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HRP20230613T1 - Tableta koja sadrži derivat metoksiureje i čestice manitola - Google Patents

Tableta koja sadrži derivat metoksiureje i čestice manitola Download PDF

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Publication number
HRP20230613T1
HRP20230613T1 HRP20230613TT HRP20230613T HRP20230613T1 HR P20230613 T1 HRP20230613 T1 HR P20230613T1 HR P20230613T T HRP20230613T T HR P20230613TT HR P20230613 T HRP20230613 T HR P20230613T HR P20230613 T1 HRP20230613 T1 HR P20230613T1
Authority
HR
Croatia
Prior art keywords
methoxyurea
tablet
film envelope
tetrahydrothieno
difluorobenzyl
Prior art date
Application number
HRP20230613TT
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English (en)
Inventor
Ikuro YAMANE
Yukihiro Nomura
Yutaka Nishimoto
Wataru Hoshina
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.)
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Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=56789547&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HRP20230613(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 HRP20230613T1 publication Critical patent/HRP20230613T1/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
    • A61K9/20Pills, 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
    • A61K9/20Pills, 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
    • A61K9/2013Organic 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
    • 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
    • A61K31/495Heterocyclic 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
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • A61K47/34Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • 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
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2886Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Claims (10)

1. Tableta koja sadrži: N-(4-(1-(2,6-difluorobenzil)-5-((dimetilamino)metil)-3-(6-metoksi-3-piridazinil)-2,4-diokso-1,2,3,4-tetrahidrotieno[2,3-d]pirimidin-6-il)fenil)-N'-metoksiureju ili njezinu sol u količini od 40 mg mjereno na temelju slobodnog oblika N-(4-(1-(2,6-difluorobenzil)-5-((dimetilamino)metil)-3-(6-metoksi-3-piridazinil)-2,4-diokso-1,2,3,4-tetrahidrotieno[2,3-d]pirimidin-6-il)fenil)-N'-metoksiureje, 51 mg čestica D-manitola koje imaju prosječnu veličinu čestica od 70 - 200 µm, 5 mg natrijevog škrobnog glikolata, 3 mg hidroksipropilceluloze, i 1 mg magnezijevog stearata.
2. Tableta prema zahtjevu 1, naznačena time što dodatno sadrži filmsku ovojnicu, pri čemu filmska ovojnica sadrži hidroksipropilmetilcelulozu, titanijev oksid i crveni željezov oksid.
3. Tableta prema zahtjevu 1, naznačena time što dodatno sadrži filmsku ovojnicu, pri čemu filmska ovojnica sadrži 3,56 mg hidroksipropilmetilceluloze, 0,40 mg titanijevog oksida i 0,04 mg crvenog željezovog oksida.
4. Tableta koja sadrži: N-(4-(1-(2,6-difluorobenzil)-5-((dimetilamino)metil)-3-(6-metoksi-3-piridazinil)-2,4-diokso-1,2,3,4-tetrahidrotieno[2,3-d]pirimidin-6-il)fenil)-N'-metoksiureju ili njezinu sol u količini od 120 mg mjereno na temelju slobodnog oblika N-(4-(1-(2,6-difluorobenzil)-5-((dimetilamino)metil)-3-(6-metoksi-3-piridazinil)-2,4-diokso-1,2,3,4-tetrahidrotieno[2,3-d]pirimidin-6-il)fenil)-N'-metoksiureje, 153 mg čestica D-manitola koje imaju prosječnu veličinu čestica od 70 - 200 µm, 15 mg natrijevog škrobnog glikolata, 9 mg hidroksipropilceluloze, i 3 mg magnezijevog stearata.
5. Tableta prema zahtjevu 4, naznačena time što dodatno sadrži filmsku ovojnicu, pri čemu filmska ovojnica sadrži hidroksipropilmetilcelulozu, titanijev oksid i crveni željezov oksid.
6. Tableta koja sadrži: N-(4-(1-(2,6-difluorobenzil)-5-((dimetilamino)metil)-3-(6-metoksi-3-piridazinil)-2,4-diokso-1,2,3,4-tetrahidrotieno[2,3-d]pirimidin-6-il)fenil)-N'-metoksiureju ili njezinu sol u količini od 80 mg mjereno na temelju slobodnog oblika N-(4-(1-(2,6-difluorobenzil)-5-((dimetilamino)metil)-3-(6-metoksi-3-piridazinil)-2,4-diokso-1,2,3,4-tetrahidrotieno[2,3-d]pirimidin-6-il)fenil)-N'-metoksiureje, 102 mg čestica D-manitola koje imaju prosječnu veličinu čestica od 70 - 200 µm, 10 mg natrijevog škrobnog glikolata, 6 mg hidroksipropilceluloze, i 2 mg magnezijevog stearata.
7. Tableta prema zahtjevu 6, naznačena time što dodatno sadrži filmsku ovojnicu, pri čemu filmska ovojnica sadrži hidroksipropilmetilcelulozu, titanijev oksid i crveni željezov oksid.
8. Tableta prema zahtjevu 6, naznačena time što dodatno sadrži filmsku ovojnicu, pri čemu filmska ovojnica sadrži 7,12 mg hidroksipropilmetilceluloze, 0,80 mg titanijevog oksida i 0,08 mg crvenog željezovog oksida.
9. Tableta prema bilo kojem od zahtjeva 1-8, naznačena time što čestice D-manitola imaju prosječnu veličinu čestica od 75 - 150 µm.
10. Postupak za izradu tablete prema bilo kojem od zahtjeva 1, 4 ili 6, naznačen time što navedeni postupak obuhvaća: 1) miješanje N-(4-(1-(2,6-difluorobenzil)-5-((dimetilamino)metil)-3-(6-metoksi-3-piridazinil)-2,4-diokso-1,2,3,4-tetrahidrotieno[2,3-d]pirimidin-6-il)fenil)-N'-metoksiureje ili njezine soli s česticama D-manitola koje imaju prosječnu veličinu čestica od 70 - 200 µm i natrijevog škrobnog glikolata; 2) raspršivanje u smjesu iz koraka 1) otopine hidroksipropilceluloze u otapalu ili mediju za raspršivanje; 3) sušenje ili prosijavanje smjese iz koraka 2) da se dobije granulirani prah ili prosijani prah; 4) dodavanje magnezijevog stearata u granulirani prah ili prosijani prah iz koraka 3) i miješanje da se dobiju granule za tabletiranje; 5) tabletiranje granula iz koraka 4) da se dobije jezgra tablete; i, izborno, 6) raspršivanje otopine za oblaganje filmom na jezgru tablete iz koraka 5) kako bi se dobila tableta obložena filmom.
HRP20230613TT 2015-02-26 2016-02-25 Tableta koja sadrži derivat metoksiureje i čestice manitola HRP20230613T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
JP2015037462 2015-02-26
PCT/JP2016/055540 WO2016136849A1 (ja) 2015-02-26 2016-02-25 固形製剤
EP16755593.7A EP3263110B1 (en) 2015-02-26 2016-02-25 A tablet comprising a methoxyurea derivative and mannitol particles

