DK2526932T3 - Farmaceutisk sammensætning - Google Patents

Farmaceutisk sammensætning Download PDF

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Publication number
DK2526932T3
DK2526932T3 DK12163626.0T DK12163626T DK2526932T3 DK 2526932 T3 DK2526932 T3 DK 2526932T3 DK 12163626 T DK12163626 T DK 12163626T DK 2526932 T3 DK2526932 T3 DK 2526932T3
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DK
Denmark
Prior art keywords
antagonist
naltrexone
release
sequestering
subunit
Prior art date
Application number
DK12163626.0T
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English (en)
Inventor
Alfred Liang
Frank Matthews
Garth Boehm
Lijuan Tang
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Alpharma Pharmaceuticals Llc
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=38834070&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=DK2526932(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Alpharma Pharmaceuticals Llc filed Critical Alpharma Pharmaceuticals Llc
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Publication of DK2526932T3 publication Critical patent/DK2526932T3/da

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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • 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
    • 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
    • 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
    • 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
    • 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
    • A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • 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
    • 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
    • A61K9/5015—Organic compounds, e.g. fats, sugars
    • 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
    • A61K9/5026—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
    • A61K9/48—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
    • 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]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/15—Medicinal preparations ; Physical properties thereof, e.g. dissolubility

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biomedical Technology (AREA)
  • Emergency Medicine (AREA)
  • Neurosurgery (AREA)
  • General Physics & Mathematics (AREA)
  • Addiction (AREA)
  • Pain & Pain Management (AREA)
  • Neurology (AREA)
  • Pathology (AREA)
  • Molecular Biology (AREA)
  • Food Science & Technology (AREA)
  • Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • Immunology (AREA)
  • Rheumatology (AREA)
  • Biophysics (AREA)
  • Psychiatry (AREA)
  • Hematology (AREA)
  • Urology & Nephrology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Claims (13)

1. Sekvestreringsunderenhed omfattende: a. en kerne; b. et lag, der coater kernen, omfattende en opioidantagonist, som er nalt-rexon eller et farmaceutisk acceptabelt salt deraf; c. et sekvestreringspolymerlag, der coater naltrexon, hvor polymerlaget omfatter en acrylpolymer, et ladningsneutraliserende overfladeaktivt stof og talkum, hvor acrylpolymeren er Eudragit® RS, og hvor talkummet er til stede i en mængde på 75 % til 125 % på v/v-basis i forhold til kvantiteten af acrylpolymeren.
2. Sekvestreringsunderenhed ifølge krav 1, hvor det overfladeaktive stof er udvalgt fra gruppen bestående af natriumlaurylsulfat, natriumdocusat, dioc-tylnatriumsulfosuccinat, natriumlaurylsarcosinat, natriummethylcocyltaurat, magnesiumlaurylsulfat, dioctylnatriumsulfosuccinat og natriumdodecylben-zensulfonat.
3. Sekvestreringsunderenhed ifølge krav 2, hvor det overfladeaktive stof er natriumlaurylsulfat.
4. Sekvestreringsunderenhed ifølge et hvilket som helst af de foregående krav, hvor det overfladeaktive stof er til stede i en mængde, der er mindre end 6,3 %, på v/v-basis, i forhold til kvantiteten af tilstedeværende polymer.
5. Sekvestreringsunderenhed ifølge et hvilket som helst af de foregående krav, hvor sekvestreringspolymeren og talkummet er til stede i et forhold på ca. 1:1 på v/v-basis.
6. Sekvestreringsunderenhed ifølge et hvilket som helst af de foregående krav, hvor mindst 95 % af opioidantagonisten sekvestreres i mindst 72 timer efter indgivelse til et menneske.
7. Farmaceutisk sammensætning omfattende en flerhed af sekvestrerings-underenheder ifølge et hvilket som helst af kravene 1 til 6 og yderligere omfattende en opioidagonist i frigivelig form.
8. Farmaceutisk sammensætning ifølge krav 7, hvor opioidagonisten er i form af en separat terapeutisk-middel-underenhed.
9. Farmaceutisk sammensætning ifølge krav 7 eller 8, hvor opioidagonisten er oxycodon, morph in eller et farmaceutisk acceptabelt salt deraf.
10. Oral doseringsform omfattende en flerhed af sekvestreringsunderenheder ifølge et hvilket som helst af kravene 1 til 6 i kombination med en separat terapeutisk-middel-underenhed, hvor terapeutisk-middel-underenhed en omfatter et terapeutisk middel i frigivelig form.
11. Oral doseringsform ifølge krav 10, hvor det terapeutiske middel er en opioidagonist udvalgt blandt oxycodon, morphin eller et farmaceutisk acceptabelt salt deraf.
12. Sekvestreringsunderenhed ifølge et hvilket som helst af kravene 1 til 6, hvor opioiantagonisten er naltrexonhydrochlorid, eller en farmaceutisk sammensætning eller en oral doseringsform ifølge et hvilket som helst af kravene 7 til 11, hvor opioidantagonisten er naltrexonhydrochlorid, og opioidagonisten oxycodonhydrochlorid eller morphinsulfat.
13. Sekvestreringspolymerlag-coating ifølge et hvilket som helst af kravene 1 til 6.
DK12163626.0T 2006-06-19 2007-06-19 Farmaceutisk sammensætning DK2526932T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US81494906P 2006-06-19 2006-06-19
EP07809672A EP2034975B8 (en) 2006-06-19 2007-06-19 Pharmaceutical compositions

Publications (1)

Publication Number Publication Date
DK2526932T3 true DK2526932T3 (da) 2017-07-17

Family

ID=38834070

Family Applications (4)

Application Number Title Priority Date Filing Date
DK12153443.2T DK2484346T3 (da) 2006-06-19 2007-06-19 Farmaceutiske sammensætninger
DK12163626.0T DK2526932T3 (da) 2006-06-19 2007-06-19 Farmaceutisk sammensætning
DK07809672.4T DK2034975T3 (da) 2006-06-19 2007-06-19 Farmaceutiske sammensætninger
DK13154883.6T DK2719378T3 (da) 2006-06-19 2007-06-19 Farmaceutiske sammensætninger

Family Applications Before (1)

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DK12153443.2T DK2484346T3 (da) 2006-06-19 2007-06-19 Farmaceutiske sammensætninger

Family Applications After (2)

Application Number Title Priority Date Filing Date
DK07809672.4T DK2034975T3 (da) 2006-06-19 2007-06-19 Farmaceutiske sammensætninger
DK13154883.6T DK2719378T3 (da) 2006-06-19 2007-06-19 Farmaceutiske sammensætninger

Country Status (22)

Country Link
US (9) US8158156B2 (da)
EP (4) EP2719378B1 (da)
JP (1) JP5566102B2 (da)
KR (3) KR20140079441A (da)
CN (1) CN101677963B (da)
AT (1) ATE552829T1 (da)
AU (4) AU2007261451A1 (da)
BR (1) BRPI0714039A8 (da)
CA (1) CA2655835C (da)
CY (4) CY1112868T1 (da)
DK (4) DK2484346T3 (da)
ES (4) ES2600141T3 (da)
HU (3) HUE033058T2 (da)
IL (2) IL195834A (da)
MX (1) MX2008016372A (da)
NZ (1) NZ573757A (da)
PL (4) PL2719378T3 (da)
PT (4) PT2526932T (da)
RU (1) RU2445077C2 (da)
SI (4) SI2719378T1 (da)
WO (1) WO2007149438A2 (da)
ZA (1) ZA200810501B (da)

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