RU2006122599A - Способ изготовления твердого, орально применяемого фармацевтического состава - Google Patents
Способ изготовления твердого, орально применяемого фармацевтического состава Download PDFInfo
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- RU2006122599A RU2006122599A RU2006122599/15A RU2006122599A RU2006122599A RU 2006122599 A RU2006122599 A RU 2006122599A RU 2006122599/15 A RU2006122599/15 A RU 2006122599/15A RU 2006122599 A RU2006122599 A RU 2006122599A RU 2006122599 A RU2006122599 A RU 2006122599A
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- 239000008194 pharmaceutical composition Substances 0.000 title claims 22
- 238000004519 manufacturing process Methods 0.000 title claims 3
- 239000007787 solid Substances 0.000 title claims 3
- 239000013543 active substance Substances 0.000 claims 8
- 238000000034 method Methods 0.000 claims 7
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims 5
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims 5
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims 5
- 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 5
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 claims 4
- 238000005469 granulation Methods 0.000 claims 4
- 230000003179 granulation Effects 0.000 claims 4
- 235000019333 sodium laurylsulphate Nutrition 0.000 claims 4
- 208000001435 Thromboembolism Diseases 0.000 claims 3
- 239000011230 binding agent Substances 0.000 claims 3
- 230000002265 prevention Effects 0.000 claims 3
- 229940079593 drug Drugs 0.000 claims 2
- 239000003814 drug Substances 0.000 claims 2
- 239000008187 granular material Substances 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
- 238000009736 wetting Methods 0.000 claims 2
- 239000000080 wetting agent Substances 0.000 claims 2
- -1 3-oxo-4-morpholinyl Chemical group 0.000 claims 1
- 239000004480 active ingredient Substances 0.000 claims 1
- 239000000654 additive Substances 0.000 claims 1
- 239000007788 liquid Substances 0.000 claims 1
- 230000003020 moisturizing effect Effects 0.000 claims 1
- 125000001997 phenyl group Chemical group [H]C1=C([H])C([H])=C(*)C([H])=C1[H] 0.000 claims 1
- 239000000725 suspension Substances 0.000 claims 1
- 239000002966 varnish Substances 0.000 claims 1
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- A—HUMAN NECESSITIES
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- 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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- 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
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- A61K9/1617—Organic compounds, e.g. phospholipids, fats
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- A61K9/1605—Excipients; Inactive ingredients
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- 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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- 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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- Public Health (AREA)
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- General Health & Medical Sciences (AREA)
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- 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 (25)
1. Способ изготовления твердого, орально применяемого фармацевтического состава, содержащего гидролизованную форму 5-хлор-N-({(5S)-2-оксо-3-[4-(3-оксо-4-морфолинил)фенил]-1,3-оксазолидин-5-ил}-метил)-2-тиофенкарбоксамида (I), отличающийся тем, что
(a) сначала путем увлажнительного гранулирования изготавливают гранулят, содержащий гидролизованную форму действующего вещества (I),
(b) затем гранулят при необходимости при добавлении фармацевтически пригодных добавок преобразуют в фармацевтический состав.
2. Способ по п.1, отличающийся тем, что в качестве метода увлажнительного гранулирования используют гранулирование в псевдоожиженном слое.
3. Способ по п.1, отличающийся тем, что действующее вещество (I) используют в кристаллической форме.
4. Способ по п.3, отличающийся тем, что действующее вещество (I) используют в микрокристаллической форме.
5. Способ по п.1, отличающийся тем, что действующее вещество (I) вводят на стадии увлажнительного гранулирования в виде суспензии в гранулирующей жидкости.
6. Способ по одному из пп.1-5, отличающийся тем, что фармацевтический состав является таблеткой, быстро высвобождающей действующее вещество (I).
7. Твердый, орально применимый фармацевтический состав, содержащий гидролизованную форму 5-хлор-N-({(5S)-2-оксо-3-[4-(3-оксо-4-морфолинил)фенил]-1,3-оксазолидин-5-ил}метил)-2-тиофенкарбоксамида (I).
8. Фармацевтический состав по п.7, содержащий действующее вещество (I) в кристаллической форме.
9. Фармацевтический состав по п.8, содержащий действующее вещество (I) в микрокристаллической форме.
10. Фармацевтический состав по одному из пп.7-9, отличающийся тем, что действующее вещество (I) содержится в концентрации от 1 до 60% в пересчете на общую массу препарата.
11. Фармацевтический состав по одному из пп.7-9, содержащий в качестве смачивающего средства лаурилсульфат натрия.
12. Фармацевтический состав по п.10, содержащий в качестве смачивающего средства лаурилсульфат натрия.
13. Фармацевтический состав по п.11, содержащий лаурилсульфат натрия в концентрации от 0,1 до 5% в пересчете на общую массу.
14. Фармацевтический состав по п.12, содержащий лаурилсульфат натрия в концентрации от 0,1 до 5% в пересчете на общую массу.
15. Фармацевтический состав по одному из пп.7-9 или 12-14, содержащий в качестве гидрофильного связующего гидроксипропилметилцеллюлозу.
16. Фармацевтический состав по п.10, содержащий в качестве гидрофильного связующего гидроксипропилметилцеллюлозу.
17. Фармацевтический состав по п.11, содержащий в качестве гидрофильного связующего гидроксипропилметилцеллюлозу.
