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HRP20140635T1 - Multiäśestice - Google Patents

Multiäśestice Download PDF

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Publication number
HRP20140635T1
HRP20140635T1 HRP20140635TT HRP20140635T HRP20140635T1 HR P20140635 T1 HRP20140635 T1 HR P20140635T1 HR P20140635T T HRP20140635T T HR P20140635TT HR P20140635 T HRP20140635 T HR P20140635T HR P20140635 T1 HRP20140635 T1 HR P20140635T1
Authority
HR
Croatia
Prior art keywords
multiparticles
oxycodone
pharmaceutical form
plasticizer
lubricant
Prior art date
Application number
HRP20140635TT
Other languages
English (en)
Inventor
Malcolm Walden
Geoffrey Gerard Hayes
Hassan Mohammad
Harjit Tamber
Steve Whitelock
Vincenzo Martinelli
Original Assignee
Euro-Celtique S.A.
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=33556051&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HRP20140635(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority claimed from GB0315137A external-priority patent/GB0315137D0/en
Priority claimed from GB0403102A external-priority patent/GB0403102D0/en
Priority claimed from GB0413454A external-priority patent/GB0413454D0/en
Application filed by Euro-Celtique S.A. filed Critical Euro-Celtique S.A.
Publication of HRP20140635T1 publication Critical patent/HRP20140635T1/hr

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1635Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/38Heterocyclic compounds having sulfur as a ring hetero atom
    • A61K31/385Heterocyclic compounds having sulfur as a ring hetero atom having two or more sulfur atoms in the same ring
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic 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
    • A61K31/47Quinolines; Isoquinolines
    • A61K31/485Morphinan derivatives, e.g. morphine, codeine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/04Centrally acting analgesics, e.g. opioids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A61P29/02Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID] without antiinflammatory effect

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Pain & Pain Management (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Rheumatology (AREA)
  • Emergency Medicine (AREA)
  • Molecular Biology (AREA)
  • Neurology (AREA)
  • Biophysics (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Compositions Of Macromolecular Compounds (AREA)
  • Processes Of Treating Macromolecular Substances (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Manufacturing Of Micro-Capsules (AREA)

Claims (33)

