HRP20141006T1 - Farmaceutski pripravci koji sadrže 2-okso-1-pirolidin derivate - Google Patents

Farmaceutski pripravci koji sadrže 2-okso-1-pirolidin derivate Download PDF

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Publication number
HRP20141006T1
HRP20141006T1 HRP20141006AT HRP20141006T HRP20141006T1 HR P20141006 T1 HRP20141006 T1 HR P20141006T1 HR P20141006A T HRP20141006A T HR P20141006AT HR P20141006 T HRP20141006 T HR P20141006T HR P20141006 T1 HRP20141006 T1 HR P20141006T1
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Croatia
Prior art keywords
particles
cyclodextrin
preparation according
mass
relation
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HRP20141006AT
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English (en)
Inventor
Serge Cuypers
Monique Berwaer
Domenico Fanara
Valery Barillaro
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Ucb Pharma, S.A.
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Publication of HRP20141006T1 publication Critical patent/HRP20141006T1/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
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • A61K9/1623Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • A61K31/40Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/4015Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil having oxo groups directly attached to the heterocyclic ring, e.g. piracetam, ethosuximide
    • 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
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/40Cyclodextrins; Derivatives thereof
    • 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
    • A61K9/14Particulate 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
    • A61K9/20Pills, 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
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • 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
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/286Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Organic Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pain & Pain Management (AREA)
  • Inorganic Chemistry (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Claims (16)

1. Oralni farmaceutski pripravak, u čvrstom obliku tableta, koji sadrži čestice, a spomenute čestice sadrže aktivni sastojak i, kao ekscipijent, 0.1% do 60% po masi najmanje jednog ciklodekstrin agensa, u odnosu na ukupnu masu čestica; pri čemu je aktivni sastojak 2-okso-1-pirolidin derivat formule (I) [image] gdje, R1 je C1-10 alkil ili C2-6 alkenil, R2 je C1-10 alkil ili C2-6 alkenil; X je -CONR4R5, COOH, -COOR3 ili CN; R3 je C1-10 alkil; R4 je vodik ili C1-10 alkil; R5 je vodik ili C1-10 alkil.
2. Pripravak prema zahtjevu 1, naznačen time da R1 je n-propil ili 2,2-difluorovinil; R2 je etil; i X je -CONH2.
3. Pripravak prema zahtjevu 1 ili 2, naznačen time da je ciklodekstrin agens izabran između alfa ciklodekstrina, beta ciklodekstrina, hidroksipropil beta ciklodekstrina, metil beta ciklodekstrina sulfobutil beta ciklodekstrina, gama ciklodekstrina, i hidroksipropil gama ciklodekstrina.
4. Pripravak prema zahtjevu 3, naznačen time da je ciklodekstrin agens beta ciklodekstrin.
5. Pripravak prema bilo kojem od zahtjeva 1 do 4, naznačen time da čestice sadrže 1.0 do 30% po masi ciklodekstrin agensa u odnosu na ukupnu masu čestica.
6. Pripravak prema bilo kojem od prethodnih zahtjeva 1 do 5, naznačen time da čestice sadrže dezintegrant, kao ekscipijent.
7. Pripravak prema zahtjevu 6, naznačen time da je dezintegrant natrij kroskarmeloza.
8. Pripravak prema zahtjevu 6 ili 7, naznačen time da čestice sadrže 0,5 do 25% po masi dezintegranta, u odnosu na ukupnu masu čestica.
9. Pripravak prema bilo kojem od prethodnih zahtjeva, naznačen time da čestice sadrže diluent, kao ekscipijent.
10. Pripravak prema zahtjevu 9, naznačen time da je diluent laktoza monohidrat.
11. Pripravak prema zahtjevu 9 ili 10, naznačen time da čestice sadrže 5 do 95% po masi diluenta u odnosu na ukupnu masu čestica.
12. Pripravak prema zahtjevu 2, koji sadrži čestice, a spomenute čestice sadrže - Brivaracetam kao aktivni sastojak; - do 60% po masi bar jednog ciklodekstrin agensa; - 0.5 do 25% po masi dezintegranta; i - 5 do 95% po masi diluenta; u odnosu na ukupnu masu čestica.
13. Pripravak prema zahtjevu 2, koji se sastoji od čestica, a spomenute čestice sadrže - Brivaracetam kao aktivni sastojak; - do 60% po masi bar jednog ciklodekstrin agensa; - 0.5 do 25% po masi natrij kroskarmeloze; i - 5 do 95 po masi% laktoze monohidrata; u odnosu na ukupnu masu čestica.
14. Postupak za pripremu pripravaka prema bilo kojem od prethodnih zahtjeva, naznačen time što uključuje najmanje jedan korak suhe granulacije.
15. Postupak prema zahtjevu 14, koji uključuje - prvi korak u kojem se aktivni sastojak, ciklodekstrin agens, i ekscipijenti miješaju; - drugi korak u kojem se tako nastala mješavina komprimira i/ili kompaktira; i - treći korak u kojem se mješavina melje da se dobiju čestice.
16. Postupak prema zahtjevu 15 koji uključuje - četvrti korak u kojem se dobijene čestice, i ekscipijenti miješaju; i - peti korak u kojem se konačna mješavina komprimira i/ili kompaktira u cilju dobivanja tableta.
HRP20141006AT 2009-01-29 2014-10-21 Farmaceutski pripravci koji sadrže 2-okso-1-pirolidin derivate HRP20141006T1 (hr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP09100083 2009-01-29
PCT/EP2010/050892 WO2010094535A1 (en) 2009-01-29 2010-01-27 Pharmaceutical compositions comprising 2-oxo-1-pyrrolidine derivatives

