CO5611137A2 - Composiciones de clorhidrato de naltrexona - Google Patents

Composiciones de clorhidrato de naltrexona

Info

Publication number
CO5611137A2
CO5611137A2 CO04090752A CO04090752A CO5611137A2 CO 5611137 A2 CO5611137 A2 CO 5611137A2 CO 04090752 A CO04090752 A CO 04090752A CO 04090752 A CO04090752 A CO 04090752A CO 5611137 A2 CO5611137 A2 CO 5611137A2
Authority
CO
Colombia
Prior art keywords
compositions
naltrexone
chlorhydrate
stabilizing
methods
Prior art date
Application number
CO04090752A
Other languages
English (en)
Inventor
Benjamin Oshlack
Huang Hua-Pin
Philip Goliber
Richard Mannion
Original Assignee
Euro Celtique Sa
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 Euro Celtique Sa filed Critical Euro Celtique Sa
Publication of CO5611137A2 publication Critical patent/CO5611137A2/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
    • A61K9/14—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
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K31/4353—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 ortho- or peri-condensed with heterocyclic ring systems
    • 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
    • A61K9/14—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
    • A61K9/20—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
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • 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
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic 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
    • A61K9/48—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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Emergency Medicine (AREA)
  • Inorganic Chemistry (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Pain & Pain Management (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)

Abstract

1.- Una composición farmacéutica de clorhidrato de naltrexona en una cantidad de 20 mg o menos, y un estabilizador que inhibe formación de al menos un producto de degradación de clorhidrato de naltrexona.2.- La composición farmacéutica de la reivindicación 1, en donde dicho estabilizador inhibe la formación de un producto de degradación seleccionado del grupo que consiste de 10-hidroxinaltrexona; 10-cetonaltrexona;2´bisnaltrexona (seudonaltrexona), óxido de 2,2´bisnaltrexona; dióxidos de 2,2´disnaltrexona;aducto de aldol de naltrexona y 10-hidroxinaltrexona, aducto de aldol de naltrexona y 10-cetonaltrexona; naltrexona-N-óxido; 10-hidroxinaltrexona-N-óxido; 10-cetonaltrexona-N-óxido, semiquinonas de naltrexona; peróxidos de radical libre de naltrexona; aducto de aldol denaltrexona; aductos de aldol de naltrexona acoplada en la posición 7,6; aductos de aldol de naltrexona acoplados en la posición 6,5; aducto ligado a éter de naltrexona; aducto ligado a éter de naltrexona y 10-hidroxinaltrexona; aducto ligado a éter de naltrexona y 10-cetonaltrexona;naltrexona deshidrogenada; hidroxi-naltrexona;ceto-naltrexona; sales de estos y mezclas de estos.3.- Una composición farmacéutica que comprende:clorhidrato de naltrexona en una cantidad de 20 mg o menos; yun estabilizador;dicha composición manteniendo al menos aproximadamente 90% de dicho clorhidrato de naltrexona en forma no degradada después de almacenamiento durante un mes a 40±2°C y 75±5% de humedad relativa.4.- La composición farmacéutica de la reivindicación 3, en donde dicha composición mantiene al menos aproximadamente 95% de clorhidrato de naltrexona en forma no degradada después de almacenamiento durante un mes a 40±2°C y 75±5% de unidad relativa.
CO04090752A 2002-03-14 2004-09-13 Composiciones de clorhidrato de naltrexona CO5611137A2 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US36452102P 2002-03-14 2002-03-14

Publications (1)

Publication Number Publication Date
CO5611137A2 true CO5611137A2 (es) 2006-02-28

Family

ID=28041930

Family Applications (1)

Application Number Title Priority Date Filing Date
CO04090752A CO5611137A2 (es) 2002-03-14 2004-09-13 Composiciones de clorhidrato de naltrexona

Country Status (15)

Country Link
US (2) US20030229111A1 (es)
EP (2) EP2289492B1 (es)
JP (2) JP4683842B2 (es)
KR (1) KR20040098660A (es)
CN (1) CN1652752A (es)
AT (1) ATE510534T1 (es)
AU (1) AU2003220290B2 (es)
BR (1) BR0308452A (es)
CA (2) CA2478558C (es)
CO (1) CO5611137A2 (es)
ES (1) ES2616981T3 (es)
IL (1) IL163911A0 (es)
MX (1) MXPA04008772A (es)
RU (1) RU2004130441A (es)
WO (1) WO2003077867A2 (es)

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Also Published As

Publication number Publication date
US20030229111A1 (en) 2003-12-11
IL163911A0 (en) 2005-12-18
ES2616981T3 (es) 2017-06-15
EP1482912B1 (en) 2011-05-25
CA2478558C (en) 2012-09-11
BR0308452A (pt) 2006-06-06
ATE510534T1 (de) 2011-06-15
JP2009143948A (ja) 2009-07-02
CA2748620C (en) 2014-03-11
EP1482912A4 (en) 2006-11-15
WO2003077867A3 (en) 2004-09-02
US20170100337A1 (en) 2017-04-13
JP4683842B2 (ja) 2011-05-18
RU2004130441A (ru) 2005-05-20
EP2289492A3 (en) 2011-12-21
CA2748620A1 (en) 2003-09-25
KR20040098660A (ko) 2004-11-20
MXPA04008772A (es) 2004-12-06
JP5291483B2 (ja) 2013-09-18
EP2289492B1 (en) 2016-12-07
CA2478558A1 (en) 2003-09-25
EP1482912A2 (en) 2004-12-08
AU2003220290A1 (en) 2003-09-29
EP2289492A2 (en) 2011-03-02
JP2005531515A (ja) 2005-10-20
AU2003220290B2 (en) 2007-06-14
WO2003077867A2 (en) 2003-09-25
CN1652752A (zh) 2005-08-10

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