1. Multičestice kontroliranog oslobađanja, ekstrudirane iz taline, koje sadrže (a) oksikodon, (b) u vodi netopljivi amonijev metakrilat kopolimer, (c) plastifikator, (d) lubrikant i (e) modifikator propustljivosti vode, pri čemu je taj modifikator propustljivosti vode mikrokristalinična celuloza, kroskarmeloza natrij, krospovidon ili natrijev škrob glikolat.
2. Multičestice prema zahtjevu 1, gdje je oksikodon prisutan kao farmaceutski prihvatljiva sol.
3. Multičestice prema zahtjevu 2, gdje je oksikodon prisutan kao oksikodon hidroklorid.
4. Multičestice prema bilo kojem od zahtjeva 1 do 3, gdje se plastifikator izabire između cetilnog alkohola, stearil alkohola, cetostearil alkohola, sorbitola, saharoze, polietilen glikol visoke molekulske težine, dibutil sebacat, tributil citrat, trietil citrat, propilen glikol i polietilen glikol niske molekulske težine.
5. Multičestice prema zahtjevu 4, gdje je plastifikator stearil alkohol.
6. Multičestice prema zahtjevu 4, gdje je plastifikator polietilen glikol visoke molekulske težine.
7. Multičestice prema bilo kojem od zahtjeva 1 do 6, gdje se lubrikant izabire između gliceril behenata, talka i silicijevog dioksida.
8. Multičestice prema zahtjevu 7, gdje je lubrikant gliceril behenat.
9. Multičestice prema bilo kojem od zahtjeva 1 do 6, gdje je lubrikant stearinska kiselina ili sol stearat.
10. Multičestice prema bilo kojem od zahtjeva 1 do 9, gdje je modifikator propustljivosti vode mikrokristalinična celuloza.
11. Multičestice prema bilo kojem od zahtjeva 1 do 10, gdje su količine sastojaka od (a) do (e) dane u postotcima u sljedećoj tablici, na temelju ukupne težine pet sastojaka: oksikodon kao hidroklorid 3 do 50 netopljivi amonijev metakrilat kopolimer 25 do 85 plastifikator 1 do 30 lubrikant 1 do 25 modifikator propustljivosti vode 1 do 40
12. Muitičestice prema zahtjevu 11, gdje su količine sastojaka od (a) do (e) dane u postotcima u sljedećoj tablici, na temelju ukupne težine pet sastojaka: oksikodon kao hidroklorid 5 do 40 netopljivi amonijev metakrilat kopolimer 35 do 75 plastifikator 3 do 25 lubrikant 2 do 25 modifikator propustljivosti vode 1 do 30
13. Multičestice prema zahtjevu 11, gdje su količine sastojaka od (a) do (e) dane u postotcima u sljedećoj tablici, na temelju ukupne težine pet sastojaka: oksikodon kao hidroklorid 7,5 do 35 netopljivi amonijev metakrilat kopolimer 50 do 65 plastifikator 5 do 15 lubrikant 2 do 25 modifikator propustljivosti vode 1 do 20
14. Farmaceutski oblik u pojedinačnom dozirnom obliku koji sadrži multičestice prema bilo kojem od prethodnih zahtjeva.
15. Farmaceutski oblik prema zahtjevu 14, gdje pojedinačna doza daje dozu oksikodona koja je dovoljna za analgetski učinak u ljudskog bolesnika.
16. Farmaceutski oblik prema zahtjevu 15 koji je bioekvivalentan OxyContin® tabletama.
17. Farmaceutski oblik prema zahtjevu 15 ili 16, gdje je dovoljna doza oksikodona 5 do 400 mg.
18. Farmaceutski oblik prema zahtjevu 17, gdje je pojedinačna doza oksikodona 5 mg, 10 mg, 20 mg, 40 mg, 80 mg ili 160 mg.
19. Farmaceutski oblik prema bilo kojem od zahtjeva 14 do 18 u obliku kapsule napunjene tim multičesticama.
20. Farmaceutski oblik prema zahtjevu 19, gdje se multičestice pune u tvrde želatinske kapsule od kojih svaka sadrži pojedinačnu dozu.
21. Farmaceutski oblik prema zahtjevu 20, gdje je napunjena težina u kapsuli u rasponu 120 do 500 mg.
22. Farmaceutski oblik prema bilo kojem od zahtjeva 14 do 21, namijenjen primjeni u intervalima od 12 sati.
23. Farmaceutski oblik prema bilo kojem od zahtjeva 14, 15 i 17 do 21, namijenjen primjeni u intervalima od 24 sata.
24. Farmaceutski oblik koji sadrži multičestice prema bilo kojem od zahtjeva 1 do 13 i multičestice antagonista oksikodona.
25. Postupak pripreme multičestica prema zahtjevu 1 koji obuhvaća pripremu smjese koja sadrži (a) oksikodon, (b) u vodi netopljivi amonijev metakrilat kopolimer, (c) plastifikator, (d) lubrikant i (e) modifikator propustljivosti vode, pri čemu je taj modifikator propustljivosti vode mikrokristalinična celuloza, kroskarmeloza natrij, krospovidon ili natrijev škrob glikolat; te ekstruziju smjese.
26. Oblik prema bilo kojem od zahtjeva 14 do 24 za uporabu u medicini.
27. Oblik prema bilo kojem od zahtjeva 14 do 24 za uporabu za ublažavanje bolova.
28. Oblik prema bilo kojem od zahtjeva 14 do 24 za dobivanje analgetskog učinka.
29. Multičestice prema bilo kojem od zahtjeva 1 do 13 za uporabu u medicini.
30. Multičestice prema bilo kojem od zahtjeva 1 do 13 za uporabu za ublažavanje bolova.
31. Multičestice prema bilo kojem od zahtjeva 1 do 13 za dobivanje analgetskog učinka.
32. Uporaba multičestica prema bilo kojem od zahtjeva 1 do 13 u pripremi oblika za uporabu za ublažavanje bolova.
33. Uporaba multičestica prema bilo kojem od zahtjeva 1 do 13 u pripremi oblika koji ima analgetski učinak.
HRP20140635TT 2003-06-27 2014-07-04 Multiäśestice HRP20140635T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GB0315137A GB0315137D0 (en) 2003-06-27 2003-06-27 Multiparticulates
GB0403102A GB0403102D0 (en) 2004-02-12 2004-02-12 Multiparticulates
GB0413454A GB0413454D0 (en) 2004-06-16 2004-06-16 Multiparticulates

