CL2013000477A1 - Formulacion farmaceutica oral de liberacion inmediata que comprende nalbufina o una sal de la misma, y al menos, un soporte de granulacion hidrofilo, un aglutinante hidrofilo y un lubricante, util para el tratamiento del dolor y la dependencia a los opioides. - Google Patents

Formulacion farmaceutica oral de liberacion inmediata que comprende nalbufina o una sal de la misma, y al menos, un soporte de granulacion hidrofilo, un aglutinante hidrofilo y un lubricante, util para el tratamiento del dolor y la dependencia a los opioides.

Info

Publication number
CL2013000477A1
CL2013000477A1 CL2013000477A CL2013000477A CL2013000477A1 CL 2013000477 A1 CL2013000477 A1 CL 2013000477A1 CL 2013000477 A CL2013000477 A CL 2013000477A CL 2013000477 A CL2013000477 A CL 2013000477A CL 2013000477 A1 CL2013000477 A1 CL 2013000477A1
Authority
CL
Chile
Prior art keywords
hydrophilic
nalbuphine
pain
lubricant
salt
Prior art date
Application number
CL2013000477A
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=CL2013000477(A1) "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 CL2013000477A1 publication Critical patent/CL2013000477A1/es

Links

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
    • A61K9/20—Pills, tablets, discs, rods
    • 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
    • A61K9/0012—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)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (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)

Abstract

Formulación farmacéutica oral de liberación inmediata que comprende nalbufina o una sal de la misma, y al menos, un soporte de granulación hidrófilo, un aglutinante hidrófilo y un lubricante, útil para el tratamiento del dolor y la dependencia a los opioides.
CL2013000477A 2010-08-20 2013-02-18 Formulacion farmaceutica oral de liberacion inmediata que comprende nalbufina o una sal de la misma, y al menos, un soporte de granulacion hidrofilo, un aglutinante hidrofilo y un lubricante, util para el tratamiento del dolor y la dependencia a los opioides. CL2013000477A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
FR1056689A FR2963889B1 (fr) 2010-08-20 2010-08-20 Formulations a base de nalbuphine et leurs utilisations

Publications (1)

Publication Number Publication Date
CL2013000477A1 true CL2013000477A1 (es) 2013-06-28

Family

ID=43426302

Family Applications (1)

Application Number Title Priority Date Filing Date
CL2013000477A CL2013000477A1 (es) 2010-08-20 2013-02-18 Formulacion farmaceutica oral de liberacion inmediata que comprende nalbufina o una sal de la misma, y al menos, un soporte de granulacion hidrofilo, un aglutinante hidrofilo y un lubricante, util para el tratamiento del dolor y la dependencia a los opioides.

Country Status (31)

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

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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
US8637538B1 (en) 2012-12-14 2014-01-28 Trevi Therapeutics, Inc. Methods for treatment of pruritis
JP2016506398A (ja) * 2012-12-14 2016-03-03 トレビ セラピューティクス インコーポレイテッド そう痒の処置法
CA3042642A1 (en) 2013-08-12 2015-02-19 Pharmaceutical Manufacturing Research Services, Inc. Extruded immediate release abuse deterrent pill
US9492444B2 (en) 2013-12-17 2016-11-15 Pharmaceutical Manufacturing Research Services, Inc. Extruded extended release abuse deterrent pill
WO2015095391A1 (en) 2013-12-17 2015-06-25 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
AU2015336065A1 (en) 2014-10-20 2017-05-04 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
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KR102664288B1 (ko) * 2018-09-14 2024-05-09 케러 테라퓨틱스, 인코포레이티드 카파 오피오이드 수용체 효능제의 경구 제형
IL294601A (en) 2020-01-10 2022-09-01 Trevi Therapeutics Inc Methods of administration of nalbuphine
EP4121083A4 (en) 2020-03-18 2023-11-29 Cara Therapeutics, Inc. OLIGOSACCHARIDE FORMULATIONS OF KAPPA OPIOID RECEPTOR AGONISTS

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Also Published As

Publication number Publication date
JP2016166230A (ja) 2016-09-15
CA2804333C (fr) 2019-03-19
PL2605757T3 (pl) 2015-12-31
PH12013500289A1 (en) 2016-10-26
PT2605757E (pt) 2015-10-19
CA2804333A1 (fr) 2012-02-23
KR20130099914A (ko) 2013-09-06
DK2605757T3 (en) 2015-10-05
CN103025317A (zh) 2013-04-03
JP6173521B2 (ja) 2017-08-02
RS54244B1 (sr) 2015-12-31
TWI522100B (zh) 2016-02-21
TW201302198A (zh) 2013-01-16
IL224230A (en) 2017-03-30
HRP20151021T1 (hr) 2015-11-06
EP2605757B1 (fr) 2015-07-01
HUE027664T2 (en) 2016-10-28
US20160271124A1 (en) 2016-09-22
EP2605757A2 (fr) 2013-06-26
FR2963889A1 (fr) 2012-02-24
AR082493A1 (es) 2012-12-12
FR2963889B1 (fr) 2013-04-12
EA201300258A1 (ru) 2013-06-28
KR101801424B1 (ko) 2017-11-24
SG187566A1 (en) 2013-03-28
EA024945B1 (ru) 2016-11-30
BR112013004016A2 (pt) 2016-06-28
JP2013534242A (ja) 2013-09-02
ES2548535T3 (es) 2015-10-19
NZ605469A (en) 2015-01-30
WO2012022919A2 (fr) 2012-02-23
MA34484B1 (fr) 2013-08-01
SMT201500257B (it) 2016-01-08
SI2605757T1 (sl) 2015-11-30
US10441585B2 (en) 2019-10-15
AU2011290614A1 (en) 2013-01-31
AU2011290614B2 (en) 2015-11-19
UA110945C2 (uk) 2016-03-10
US20130123294A1 (en) 2013-05-16
WO2012022919A3 (fr) 2012-05-10
MX354416B (es) 2018-03-05
CN103025317B (zh) 2016-08-17
CY1116729T1 (el) 2017-03-15
MX2013001985A (es) 2013-05-09

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