DK1551372T3 - Sekvestreringsunderenhed og relaterede sammensætninger og fremgangsmåder - Google Patents

Sekvestreringsunderenhed og relaterede sammensætninger og fremgangsmåder Download PDF

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Publication number
DK1551372T3
DK1551372T3 DK03752490.7T DK03752490T DK1551372T3 DK 1551372 T3 DK1551372 T3 DK 1551372T3 DK 03752490 T DK03752490 T DK 03752490T DK 1551372 T3 DK1551372 T3 DK 1551372T3
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DK
Denmark
Prior art keywords
opioid antagonist
release
composition
opioid
cellulose
Prior art date
Application number
DK03752490.7T
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English (en)
Inventor
Garth Boehm
Original Assignee
Alpharma Pharmaceuticals Llc
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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
    • A61K9/48—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
    • 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
    • A61K9/20—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
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • 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]

Claims (20)

1. Farmaceutisk sammensætning i form af en perle, pellet, granulat eller sfæro-ide, omfattende en underenhed, der omfatter en opioidantagonist i sekvestre-ret form, hvilken underenhed er coatet med en opioidagonist i frigivelig form, hvor underenheden, der omfatter opioidantagonisten i sekvestreretform, yderligere omfatter en kerne og et materiale, der er uigennemtrængeligt for opioidantagonisten, der er udformet til at forhindre frigivelse af mindst 90 % af opioidantagonisten i mave-tarm-kanalen i et tidsrum, der er større end 24 timer, som fastlagt ved opløsningstest i henhold til USP26 kapitel <711 >, under anvendelse af apparat 1 (baskets) ved 50 rpm, 500 ml vand ved 37 °C, og ved tagning af prøver til undersøgelse for forekomst af opioidantagonisten.
2. Sammensætning ifølge krav 1, hvor kernen og materialet, der er uigennemtrængeligt for opioidantagonisten, er udformet til at forhindre frigivelse af mindst 95 % af opioidantagonisten.
3. Sammensætning ifølge krav 2, hvor kernen og materialet, der er uigennemtrængeligt for opioidantagonisten, er udformet til at forhindre frigivelse af mindst 99 % af opioidantagonisten.
4. Sammensætning ifølge krav 1, hvor tidsrummet er mindst 48 timer.
5. Sammensætning ifølge krav 4, hvor tidsrummet er mindst 72 timer.
6. Sammensætning ifølge krav 1, hvor materialet, der er uigennemtrængeligt for opioidantagonisten, omfatter et hydrofobt materiale.
7. Sammensætning ifølge krav 1, hvor materialet, der er uigennemtrængeligt for opioidantagonisten, omfatter en polymer, der er uopløselig i mave-tarm-kanalen.
8. Sammensætning ifølge krav 7, hvor polymeren er en cellulosepolymer eller en acrylpolymer.
9. Sammensætning ifølge krav 8, hvor cellulosen er udvalgt fra gruppen bestående af ethylcellulose, celluloseacetat, cellulosepropionat, celluloseacetat-propionat, celluloseacetatbutyrat, celluloseacetatphthalat, cellulosetriacetat og kombinationer deraf.
10. Sammensætning ifølge krav 8, hvor acrylpolymeren er udvalgt fra gruppen bestående af en methacrylpolymer, acrylsyre- og methacrylsyrecopolymerer, methylmethacrylatcopolymerer, ethoxyethylmethacrylater, cyanoethyl-methacrylat, poly(acrylsyre), poly(methacrylsyre), methacrylsyrealky-lamidcopolymer, poly(methylmethacrylat), polymethacrylat, poly(methyl-methacrylat)copolymer, polyacrylamid, aminoalkylmethacrylatcopolymer, poly(methacrysyreanhydrid), glycidylmethacrylatcopolymerer og kombinationer deraf.
11. Sammensætning ifølge krav 10, hvor methacrylpolymeren er en ammonio-methacrylcopolymer.
