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PL2605757T3 - Preparaty oparte na nalbufinie i ich zastosowania - Google Patents

Preparaty oparte na nalbufinie i ich zastosowania

Info

Publication number
PL2605757T3
PL2605757T3 PL11758519T PL11758519T PL2605757T3 PL 2605757 T3 PL2605757 T3 PL 2605757T3 PL 11758519 T PL11758519 T PL 11758519T PL 11758519 T PL11758519 T PL 11758519T PL 2605757 T3 PL2605757 T3 PL 2605757T3
Authority
PL
Poland
Prior art keywords
nalbuphine
based formulations
formulations
Prior art date
Application number
PL11758519T
Other languages
English (en)
Inventor
Christophe Lebon
Pascal Suplie
David Olivier Paul
Original Assignee
Debregeas Et Associes Pharma
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=43426302&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=PL2605757(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Debregeas Et Associes Pharma filed Critical Debregeas Et Associes Pharma
Publication of PL2605757T3 publication Critical patent/PL2605757T3/pl

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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • 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
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2009—Inorganic compounds
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • 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
    • 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
    • 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]
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • A61K9/1676—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings with drug-free core

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Emergency Medicine (AREA)
  • Addiction (AREA)
  • Psychiatry (AREA)
  • Pain & Pain Management (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Inorganic Chemistry (AREA)
  • Rheumatology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
PL11758519T 2010-08-20 2011-08-18 Preparaty oparte na nalbufinie i ich zastosowania PL2605757T3 (pl)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
FR1056689A FR2963889B1 (fr) 2010-08-20 2010-08-20 Formulations a base de nalbuphine et leurs utilisations
PCT/FR2011/051929 WO2012022919A2 (fr) 2010-08-20 2011-08-18 Formulations à base de nalbuphine et leurs utilisations
EP11758519.0A EP2605757B1 (fr) 2010-08-20 2011-08-18 Formulations a base de nalbuphine et leurs utilisations

Publications (1)

Publication Number Publication Date
PL2605757T3 true PL2605757T3 (pl) 2015-12-31

Family

ID=43426302

Family Applications (1)

Application Number Title Priority Date Filing Date
PL11758519T PL2605757T3 (pl) 2010-08-20 2011-08-18 Preparaty oparte na nalbufinie i ich zastosowania

Country Status (31)

Country Link
US (2) US20130123294A1 (pl)
EP (1) EP2605757B1 (pl)
JP (2) JP2013534242A (pl)
KR (1) KR101801424B1 (pl)
CN (1) CN103025317B (pl)
AR (1) AR082493A1 (pl)
AU (1) AU2011290614B2 (pl)
BR (1) BR112013004016A2 (pl)
CA (1) CA2804333C (pl)
CL (1) CL2013000477A1 (pl)
CY (1) CY1116729T1 (pl)
DK (1) DK2605757T3 (pl)
EA (1) EA024945B1 (pl)
ES (1) ES2548535T3 (pl)
FR (1) FR2963889B1 (pl)
HR (1) HRP20151021T1 (pl)
HU (1) HUE027664T2 (pl)
IL (1) IL224230A (pl)
MA (1) MA34484B1 (pl)
MX (1) MX354416B (pl)
NZ (1) NZ605469A (pl)
PH (1) PH12013500289A1 (pl)
PL (1) PL2605757T3 (pl)
PT (1) PT2605757E (pl)
RS (1) RS54244B1 (pl)
SG (1) SG187566A1 (pl)
SI (1) SI2605757T1 (pl)
SM (1) SMT201500257B (pl)
TW (1) TWI522100B (pl)
UA (1) UA110945C2 (pl)
WO (1) WO2012022919A2 (pl)

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2919903B1 (en) 2012-11-14 2020-07-22 W.R. Grace & CO. - CONN. Compositions containing a biologically active material and a non-ordered inorganic oxide
EP2931279B1 (en) * 2012-12-14 2024-03-20 Trevi Therapeutics, Inc. Methods for treating pruritus
US8637538B1 (en) 2012-12-14 2014-01-28 Trevi Therapeutics, Inc. Methods for treatment of pruritis
US20140179727A1 (en) 2012-12-14 2014-06-26 Trevi Therapeutics, Inc. Methods for treating pruritus
US8987289B2 (en) 2012-12-14 2015-03-24 Trevi Therapeutics, Inc. Methods for treating pruritus
CA2919892C (en) 2013-08-12 2019-06-18 Pharmaceutical Manufacturing Research Services, Inc. Extruded immediate release abuse deterrent pill
US10172797B2 (en) 2013-12-17 2019-01-08 Pharmaceutical Manufacturing Research Services, Inc. Extruded extended release abuse deterrent pill
US9492444B2 (en) 2013-12-17 2016-11-15 Pharmaceutical Manufacturing Research Services, Inc. Extruded extended release abuse deterrent pill
DK3169315T3 (da) 2014-07-17 2020-08-10 Pharmaceutical Manufacturing Res Services In Væskefyldt doseringsform til forhindring af misbrug med øjeblikkelig frigivelse
EP3209282A4 (en) 2014-10-20 2018-05-23 Pharmaceutical Manufacturing Research Services, Inc. Extended release abuse deterrent liquid fill dosage form
CN105560202B (zh) * 2016-03-11 2019-05-24 广州玻思韬控释药业有限公司 一种盐酸纳布啡凝胶骨架缓释片的制备方法及应用
IL318587A (en) 2018-07-23 2025-03-01 Trevi Therapeutics Inc Treatment of chronic cough, shortness of breath and wheezing
MY196513A (en) 2018-09-14 2023-04-18 Cara Therapeutics Inc Oral Formulations of Kappa Opioid Receptor Agonists
IL294601A (en) 2020-01-10 2022-09-01 Trevi Therapeutics Inc Methods of administration of nalbuphine
JP2023518711A (ja) 2020-03-18 2023-05-08 カラ セラピューティクス インコーポレイテッド κオピオイド受容体作動薬のオリゴ糖製剤

