CA3089114A1 - Pharmaceutical composition for sustained release delivery of buprenorphine - Google Patents

Pharmaceutical composition for sustained release delivery of buprenorphine Download PDF

Info

Publication number
CA3089114A1
CA3089114A1 CA3089114A CA3089114A CA3089114A1 CA 3089114 A1 CA3089114 A1 CA 3089114A1 CA 3089114 A CA3089114 A CA 3089114A CA 3089114 A CA3089114 A CA 3089114A CA 3089114 A1 CA3089114 A1 CA 3089114A1
Authority
CA
Canada
Prior art keywords
buprenorphine
acid
pharmaceutical composition
amount
composition
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.)
Pending
Application number
CA3089114A
Other languages
English (en)
French (fr)
Inventor
Yuhua Li
MingHsin LI
Chen-Chang Lee
Chia-Ying Yang
Chih-Ying Lin
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.)
Foresee Pharmaceuticals Co Ltd
Original Assignee
Foresee Pharmaceuticals Co Ltd
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 Foresee Pharmaceuticals Co Ltd filed Critical Foresee Pharmaceuticals Co Ltd
Publication of CA3089114A1 publication Critical patent/CA3089114A1/en
Pending legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic 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
    • A61K31/47Quinolines; Isoquinolines
    • A61K31/485Morphinan derivatives, e.g. morphine, codeine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/44Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/06Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/04Centrally acting analgesics, e.g. opioids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/30Drugs for disorders of the nervous system for treating abuse or dependence
    • A61P25/36Opioid-abuse

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Emergency Medicine (AREA)
  • Biomedical Technology (AREA)
  • Addiction (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Psychiatry (AREA)
  • Dermatology (AREA)
  • Pain & Pain Management (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
CA3089114A 2018-01-22 2019-01-21 Pharmaceutical composition for sustained release delivery of buprenorphine Pending CA3089114A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201862620317P 2018-01-22 2018-01-22
US62/620,317 2018-01-22
PCT/US2019/014422 WO2019144079A1 (en) 2018-01-22 2019-01-21 Pharmaceutical composition for sustained release delivery of buprenorphine

Publications (1)

Publication Number Publication Date
CA3089114A1 true CA3089114A1 (en) 2019-07-25

Family

ID=67301573

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3089114A Pending CA3089114A1 (en) 2018-01-22 2019-01-21 Pharmaceutical composition for sustained release delivery of buprenorphine

Country Status (9)

Country Link
US (1) US11419866B2 (https=)
EP (1) EP3743072B1 (https=)
JP (1) JP2021511326A (https=)
CN (1) CN112236142A (https=)
AU (1) AU2019209416A1 (https=)
CA (1) CA3089114A1 (https=)
ES (1) ES2965836T3 (https=)
TW (1) TW201936191A (https=)
WO (1) WO2019144079A1 (https=)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113117092A (zh) * 2020-01-14 2021-07-16 中国科学院上海药物研究所 一种非水缓释递药系统
WO2021143745A1 (zh) * 2020-01-14 2021-07-22 中国科学院上海药物研究所 一种长效罗哌卡因药物组合物及其制备方法和用途
CA3211413A1 (en) * 2021-02-18 2022-08-25 Navin Saxena Research And Technology Private Limited Non-aqueous injectable composition for sustained release of buprenorphine and use thereof
KR20250036827A (ko) * 2022-06-24 2025-03-14 에일러 파마슈티컬스 아이엔씨. 부프레노르핀의 안정한 약제학적 조성물 및 이의 제조 방법 및 용도

Family Cites Families (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU8533582A (en) * 1981-07-10 1984-01-12 Reckitt & Colman Products Limited Stable solutions of buprenorphine
US4626539A (en) 1984-08-10 1986-12-02 E. I. Dupont De Nemours And Company Trandermal delivery of opioids
CA2002299A1 (en) * 1988-11-10 1990-05-10 Eugene G. Drust Compositions for the transdermal delivery of buprenorphine salts
IT1302682B1 (it) 1998-10-16 2000-09-29 Formenti Farmaceutici Spa Composizioni farmaceutiche orali contenenti buprenorfina
EP1554290B1 (en) 2002-10-25 2009-09-30 Euro-Celtique S.A. Analogs and prodrugs of buprenorphine
CN1263760C (zh) 2002-11-12 2006-07-12 财团法人奇美医院 新颖的丁丙诺啡酯衍生物及其制备方法,以及长效作用镇痛药学组合物
US8236292B2 (en) 2004-06-04 2012-08-07 Camurus Ab Liquid depot formulations
AU2006316607A1 (en) * 2005-11-21 2007-05-31 Schering-Plough Pty. Limited Pharmaceutical compositions comprising buprenorphine
US20090270438A1 (en) * 2006-10-18 2009-10-29 Clive Booles Novel compositions and formulations
EP2262367A4 (en) * 2008-03-08 2011-04-20 Theraquest Biosciences Inc PHARMACEUTICAL ORAL COMPOSITIONS OF BUPRENORPHINE AND METHOD FOR THEIR USE
CN102113008A (zh) 2008-05-30 2011-06-29 兰迪帕特网络公司 用于提供在线服务和软件的方法和系统
GB0815435D0 (en) * 2008-08-22 2008-10-01 Camurus Ab Formulations
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
AU2011295694B2 (en) * 2010-09-03 2015-02-05 Zoetis Belgium S.A. High dose buprenorphine compositions and use as analgesic
WO2014016428A1 (en) 2012-07-26 2014-01-30 Camurus Ab Opioid formulations
US9918981B2 (en) * 2013-09-10 2018-03-20 Insys Development Company, Inc. Liquid buprenorphine formulations
GB201404139D0 (en) 2014-03-10 2014-04-23 Rb Pharmaceuticals Ltd Sustained release buprenorphine solution formulations
CA3015557C (en) 2014-11-07 2019-07-16 Indivior Uk Limited The use of sustained-release buprenorphine formulations for the treatment of pain or opioid use disorders

Also Published As

Publication number Publication date
EP3743072A1 (en) 2020-12-02
CN112236142A (zh) 2021-01-15
WO2019144079A1 (en) 2019-07-25
ES2965836T3 (es) 2024-04-17
EP3743072B1 (en) 2023-10-25
US11419866B2 (en) 2022-08-23
JP2021511326A (ja) 2021-05-06
EP3743072C0 (en) 2023-10-25
US20200345724A1 (en) 2020-11-05
EP3743072A4 (en) 2021-09-22
TW201936191A (zh) 2019-09-16
AU2019209416A1 (en) 2020-07-30

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