HRP20080150T4 - Postupak za proizvodnju krutog farmaceutskog sastava koji sadrži 5-klor-n-({(5s)-2-oksa-3-[4-(3-okso-4-morfolinil)-fenil]-1,3-oksazolidin-5-il}-metil)-2-tiofenkarboksamid i koji se može aplicirati oralno - Google Patents
Postupak za proizvodnju krutog farmaceutskog sastava koji sadrži 5-klor-n-({(5s)-2-oksa-3-[4-(3-okso-4-morfolinil)-fenil]-1,3-oksazolidin-5-il}-metil)-2-tiofenkarboksamid i koji se može aplicirati oralno Download PDFInfo
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- HRP20080150T4 HRP20080150T4 HRP20080150TT HRP20080150T HRP20080150T4 HR P20080150 T4 HRP20080150 T4 HR P20080150T4 HR P20080150T T HRP20080150T T HR P20080150TT HR P20080150 T HRP20080150 T HR P20080150T HR P20080150 T4 HRP20080150 T4 HR P20080150T4
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- pharmaceutical composition
- oxo
- composition according
- active substance
- oxazolidin
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- 239000008194 pharmaceutical composition Substances 0.000 title claims 18
- 238000000034 method Methods 0.000 title claims 9
- 239000007787 solid Substances 0.000 title claims 5
- 238000004519 manufacturing process Methods 0.000 title claims 4
- 239000013543 active substance Substances 0.000 claims 9
- 238000005550 wet granulation Methods 0.000 claims 3
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 claims 2
- 239000008187 granular material Substances 0.000 claims 2
- 238000005469 granulation Methods 0.000 claims 2
- 230000003179 granulation Effects 0.000 claims 2
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims 2
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 claims 2
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims 2
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims 2
- 238000011321 prophylaxis Methods 0.000 claims 2
- KGFYHTZWPPHNLQ-AWEZNQCLSA-N rivaroxaban Chemical compound S1C(Cl)=CC=C1C(=O)NC[C@@H]1OC(=O)N(C=2C=CC(=CC=2)N2C(COCC2)=O)C1 KGFYHTZWPPHNLQ-AWEZNQCLSA-N 0.000 claims 2
- 235000019333 sodium laurylsulphate Nutrition 0.000 claims 2
- 230000009424 thromboembolic effect Effects 0.000 claims 2
- 238000011282 treatment Methods 0.000 claims 2
- 239000011230 binding agent Substances 0.000 claims 1
- 239000011248 coating agent Substances 0.000 claims 1
- 238000000576 coating method Methods 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 238000009472 formulation Methods 0.000 claims 1
- 239000007788 liquid Substances 0.000 claims 1
- 239000000203 mixture Substances 0.000 claims 1
- 239000000126 substance Substances 0.000 claims 1
- 239000000080 wetting agent Substances 0.000 claims 1
Classifications
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- 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
-
- 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
- A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
- A61K31/5375—1,4-Oxazines, e.g. morpholine
- A61K31/5377—1,4-Oxazines, e.g. morpholine not condensed and containing further heterocyclic rings, e.g. timolol
-
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
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- 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
- A61K9/1611—Inorganic compounds
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- A—HUMAN NECESSITIES
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- 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
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- 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
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- 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
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- 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
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- A—HUMAN NECESSITIES
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- A61K9/20—Pills, tablets, discs, rods
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
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- A—HUMAN NECESSITIES
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- A61K9/00—Medicinal preparations characterised by special physical form
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- A61K9/2013—Organic compounds, e.g. phospholipids, fats
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- 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
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- 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
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- A61K9/20—Pills, tablets, discs, rods
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
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- 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
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- A—HUMAN NECESSITIES
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- A—HUMAN NECESSITIES
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- 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
- A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
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- A—HUMAN NECESSITIES
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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- A—HUMAN NECESSITIES
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- A—HUMAN NECESSITIES
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Molecular Biology (AREA)
- Biophysics (AREA)
- Inorganic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Hematology (AREA)
- Diabetes (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Cardiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Heterocyclic Carbon Compounds Containing A Hetero Ring Having Nitrogen And Oxygen As The Only Ring Hetero Atoms (AREA)
- Plural Heterocyclic Compounds (AREA)
Claims (19)
1. Postupak za proizvodnju krutog farmaceutskog sastava koji se može aplicirati oralno i koji sadrži 5-kloro-N-({(5S)-2-okso-3-[4-(3-okso-4-morfolinil)-fenil]-1,3-oksazolidin-5-il}-metil)-2-tiofenkarboksamid (I) u hidrofiliziranom obliku, naznačen time, da
(a) najprije se postupkom mokrog granuliranja proizvodi granulat koji sadrži aktivnu tvar (I) u hidrofiliziranom obliku, i
(b) zatim se granulat, prema potrebi uz dodavanje farmaceutski prikladnih dodatnih tvari, pretvara u farmaceutski sastav,
pri čemu se kao postupak mokrog granuliranja primjenjuje postupak granuliranja u fluidiziranom sloju.
