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PL2398468T3 - Kompozycje farmaceutyczne zawierające zasadę prasugrelu lub jej farmaceutycznie dopuszczalne kwasowe sole addycyjne i sposoby ich otrzymywania - Google Patents

Kompozycje farmaceutyczne zawierające zasadę prasugrelu lub jej farmaceutycznie dopuszczalne kwasowe sole addycyjne i sposoby ich otrzymywania

Info

Publication number
PL2398468T3
PL2398468T3 PL10704517T PL10704517T PL2398468T3 PL 2398468 T3 PL2398468 T3 PL 2398468T3 PL 10704517 T PL10704517 T PL 10704517T PL 10704517 T PL10704517 T PL 10704517T PL 2398468 T3 PL2398468 T3 PL 2398468T3
Authority
PL
Poland
Prior art keywords
processes
preparation
pharmaceutically acceptable
pharmaceutical compositions
acid addition
Prior art date
Application number
PL10704517T
Other languages
English (en)
Inventor
Simon Kukec
Mitja Stukelj
Franc Vrecer
Sabina Trost
Klavdija Meznar
Alen Kljajic
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=42104454&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=PL2398468(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Krka, D.D., Novo Mesto filed Critical Krka, D.D., Novo Mesto
Publication of PL2398468T3 publication Critical patent/PL2398468T3/pl

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
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/4353Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/4365Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system having sulfur as a ring hetero atom, e.g. ticlopidine
    • 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
    • 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
    • A61K9/2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • 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
    • A61K9/2095Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • 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
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Steroid Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
PL10704517T 2009-02-17 2010-02-17 Kompozycje farmaceutyczne zawierające zasadę prasugrelu lub jej farmaceutycznie dopuszczalne kwasowe sole addycyjne i sposoby ich otrzymywania PL2398468T3 (pl)

Applications Claiming Priority (8)

Application Number Priority Date Filing Date Title
SI200900040 2009-02-17
SI200900155 2009-06-02
SI200900186 2009-07-09
SI200900194 2009-07-15
SI200900309 2009-10-20
SI200900396 2009-12-28
SI201000006 2010-01-14
EP10704517.1A EP2398468B1 (en) 2009-02-17 2010-02-17 Pharmaceutical compositions comprising prasugrel base or its pharmaceutically acceptable acid addition salts and processes for their preparation

Publications (1)

Publication Number Publication Date
PL2398468T3 true PL2398468T3 (pl) 2017-06-30

Family

ID=42104454

Family Applications (1)

Application Number Title Priority Date Filing Date
PL10704517T PL2398468T3 (pl) 2009-02-17 2010-02-17 Kompozycje farmaceutyczne zawierające zasadę prasugrelu lub jej farmaceutycznie dopuszczalne kwasowe sole addycyjne i sposoby ich otrzymywania

Country Status (5)

Country Link
EP (1) EP2398468B1 (pl)
EA (1) EA024980B1 (pl)
PL (1) PL2398468T3 (pl)
SI (1) SI2398468T1 (pl)
WO (1) WO2010094471A1 (pl)

Families Citing this family (26)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010094471A1 (en) 2009-02-17 2010-08-26 Krka, D. D., Novo Mesto Pharmaceutical compositions comprising prasugrel base or its pharmaceutically acceptable acid addition salts and processes for their preparation
DE102009036646A1 (de) * 2009-08-07 2011-02-10 Ratiopharm Gmbh Prasugrel in nicht-kristalliner Form und pharmazeutische Zusammensetzung davon
JP2013032289A (ja) * 2009-10-28 2013-02-14 Daiichi Sankyo Co Ltd ワックス安定製剤
WO2011052499A1 (ja) * 2009-10-28 2011-05-05 第一三共株式会社 貯蔵安定性が改善された医薬組成物
EP2360159A1 (de) 2010-02-11 2011-08-24 Ratiopharm GmbH Prasugrel in mikronisierter, kristalliner Form und pharmazeutische Zusammensetzung davon
EP2883877A1 (en) 2010-04-08 2015-06-17 Teva Pharmaceutical Industries, Ltd. Crystalline forms of prasugrel salts
CN102232949A (zh) * 2010-04-27 2011-11-09 孙远 提高药物溶出度的组合物及其制备方法
TR201005900A1 (tr) * 2010-07-19 2012-02-21 Sanovel İlaç San. Ve Ti̇c. A.Ş. Geliştirilmiş stabiliteye sahip prasugrel granülleri.
WO2012027222A1 (en) 2010-08-24 2012-03-01 Rutgers, The State University Of New Jersey Formulation and manufacture of pharmaceuticals by impregnation onto porous carriers
TWI557130B (zh) * 2011-04-25 2016-11-11 孫遠 提高藥物溶出度的組成物及其製備方法
CZ2011872A3 (cs) 2011-12-22 2013-07-03 Zentiva, K.S. Farmaceutická formulace prasugrelu hydrobromidu
US8603537B2 (en) 2012-04-02 2013-12-10 Egis Pharmaceuticals Plc Prasugrel containing quickly released stable oral pharmaceutical compositions
WO2014060554A1 (en) * 2012-10-19 2014-04-24 Sanovel Ilac Sanayi Ve Ticaret A.S. Prasugrel formulations
WO2014060560A1 (en) * 2012-10-19 2014-04-24 Sanovel Ilac Sanayi Ve Ticaret A.S. Solid oral formulations of prasugrel
CN103893137B (zh) * 2012-12-27 2017-09-29 上海创诺制药有限公司 一种制备普拉格雷片剂的方法
CN104173316B (zh) * 2013-05-22 2018-05-18 山东新时代药业有限公司 一种氢溴酸普拉格雷的胶囊剂
EP2979693A1 (en) * 2014-08-01 2016-02-03 Zaklady Farmaceutyczne Polpharma SA Pharmaceutical composition comprising prasugrel or pharmaceutically acceptable salt thereof and process for its preparation
WO2016122421A1 (en) * 2015-01-29 2016-08-04 Pharmactive Ilaç Sanayi Ve Ticaret A.Ş. Stable pharmaceutical compositions containing prasugrel base
EP3156049A1 (en) * 2015-10-15 2017-04-19 Alembic Pharmaceuticals Limited Pharmaceutical composition of prasugrel
GR1009230B (el) * 2016-10-12 2018-02-22 Φαρματεν Αβεε Φαρμακευτικο σκευασμα που περιλαμβανει βεσυλικη πρασουγρελη
EP3528790A1 (en) 2016-10-21 2019-08-28 Laboratorios Lesvi S.L. Pharmaceutical formulations of prasugrel and processes for the preparation thereof
EA039449B1 (ru) 2017-03-27 2022-01-28 Фрути Холдингс Лимитед Слаборастворимый комплекс или его сольват, фармацевтическая композиция и их применение
CN111714458A (zh) * 2019-03-18 2020-09-29 上海复星星泰医药科技有限公司 盐酸普拉格雷的缓释颗粒、含其的制剂及其制备方法
WO2021188517A1 (en) * 2020-03-17 2021-09-23 Rutgers, The State University Of New Jersey Continuous melt-coating of active pharmaceutical ingredients using surfactants for dissolution enhancement
JP7584249B2 (ja) * 2020-07-27 2024-11-15 東和薬品株式会社 プラスグレルを含む混合物の混合方法及びその利用
EP4568654A1 (en) * 2022-08-12 2025-06-18 F. Hoffmann-La Roche AG Use of co-processed excipients in continuous manufacturing of solid dosage forms

