HRP20151189T1 - Produkti za dostavu opioida otporni na neovlašteno rukovanje - Google Patents

Produkti za dostavu opioida otporni na neovlašteno rukovanje Download PDF

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Publication number
HRP20151189T1
HRP20151189T1 HRP20151189TT HRP20151189T HRP20151189T1 HR P20151189 T1 HRP20151189 T1 HR P20151189T1 HR P20151189T T HRP20151189T T HR P20151189TT HR P20151189 T HRP20151189 T HR P20151189T HR P20151189 T1 HRP20151189 T1 HR P20151189T1
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Croatia
Prior art keywords
dosage form
oral dosage
pharmaceutical oral
particle
form according
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HRP20151189TT
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English (en)
Inventor
Benjamin Oshlack
Glenn Van Buskirk
Mark Chasin
Hua-Pin Huang
Vijay Vashi
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Euro-Celtique S.A.
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Application filed by Euro-Celtique S.A. filed Critical Euro-Celtique S.A.
Publication of HRP20151189T1 publication Critical patent/HRP20151189T1/hr

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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
    • A61K9/20—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
    • A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
    • 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
    • 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
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K9/20—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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/282—Organic compounds, e.g. fats
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/282—Organic compounds, e.g. fats
    • A61K9/2826—Sugars or sugar alcohols, e.g. sucrose; Derivatives thereof
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846—Poly(meth)acrylates
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
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    • 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
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    • 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
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular 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
    • A61K9/5084—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
    • 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
    • A61K9/51—Nanocapsules; Nanoparticles
    • A61K9/5107—Excipients; Inactive ingredients
    • A61K9/5123—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
    • A61K9/51—Nanocapsules; Nanoparticles
    • A61K9/5107—Excipients; Inactive ingredients
    • A61K9/513—Organic macromolecular compounds; Dendrimers
    • A61K9/5138—Organic macromolecular compounds; Dendrimers 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • 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
    • 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
    • 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
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    • 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
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
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    • 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

Claims (9)

1. Farmaceutski oralni dozni oblik koji sadrži (a) česticu koja sadrži opioid antagonist raspršen u matrici dobivenoj ekstrudiranjem taline, pri čemu matrica sadrži između 1% i 80% po masi jednog ili više farmaceutski prihvatljivih prvih hidrofobnih materijala, i (b) sloj drugog hidrofobnog materijala koji oblaže česticu.
2. Farmaceutski oralni dozni oblik koji sadrži (a) česticu koja sadrži opioid antagonist raspršen u matrici dobivenoj ekstrudiranjem taline, pri čemu matrica sadrži jedan ili više farmaceutski prihvatljivih prvih hidrofobnih materijala; i (b) sloj drugog hidrofobnog materijala koji oblaže česticu u količini od 2% do 30% po masi, zasnovano na masi čestice.
3. Farmaceutski oralni dozni oblik prema zahtjevu 1, gdje je sloj drugog hidrofobnog materijala koji oblaže česticu u količini od 2% do 30% po masi, zasnovano na masi čestice.
4. Farmaceutski oralni dozni oblik prema bilo kojem od zahtjeva 1 do 3, koji sadrži množinu čestica koje sadrže opioid antagonist.
5. Farmaceutski oralni dozni oblik prema zahtjevu 4, koji nadalje sadrži množinu čestica koje sadrže opioid agonist raspršen u trećem hidrofobnom materijalu.
6. Farmaceutski oralni dozni oblik prema bilo kojem od zahtjeva 1 do 5, pri čemu prvi, drugi i/ili treći hidrofobni materijal je odabran iz skupine koja se sastoji od celuloznog polimera, akrilnog polimera i kopolimera, polimera i kopolimera metakrilne kiseline, šelaka, zeina, hidrogeniranog ricinusovog ulja, hidrogeniranog biljnog ulja, te njihovih smjesa.
7. Farmaceutski oralni dozni oblik prema bilo kojem od zahtjeva 1 do 6, gdje je opioid antagonist odabran iz skupine koja se sastoji od naltreksona, naloksona, nalmefena, ciklazacina, levalorfana, njihovih farmaceutski prihvatljivih soli, ili njihovih smjesa.
8. Farmaceutski oralni dozni oblik prema bilo kojem od zahtjeva 5 do 7, gdje je opioid agonist odabran iz skupine koja se sastoji od alfentanila, alilprodina, alfaprodina, anileridina, benzilmorfina, bezitramida, buprenorfina, butorfanola, klonitazena, kodeina, dezomorfina, dekstromoramida, dezocina, diampromida, diamorfona, dihidrokodeina, dihidromorfina, dimenoksadola, dimefeptanola, dimetiltiambutena, dioksafetil butirata, dipipanona, eptazocina, etoheptazina, etilmetiltiambutena, etilmorfina, etonitazena, etorfina, dihidroetorpliina, fentanila i derivata, heroina, hidrokodona, hidromorfona, hidroksipetidina, izometadona, ketobemidona, levorfanola, levofenacilmorfana, lofentanila, meperidina, meptazinola, metazocina, metadona, metopona, morfija, miropliina, narceina, nikomorfina, norlevorfanola, normetadona, nalorfina, nalbufena, normorfina, norpipanona, opijuma, oksikodona, oksimorfona, papavereta, pentazocina, fenadoksona, fenomorfana, fenazocina, fenoperidina, piminodina, piritramida, profetazina, promedola, properidina, propoksifena, sufenatila, tilidina, tramadola, njihovih farmaceutski prihvatljivih soli, te njihovih smjesa.
9. Farmaceutski oralni dozni oblik prema bilo kojem od zahtjeva 4 do 8, gdje je omjer opioid agonista i opioid antagonista od 1:1 do 50:1 po masi.
HRP20151189TT 2003-04-21 2015-11-05 Produkti za dostavu opioida otporni na neovlašteno rukovanje HRP20151189T1 (hr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US46432303P 2003-04-21 2003-04-21
EP10010924.8A EP2269579B1 (en) 2003-04-21 2004-04-19 Tamper-resistant products for opioid delivery