12. Sammensætning ifølge krav 1, hvor materialet, der er uigennemtrængeligt for opioidantagonisten, er udvalgt fra gruppen bestående af polymælkesyre, polyglycolsyre, en copolymer af polymælkesyre og polyglycolsyre og kombinationer deraf.
13. Sammensætning ifølge krav 1, hvor underenheden, der omfatter opioidantagonisten i sekvestreret form, yderligere omfatter et andet materiale, der er uigennemtrængeligt for opioidantagonisten, og hvor kernen er coatet med det første materiale, der er er uigennemtrængeligt for opioidantagonisten, som på sin side er coatet med opioidantagonisten, som på sin side er coatet med det andet materiale, der er uigennemtrængeligt for opioidantagonisten.
14. Sammensætning ifølge krav 13, hvor det første materiale, der er uigennemtrængeligt for opioidantagonisten, er det samme som det andet materiale, der er uigennemtrængeligt for opioidantagonisten.
15. Sammensætning ifølge krav 1, hvor opioidantagonisten er inkorporeret i kernen, og kernen er coatet med materialet, der er uigennemtrængeligt for opioidantagonisten.
16. Sammensætning ifølge krav 1, hvor kernen omfatter et vanduopløseligt materiale, og kernen er coatet med opioidantagonisten, som på sin side er coatet med materialet, der er uigennemtrængeligt for opioidantagonisten.
17. Sammensætning ifølge krav 16, hvor det vanduopløselige materiale er udvalgt fra gruppen bestående af mikrokrystallinsk cellulose, et calciumsalt og en voks.
18. Sammensætning ifølge krav 1, hvor opioidagonisten er udvalgt fra gruppen bestående af alfentanil, allylprodin, alphaprodin, anileridin, benzylmorphin, be-zitramid, buprenorphin, butorphanol, clonitazen, codein, cyclazocin, desomorphin, dextromoramid, dezocin, diampromid, dihydrocodein, dihydroe-torphin, dihydromorphin, dimenoxadol, dimepheptanol, dimethylthiambuten, dioxaphetylbutyrat, dipipanon, eptazocin, ethoheptazin, ethylmethylthiambu-ten, ethylmorphin, etonitazen, etorphin, fentanyl, heroin, hydrocodon, hydro-morphon, hydroxypethidin, isomethadon, ketobemidon, levallorphan, levorphanol, levophenacylmorphan, lofentanil, meperidin, meptazinol, metazo-cin, methadon, metopon, morphin, myrophin, nalbuphin, narcein, nicomorphin, norlevorphanol, normethadon, nalorphin, normorphin, norpipanon, opium, oxy-codon, oxymorphon, papaveretum, pentazocin, phenadoxon, phenazocin, phenomorphan, phenoperidin, piminodin, piritramid, propheptazin, promedol, properidin, propiram, propoxyphen, sufentanil, tramadol, tilidin, farmaceutisk acceptable salte deraf og kombinationer deraf.
19. Sammensætning ifølge krav 18, hvor opioidantagonisten er udvalgt fra gruppen bestående af naltrexon, naloxon, nalmefen, cyclazacin, levallorphan, farmaceutisk acceptable salte deraf og kombinationer deraf.
20. Kapsel, der er egnet til oral indgivelse, omfattende en flerhed perlerne, pelletsene, granulaterne eller sfæroiderne ifølge krav 1.
DK03752490.7T 2002-09-20 2003-09-22 Sekvestreringsunderenhed og relaterede sammensætninger og fremgangsmåder DK1551372T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US41220802P 2002-09-20 2002-09-20
PCT/US2003/029475 WO2004026283A1 (en) 2002-09-20 2003-09-22 Sequestering subunit and related compositions and metohds

Publications (1)

Publication Number Publication Date
DK1551372T3 true DK1551372T3 (da) 2018-07-23

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Country Status (13)

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US (4) US7815934B2 (da)
EP (4) EP2422772A3 (da)
CN (1) CN1703200B (da)
AU (2) AU2003270778B2 (da)
CA (1) CA2499550C (da)
CY (1) CY1120720T1 (da)
DK (1) DK1551372T3 (da)
ES (1) ES2677769T3 (da)
HU (1) HUE038446T2 (da)
NO (1) NO20051855L (da)
PT (1) PT1551372T (da)
SI (1) SI1551372T1 (da)
WO (1) WO2004026283A1 (da)

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