2. Postupak prema zahtjevu 1 ili 2, naznačen time, da se aktivna tvar (I) upotrebljava u kristaliničnom obliku.
3. Postupak prema zahtjevu 3, naznačen time, da se aktivna tvar (I) upotrebljava u mikroniziranom obliku.
4. Postupak prema bilo kojem zahtjevu od 1 do 3, naznačen time, da se aktivna tvar (I) suspendirana u tekućini za granuliranje, unosi u uređaj za mokro granuliranje.
5. Postupak prema bilo kojem zahtjevu 1 do 4, naznačen time, da je farmaceutski sastav tableta koja brzo oslobađa aktivnu tvar (I).
6. Kruti farmaceutski sastav koji se može aplicirati oralno, naznačen time, da se on proizvodi postupkom prema zahtjevu 1.
7. Kruti farmaceutski sastav koji se može aplicirati oralno, naznačen time,
da on sadrži 5-kloro-N-({(5S)-2-okso-3-[4-(3-okso-4-morfolinil)-fenil]-1,3-
oksazolidin-5-il}-metil-2-tiofenkarboksamid (I) u hidrofiliziranom obliku, koji se može proizvoditi postupkom prema zahtjevu 1.
8. Farmaceutski sastav prema zahtjevu 7, naznačen time, da on sadrži aktivnu tvar (I) u kristaliničnom obliku.
9. Farmaceutski sastav prema zahtjevu 8, naznačen time, da on sadrži aktivnu tvar (I) u mikroniziranom obliku.
10. Farmaceutski sastav prema bilo kojem zahtjevu od 6 do 9, naznačen time, da je aktivna tvar (I) prisutna s koncentracijom od 1 do 60% u odnosu na ukupnu masu formulacije.
11. Farmaceutski sastav prema bilo kojem zahtjevu 6 do 10, naznačen time, da on kao sredstvo za vlaženje, sadrži natrijev laurilsulfat.
12. Farmaceutski sastav prema zahtjevu 11, naznačen time, da on sadrži natrijev laurilsulfat s koncentracijom od 0,1 do 5% u odnosu na ukupnu masu.
13. Farmaceutski sastav prema bilo kojem zahtjevu od 6 do 12, naznačen time, da on kao hidrofilno vezivo, sadrži hidroksipropilmetilcelulozu.
14. Farmaceutski sastav prema zahtjevu 13, naznačen time, da on sadrži hidroksipropilmetilcelulozu s koncentracijom od 1 do 15% u odnosu na ukupnu masu.
