HRP20130245T1 - Kvetiapinski pripravak - Google Patents

Kvetiapinski pripravak Download PDF

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Publication number
HRP20130245T1
HRP20130245T1 HRP20130245AT HRP20130245T HRP20130245T1 HR P20130245 T1 HRP20130245 T1 HR P20130245T1 HR P20130245A T HRP20130245A T HR P20130245AT HR P20130245 T HRP20130245 T HR P20130245T HR P20130245 T1 HRP20130245 T1 HR P20130245T1
Authority
HR
Croatia
Prior art keywords
pharmaceutical preparation
weight
preparation according
quetiapine
acid
Prior art date
Application number
HRP20130245AT
Other languages
English (en)
Inventor
Matej Pavli
Rok Dreu
Sasa Baumgartner
Odon Planinsek
Robert Pisek
Franc Vrecer
Miha Vrbinc
Original Assignee
Krka, Tovarna Zdravil, D.D., Novo Mesto
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=41112567&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HRP20130245(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority claimed from SI200800193A external-priority patent/SI22850A/sl
Application filed by Krka, Tovarna Zdravil, D.D., Novo Mesto filed Critical Krka, Tovarna Zdravil, D.D., Novo Mesto
Publication of HRP20130245T1 publication Critical patent/HRP20130245T1/hr

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Classifications

    • 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
    • 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
    • A61K31/554Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having at least one nitrogen and one sulfur as ring hetero atoms, e.g. clothiapine, diltiazem
    • 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
    • A61K9/2009Inorganic compounds
    • 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
    • A61K9/2013Organic 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
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/2031Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • 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
    • A61K9/1641Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Hydrogenated Pyridines (AREA)

Claims (13)

1. Farmaceutski pripravak s produljenim otpuštanjem, koji sadrži kvetiapin, ili njegovu sol, i λ-karagenan, naznačen time što navedeni pripravak dolazi u obliku tablete.
2. Farmaceutski pripravak u skladu s patentnim zahtjevom 1, naznačen time što je kvetiapin u obliku kvetiapin-hemifumarata.
3. Farmaceutski pripravak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što dodatno sadrži organsku kiselinu.
4. Farmaceutski pripravak u skladu s patentnim zahtjevom 3, naznačen time što se organsku kiselinu bira iz skupine koju čine limunska kiselina, fumarna kiselina, vinska kiselina, benzojeva kiselina, jabučna kiselina, askorbinska kiselina, jantarna kiselina i njihove smjese.
5. Farmaceutski pripravak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što dodatno sadrži anionski polimer.
6. Farmaceutski pripravak u skladu s patentnim zahtjevom 5, naznačen time što se anionski polimer bira iz skupine koju čine celulozni acetat-ftalat, kopolimer metakrilne kiseline, celulozni acetat-sukcinat, polivinil-acetat-ftalat, hidroksipropilmetilcelulozni ftalat i/ili njihove smjese.
7. Farmaceutski pripravak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što dodatno sadrži polietilen-glikol.
8. Farmaceutski pripravak u skladu s patentnim zahtjevom 7, naznačen time što je molekulska težina polietilen-glikola u rasponu od 4.000 do 8.000.
9. Farmaceutski pripravak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što dodatno sadrži manitol.
10. Farmaceutski pripravak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što sadrži: 25 do 55 %, težinski, po mogućnosti 30 do 45 %, težinski, kvetiapina, po mogućnosti u obliku kvetiapin-hemifumarata, 15 do 65 %, težinski, po mogućnosti 20 do 55 %, težinski, neželirajućeg karagenana, po mogućnosti λ-karagenana, te izborno 1 do 2 %, težinski, maziva, po mogućnosti magnezijevog stearata, na osnovu ukupne težine pripravka.
11. Farmaceutski pripravak u skladu s patentnim zahtjevom 10, naznačen time što dodatno sadrži: 10 do 40 %, težinski, razrjeđivača, po mogućnosti laktoze, a osobito α-laktoza monohidrata, manitola i/ili dikalcijevog fosfata dihidrata i/ili 5 do 15 %, težinski, organske kiseline, po mogućnosti limunske kiseline i/ili fumarne kiseline i/ili 10 do 35 %, težinski, anionskog polimera, a osobito HPMC-acetat-sukcinata i/ili kopolimera metakrilne kiseline i/ili 12 do 24 %, težinski, polietilen-glikola, a osobito polietilen-glikola, prosječne molekulske težine od 4.000, na osnovu ukupne težine pripravka.
12. Farmaceutski pripravak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što je kvetiapin u obliku kvetiapin-hemifumarata, u kristalnom obliku I iz dokumenta WO 03/080065.
13. Farmaceutski pripravak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što sadrži 50 do 800 mg kvetiapina u obliku kvetiapin-hemifumarata.
HRP20130245AT 2008-08-01 2013-03-21 Kvetiapinski pripravak HRP20130245T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
SI200800193A SI22850A (sl) 2008-08-01 2008-08-01 Pripravek kvetiapina
SI200900073 2009-03-18
PCT/EP2009/005573 WO2010012490A1 (en) 2008-08-01 2009-07-31 Quetiapine composition

