EA029539B8 - Фармацевтическая композиция ситаглиптина - Google Patents

Фармацевтическая композиция ситаглиптина

Info

Publication number
EA029539B8
EA029539B8 EA201391371A EA201391371A EA029539B8 EA 029539 B8 EA029539 B8 EA 029539B8 EA 201391371 A EA201391371 A EA 201391371A EA 201391371 A EA201391371 A EA 201391371A EA 029539 B8 EA029539 B8 EA 029539B8
Authority
EA
Eurasian Patent Office
Prior art keywords
sitagliptin
pharmaceutical composition
pharmaceutical compositions
compositions
processes
Prior art date
Application number
EA201391371A
Other languages
English (en)
Other versions
EA029539B1 (ru
EA201391371A1 (ru
Inventor
Мая Прескар
Весна Крошель
Сабина Трошт
Луция Хвалец
Ален Кляйиц
Полона Буковец
Original Assignee
Крка, Товарна Здравил, Д.Д., Ново Место
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 Крка, Товарна Здравил, Д.Д., Ново Место filed Critical Крка, Товарна Здравил, Д.Д., Ново Место
Publication of EA201391371A1 publication Critical patent/EA201391371A1/ru
Publication of EA029539B1 publication Critical patent/EA029539B1/ru
Publication of EA029539B8 publication Critical patent/EA029539B8/ru

Links

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
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K31/4985Pyrazines or piperazines ortho- or peri-condensed with heterocyclic ring systems
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

Изобретение относится к стабильным фармацевтическим композициям, содержащим аморфный ситаглиптин, а также к способам получения этих композиций. Фармацевтические композиции получают из раствора, содержащего ситаглиптин и ингибитор кристаллизации.
EA201391371A 2011-03-29 2012-03-29 Фармацевтическая композиция ситаглиптина EA029539B8 (ru)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
SI201100115 2011-03-29
PCT/EP2012/055736 WO2012131005A1 (en) 2011-03-29 2012-03-29 Pharmaceutical composition of sitagliptin

Publications (3)

Publication Number Publication Date
EA201391371A1 EA201391371A1 (ru) 2014-02-28
EA029539B1 EA029539B1 (ru) 2018-04-30
EA029539B8 true EA029539B8 (ru) 2018-06-29

Family

ID=45922684

Family Applications (1)

Application Number Title Priority Date Filing Date
EA201391371A EA029539B8 (ru) 2011-03-29 2012-03-29 Фармацевтическая композиция ситаглиптина

Country Status (4)

Country Link
EP (1) EP2691083B1 (ru)
EA (1) EA029539B8 (ru)
SI (1) SI2691083T1 (ru)
WO (1) WO2012131005A1 (ru)

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WO2013084210A1 (en) * 2011-12-08 2013-06-13 Ranbaxy Laboratories Limited Amorphous form of sitagliptin salts
IN2014MU00212A (ru) * 2014-01-21 2015-08-28 Cadila Healthcare Ltd
WO2015114152A1 (en) * 2014-02-03 2015-08-06 Galenicum Health S.L. Stable pharmaceutical compositions containing sitagliptin in the form of immediate release tablets
IN2014MU00651A (ru) * 2014-02-25 2015-10-23 Cadila Healthcare Ltd
CN108144065B (zh) * 2016-12-06 2023-05-16 江苏恒瑞医药股份有限公司 一种dpp-4抑制剂的药物组合物
MX2016016260A (es) 2016-12-08 2018-06-07 Alparis Sa De Cv Nuevas formas solidas de sitagliptina.
WO2019094688A1 (en) * 2017-11-10 2019-05-16 Dispersol Technologies, Llc Improved drug formulations
WO2021076066A1 (en) 2019-10-14 2021-04-22 Santa Farma İlaç Sanayi̇ A.Ş. Oral formulations comprising sitagliptin hci monohydrate with improved pharmaceutical characteristics
EP3811930A1 (en) * 2019-10-24 2021-04-28 Authenda Pharmaceuticals AG Oral gliptin compositions and method for preparation thereof
GR1010089B (el) 2020-09-15 2021-09-27 Φαρματεν Α.Β.Ε.Ε. Στερεη φαρμακοτεχνικη μορφη περιεχουσα σιταγλιπτινη και μεθοδος παρασκευης αυτης
CN116459227B (zh) * 2023-05-11 2024-07-26 宙晟智维生命科学(上海)有限公司 一种西格列汀片及其制备方法