Publications (1)

Publication Number Publication Date
HRP20230613T1 true HRP20230613T1 (hr) 2023-09-29

Family

ID=56789547

Family Applications (1)

Application Number Title Priority Date Filing Date
HRP20230613TT HRP20230613T1 (hr) 2015-02-26 2016-02-25 Tableta koja sadrži derivat metoksiureje i čestice manitola

Country Status (23)

Country Link
US (2) US10350170B2 (hr)
EP (3) EP4233847B1 (hr)
JP (1) JP6730978B2 (hr)
CN (1) CN107249590A (hr)
AU (1) AU2016224503B2 (hr)
BR (1) BR112017018173A2 (hr)
CA (1) CA2978223A1 (hr)
CY (1) CY1126118T1 (hr)
DK (2) DK4233847T3 (hr)
ES (1) ES2950995T3 (hr)
FI (2) FI4233847T3 (hr)
HR (1) HRP20230613T1 (hr)
HU (1) HUE062269T2 (hr)
IL (1) IL254132B (hr)
LT (1) LT3263110T (hr)
MX (1) MX2017010945A (hr)
MY (1) MY180680A (hr)
PL (1) PL3263110T3 (hr)
PT (1) PT3263110T (hr)
RS (1) RS64377B1 (hr)
SI (1) SI3263110T1 (hr)
TW (1) TWI744224B (hr)
WO (1) WO2016136849A1 (hr)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
UY35058A (es) 2012-09-28 2014-04-30 Takeda Pharmaceutical Método de producción de derivado de tienopirimidina
MX2019003733A (es) * 2016-09-30 2019-09-26 Myovant Sciences Gmbh Tratamiento de cancer de prostata.
SI3518933T1 (sl) 2016-09-30 2022-06-30 Myovant Sciences Gmbh Metode zdravljenja materničnih miom in endometrioze
TW201912157A (zh) 2017-08-18 2019-04-01 美商艾伯維有限公司 治療子宮內膜異位症、子宮纖維瘤、多囊性卵巢症候群及子宮腺肌症之固體醫藥調配物
CN111698992A (zh) 2017-08-18 2020-09-22 艾伯维公司 用于治疗子宫内膜异位症、子宫肌瘤、多囊卵巢综合症或子宫腺肌症的药物配制物
EP3765464A1 (en) 2018-03-14 2021-01-20 Teva Pharmaceuticals USA, Inc. Solid state forms of relugolix
JP2022542159A (ja) 2019-08-02 2022-09-29 ジョンソン、マッセイ、パブリック、リミテッド、カンパニー 固体形態レルゴリクス(Relugolix)
JP7029875B1 (ja) 2020-05-15 2022-03-04 塩野義製薬株式会社 不純物の生成を抑制した医薬組成物
KR20230028732A (ko) 2020-05-29 2023-03-02 마이오반트 사이언시즈 게엠베하 고나도트로핀 방출 호르몬 길항제의 복합 고형 경구 투여 형태
EP4243829A1 (en) 2020-11-11 2023-09-20 Myovant Sciences GmbH Methods of administering relugolix
CN118451082A (zh) 2021-10-18 2024-08-06 住友制药瑞士有限公司 N-(4-(1-(2,6-二氟苄基)-5-((二甲基氨基)甲基)-3-(6-甲氧基-3-哒嗪基)-2,4-二氧代-1,2,3,4-四氢噻吩并[2,3-d]嘧啶-6-基)苯基)-N'-甲氧基脲的乙醇溶剂化物的结晶形式
CN115671069A (zh) * 2022-11-24 2023-02-03 北京鑫开元医药科技有限公司 一种瑞卢戈利片剂及其制备方法

