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

    • 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
    • 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
    • A61K31/435—Heterocyclic 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
    • A61K31/4353—Heterocyclic 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
    • A61K31/4365—Heterocyclic 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
    • 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
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • 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
    • A61K9/2095—Tabletting 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
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—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
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
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)

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* Cited by examiner, † Cited by third party
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EP2398468B1 (en) 2009-02-17 2016-11-30 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
KR20140110096A (ko) 2010-04-08 2014-09-16 테바 파마슈티컬 인더스트리즈 리미티드 프라수그렐 염의 결정형
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.
EP2608773A4 (en) 2010-08-24 2014-03-05 Univ Rutgers FORMULATION AND MANUFACTURE OF PHARMACEUTICAL PRODUCTS BY IMPREGNATING ON POROUS SUBSTRATES
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
EP2722037A1 (en) * 2012-10-19 2014-04-23 Sanovel Ilac Sanayi ve Ticaret A.S. Prasugrel formulations
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
EP3486233B1 (en) 2017-03-27 2021-01-27 Fruithy Holdings Limited Poorly soluble complex or solvate thereof, pharmaceutical composition, and application thereof
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
WO2024033460A1 (en) * 2022-08-12 2024-02-15 F. Hoffmann-La Roche Ag Use of co-processed excipients in continuous manufacturing of solid dosage forms

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WO2008060934A2 (en) * 2006-11-14 2008-05-22 Acusphere, Inc. Formulations of tetrahydropyridine antiplatelet agents for parenteral or oral administration
TWI428151B (zh) * 2006-12-07 2014-03-01 Daiichi Sankyo Co Ltd 含有甘露醇或乳糖之固形製劑
KR20090087041A (ko) 2006-12-07 2009-08-14 일라이 릴리 앤드 캄파니 프라수그렐을 포함하는 물품
BRPI0719395C1 (pt) * 2006-12-07 2021-05-25 Daiichi Sankyo Co Ltd tablete revestido de filme
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EP2398468B1 (en) 2009-02-17 2016-11-30 KRKA, D.D., Novo Mesto Pharmaceutical compositions comprising prasugrel base or its pharmaceutically acceptable acid addition salts and processes for their preparation
WO2011004392A1 (en) 2009-07-06 2011-01-13 Glenmark Generics Limited Crystalline form of prasugrel hydrobromide, preparation and application thereof

Also Published As

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

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