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WO2006033848A1 (en) * 2004-09-15 2006-03-30 Merck & Co., Inc. Amorphous form of a phosphoric acid salt of a dipeptidyl peptidase-iv inhibitor
US20070172525A1 (en) * 2007-03-15 2007-07-26 Ramesh Sesha Anti-diabetic combinations
WO2008000418A2 (en) * 2006-06-27 2008-01-03 Sandoz Ag New method for salt preparation
US20080064701A1 (en) * 2007-04-24 2008-03-13 Ramesh Sesha Anti-diabetic combinations
WO2009111200A1 (en) * 2008-03-04 2009-09-11 Merck & Co., Inc. Pharmaceutical compositions of a combination of metformin and a dipeptidyl peptidase-iv inhibitor
US20100249140A1 (en) * 2009-03-30 2010-09-30 Teva Pharmaceutical Industries Ltd. Solid state forms of sitagliptin salts
WO2011127106A1 (en) * 2010-04-08 2011-10-13 Bristol-Myers Squibb Company Pyrimidinylpiperidinyloxypyridinone analogues as gpr119 modulators
WO2012031124A2 (en) * 2010-09-03 2012-03-08 Bristol-Myers Squibb Company Drug formulations using water soluble antioxidants
WO2012076973A2 (en) * 2010-12-09 2012-06-14 Aurobindo Pharma Limited Novel salts of dipeptidyl peptidase iv inhibitor

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UA74912C2 (en) 2001-07-06 2006-02-15 Merck & Co Inc Beta-aminotetrahydroimidazo-(1,2-a)-pyrazines and tetratriazolo-(4,3-a)-pyrazines as inhibitors of dipeptylpeptidase for the treatment or prevention of diabetes
JO2625B1 (en) 2003-06-24 2011-11-01 ميرك شارب اند دوم كوربوريشن Phosphoric acid salts of dipeptidyl betidase inhibitor 4
JP2007504230A (ja) 2003-09-02 2007-03-01 メルク エンド カムパニー インコーポレーテッド ジペプチジルペプチダーゼ−iv阻害剤のリン酸塩の新規結晶性形態
EP1667524A4 (en) 2003-09-23 2009-01-14 Merck & Co Inc NOVEL CRYSTALLINE FORM OF A PHOSPHORIC ACID SALT OF A DIPEPTIDYL PEPTASE-IV INHIBITOR
WO2005072530A1 (en) 2004-01-16 2005-08-11 Merck & Co., Inc. Novel crystalline salts of a dipeptidyl peptidase-iv inhibitor
EP1909776A2 (en) 2005-07-25 2008-04-16 Merck & Co., Inc. Dodecylsulfate salt of a dipeptidyl peptidase-iv inhibitor
KR20070111099A (ko) 2006-05-16 2007-11-21 영진약품공업주식회사 시타글립틴 염산염의 신규 결정형, 이의 제조 방법과 이를포함하는 약학적 조성물
WO2009084024A2 (en) 2007-11-02 2009-07-09 Glenmark Generics Limited A process for the preparation of r-sit agliptin and its pharmaceutically acceptable salts thereof
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KR20110038011A (ko) 2008-07-03 2011-04-13 라티오팜 게엠베하 시타글립틴의 결정질 염
EP2324027B1 (en) 2008-07-29 2016-02-24 Medichem, S.A. New crystalline salt forms of a 5,6,7,8-tetrahydro-1,2,4- triazolo[4,3-a]pyrazine derivative
EP2331545B1 (en) 2008-08-27 2013-10-02 Cadila Healthcare Limited Improved process for preparation of (2r)-4-oxo-4-[3- (trifluoromethyl)-5,6-dihydro [1,2,4]-triazolo[4,3-a]pyrazin- 7(8h)-yl]-l-(2,4,5-trifluorophenyl)butan-2-amine&new impurities in preparation thereof
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WO2006033848A1 (en) * 2004-09-15 2006-03-30 Merck & Co., Inc. Amorphous form of a phosphoric acid salt of a dipeptidyl peptidase-iv inhibitor
WO2008000418A2 (en) * 2006-06-27 2008-01-03 Sandoz Ag New method for salt preparation
US20070172525A1 (en) * 2007-03-15 2007-07-26 Ramesh Sesha Anti-diabetic combinations
US20080064701A1 (en) * 2007-04-24 2008-03-13 Ramesh Sesha Anti-diabetic combinations
WO2009111200A1 (en) * 2008-03-04 2009-09-11 Merck & Co., Inc. Pharmaceutical compositions of a combination of metformin and a dipeptidyl peptidase-iv inhibitor
US20100249140A1 (en) * 2009-03-30 2010-09-30 Teva Pharmaceutical Industries Ltd. Solid state forms of sitagliptin salts
WO2011127106A1 (en) * 2010-04-08 2011-10-13 Bristol-Myers Squibb Company Pyrimidinylpiperidinyloxypyridinone analogues as gpr119 modulators
WO2012031124A2 (en) * 2010-09-03 2012-03-08 Bristol-Myers Squibb Company Drug formulations using water soluble antioxidants
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Also Published As

Publication number Publication date
EP2691083B1 (en) 2017-08-02
WO2012131005A1 (en) 2012-10-04
SI2691083T1 (sl) 2017-12-29
EA029539B1 (ru) 2018-04-30
EA201391371A1 (ru) 2014-02-28
EP2691083A1 (en) 2014-02-05

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MM4A Lapse of a eurasian patent due to non-payment of renewal fees within the time limit in the following designated state(s)

Designated state(s): AM AZ BY KZ KG MD TJ TM