HRP20161329T1 - Oralni oblici doziranja koji sadrže likarbazepin acetat - Google Patents

Oralni oblici doziranja koji sadrže likarbazepin acetat Download PDF

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Publication number
HRP20161329T1
HRP20161329T1 HRP20161329TT HRP20161329T HRP20161329T1 HR P20161329 T1 HRP20161329 T1 HR P20161329T1 HR P20161329T T HRP20161329T T HR P20161329TT HR P20161329 T HRP20161329 T HR P20161329T HR P20161329 T1 HRP20161329 T1 HR P20161329T1
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pharmaceutical preparation
oral dosage
preparation
dosage form
weight
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HRP20161329TT
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Teófilo Cardoso de VASCONCELOS
Ricardo Jorge Dos Santos Lima
Rui Cerdeira De Campos Costa
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Bial - Portela & Ca., S.A.
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Publication of HRP20161329T1 publication Critical patent/HRP20161329T1/hr

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    • 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
    • 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
    • A61K31/55Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • 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
    • 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
    • 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
    • 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
    • A61K9/1682Processes
    • 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
    • A61K9/1682Processes
    • A61K9/1694Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/2027Organic 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
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, 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
    • A61K9/2077Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • AHUMAN NECESSITIES
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2095Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4866Organic macromolecular compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • 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
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/08Antiepileptics; Anticonvulsants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/18Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
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  • Engineering & Computer Science (AREA)
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  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Zoology (AREA)
  • Pain & Pain Management (AREA)
  • Psychiatry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Claims (24)

