-20
EP3360538A1 (en) 2018-08-15
WO2011154724A9 (en) 2012-08-16
DK2579874T3 (da) 2018-01-29
IL223488A (en) 2017-10-31
KR101865689B1 (ko) 2018-06-08
WO2011154724A3 (en) 2012-07-12
EP2579874A2 (en) 2013-04-17
GB2513267A (en) 2014-10-22
RU2012157244A (ru) 2014-07-20
GB2481018A (en) 2011-12-14
JP2013533230A (ja) 2013-08-22
LT2579874T (lt) 2018-02-12
BR112012031290A2 (pt) 2016-11-01
EP2579874B1 (en) 2018-01-10
CY1120761T1 (el) 2019-12-11
US8921387B2 (en) 2014-12-30
KR20130135026A (ko) 2013-12-10
NZ604026A (en) 2015-01-30

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