Publications (1)

Publication Number Publication Date
HRP20140635T1 true HRP20140635T1 (hr) 2014-09-26

Family

ID=33556051

Family Applications (2)

Application Number Title Priority Date Filing Date
HR20100127T HRP20100127T1 (hr) 2003-06-27 2004-06-23 Višečestični oblici
HRP20140635TT HRP20140635T1 (hr) 2003-06-27 2014-07-04 Multiäśestice

Family Applications Before (1)

Application Number Title Priority Date Filing Date
HR20100127T HRP20100127T1 (hr) 2003-06-27 2004-06-23 Višečestični oblici

Country Status (25)

Country Link
EP (2) EP1644002B1 (hr)
JP (2) JP5348841B2 (hr)
KR (1) KR101116518B1 (hr)
AR (1) AR044935A1 (hr)
AT (1) ATE453394T1 (hr)
AU (1) AU2004251481B2 (hr)
BR (1) BRPI0411901B1 (hr)
CA (1) CA2530385C (hr)
CY (2) CY1109917T1 (hr)
DE (1) DE602004024888D1 (hr)
DK (2) DK1644002T3 (hr)
EA (1) EA013424B1 (hr)
ES (2) ES2490598T3 (hr)
HR (2) HRP20100127T1 (hr)
IL (1) IL172730A (hr)
MX (1) MXPA05013799A (hr)
MY (1) MY176831A (hr)
NO (1) NO20060443L (hr)
NZ (1) NZ544181A (hr)
PE (1) PE20050286A1 (hr)
PL (2) PL1889621T3 (hr)
PT (2) PT1889621E (hr)
SI (2) SI1889621T1 (hr)
TW (1) TWI357815B (hr)
WO (1) WO2005000310A1 (hr)

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Also Published As

Publication number Publication date
EP1644002B1 (en) 2009-12-30
EA013424B1 (ru) 2010-04-30
DE602004024888D1 (de) 2010-02-11
CA2530385A1 (en) 2005-01-06
AR044935A1 (es) 2005-10-12
NO20060443L (no) 2006-01-27
PT1889621E (pt) 2014-08-27
CA2530385C (en) 2013-05-28
DK1644002T3 (da) 2010-04-19
AU2004251481A1 (en) 2005-01-06
MXPA05013799A (es) 2006-03-13
TWI357815B (en) 2012-02-11
MY176831A (en) 2020-08-24
WO2005000310A1 (en) 2005-01-06
TW200510000A (en) 2005-03-16
JP2007520429A (ja) 2007-07-26
SI1889621T1 (sl) 2014-09-30
SI1644002T1 (sl) 2010-03-31
PL1889621T3 (pl) 2014-10-31
NO333779B1 (hr) 2013-09-16
PT1644002E (pt) 2010-03-03
NZ544181A (en) 2008-12-24
CY1109917T1 (el) 2014-09-10
EP1889621B1 (en) 2014-05-21
JP5960089B2 (ja) 2016-08-02
PE20050286A1 (es) 2005-06-13
KR20060026892A (ko) 2006-03-24
ATE453394T1 (de) 2010-01-15
EP1889621A1 (en) 2008-02-20
DK1889621T3 (da) 2014-08-11
PL1644002T3 (pl) 2010-05-31
EA200600111A1 (ru) 2006-06-30
KR101116518B1 (ko) 2012-03-13
BRPI0411901A (pt) 2006-08-08
ES2490598T3 (es) 2014-09-04
EP1644002A1 (en) 2006-04-12
JP2013209387A (ja) 2013-10-10
IL172730A (en) 2010-12-30
JP5348841B2 (ja) 2013-11-20
IL172730A0 (en) 2006-04-10
CY1115415T1 (el) 2017-01-04
BRPI0411901B1 (pt) 2019-04-02
AU2004251481B2 (en) 2010-01-28
HRP20100127T1 (hr) 2010-04-30
ES2337468T3 (es) 2010-04-26

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