DK2403482T3 - Misbrugsresistent formulering - Google Patents

Misbrugsresistent formulering Download PDF

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Publication number
DK2403482T3
DK2403482T3 DK10711246.8T DK10711246T DK2403482T3 DK 2403482 T3 DK2403482 T3 DK 2403482T3 DK 10711246 T DK10711246 T DK 10711246T DK 2403482 T3 DK2403482 T3 DK 2403482T3
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DK
Denmark
Prior art keywords
composition
excipient
active ingredient
forming agent
composition according
Prior art date
Application number
DK10711246.8T
Other languages
English (en)
Inventor
Susanne Bredenberg
Anna Dahlgren
Anders Sägström
Hakan Engqvist
Original Assignee
Emplicure Ab
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 Emplicure Ab filed Critical Emplicure Ab
Application granted granted Critical
Publication of DK2403482T3 publication Critical patent/DK2403482T3/da

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Classifications

    • 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
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445—Non condensed piperidines, e.g. piperocaine
    • A61K31/4468—Non condensed piperidines, e.g. piperocaine having a nitrogen directly attached in position 4, e.g. clebopride, fentanyl
    • 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
    • A61K9/1611—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
    • A61K9/14—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
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1635—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
    • A61K9/14—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
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • 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

Claims (15)

1. Farmaceutisk sammensætning med langvarig frigivelse, som omfatter et fast, sammenhængende netværk, der omfatter en excipiens med en høj mekanisk styrke, hvilket netværk også omfatter porer, i hvilke porer er iblandet en blanding af en aktiv bestanddel og et filmdannende middel, kendetegnet ved, at det filmdannende middel er et enterisk coatingmateriale, og at porerne er dannet under fremstillingen af sammensætningen, hvor excipiensen er baseret på et eller flere keramiske materialer eller er baseret på et eller flere geopolymermaterialer.
2. Sammensætning ifølge krav 1, hvor excipiensen er uorganisk.
3. Sammensætning ifølge krav 1 eller krav 2, hvor den aktive bestanddel, der anvendes, er et opioidanalgetikum.
4. Sammensætning ifølge krav 3, hvor opioidanalgetikummet er udvalgt blandt buprenorphin, alfentanil, sufentanil, remifentanil og fentanyl.
5. Sammensætning ifølge krav 1, hvor excipiensen er baseret på et eller flere keramiske materialer, og hvor det keramiske materiale er et calciumaluminat, et aluminiumsilikat eller et halloysit.
6. Sammensætning ifølge et hvilket som helst af de foregående krav, hvor kornstørrelsen af excipiensen er under ca. 20 pm.
7. Sammensætning ifølge et hvilket som helst af de foregående krav, hvor det filmdannende middel er en copolymer, der er afledt af methacrylsyre og ethylacrylat eller en neutral methacrylpolymer.
8. Sammensætning ifølge et hvilket som helst af de foregående krav, som yderligere omfatter et pelleteringshjælpemateriale.
9. Sammensætning ifølge krav 8, hvor pelleteringshjælpematerialet er mikro-krystallinsk cellulose.
10. Fremgangsmåde til fremstilling af en sammensætning ifølge et hvilket som helst af de foregående krav, som omfatter at blande excipiensen med høj mekanisk styrke og den aktive bestanddel, og dernæst tilsætte det filmdannende middel sammen med, eller i, en væske, således at der dannes et vådt granulat.
11. Fremgangsmåde ifølge krav 10, som yderligere omfatter: (I) ekstrudering af granulatet; (II) sfæronisering; (III) tørring; og/eller (IV) hærdning.
12. Sammensætning, der kan opnås ved en fremgangsmåde ifølge krav 10 eller krav 11.
13. Sammensætning ifølge et hvilket som helst af kravene 1 til 9 eller 12 til anvendelse som medicin.
14. Sammensætning ifølge et hvilket som helst af kravene 3 eller 4 til 9 eller 12 (afhængigt af krav 3), til anvendelse ved smertebehandling.
15. Anvendelse af en sammensætning ifølge et hvilket som helst af kravene 3 eller 4 til 9 eller 12 (afhængigt af krav 3), til fremstilling af et medikament til smertebehandling.
DK10711246.8T 2009-03-04 2010-03-02 Misbrugsresistent formulering DK2403482T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB2009000592 2009-03-04
PCT/GB2010/000374 WO2010100414A1 (en) 2009-03-04 2010-03-02 Abuse resistant formulation

Publications (1)

Publication Number Publication Date
DK2403482T3 true DK2403482T3 (da) 2018-03-05

Family

ID=40823586

Family Applications (1)

Application Number Title Priority Date Filing Date
DK10711246.8T DK2403482T3 (da) 2009-03-04 2010-03-02 Misbrugsresistent formulering

Country Status (17)

Country Link
US (2) US9622972B2 (da)
EP (1) EP2403482B1 (da)
JP (1) JP5728705B2 (da)
KR (1) KR101751906B1 (da)
CN (1) CN102341096B (da)
AU (1) AU2010219449B2 (da)
BR (1) BRPI1009121A2 (da)
CA (1) CA2753664C (da)
DK (1) DK2403482T3 (da)
EA (1) EA031154B1 (da)
ES (1) ES2660674T3 (da)
IL (1) IL214583A (da)
MX (1) MX336355B (da)
NO (1) NO2403482T3 (da)
NZ (1) NZ594513A (da)
PL (1) PL2403482T3 (da)
WO (1) WO2010100414A1 (da)

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Also Published As

Publication number Publication date
PL2403482T3 (pl) 2018-06-29
CN102341096B (zh) 2015-02-18
MX2011009214A (es) 2011-09-28
JP5728705B2 (ja) 2015-06-03
EA201101281A1 (ru) 2012-02-28
KR20110122838A (ko) 2011-11-11
IL214583A0 (en) 2011-09-27
WO2010100414A1 (en) 2010-09-10
CN102341096A (zh) 2012-02-01
EA031154B1 (ru) 2018-11-30
ES2660674T3 (es) 2018-03-23
MX336355B (es) 2016-01-14
US20120015007A1 (en) 2012-01-19
AU2010219449B2 (en) 2014-12-18
CA2753664A1 (en) 2010-09-10
AU2010219449A1 (en) 2011-09-01
KR101751906B1 (ko) 2017-06-29
BRPI1009121A2 (pt) 2018-06-19
JP2012519675A (ja) 2012-08-30
NZ594513A (en) 2013-10-25
EP2403482B1 (en) 2017-12-27
CA2753664C (en) 2019-11-05
IL214583A (en) 2016-04-21
US10543203B2 (en) 2020-01-28
US9622972B2 (en) 2017-04-18
US20170239229A1 (en) 2017-08-24
NO2403482T3 (da) 2018-05-26
EP2403482A1 (en) 2012-01-11

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