Family Cites Families (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TW284688B (hr) 1991-11-20 1996-09-01 Takeda Pharm Industry Co Ltd
FR2710637B1 (fr) * 1993-09-28 1995-12-08 Roquette Freres Mannitol pulvérulent de friabilité modérée et son procédé de préparation.
JP3854648B2 (ja) * 1994-04-19 2006-12-06 武田薬品工業株式会社 縮合チオフェン誘導体、その製造法及び用途
TW449600B (en) 1994-04-19 2001-08-11 Takeda Chemical Industries Ltd Condensed-ring thiophene derivatives, their production and use
TWI225863B (en) * 1999-03-24 2005-01-01 Takeda Chemical Industries Ltd Thienopyrimidine compounds, their production and use
JP5072166B2 (ja) * 2002-01-30 2012-11-14 武田薬品工業株式会社 チエノピリミジン化合物、その製造法および用途
EP1479684A4 (en) 2002-01-30 2006-01-04 Takeda Pharmaceutical THIENOPYRIMIDINES, PROCESS FOR THEIR PRODUCTION AND THEIR USE
PL208114B1 (pl) * 2002-02-26 2011-03-31 Astrazeneca Ab Kompozycja farmaceutyczna, sposób jej wytwarzania i zastosowanie
JP4039574B2 (ja) * 2003-01-29 2008-01-30 武田薬品工業株式会社 チエノピリミジン化合物およびその用途
DK1591446T3 (da) 2003-01-29 2013-06-10 Takeda Pharmaceutical Thienopyrimidinforbindelser og anvendelse deraf.
JP2006035365A (ja) * 2004-07-26 2006-02-09 Hitachi Koki Co Ltd 携帯用切断工具
EP2329823A4 (en) * 2008-09-03 2013-04-03 Takeda Pharmaceutical METHOD FOR IMPROVING CAPACITY OF PREPARATION TO BE ABSORBED AND PREPARATION WHICH CAPACITY TO BE ABSORBED IS IMPROVED
JP2015037462A (ja) 2012-06-01 2015-02-26 株式会社コナミデジタルエンタテインメント ゲーム装置、ゲーム方法、及びプログラム
UY35058A (es) 2012-09-28 2014-04-30 Takeda Pharmaceutical Método de producción de derivado de tienopirimidina
JOP20200097A1 (ar) * 2013-01-15 2017-06-16 Aragon Pharmaceuticals Inc معدل مستقبل أندروجين واستخداماته

Also Published As

Publication number Publication date
TW201639575A (zh) 2016-11-16
RS64377B1 (sr) 2023-08-31
EP3263110A4 (en) 2018-11-07
DK4233847T3 (da) 2024-09-30
JP6730978B2 (ja) 2020-07-29
US20180036250A1 (en) 2018-02-08
HUE062269T2 (hu) 2023-10-28
ES2950995T3 (es) 2023-10-17
MY180680A (en) 2020-12-06
TWI744224B (zh) 2021-11-01
FI4233847T3 (fi) 2024-09-24
US20200000730A1 (en) 2020-01-02
CY1126118T1 (el) 2023-11-15
PL3263110T3 (pl) 2023-11-06
NZ735026A (en) 2021-09-24
WO2016136849A1 (ja) 2016-09-01
EP3263110B1 (en) 2023-05-10
JPWO2016136849A1 (ja) 2017-12-07
CN107249590A (zh) 2017-10-13
CA2978223A1 (en) 2016-09-01
FI3263110T3 (fi) 2023-07-25
EP4454708A2 (en) 2024-10-30
SI3263110T1 (sl) 2023-09-29
US10350170B2 (en) 2019-07-16
EP4233847A1 (en) 2023-08-30
BR112017018173A2 (pt) 2018-04-10
IL254132B (en) 2020-02-27
LT3263110T (lt) 2023-07-10
EP4233847B1 (en) 2024-07-10
EP4454708A3 (en) 2024-11-13
DK3263110T3 (da) 2023-07-31
MX2017010945A (es) 2018-07-06
EP3263110A1 (en) 2018-01-03
PT3263110T (pt) 2023-08-01
AU2016224503A1 (en) 2017-09-14
AU2016224503B2 (en) 2021-07-08
IL254132A0 (en) 2017-10-31

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