HRP20161617T4 - Čvrsti farmaceutski sastav koji sadrži rivaroksaban - Google Patents
Čvrsti farmaceutski sastav koji sadrži rivaroksaban Download PDFInfo
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- HRP20161617T4 HRP20161617T4 HRP20161617TT HRP20161617T HRP20161617T4 HR P20161617 T4 HRP20161617 T4 HR P20161617T4 HR P20161617T T HRP20161617T T HR P20161617TT HR P20161617 T HRP20161617 T HR P20161617T HR P20161617 T4 HRP20161617 T4 HR P20161617T4
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- Prior art keywords
- mass
- amount
- rivaroxaban
- filler
- composition
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- 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 title claims 7
- 229960001148 rivaroxaban Drugs 0.000 title claims 7
- 239000007787 solid Substances 0.000 title claims 3
- 239000008194 pharmaceutical composition Substances 0.000 title claims 2
- 238000000034 method Methods 0.000 claims 17
- 239000000203 mixture Substances 0.000 claims 14
- 238000002844 melting Methods 0.000 claims 7
- 239000000945 filler Substances 0.000 claims 6
- 239000011230 binding agent Substances 0.000 claims 5
- 239000000546 pharmaceutical excipient Substances 0.000 claims 5
- 230000008018 melting Effects 0.000 claims 4
- 239000004094 surface-active agent Substances 0.000 claims 4
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 4
- 239000012752 auxiliary agent Substances 0.000 claims 3
- 235000014113 dietary fatty acids Nutrition 0.000 claims 3
- 239000000194 fatty acid Substances 0.000 claims 3
- 229930195729 fatty acid Natural products 0.000 claims 3
- 239000008187 granular material Substances 0.000 claims 3
- 229920001983 poloxamer Polymers 0.000 claims 3
- 150000003839 salts Chemical class 0.000 claims 3
- 239000012453 solvate Substances 0.000 claims 3
- -1 sorbitan fatty acid ester Chemical class 0.000 claims 3
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 claims 2
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical compound [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 claims 2
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 claims 2
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims 2
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 claims 2
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims 2
- 229930195725 Mannitol Natural products 0.000 claims 2
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims 2
- 229920003171 Poly (ethylene oxide) Polymers 0.000 claims 2
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims 2
- TVXBFESIOXBWNM-UHFFFAOYSA-N Xylitol Natural products OCCC(O)C(O)C(O)CCO TVXBFESIOXBWNM-UHFFFAOYSA-N 0.000 claims 2
- 125000004432 carbon atom Chemical group C* 0.000 claims 2
- 150000004665 fatty acids Chemical class 0.000 claims 2
- 150000002314 glycerols Chemical class 0.000 claims 2
- 239000008101 lactose Substances 0.000 claims 2
- 239000000314 lubricant Substances 0.000 claims 2
- 229960003511 macrogol Drugs 0.000 claims 2
- 239000000594 mannitol Substances 0.000 claims 2
- 235000010355 mannitol Nutrition 0.000 claims 2
- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 claims 2
- 239000008108 microcrystalline cellulose Substances 0.000 claims 2
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims 2
- 229940016286 microcrystalline cellulose Drugs 0.000 claims 2
- 238000002156 mixing Methods 0.000 claims 2
- 229920001223 polyethylene glycol Polymers 0.000 claims 2
- 238000002360 preparation method Methods 0.000 claims 2
