ES2631980T3 - Formas de dosificación orales farmacéuticas que comprenden dabigatrán etexilato y sus sales farmacéuticamente aceptables - Google Patents
Formas de dosificación orales farmacéuticas que comprenden dabigatrán etexilato y sus sales farmacéuticamente aceptables Download PDFInfo
- Publication number
- ES2631980T3 ES2631980T3 ES11732405.3T ES11732405T ES2631980T3 ES 2631980 T3 ES2631980 T3 ES 2631980T3 ES 11732405 T ES11732405 T ES 11732405T ES 2631980 T3 ES2631980 T3 ES 2631980T3
- Authority
- ES
- Spain
- Prior art keywords
- coated
- dabigatran etexilate
- pharmaceutically acceptable
- acceptable salts
- dosage forms
- Prior art date
- Legal status (The legal status 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 status listed.)
- Active
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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
- A61K9/5078—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings with drug-free core
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1682—Processes
-
- 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
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
- A61K31/4439—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
- A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
Landscapes
- Health & Medical Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Chemical & Material Sciences (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Procedimiento para la preparación de una forma de dosificación oral sólida que comprende dabigatrán etexilato o una sal del mismo como sustancia activa y que comprende un núcleo esférico, en el que (a) el núcleo esférico se recubre con una disolución de ácido tartárico y opcionalmente un aglutinante y/o excipientes farmacéuticos inertes adicionales sin formación de capas en polvo de ácido tartárico, (b) el núcleo recubierto de la etapa (a) se recubre con una capa aislante, y (c) el núcleo recubierto con una capa aislante de la etapa (b) se recubre con capas adicionales en el que por lo menos una de las capas adicionales es una capa que comprende la sustancia activa.
Description
Claims (1)
-
imagen1
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
SI201000196 | 2010-07-01 | ||
SI201000196 | 2010-07-01 | ||
SI201000209 | 2010-07-12 | ||
SI201000209 | 2010-07-12 | ||
PCT/EP2011/061140 WO2012001156A2 (en) | 2010-07-01 | 2011-07-01 | Pharmaceutical oral dosage forms comprising dabigatran etexilate and its pharmaceutically acceptable salts |
Publications (1)
Publication Number | Publication Date |
---|---|
ES2631980T3 true ES2631980T3 (es) | 2017-09-07 |
Family
ID=44628481
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
ES11732405.3T Active ES2631980T3 (es) | 2010-07-01 | 2011-07-01 | Formas de dosificación orales farmacéuticas que comprenden dabigatrán etexilato y sus sales farmacéuticamente aceptables |
Country Status (8)
Country | Link |
---|---|
US (1) | US20130177652A1 (es) |
EP (1) | EP2588090B2 (es) |
EA (1) | EA022969B1 (es) |
ES (1) | ES2631980T3 (es) |
PL (1) | PL2588090T3 (es) |
PT (1) | PT2588090T (es) |
SI (1) | SI2588090T1 (es) |
WO (1) | WO2012001156A2 (es) |
Families Citing this family (19)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
SI2817000T1 (sl) * | 2012-02-21 | 2022-02-28 | Towa Pharmaceutical Europe, S.L. | Oralna farmacevtska sestava dabigatran eteksilata |
EP2740471B1 (en) | 2012-12-07 | 2015-05-27 | Hexal AG | Oral pharmaceutical composition comprising dabigatran etexilate |
CN103127109B (zh) * | 2013-02-05 | 2014-08-13 | 南京华威医药科技开发有限公司 | 含达比加群酯或其盐和水合物的药用组合 |
EP2835370A1 (en) | 2013-08-08 | 2015-02-11 | Medichem, S.A. | New crystals of dabigatran etexilate mesylate |
WO2015071841A1 (en) | 2013-11-12 | 2015-05-21 | Druggability Technologies Holdings Limited | Complexes of dabigatran and its derivatives, process for the preparation thereof and pharmaceutical compositions containing them |
WO2015113324A1 (zh) * | 2014-01-30 | 2015-08-06 | 杭州领业医药科技有限公司 | 达比加群酯及其盐的投药制剂及其制备方法 |
US20150366813A1 (en) * | 2014-06-20 | 2015-12-24 | Banner Life Sciences Llc | Liquid-filled immediate release soft gelatin capsules |
WO2016016853A1 (en) * | 2014-07-31 | 2016-02-04 | Sun Pharmaceutical Industries Limited | Method of controlling carbamoyl impurity in pharmaceutical compositions of dabigatran |
CN105640909B (zh) * | 2014-11-14 | 2019-09-20 | 正大天晴药业集团股份有限公司 | 一种含有达比加群酯的药用组合物 |
WO2019004980A2 (en) * | 2017-05-10 | 2019-01-03 | Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi | SOLID ORAL PHARMACEUTICAL COMPOSITIONS OF DABIGATRAN DEXILATE |
