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DK2517710T3 - Orale opioid-agonist-formuleringer sikret mod forfalskning - Google Patents

Orale opioid-agonist-formuleringer sikret mod forfalskning Download PDF

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Publication number
DK2517710T3
DK2517710T3 DK12167170.5T DK12167170T DK2517710T3 DK 2517710 T3 DK2517710 T3 DK 2517710T3 DK 12167170 T DK12167170 T DK 12167170T DK 2517710 T3 DK2517710 T3 DK 2517710T3
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DK
Denmark
Prior art keywords
opioid
antagonist
dosage form
naltrexone
opioid antagonist
Prior art date
Application number
DK12167170.5T
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English (en)
Inventor
Benjamin Oshlack
Curtis Wright
David J Haddox
Original Assignee
Euro Celtique Sa
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Application filed by Euro Celtique Sa filed Critical Euro Celtique Sa
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Publication of DK2517710T3 publication Critical patent/DK2517710T3/da

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    • 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
    • A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
    • A—HUMAN NECESSITIES
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    • 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
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    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0043—Nose
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    • A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
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  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
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Claims (10)

1. Opioidantagonist-sammensætning omfattende en opioidantagonist disper-geret i en smelteekstruderet matrix, hvor matrixen omfatter et eller flere af et farmaceutisk acceptabelt hydrofobisk materiale og gør antagonisten i det væsentlige ikke-frigivelig, når doseringsformen indgives intakt, således at forholdet mellem mængden af antagonist, der frigives fra doseringsformen efter manipulation, og mængden af den antagonist, der frigives fra den intakte doseringsform, er ca. 4:1 eller mere, baseret på in vitro-opløsning af doseringsformen ved 1 time i 900 ml simuleret mavevæske ("Simulated Gastric Fluid") under anvendelse af et USP Type II (paddle) apparat ved 75 omdr./min. ved 37 grader.
2. Opioidantagonist-sammensætning ifølge krav 1, hvor opioidantagonisten er udvalgt fra gruppen bestående af naloxon, naltrexon, nalmefen, cyclazo-cin, levallorphan, salte og blandinger deraf.
3. Opioidantagonist-sammensætning ifølge krav 1 eller 2, hvor opioidantagonisten er naltrexon.
4. Opioidantagonist-sammensætning ifølge krav 1-3, hvor opioidantagonisten foreligger i en mængde på 10 ng til 275 mg.
5. Opioidantagonist-sammensætning ifølge krav 3, hvor naltrexon foreligger med 0,5-5 mg.
6. Oral doseringsform omfattende en opioidagonist og opioidantagonist-sammensætningen ifølge et af kravene 1-5.
7. Oral doseringsform ifølge krav 6, hvor opioidagonisten er udvalgt fra gruppen bestående af hydrocodon, morphin, hydromorphon, oxycodon, codein, levorphanol, meperidin, methadon, oxymorphon, buprenorphin, fentanyl og derivater deraf, dipanon, heroin, tramadol, etorphin, dihydroetorphin, butor-phanol, levorphandol, salte deraf og blandinger deraf.
8. Oral doseringsform ifølge krav 6 eller 7, hvor opioidagonisten er oxycodon eller hydrocodon.
9. Oral doseringsform ifølge et af kravene 6-8, hvor opioidagonisten omfatter hydrocodon, oxycodon eller farmaceutisk acceptable salte deraf, og opioi-dantagonisten, som foreligger i en i det væsentlige ikke-frigivelig form, omfatter naloxon, naltrexon eller farmaceutisk acceptable salte deraf.
10. Doseringsform ifølge et af kravene 6-9, hvor forholdet mellem opioidagonisten og opioidantagonisten er fra 1:1 til 50:1, fra 1:1 til 20:1 eller fra 1:1 til 10:1.
DK12167170.5T 2000-02-08 2001-02-08 Orale opioid-agonist-formuleringer sikret mod forfalskning DK2517710T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US18136900P 2000-02-08 2000-02-08
EP09006024A EP2092936B1 (en) 2000-02-08 2001-02-08 Tamper-resistant oral opioid agonist formulations

Publications (1)

Publication Number Publication Date
DK2517710T3 true DK2517710T3 (da) 2015-05-26

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Application Number Title Priority Date Filing Date
DK12167170.5T DK2517710T3 (da) 2000-02-08 2001-02-08 Orale opioid-agonist-formuleringer sikret mod forfalskning
DK09006024.5T DK2092936T3 (da) 2000-02-08 2001-02-08 Orale opioid-agonist-formuleringer sikret mod forfalskning
DK10011790.2T DK2283842T3 (da) 2000-02-08 2001-02-08 Orale opioid-agonist-formuleringer sikret mod forfalskning
DK10011789.4T DK2277521T3 (da) 2000-02-08 2001-02-08 Orale opioid-agonist-formuleringer sikret mod forfalskning
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