Publications (1)

Publication Number Publication Date
HRP20130245T1 true HRP20130245T1 (hr) 2013-04-30

Family

ID=41112567

Family Applications (1)

Application Number Title Priority Date Filing Date
HRP20130245AT HRP20130245T1 (hr) 2008-08-01 2013-03-21 Kvetiapinski pripravak

Country Status (10)

Country Link
EP (1) EP2262486B1 (hr)
DE (1) DE202009018024U1 (hr)
DK (1) DK2262486T3 (hr)
EA (1) EA018638B1 (hr)
ES (1) ES2402342T3 (hr)
HR (1) HRP20130245T1 (hr)
PL (1) PL2262486T3 (hr)
PT (1) PT2262486E (hr)
SI (1) SI2262486T1 (hr)
WO (1) WO2010012490A1 (hr)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2309994A2 (en) * 2008-07-01 2011-04-20 Lupin Limited Sustained release pharmaceutical compositions comprising quetiapine
EP2373319B1 (en) * 2009-01-05 2013-07-31 Torrent Pharmaceuticals Limited Sustained release pharmaceutical composition of quetiapine and process for preparation thereof
EP2233130A1 (en) * 2009-03-23 2010-09-29 Genepharm (Europe) Trading Limited A sustained release oral composition of an antipsychotic agent
WO2011154118A1 (en) 2010-06-07 2011-12-15 Alfred E. Tiefenbacher (Gmbh & Co. Kg) Quetiapine prolonged-release tablets
TR201008261A1 (tr) 2010-10-08 2012-04-24 Sanovel İlaç San. Ve Ti̇c. A.Ş. Kontrollü salım gerçekleştiren ketiapin formülasyonları
DE102011115690A1 (de) 2011-10-11 2013-04-11 Acino Pharma Ag Quetiapin enthaltende Formulierungen
WO2013169977A2 (en) * 2012-05-10 2013-11-14 Fmc Corporation Controlled release solid dose form
RS62844B1 (sr) 2015-06-18 2022-02-28 Estetra Srl Orodisperzibilna dozna jedinica koja sadrži komponentu estetrola
JOP20200260A1 (ar) 2018-04-19 2019-10-19 Estetra Sprl مركبات واستخداماتها للتخفيف من الأعراض المصاحبة لانقطاع الطمث
TWI801561B (zh) 2018-04-19 2023-05-11 比利時商依思特拉私人有限責任公司 化合物及其用於緩解絕經相關症狀的用途

Family Cites Families (17)

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Publication number Priority date Publication date Assignee Title
GB8607684D0 (en) 1986-03-27 1986-04-30 Ici America Inc Thiazepine compounds
GB8705574D0 (en) 1987-03-10 1987-04-15 Ici Plc Preparation of thiazepine compound
GB9611328D0 (en) 1996-05-31 1996-08-07 Zeneca Ltd Pharmaceutical compositions
GB9716161D0 (en) 1997-08-01 1997-10-08 Zeneca Ltd Process
IT1297461B1 (it) 1997-10-29 1999-12-17 Ciocca Maurizio Preparazione di compresse a rilascio controllato a base di complessi tra carragenano e farmaci basici solubili
GB9922271D0 (en) 1999-09-21 1999-11-17 Zeneca Ltd Formulation
HU227039B1 (en) 2000-01-25 2010-05-28 Egis Gyogyszergyar Nyilvanosan New process for the production of quetiapine and intermediates therefor
US6287599B1 (en) 2000-12-20 2001-09-11 Shire Laboratories, Inc. Sustained release pharmaceutical dosage forms with minimized pH dependent dissolution profiles
AR034517A1 (es) 2001-06-21 2004-02-25 Astrazeneca Ab Formulacion farmaceutica
JP3624954B1 (ja) 2001-11-07 2005-03-02 藤沢薬品工業株式会社 分散不良薬物の溶出性を改善する方法
CA2479668A1 (en) 2002-03-20 2003-10-02 Teva Pharmaceutical Industries Ltd. Crystalline forms of quetiapine hemifumarate
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Also Published As

Publication number Publication date
WO2010012490A1 (en) 2010-02-04
EA201100286A1 (ru) 2011-08-30
ES2402342T3 (es) 2013-04-30
EP2262486A1 (en) 2010-12-22
EA018638B1 (ru) 2013-09-30
PT2262486E (pt) 2013-03-27
DE202009018024U1 (de) 2010-12-09
EP2262486B1 (en) 2013-01-02
SI2262486T1 (sl) 2013-04-30
DK2262486T3 (da) 2013-03-25
PL2262486T3 (pl) 2013-06-28

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