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HRP20151189T1 true HRP20151189T1 (hr) 2015-12-04

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ID=33310873

Family Applications (3)

Application Number Title Priority Date Filing Date
HR20100289T HRP20100289T1 (hr) 2003-04-21 2010-05-24 Proizvodi otporni na miješanje za opioidnu primjenu
HRP20120587TT HRP20120587T1 (hr) 2003-04-21 2012-07-13 Proizvodi otporni na neovlašteno otvaranje za primjenu opioida i ostalih lijekova pogodnih za zlouporabu
HRP20151189TT HRP20151189T1 (hr) 2003-04-21 2015-11-05 Produkti za dostavu opioida otporni na neovlašteno rukovanje

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Application Number Title Priority Date Filing Date
HR20100289T HRP20100289T1 (hr) 2003-04-21 2010-05-24 Proizvodi otporni na miješanje za opioidnu primjenu
HRP20120587TT HRP20120587T1 (hr) 2003-04-21 2012-07-13 Proizvodi otporni na neovlašteno otvaranje za primjenu opioida i ostalih lijekova pogodnih za zlouporabu

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US (2) US9149436B2 (hr)
EP (5) EP2269579B1 (hr)
JP (2) JP4942476B2 (hr)
KR (1) KR101227067B1 (hr)
CN (1) CN1809340B (hr)
AR (1) AR056243A1 (hr)
AT (2) ATE458473T1 (hr)
AU (2) AU2004232001B2 (hr)
BR (1) BRPI0409623A (hr)
CA (1) CA2519552C (hr)
CL (1) CL2004000851A1 (hr)
CO (1) CO5700707A2 (hr)
CY (3) CY1110022T1 (hr)
DE (1) DE602004025687D1 (hr)
DK (3) DK2179724T3 (hr)
EA (1) EA009619B1 (hr)
ES (3) ES2341546T3 (hr)
HK (1) HK1091392A1 (hr)
HR (3) HRP20100289T1 (hr)
HU (1) HUE028041T2 (hr)
IL (2) IL171563A (hr)
ME (1) ME00310B (hr)
MX (1) MXPA05011279A (hr)
MY (1) MY135852A (hr)
NO (1) NO328032B1 (hr)
NZ (1) NZ542446A (hr)
PE (1) PE20050140A1 (hr)
PL (3) PL2179724T3 (hr)
PT (3) PT2269579E (hr)
RS (1) RS50925B (hr)
SA (2) SA08290434B1 (hr)
SI (3) SI2179724T1 (hr)
TW (1) TWI347201B (hr)
UA (1) UA84288C2 (hr)
UY (1) UY28281A1 (hr)
WO (1) WO2004093801A2 (hr)
ZA (1) ZA200507691B (hr)

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