TR201706848A2 (tr) * | 2017-05-10 | 2018-11-21 | Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi | Dabigatran eteksi̇lat i̇çeren kati oral farmasöti̇k kompozi̇syonlar |
TR201722323A2 (tr) | 2017-12-27 | 2019-07-22 | Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi | Dabi̇gatranin oral farmasöti̇k kompozi̇syonlari |
TR201722186A2 (tr) | 2017-12-27 | 2019-07-22 | Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi | Dabi̇gatranin farmasöti̇k kompozi̇syonlari |
TR201722630A2 (es) | 2017-12-28 | 2019-07-22 | Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi | |
WO2020032885A2 (en) * | 2018-05-04 | 2020-02-13 | Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi | Capsule-in-capsule compositions of dabigatran etexilate |
EP3771465A1 (en) | 2019-08-01 | 2021-02-03 | Zaklady Farmaceutyczne Polpharma SA | Pharmaceutical composition comprising dabigatran etexilate |
EP4061369A4 (en) * | 2019-11-19 | 2024-04-10 | Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi | PHARMACEUTICAL FORM COMPRISING AN ACIDIC SUBSTANCE |
WO2023139243A1 (en) * | 2022-01-21 | 2023-07-27 | Adamed Pharma S.A | A process for preparation of tartaric acid cores for dabigatran pellets and the pellets containing dabigatran |
CN116687877B (zh) * | 2023-08-07 | 2023-11-10 | 山东国邦药业有限公司 | 一种酒石酸泰万菌素干混悬剂及其制备方法 |
Family Cites Families (11)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
PE121699A1 (es) | 1997-02-18 | 1999-12-08 | Boehringer Ingelheim Pharma | Heterociclos biciclicos disustituidos como inhibidores de la trombina |
SI1870100T1 (sl) | 2002-03-07 | 2012-05-31 | Boehringer Ingelheim Int | Metansulfonat etil estra heksiloksikarbonilamino imino metil fenilamino metil metil H benzimidazol karbonil piridin il amino propionske kisline |
US20030181488A1 (en) | 2002-03-07 | 2003-09-25 | Boehringer Ingelheim Pharma Gmbh & Co. Kg | Administration form for the oral application of 3-[(2-{[4-(hexyloxycarbonylamino-imino-methyl)-phenylamino]-methyl}-1-methyl-1H-benzimidazol-5-carbonyl)-pyridin-2-yl-amino]-propionic acid ethyl ester and the salts thereof |
DE10337697A1 (de) | 2003-08-16 | 2005-03-24 | Boehringer Ingelheim Pharma Gmbh & Co. Kg | Tablette enthaltend 3-[(2-{[4-(Hexyloxycarbonylamino-imino-methyl)-phenyl-amino]-methyl}-1-methyl-1H-benzimidazol-5-carbonyl)-pyridin-2-yl-amino]-propionsäure-ethylester oder dessen Salze |
DE10339862A1 (de) | 2003-08-29 | 2005-03-24 | Boehringer Ingelheim Pharma Gmbh & Co. Kg | 3-[(2-{[4-(Hexyloxycarbonylamino-imino-methyl)- phenylamino]-methyl}-1-methyl-1H-benzimidazol-5-carbonyl)-pyridin-2-yl-amino]-propionsäure-ethylester-Methansulfonat und dessen Verwendung als Arzneimittel |
DE10341043A1 (de) | 2003-09-03 | 2005-03-31 | Boehringer Ingelheim Pharma Gmbh & Co. Kg | Neue oral zu applizierende Darreichungsform für 3-[(2-{[4-Hexyloxycarbonylamino-imino-methyl)-phenylamino]-methyl}-1-methyl-1H-benzimidazol-5-carbonyl)-pyridin-2-yl-amino]-propionsäure-ethylester und dessen Salze |
WO2009097156A1 (en) * | 2008-02-01 | 2009-08-06 | Barr Laboratories, Inc. | Pharmaceutical capsules comprising extended release dipyridamole pellets |
US20110129538A1 (en) | 2008-03-28 | 2011-06-02 | Boehringer Ingelheim International Gmbh | Process for preparing orally administered dabigatran formulations |
WO2009118321A1 (de) | 2008-03-28 | 2009-10-01 | Boehringer Ingelheim International Gmbh | Verfahren zur herstellung von säurepellets |
US8277804B2 (en) * | 2008-05-21 | 2012-10-02 | Alderbio Holdings Llc | Antagonists of IL-6 to prevent or treat thrombosis |
EP2638897A1 (en) * | 2008-07-14 | 2013-09-18 | Boehringer Ingelheim International Gmbh | Method for Manufacturing medicinal Compounds containing Dabigatran |
-
2011
- 2011-07-01 PT PT117324053T patent/PT2588090T/pt unknown
- 2011-07-01 EP EP11732405.3A patent/EP2588090B2/en active Active
- 2011-07-01 ES ES11732405.3T patent/ES2631980T3/es active Active
- 2011-07-01 EA EA201291421A patent/EA022969B1/ru unknown
- 2011-07-01 PL PL11732405T patent/PL2588090T3/pl unknown
- 2011-07-01 WO PCT/EP2011/061140 patent/WO2012001156A2/en active Application Filing
- 2011-07-01 US US13/807,882 patent/US20130177652A1/en not_active Abandoned
- 2011-07-01 SI SI201131189A patent/SI2588090T1/sl unknown
Also Published As
Publication number | Publication date |
---|---|
EA022969B1 (ru) | 2016-03-31 |
WO2012001156A3 (en) | 2012-08-30 |
US20130177652A1 (en) | 2013-07-11 |
EA201291421A1 (ru) | 2013-05-30 |
PT2588090T (pt) | 2017-06-26 |
PL2588090T3 (pl) | 2017-12-29 |
EP2588090B1 (en) | 2017-04-19 |
WO2012001156A2 (en) | 2012-01-05 |
SI2588090T1 (sl) | 2017-06-30 |
EP2588090B2 (en) | 2023-11-22 |
EP2588090A2 (en) | 2013-05-08 |
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