HRP20171518T1 - Tabletni pripravak bez prouzrokovanja kvarova kod tabletiranja - Google Patents

Tabletni pripravak bez prouzrokovanja kvarova kod tabletiranja Download PDF

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Publication number
HRP20171518T1
HRP20171518T1 HRP20171518TT HRP20171518T HRP20171518T1 HR P20171518 T1 HRP20171518 T1 HR P20171518T1 HR P20171518T T HRP20171518T T HR P20171518TT HR P20171518 T HRP20171518 T HR P20171518T HR P20171518 T1 HRP20171518 T1 HR P20171518T1
Authority
HR
Croatia
Prior art keywords
tablet
methyl
microcrystalline cellulose
benzonitrile
dioxo
Prior art date
Application number
HRP20171518TT
Other languages
English (en)
Inventor
Akihiko Ono
Shigeyuki Marunaka
Makoto Fukuta
Original Assignee
Takeda Pharmaceutical Company Limited
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=39156227&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HRP20171518(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Takeda Pharmaceutical Company Limited filed Critical Takeda Pharmaceutical Company Limited
Publication of HRP20171518T1 publication Critical patent/HRP20171518T1/hr

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Classifications

    • 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
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/513—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim having oxo groups directly attached to the heterocyclic ring, e.g. cytosine
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Diabetes (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Emergency Medicine (AREA)
  • Endocrinology (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Claims (9)

1. Tableta, naznačena time, da obuhvaća sljedeće (A) i (B): (A) granula koja obuhvaća farmaceutski djelotvorni sastojak odabran od 2-[[6-[(3R)-3-amino-1-piperidinil]-3,4-dihidro-3-metil-2,4-diokso-1(2H)-pirimidinil]metil]-benzonitrila i od jedne soli od 2-[[6-[(3R)-3-amino-1-piperidinil]-3,4-dihidro-3-metil-2,4-diokso-1(2H)-pirimidinil]metil]-benzonitrila, te mikrokristaličnu celulozu; (B) pomoćno sredstvo za tabletiranje, koje obuhvaća magnezijev stearat i mikrokristaličnu celulozu.
2. Tableta prema zahtjevu 1, naznačena time, da sadržaj mikrokristalične celuloze kod (A) i mikrokristalične celuloze kod (B) u tableti, iznosi od 5 do 40 masenih % odnosno od 2 do 20 masenih %.
3. Tableta prema zahtjevu 1, naznačena time, da je čvrstoća od 70 do 200 N.
4. Tableta prema zahtjevu 1, naznačena time, da je ne manje od 85% farmaceutski djelotvornog sastojka rastopljeno u 15 min, kada se tableta podvrgava ispitivanju rastapanja prema postupku miješanja s lopaticama (engl. Paddle Method) na 37°C, s 50 okretaja u minuti, s uporabom kao testne otopine 0,01 N klorovodične kiseline ili drugog fluida prema Japanskoj farmakopeji (pH-vrijednosti 6,8).
5. Tableta prema zahtjevu 1, naznačena time, da granula iz (A) nadalje obuhvaća manitol.
6. Postupak proizvodnje tablete, naznačen time, da obuhvaća miješanje (A) granule koja obuhvaća farmaceutski djelotvorni sastojak odabran od 2-[[6-[(3R)-3-amino-1-piperidinil]-3,4-dihidro-3-metil-2,4-diokso-1(2H)-pirimidinil]metil]-benzonitrila i sol od 2-[[6-[(3R)-3-amino-1-piperidinil]-3,4-dihidro-3-metil-2,4-diokso-1(2H)-pirimidinil]metil]-benzonitrila i mikrokristaličnu celulozu, s (B) pomoćnim sredstvom za tabletiranje, koje obuhvaća magnezijev stearat i mikrokristaličnu celulozu, a zatim udaranje smjese.
7. Postupak prema zahtjevu 6, naznačen time, da sadržaj mikrokristalične celuloze kod (A) i mikrokristalične celuloze kod (B) u tableti, iznosi od 5 do 40 masenih % odnosno od 2 do 20 masenih %.
8. Postupak prema zahtjevu 6, naznačen time, da granula od (A) nadalje obuhvaća manitol.
9. Tableta prema zahtjevu 1, naznačena time, da pomoćno sredstvo za tabletiranje nadalje obuhvaća dezintegrator.
HRP20171518TT 2007-02-01 2017-10-09 Tabletni pripravak bez prouzrokovanja kvarova kod tabletiranja HRP20171518T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
JP2007023584 2007-02-01
EP08710828.8A EP2124901B1 (en) 2007-02-01 2008-01-30 Tablet preparation without causing a tableting trouble
PCT/JP2008/051896 WO2008093878A1 (en) 2007-02-01 2008-01-30 Tablet preparation without causing a tableting trouble

Publications (1)

Publication Number Publication Date
HRP20171518T1 true HRP20171518T1 (hr) 2017-11-17

Family

ID=39156227

Family Applications (1)

Application Number Title Priority Date Filing Date
HRP20171518TT HRP20171518T1 (hr) 2007-02-01 2017-10-09 Tabletni pripravak bez prouzrokovanja kvarova kod tabletiranja

Country Status (11)

Country Link
US (1) US8697125B2 (hr)
EP (1) EP2124901B1 (hr)
JP (1) JP5284967B2 (hr)
AR (1) AR065096A1 (hr)
CA (1) CA2677193C (hr)
CL (1) CL2008000280A1 (hr)
ES (1) ES2639854T3 (hr)
HR (1) HRP20171518T1 (hr)
PE (1) PE20081734A1 (hr)
TW (1) TW200836774A (hr)
WO (1) WO2008093878A1 (hr)

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Also Published As

Publication number Publication date
JP2010517936A (ja) 2010-05-27
JP5284967B2 (ja) 2013-09-11
CA2677193A1 (en) 2008-08-07
US8697125B2 (en) 2014-04-15
US20090318482A1 (en) 2009-12-24
TW200836774A (en) 2008-09-16
WO2008093878A1 (en) 2008-08-07
EP2124901B1 (en) 2017-07-19
CA2677193C (en) 2015-06-30
CL2008000280A1 (es) 2008-08-18
PE20081734A1 (es) 2009-01-19
EP2124901A1 (en) 2009-12-02
ES2639854T3 (es) 2017-10-30
AR065096A1 (es) 2009-05-13

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