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PE71699A1 (es) 1997-02-07 1999-08-03 Sepracor Inc Composicion farmaceutica de descarboetoxiloratadina sin lactosa, no higroscopica y anhidra
US20030013740A1 (en) 1998-03-27 2003-01-16 Martin P. Redmon Stable dosage forms of fluoxetine and its enantiomers
ES2305606T3 (es) 1999-04-06 2008-11-01 Sepracor Inc. Succinato de o-desmetilvenlafaxina.
US6448323B1 (en) 1999-07-09 2002-09-10 Bpsi Holdings, Inc. Film coatings and film coating compositions based on polyvinyl alcohol
EP1298132B1 (en) 2000-07-06 2006-11-22 Sankyo Company, Limited Hydropyridine derivative acid addition salts
CA2379887C (en) 2002-04-09 2004-01-20 Bernard Charles Sherman Stable tablets comprising simvastatin
JP2006525328A (ja) * 2003-05-05 2006-11-09 イーライ リリー アンド カンパニー 心疾患の治療方法
GB0325603D0 (en) 2003-11-03 2003-12-10 Sandoz Ag Organic compounds
AU2006336417A1 (en) 2005-05-10 2007-08-02 Elan Pharma International, Limited Nanoparticulate clopidogrel formulations
TWI318571B (en) 2005-06-10 2009-12-21 Lilly Co Eli Formulation of a thienopyridine platelet aggregation inhibitor
EP1940399A2 (en) 2005-08-19 2008-07-09 Eli Lilly & Company Use of par-i/par- 4 inhibitors for treating or preventing vascular diseases
JP5535616B2 (ja) 2006-03-31 2014-07-02 ルビコン リサーチ プライベート リミテッド 口腔内崩壊錠剤のための直接圧縮性複合材
WO2008060934A2 (en) * 2006-11-14 2008-05-22 Acusphere, Inc. Formulations of tetrahydropyridine antiplatelet agents for parenteral or oral administration
CA2672134C (en) * 2006-12-07 2015-02-10 Daiichi Sankyo Company, Limited Solid medicinal preparation containing mannitol or lactose
US20090291138A1 (en) * 2006-12-07 2009-11-26 Daiichi Sankyo Company, Limited Film-coated preparation having improved stability
CN101568339A (zh) 2006-12-07 2009-10-28 伊莱利利公司 普拉格雷的制品
US20100261908A1 (en) 2007-11-09 2010-10-14 Dr. Reddy's Laboratories Ltd. Processes for the preparation of prasugrel , and its salts and polymorphs
KR20100134557A (ko) 2008-01-11 2010-12-23 씨아이피엘에이 엘티디. 고체 약제학적 투여 제형
EP2112155B1 (en) 2008-04-25 2010-09-29 Sandoz AG Hydrogensulfate salt of 2-acetoxy-5-(a-cyclopropylcarbonyl-2-fluorobenzyl)-4,5,6,7-tetrahydrothieno[3,2-c]pyridine and its preparation
US20090281136A1 (en) 2008-05-08 2009-11-12 Sandeep Mhetre Prasugrel pharmaceutical formulations
WO2010094471A1 (en) 2009-02-17 2010-08-26 Krka, D. D., Novo Mesto Pharmaceutical compositions comprising prasugrel base or its pharmaceutically acceptable acid addition salts and processes for their preparation
EP2451816A4 (en) 2009-07-06 2013-02-27 Glenmark Generics Ltd CRYSTALLINE FORM OF PRASUGREL HYDROBROMIDE AND PROCESS FOR PREPARING THE SAME

Also Published As

Publication number Publication date
EP2398468A1 (en) 2011-12-28
SI2398468T1 (sl) 2017-03-31
EA201190145A1 (ru) 2012-02-28
EP2398468B1 (en) 2016-11-30
EA024980B1 (ru) 2016-11-30
WO2010094471A1 (en) 2010-08-26

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