1. Farmaceutski pripravak koji sadrži eslikarbazepin acetat u kombinaciji s vezivnim sredstvom i sredstvom za raspadanje, naznačen time da su eslikarbazepin acetat i dio u granulama prisutnog sredstva za raspadanje pripremljeni postupkom vlažne granulacije, a preostali dio sredstva za raspadanje je ekstragranuliran, te pri čemu pripravak ima nasipnu gustoću od barem 0.3 g/mL.
2. Farmaceutski pripravak prema zahtjevu 1, naznačen time da pripravak ima nasipnu gustoću od barem 0.4 g/mL.
3. Farmaceutski pripravak prema zahtjevu 1 ili zahtjevu 2, naznačen time da nadalje sadrži ekstragranularno sredstvo za podmazivanje.
4. Farmaceutski pripravak prema bilo kojem od prethodnih zahtjeva, naznačen time da sredstvo za raspadanje je kroskarmeloza natrij.
5. Farmaceutski pripravak prema bilo kojem od prethodnih zahtjeva, naznačen time da vezivno sredstvo je povidon.
6. Farmaceutski pripravak naznačen time da se proizvodi od pripravka prema bilo kojem od zahtjeva 1 do 5.
7. Farmaceutski pripravak prema zahtjevu 6, naznačen time da pripravak je tableta i ima nasipnu gustoću od 0.5-1.5 g/mL.
8. Farmaceutski pripravak prema zahtjevu 6, naznačen time da ukupna težina pripravka sadrži 0.5-70 tež.% sredstva za raspadanje.
9. Farmaceutski pripravak prema zahtjevu 6, naznačen time da ukupna težina pripravka sadrži 0.5-70 tež.% vezivnog sredstva.
10. Farmaceutski pripravak prema zahtjevu 6, naznačen time da ukupna težina pripravka sadrži 0.1-10 tež.% sredstva za podmazivanje.
11. Uporaba farmaceutskog pripravka prema bilo kojem od zahtjeva 1 do 5 naznačena time da tvori farmaceutski pripravak.
12. Uporaba prema zahtjevu 11, naznačena time da je farmaceutski pripravak tableta ili kapsula.
13. Postupak za pripremanje farmaceutskog pripravka, i proizvoljno oralnog oblika doziranja, koji sadrži vezivno sredstvo i sredstvo za raspadanje, naznačen time da postupak sadrži slijedeće korake: - miješanje eslikarbazepin acetata s dijelom ukupne količine vezivnog sredstva i dio sredstva za raspadanje; - osiguravanje granulacijske tekućine; - otapanje i raspršivanje preostalog udjela ukupne količine vezivnog sredstva u granulacijskoj tekućini; - granuliranje smjese iz koraka miješanja korištenjem granulacijske tekućine nastale u koraku otapanja i raspršivanja da se dobiju granule; - dovođenje u kontakt granula s preostalim dijelom sredstva za raspadanje da se dobije pripravak koji ima nasipnu gustoću od barem 0.3 g/mL, te - proizvoljno formiranje oralnog oblika doziranja.
14. Postupak prema zahtjevu 13, naznačen time da se eslikarbazepin acetat miješa s 20-80 tež.% ukupne količine vezivnog sredstva.
15. Postupak prema zahtjevu 13, naznačen time da je u granulama prisutno 30-70% ukupne količine sredstva za raspadanje.
16. Postupak prema bilo kojem od zahtjeva 13 do 15, naznačen time da granulacijska tekućina je voda, etanol ili njihova smjesa.
17. Postupak prema bilo kojem od zahtjeva 13 do 16, naznačen time da postupak dodatno sadrži korak sušenja granula.
18. Postupak prema bilo kojem od zahtjeva 13 do 17, naznačen time da se pripravak oblikuje u oralni oblik doziranja.
19. Postupak prema zahtjevu 18, naznačen time da se ukupna težina oralnog oblika doziranja sastoji od 0.5-70 tež.% sredstva za raspadanje.
20. Postupak prema zahtjevu 18, naznačen time da se ukupna težina oralnog oblika doziranja sastoji od 0.5-70 tež.% vezivnog sredstva.
21. Postupak prema zahtjevu 18, naznačen time da se ukupna težina oralnog oblika doziranja sastoji od 0.1-10 tež.% sredstva za podmazivanje.
22. Postupak prema bilo kojem od zahtjeva 13 do 21, naznačen time da oralni oblik doziranja je tableta i korak oblikovanja uključuje komprimiranje.
23. Postupak prema zahtjevu 22, naznačen time da tableta ima nasipnu gustoću od 0.5-1.5 g/mL.
24. Postupak prema bilo kojem od zahtjeva 13 do 21, naznačen time da oralni oblik doziranja je oblik kapsule i korak oblikovanja uključuje ispunjavanje kapsule.
HRP20161329TT 2007-10-26 2016-10-12 Oralni oblici doziranja koji sadrže likarbazepin acetat HRP20161329T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US98279007P 2007-10-26 2007-10-26
EP08842368.6A EP2214636B1 (en) 2007-10-26 2008-10-24 Oral dosage forms comprising licarbazepine acetate
PCT/PT2008/000043 WO2009054743A1 (en) 2007-10-26 2008-10-24 Oral dosage forms comprising licarbazξpine acetate

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HRP20161329T1 true HRP20161329T1 (hr) 2016-12-02

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US (5) US8372431B2 (hr)
EP (2) EP2214636B1 (hr)
JP (4) JP2011500797A (hr)
KR (3) KR20100093057A (hr)
CN (1) CN101848698A (hr)
AR (1) AR069031A1 (hr)
AU (1) AU2008317584B2 (hr)
BR (1) BRPI0818680B1 (hr)
CA (1) CA2703313C (hr)
CY (1) CY1118350T1 (hr)
DK (1) DK2214636T3 (hr)
ES (2) ES2607002T3 (hr)
HR (1) HRP20161329T1 (hr)
HU (1) HUE030788T2 (hr)
IL (1) IL205160A0 (hr)
LT (1) LT2214636T (hr)
MX (1) MX2010004323A (hr)
PL (1) PL2214636T3 (hr)
PT (2) PT2214636T (hr)
RS (1) RS55376B1 (hr)
RU (1) RU2546521C2 (hr)
SI (1) SI2214636T1 (hr)
UA (1) UA110012C2 (hr)
WO (1) WO2009054743A1 (hr)

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CN106913550B (zh) * 2017-03-10 2019-12-17 扬子江药业集团北京海燕药业有限公司 一种醋酸艾司利卡西平片的制备方法
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