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US4282215A (en) * 1980-06-17 1981-08-04 E. I. Du Pont De Nemours And Company Analgesic mixture of nalbuphine and acetylsalicylic acid, derivative or salt thereof
US4464378A (en) 1981-04-28 1984-08-07 University Of Kentucky Research Foundation Method of administering narcotic antagonists and analgesics and novel dosage forms containing same
US4366159A (en) * 1981-09-08 1982-12-28 Michael Richard Magruder Nalbuphine-narcotic analgesic composition and method of producing analgesia
US4477457A (en) * 1982-10-28 1984-10-16 E. I. Du Pont De Nemours And Company Method for inducing anorexia using nalmetrene
US6210714B1 (en) * 1993-11-23 2001-04-03 Euro-Celtique S.A. Immediate release tablet cores of acetaminophen having sustained-release coating
FI972718A0 (fi) 1996-07-02 1997-06-24 More Magic Software Mms Oy Foerfaranden och arrangemang foer distribution av ett anvaendargraenssnitt
US6372254B1 (en) * 1998-04-02 2002-04-16 Impax Pharmaceuticals Inc. Press coated, pulsatile drug delivery system suitable for oral administration
CA2343100A1 (en) 1998-09-08 2000-05-04 Srinivasan Venkateshwaran Method of making pressure sensitive adhesive matrix patches containing hydrophilic salts of drugs
JP2001089373A (ja) * 1999-09-24 2001-04-03 Tanabe Seiyaku Co Ltd 経口投与製剤
CN1679556A (zh) * 1999-12-08 2005-10-12 法马西亚公司 维得克西组合物
KR20010107754A (ko) * 2000-05-26 2001-12-07 민경윤 경구투여용 속용정의 제조 방법
US7323192B2 (en) * 2001-09-28 2008-01-29 Mcneil-Ppc, Inc. Immediate release tablet
US6680067B2 (en) 2001-11-26 2004-01-20 Oliver Yoa-Pu Hu Controlled-release pharmaceutical preparation containing nalbuphine and a process for preparing the same
RU2254852C1 (ru) 2004-01-23 2005-06-27 Ефим Давыдович Нежинский Раствор для инъекций, обладающий выраженным анальгетическим действием, и способ его получения
US8394812B2 (en) * 2005-08-24 2013-03-12 Penwest Pharmaceuticals Co. Sustained release formulations of nalbuphine
PT1931315E (pt) * 2005-08-24 2014-01-03 Endo Pharmaceuticals Inc Formulações de libertação sustentada de nalbufina
EA200802159A1 (ru) * 2006-04-25 2009-06-30 Михаил Викторович Воронков Введение агониста-антагониста пациентам с опиоидной зависимостью
US20100086586A1 (en) * 2006-12-21 2010-04-08 Brett Antony Mooney Pharmaceutical Composition
US20080207667A1 (en) * 2007-02-23 2008-08-28 Rhame Robert W Use of nalbuphine and related compounds to treat symptoms of respiratory problems
AU2010206724A1 (en) * 2009-01-22 2011-07-28 Nanotherapeutics, Inc. Process for preparing particles of opioids and compositions produced thereby
US8901113B2 (en) * 2009-09-30 2014-12-02 Acura Pharmaceuticals, Inc. Methods and compositions for deterring abuse

Also Published As

Publication number Publication date
MX2013001985A (es) 2013-05-09
AU2011290614A1 (en) 2013-01-31
TWI522100B (zh) 2016-02-21
HUE027664T2 (en) 2016-10-28
US20160271124A1 (en) 2016-09-22
FR2963889B1 (fr) 2013-04-12
KR20130099914A (ko) 2013-09-06
UA110945C2 (uk) 2016-03-10
US10441585B2 (en) 2019-10-15
EP2605757B1 (fr) 2015-07-01
CN103025317B (zh) 2016-08-17
JP2013534242A (ja) 2013-09-02
SI2605757T1 (sl) 2015-11-30
FR2963889A1 (fr) 2012-02-24
IL224230A (en) 2017-03-30
DK2605757T3 (en) 2015-10-05
KR101801424B1 (ko) 2017-11-24
SG187566A1 (en) 2013-03-28
ES2548535T3 (es) 2015-10-19
EA201300258A1 (ru) 2013-06-28
MX354416B (es) 2018-03-05
US20130123294A1 (en) 2013-05-16
RS54244B1 (sr) 2015-12-31
JP2016166230A (ja) 2016-09-15
EP2605757A2 (fr) 2013-06-26
EA024945B1 (ru) 2016-11-30
CN103025317A (zh) 2013-04-03
PH12013500289A1 (en) 2016-10-26
AU2011290614B2 (en) 2015-11-19
BR112013004016A2 (pt) 2016-06-28
WO2012022919A2 (fr) 2012-02-23
CA2804333C (fr) 2019-03-19
TW201302198A (zh) 2013-01-16
AR082493A1 (es) 2012-12-12
MA34484B1 (fr) 2013-08-01
WO2012022919A3 (fr) 2012-05-10
JP6173521B2 (ja) 2017-08-02
CA2804333A1 (fr) 2012-02-23
PT2605757E (pt) 2015-10-19
CL2013000477A1 (es) 2013-06-28
HRP20151021T1 (hr) 2015-11-06
CY1116729T1 (el) 2017-03-15
SMT201500257B (it) 2016-01-08
NZ605469A (en) 2015-01-30

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