Publications (1)

Publication Number Publication Date
HRP20141006T1 true HRP20141006T1 (hr) 2014-12-19

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Country Status (23)

Country Link
US (2) US20120108464A1 (hr)
EP (1) EP2391349B1 (hr)
JP (1) JP5576401B2 (hr)
KR (1) KR101640164B1 (hr)
CN (2) CN104083328B (hr)
AU (1) AU2010215646B2 (hr)
BR (1) BRPI1007161B1 (hr)
CA (1) CA2747395C (hr)
CY (1) CY1115673T1 (hr)
DK (1) DK2391349T3 (hr)
EA (1) EA022057B1 (hr)
ES (1) ES2511047T3 (hr)
HK (2) HK1161988A1 (hr)
HR (1) HRP20141006T1 (hr)
IL (1) IL213545A (hr)
ME (1) ME01927B (hr)
MX (1) MX2011007267A (hr)
PL (1) PL2391349T3 (hr)
PT (1) PT2391349E (hr)
RS (1) RS53554B1 (hr)
SI (1) SI2391349T1 (hr)
SM (1) SMT201400155B (hr)
WO (1) WO2010094535A1 (hr)

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* Cited by examiner, † Cited by third party
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BR112018012870A2 (pt) 2015-12-30 2018-12-04 Adamas Pharmaceuticals Inc métodos e composições para o tratamento de transtornos relacionados à crise
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CN109833300A (zh) * 2017-11-28 2019-06-04 浙江京新药业股份有限公司 一种抗癫痫药物口服组合物及其制备方法
CN110638743B (zh) * 2019-10-25 2023-03-28 乐普制药科技有限公司 一种含布立西坦的组合物
CN113288872A (zh) * 2020-02-21 2021-08-24 广东东阳光药业有限公司 一种2-吡咯烷酮衍生物的组合物及其制备方法
CN112933059A (zh) * 2021-03-25 2021-06-11 浙江昂利康制药股份有限公司 一种布立西坦片剂的干法制粒工艺
CN115192572B (zh) * 2021-04-08 2023-09-19 成都同道慧宜生物医药科技有限公司 布立西坦药剂、其制备方法和应用
CN115721624A (zh) * 2021-08-25 2023-03-03 北京海美源医药科技有限公司 一种布立西坦药物组合物及其制备方法和其应用

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Publication number Publication date
US10729653B2 (en) 2020-08-04
HK1198287A1 (en) 2015-03-27
EA022057B1 (ru) 2015-10-30
JP5576401B2 (ja) 2014-08-20
US20110281929A1 (en) 2011-11-17
EP2391349A1 (en) 2011-12-07
CA2747395A1 (en) 2010-08-26
CN104083328A (zh) 2014-10-08
RS53554B1 (en) 2015-02-27
IL213545A (en) 2016-05-31
PT2391349E (pt) 2014-10-27
PL2391349T3 (pl) 2014-12-31
IL213545A0 (en) 2011-07-31
JP2012516302A (ja) 2012-07-19
WO2010094535A1 (en) 2010-08-26
KR20120008022A (ko) 2012-01-25
BRPI1007161B1 (pt) 2022-03-22
US20120108464A1 (en) 2012-05-03
KR101640164B1 (ko) 2016-07-15
CN102292071B (zh) 2016-08-24
ES2511047T3 (es) 2014-10-22
MX2011007267A (es) 2011-08-15
CN104083328B (zh) 2017-04-12
CN102292071A (zh) 2011-12-21
SMT201400155B (it) 2015-01-15
EP2391349B1 (en) 2014-07-23
AU2010215646A1 (en) 2011-08-04
BRPI1007161A2 (pt) 2016-02-23
EA201101116A1 (ru) 2012-03-30
AU2010215646B2 (en) 2014-03-27
CA2747395C (en) 2015-01-13
HK1161988A1 (zh) 2012-08-17
CY1115673T1 (el) 2017-01-25
ME01927B (me) 2015-05-20
SI2391349T1 (sl) 2014-12-31
DK2391349T3 (da) 2014-11-03

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