18. Фармацевтический состав по п.15, содержащий гидроксипропилметилцеллюлозу в концентрации от 1 до 15% в пересчете на общую массу.
19. Фармацевтический состав по одному из п.16 или 17, содержащий гидроксипропилметилцеллюлозу в концентрации от 1 до 15% в пересчете на общую массу.
20. Фармацевтический состав по п.1 в форме таблетки.
21. Фармацевтический состав по п.20 в форме быстро высвобождающей действующее вещество таблетки.
22. Фармацевтический состав по п.20 или 21, отличающийся тем, что таблетка покрыта лаком.
23. Применение фармацевтического состава по одному из пп.7-22 для профилактики и/или лечения тромбоэмболических заболеваний.
24. Применение гидролизованной формы 5-хлор-N-({(5S)-2-оксо-3-[4-(3-оксо-4-морфолинил)фенил]-1,3-оксазолидин-5-ил}метил)-2-тио-фенкарбоксамида (I) для изготовления лекарственных средств, предназначенных для профилактики и/или лечения тромбоэмболических заболеваний.
25. Способ профилактики и/или лечения тромбоэмболических заболеваний путем применения фармацевтического состава по одному из пп.7-22.
Applications Claiming Priority (2)
| 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 |
| DE10355461.0 | 2003-11-27 |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2009127302/15A Division RU2493850C2 (ru) | 2003-11-27 | 2009-07-16 | Способ изготовления твердого, орально применимого фармацевтического состава |
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| Publication Number | Publication Date |
|---|---|
| RU2006122599A true RU2006122599A (ru) | 2008-01-10 |
| RU2379036C2 RU2379036C2 (ru) | 2010-01-20 |
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| Application Number | Title | Priority Date | Filing Date |
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| RU2006122599/15A RU2379036C2 (ru) | 2003-11-27 | 2004-11-13 | Способ изготовления твердого, орально применимого фармацевтического состава |
| RU2009127302/15A RU2493850C2 (ru) | 2003-11-27 | 2009-07-16 | Способ изготовления твердого, орально применимого фармацевтического состава |
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| RU2009127302/15A RU2493850C2 (ru) | 2003-11-27 | 2009-07-16 | Способ изготовления твердого, орально применимого фармацевтического состава |
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| EP (1) | EP1689370B2 (ru) |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE19962924A1 (de) * | 1999-12-24 | 2001-07-05 | Bayer Ag | Substituierte Oxazolidinone und ihre Verwendung |
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| DE10110438A1 (de) | 2001-03-05 | 2002-09-19 | Bayer Ag | Substituierte 2-Oxy-3,5-dicyano-4-aryl-6-aminopyridine und ihre Verwendung |
| DE10110747A1 (de) | 2001-03-07 | 2002-09-12 | Bayer Ag | Substituierte 2,6-Diamino-3,5-dicyano-4-aryl-pyridine und ihre Verwendung |
| DE10110754A1 (de) | 2001-03-07 | 2002-09-19 | Bayer Ag | Substituierte 2-Thio-3,5-dicyano-4-aryl-6-aminopyridine und ihre Verwendung |
| DE10115922A1 (de) | 2001-03-30 | 2002-10-10 | Bayer Ag | Cyclisch substituierte 2-Thio-3,5-dicyano-4-aryl-6-aminopyridine und ihre Verwendung |
| DE10115945A1 (de) | 2001-03-30 | 2002-10-02 | Bayer Ag | Substituierte 2-Carba-3,5-dicyano-4-aryl-6-aminopyridine und ihre Verwendung |
| DE10129725A1 (de) | 2001-06-20 | 2003-01-02 | Bayer Ag | Kombinationstherapie substituierter Oxazolidinone |
| DE10134481A1 (de) | 2001-07-16 | 2003-01-30 | Bayer Ag | Substituierte 2-Thio-3,5-dicyano-4-phenyl-6-aminopyridine und ihre Verwendung |
| DE10152460A1 (de) * | 2001-10-24 | 2003-05-08 | Bayer Ag | Stents |
| DE10238113A1 (de) | 2001-12-11 | 2003-06-18 | Bayer Ag | Substituierte 2-Thio-3,5-dicyano-4-phenyl-6-aminopyridine und ihre Verwendung |
| US20030161882A1 (en) | 2002-02-01 | 2003-08-28 | Waterman Kenneth C. | Osmotic delivery system |
| 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 |
| DE102004002044A1 (de) | 2004-01-15 | 2005-08-04 | Bayer Healthcare Ag | Herstellverfahren |
| 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 |
| DE102005047558A1 (de) | 2005-10-04 | 2008-02-07 | Bayer Healthcare Ag | Kombinationstherapie substituierter Oxazolidinone zur Prophylaxe und Behandlung von cerebralen Durchblutungsstörungen |
| RU2578602C2 (ru) | 2005-10-04 | 2016-03-27 | Байер Интеллектуэль Проперти Гмбх | Способ получения 5-хлор-n-(5s)-2-оксо-3-[4-(3-оксо-морфолинил)-фенил]-1,3-оксазолидин-5-ил}-метил)-2-тиофенкарбоксамида в модификации ii (варианты) |
| DE102005048824A1 (de) | 2005-10-10 | 2007-04-12 | Bayer Healthcare Ag | Behandlung und Prophylaxe von Mikroangiopathien |
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2003
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