SI3466951T1 - Proces za pripravo zaviralca CGMP-fosfodiesteraze in oralne farmacevtske formulacije, ki obsega koprecipitate tadalafila - Google Patents

Proces za pripravo zaviralca CGMP-fosfodiesteraze in oralne farmacevtske formulacije, ki obsega koprecipitate tadalafila

Info

Publication number
SI3466951T1
SI3466951T1 SI201531828T SI201531828T SI3466951T1 SI 3466951 T1 SI3466951 T1 SI 3466951T1 SI 201531828 T SI201531828 T SI 201531828T SI 201531828 T SI201531828 T SI 201531828T SI 3466951 T1 SI3466951 T1 SI 3466951T1
Authority
SI
Slovenia
Prior art keywords
tadalafil
cgmp
precipitates
preparation
pharmaceutical formulation
Prior art date
Application number
SI201531828T
Other languages
English (en)
Inventor
Matej Baric
Primoz Benkic
Sergeja Bombek
Dusan Krasovec
Vida Skrabanja
Franc Vrecer
Polona Bukovec
Grega Hudovornik
Vesna Kroselj
Original Assignee
Krka, 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
Application filed by Krka, D.D., Novo Mesto filed Critical Krka, D.D., Novo Mesto
Publication of SI3466951T1 publication Critical patent/SI3466951T1/sl

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D471/00—Heterocyclic compounds containing nitrogen atoms as the only ring hetero atoms in the condensed system, at least one ring being a six-membered ring with one nitrogen atom, not provided for by groups C07D451/00 - C07D463/00
    • C07D471/12—Heterocyclic compounds containing nitrogen atoms as the only ring hetero atoms in the condensed system, at least one ring being a six-membered ring with one nitrogen atom, not provided for by groups C07D451/00 - C07D463/00 in which the condensed system contains three hetero rings
    • C07D471/14—Ortho-condensed systems

Landscapes

  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Indole Compounds (AREA)
SI201531828T 2014-07-23 2015-07-23 Proces za pripravo zaviralca CGMP-fosfodiesteraze in oralne farmacevtske formulacije, ki obsega koprecipitate tadalafila SI3466951T1 (sl)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
SI201400267 2014-07-23
EP18205889.1A EP3466951B1 (en) 2014-07-23 2015-07-23 A process for the preparation of cgmp-phosphodiesterase inhibitor and oral pharmaceutical formulation comprising tadalafil co-precipitates

Publications (1)

Publication Number Publication Date
SI3466951T1 true SI3466951T1 (sl) 2022-05-31

Family

ID=53716504

Family Applications (2)

Application Number Title Priority Date Filing Date
SI201531828T SI3466951T1 (sl) 2014-07-23 2015-07-23 Proces za pripravo zaviralca CGMP-fosfodiesteraze in oralne farmacevtske formulacije, ki obsega koprecipitate tadalafila
SI201530752T SI3172207T1 (sl) 2014-07-23 2015-07-23 Proces za pripravo zaviralca CGMP-fosfodiesteraze in oralne farmacevtske formulacije, ki obsega koprecipitate tadalafila

Family Applications After (1)

Application Number Title Priority Date Filing Date
SI201530752T SI3172207T1 (sl) 2014-07-23 2015-07-23 Proces za pripravo zaviralca CGMP-fosfodiesteraze in oralne farmacevtske formulacije, ki obsega koprecipitate tadalafila

Country Status (4)

Country Link
EP (2) EP3172207B1 (sl)
EA (1) EA035390B1 (sl)
SI (2) SI3466951T1 (sl)
WO (1) WO2016012539A1 (sl)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109796461B (zh) * 2018-12-30 2020-09-25 江苏科本药业有限公司 一种他达拉非杂质i的制备工艺
RU2692764C1 (ru) * 2019-04-26 2019-06-27 Общество с ограниченной ответственностью "Балтфарма" Способ получения тадалафила
CN111072662B (zh) * 2019-12-23 2021-09-24 成都锦华药业有限责任公司 一种制备他达拉非i型晶体的方法
CN115184531B (zh) * 2021-04-07 2024-06-11 浙江康恩贝制药股份有限公司 一种同时测定他达拉非中3种杂质含量的方法
CN113880837A (zh) * 2021-11-04 2022-01-04 昆明源瑞制药有限公司 一种他达拉非的制备方法

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB9401090D0 (en) 1994-01-21 1994-03-16 Glaxo Lab Sa Chemical compounds
GB9511220D0 (en) 1995-06-02 1995-07-26 Glaxo Group Ltd Solid dispersions
UA71629C2 (en) 1999-08-03 2004-12-15 Lilli Icos Llc Composition containing free drug particulate form of ?-carboline (variants), method for its manufacture (variants), and method for treating sexual dysfunction
ES2318175T3 (es) * 2002-07-31 2009-05-01 Lilly Icos Llc Reaccion pictet-splenger modificada y productos preparados a partir de la misma.
KR101140110B1 (ko) 2006-07-07 2012-06-04 테바 파마슈티컬 인더스트리즈 리미티드 타달라필 및 하나 이상의 담체를 포함하는 고체 조성물
WO2008134557A2 (en) 2007-04-25 2008-11-06 Teva Pharmaceutical Industries Ltd. Solid dosage forms
US8586587B2 (en) 2009-02-26 2013-11-19 Thar Pharmaceuticals, Inc. Crystalline molecular complex of tadalafil and methylparaben
EP2238979A1 (en) 2009-04-06 2010-10-13 LEK Pharmaceuticals d.d. Active pharmaceutical ingredient adsorbed on solid support
DE102009035211A1 (de) 2009-07-29 2011-02-17 Ratiopharm Gmbh Copräzipitate umfassend einen Phosphodiesterase-5-Inhibitor (PDE-5-Inhibitor) und einen pharmazeutisch verträglichen Trägerstoff, ihre Herstellung und Verwendung
WO2012107092A1 (en) 2011-02-10 2012-08-16 Synthon Bv Pharmaceutical composition comprising tadalafil and a cyclodextrin
WO2012107541A1 (en) 2011-02-10 2012-08-16 Synthon Bv Pharmaceutical composition comprising tadalafil and a cyclodextrin
WO2014003677A1 (en) 2012-06-28 2014-01-03 Xspray Microparticles Ab Pharmaceutical compositions comprising solid dispersion particles containing tadalafil

Also Published As

Publication number Publication date
EA201790235A1 (ru) 2017-06-30
EA035390B1 (ru) 2020-06-05
EP3466951A1 (en) 2019-04-10
EP3172207A1 (en) 2017-05-31
EP3466951B1 (en) 2022-01-19
WO2016012539A1 (en) 2016-01-28
SI3172207T1 (sl) 2019-06-28
EP3172207B1 (en) 2019-03-06

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