15. Farmaceutski sastav prema bilo kojem zahtjevu od 6 do 14, naznačen time, da je on u obliku tablete.
16. Farmaceutski sastav prema zahtjevu 15, naznačen time, da je on u obliku tablete koja brzo oslobađa aktivnu tvar.
17. Farmaceutski sastav prema zahtjevu 15 ili 16, naznačen time, da je tableta prekrivena oblogom.
18. Uporaba farmaceutskog sastava prema bilo kojem zahtjevu od 6 do 17, naznačena time, da je za proizvodnju lijeka za profilaksu i/ili liječenje tromboembolijskih poremećaja.
19. Uporaba 5-kloro-N-({(5S)-2-okso-3-[4-(3-okso-4-morfolinil)-fenil]-1,3-oksazolidin-5-il}-metil)-2-tiofen-
karboksamida (I) u hidrofiliziranom obliku, naznačena time, da je za proizvodnju krutog farmaceutskog sastava koji se može aplicirati oralno, prema zahtjevu 6 ili 7, koji služi za profilaksu i/ili liječenje tromboembolijskih poremećaja.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE10355461A DE10355461A1 (de) | 2003-11-27 | 2003-11-27 | Verfahren zur Herstellung einer festen, oral applizierbaren pharmazeutischen Zusammensetzung |
PCT/EP2004/012897 WO2005060940A2 (de) | 2003-11-27 | 2004-11-13 | Verfahren zur herstellung einer festen, oral applizierbaren pharmazeutischen zusammensetzung |
EP04797879.6A EP1689370B2 (de) | 2003-11-27 | 2004-11-13 | VERFAHREN ZUR HERSTELLUNG EINER FESTEN, ORAL APPLIZIERBAREN PHARMAZEUTISCHEN ZUSAMMENSETZUNG Mit 5-Chlor-N ( { (5-2-oxo-3- [4- (3-oxo-4-morpholinyl)-phenyl]-1, 3- oxazolidin-5-yl}-methyl)-2-thiophencarboxamid |
Publications (2)
Publication Number | Publication Date |
---|---|
HRP20080150T3 HRP20080150T3 (hr) | 2008-04-30 |
HRP20080150T4 true HRP20080150T4 (hr) | 2016-12-16 |
Family
ID=34609342
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20080150TT HRP20080150T4 (hr) | 2003-11-27 | 2008-04-01 | Postupak za proizvodnju krutog farmaceutskog sastava koji sadrži 5-klor-n-({(5s)-2-oksa-3-[4-(3-okso-4-morfolinil)-fenil]-1,3-oksazolidin-5-il}-metil)-2-tiofenkarboksamid i koji se može aplicirati oralno |
Country Status (35)
Country | Link |
---|---|
US (4) | US20080026057A1 (hr) |
EP (1) | EP1689370B2 (hr) |
JP (1) | JP4852423B2 (hr) |
KR (1) | KR101151117B1 (hr) |
CN (1) | CN1886120B (hr) |
AR (2) | AR047844A1 (hr) |
AT (1) | ATE385782T1 (hr) |
AU (1) | AU2004305226B2 (hr) |
BR (1) | BRPI0416404B8 (hr) |
CA (1) | CA2547113C (hr) |
CO (1) | CO5690540A2 (hr) |
CU (1) | CU23551B7 (hr) |
CY (1) | CY1107369T1 (hr) |
DE (2) | DE10355461A1 (hr) |
DK (1) | DK1689370T4 (hr) |
EC (1) | ECSP066584A (hr) |
ES (1) | ES2300845T5 (hr) |
GT (1) | GT200400239A (hr) |
HK (1) | HK1099518A1 (hr) |
HN (1) | HN2004000490A (hr) |
HR (1) | HRP20080150T4 (hr) |
IL (1) | IL175860B2 (hr) |
MA (1) | MA28178A1 (hr) |
MY (1) | MY138386A (hr) |
NO (1) | NO340156B1 (hr) |
NZ (1) | NZ547466A (hr) |
PE (1) | PE20050666A1 (hr) |
PL (1) | PL1689370T5 (hr) |
PT (1) | PT1689370E (hr) |
RU (2) | RU2379036C2 (hr) |
SI (2) | SI1689370T2 (hr) |
TW (1) | TWI356702B (hr) |
UA (1) | UA85693C2 (hr) |
WO (1) | WO2005060940A2 (hr) |
ZA (1) | ZA200604166B (hr) |
Families Citing this family (71)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE19962924A1 (de) | 1999-12-24 | 2001-07-05 | Bayer Ag | Substituierte Oxazolidinone und ihre Verwendung |
DE10129725A1 (de) * | 2001-06-20 | 2003-01-02 | Bayer Ag | Kombinationstherapie substituierter Oxazolidinone |
DE10300111A1 (de) * | 2003-01-07 | 2004-07-15 | Bayer Healthcare Ag | Verfahren zur Herstellung von 5-Chlor-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)-phenyl]-1,3-oxazolidin-5-yl}-methyl)-2-thiophencarboxamid |
DE10355461A1 (de) | 2003-11-27 | 2005-06-23 | Bayer Healthcare Ag | Verfahren zur Herstellung einer festen, oral applizierbaren pharmazeutischen Zusammensetzung |
DE102004062475A1 (de) * | 2004-12-24 | 2006-07-06 | Bayer Healthcare Ag | Feste, oral applizierbare pharmazeutische Darreichungsformen mit modifizierter Freisetzung |
EP1685841A1 (en) | 2005-01-31 | 2006-08-02 | Bayer Health Care Aktiengesellschaft | Prevention and treatment of thromboembolic disorders |
DE102005045518A1 (de) | 2005-09-23 | 2007-03-29 | Bayer Healthcare Ag | 2-Aminoethoxyessigsäure-Derivate und ihre Verwendung |
DE102005047561A1 (de) * | 2005-10-04 | 2007-04-05 | Bayer Healthcare Ag | Feste, oral applizierbare pharmazeutische Darreichungsformen mit schneller Wirkstofffreisetzung |
EP1934208B1 (de) | 2005-10-04 | 2011-03-23 | Bayer Schering Pharma Aktiengesellschaft | Neue polymorphe form von 5-chlor-n-({ ( 5s )-2-0x0-3-[4-( 3-oxo-4-morpholinyl)-phenyl]-1,3-oxazolidin-5-yl} -methyl)-2-thiophencarboxamid |
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DE102005045518A1 (de) | 2005-09-23 | 2007-03-29 | Bayer Healthcare Ag | 2-Aminoethoxyessigsäure-Derivate und ihre Verwendung |
EP1934208B1 (de) | 2005-10-04 | 2011-03-23 | Bayer Schering Pharma Aktiengesellschaft | Neue polymorphe form von 5-chlor-n-({ ( 5s )-2-0x0-3-[4-( 3-oxo-4-morpholinyl)-phenyl]-1,3-oxazolidin-5-yl} -methyl)-2-thiophencarboxamid |
DE102005047561A1 (de) | 2005-10-04 | 2007-04-05 | Bayer Healthcare Ag | Feste, oral applizierbare pharmazeutische Darreichungsformen mit schneller Wirkstofffreisetzung |
DE102005047558A1 (de) | 2005-10-04 | 2008-02-07 | Bayer Healthcare Ag | Kombinationstherapie substituierter Oxazolidinone zur Prophylaxe und Behandlung von cerebralen Durchblutungsstörungen |
DE102005048824A1 (de) | 2005-10-10 | 2007-04-12 | Bayer Healthcare Ag | Behandlung und Prophylaxe von Mikroangiopathien |
DE102006034916A1 (de) | 2006-07-28 | 2008-01-31 | Bayer Healthcare Ag | Beschichtung künstlicher Oberflächen von medizinischen Hilfsmitteln und Geräten sowie Reinigung und/oder Vorbehandlung von Kathetern und anderen medizinischen Hilfsmitteln und Geräten |
DE102006051625A1 (de) | 2006-11-02 | 2008-05-08 | Bayer Materialscience Ag | Kombinationstherapie substituierter Oxazolidinone |
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