- 239000000600 sorbitol Substances 0.000 claims 2
- 235000010356 sorbitol Nutrition 0.000 claims 2
- 239000000811 xylitol Substances 0.000 claims 2
- 235000010447 xylitol Nutrition 0.000 claims 2
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 claims 2
- 229960002675 xylitol Drugs 0.000 claims 2
- 229920002785 Croscarmellose sodium Polymers 0.000 claims 1
- UFHFLCQGNIYNRP-UHFFFAOYSA-N Hydrogen Chemical compound [H][H] UFHFLCQGNIYNRP-UHFFFAOYSA-N 0.000 claims 1
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims 1
- RVGRUAULSDPKGF-UHFFFAOYSA-N Poloxamer Chemical group C1CO1.CC1CO1 RVGRUAULSDPKGF-UHFFFAOYSA-N 0.000 claims 1
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims 1
- 150000005215 alkyl ethers Chemical group 0.000 claims 1
- 229910000019 calcium carbonate Inorganic materials 0.000 claims 1
- 235000010216 calcium carbonate Nutrition 0.000 claims 1
- FUFJGUQYACFECW-UHFFFAOYSA-L calcium hydrogenphosphate Chemical compound [Ca+2].OP([O-])([O-])=O FUFJGUQYACFECW-UHFFFAOYSA-L 0.000 claims 1
- MKJXYGKVIBWPFZ-UHFFFAOYSA-L calcium lactate Chemical compound [Ca+2].CC(O)C([O-])=O.CC(O)C([O-])=O MKJXYGKVIBWPFZ-UHFFFAOYSA-L 0.000 claims 1
- 235000011086 calcium lactate Nutrition 0.000 claims 1
- 229960002401 calcium lactate Drugs 0.000 claims 1
- 239000001527 calcium lactate Substances 0.000 claims 1
- 239000002775 capsule Substances 0.000 claims 1
- 229910052799 carbon Inorganic materials 0.000 claims 1
- 239000004359 castor oil Substances 0.000 claims 1
- 235000019438 castor oil Nutrition 0.000 claims 1
- 239000001913 cellulose Substances 0.000 claims 1
- 239000003086 colorant Substances 0.000 claims 1
- 229960001681 croscarmellose sodium Drugs 0.000 claims 1
- 229960000913 crospovidone Drugs 0.000 claims 1
- 235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 claims 1
- 235000019700 dicalcium phosphate Nutrition 0.000 claims 1
- ZEMPKEQAKRGZGQ-XOQCFJPHSA-N glycerol triricinoleate Natural products CCCCCC[C@@H](O)CC=CCCCCCCCC(=O)OC[C@@H](COC(=O)CCCCCCCC=CC[C@@H](O)CCCCCC)OC(=O)CCCCCCCC=CC[C@H](O)CCCCCC ZEMPKEQAKRGZGQ-XOQCFJPHSA-N 0.000 claims 1
- 238000000227 grinding Methods 0.000 claims 1
- 238000009474 hot melt extrusion Methods 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 150000007524 organic acids Chemical class 0.000 claims 1
- 239000003960 organic solvent Substances 0.000 claims 1
- 229960000502 poloxamer Drugs 0.000 claims 1
- 229920000136 polysorbate Polymers 0.000 claims 1
- 229950008882 polysorbate Drugs 0.000 claims 1
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 claims 1
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 claims 1
- 229920003124 powdered cellulose Polymers 0.000 claims 1
- 235000019814 powdered cellulose Nutrition 0.000 claims 1
- 239000000377 silicon dioxide Substances 0.000 claims 1
- 235000012239 silicon dioxide Nutrition 0.000 claims 1
- 229960001866 silicon dioxide Drugs 0.000 claims 1
- APSBXTVYXVQYAB-UHFFFAOYSA-M sodium docusate Chemical group [Na+].CCCCC(CC)COC(=O)CC(S([O-])(=O)=O)C(=O)OCC(CC)CCCC APSBXTVYXVQYAB-UHFFFAOYSA-M 0.000 claims 1
- 239000008247 solid mixture Substances 0.000 claims 1
- UFTFJSFQGQCHQW-UHFFFAOYSA-N triformin Chemical compound O=COCC(OC=O)COC=O UFTFJSFQGQCHQW-UHFFFAOYSA-N 0.000 claims 1
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
- A61K9/2095—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
- 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
-
- 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
- A61K9/2009—Inorganic compounds
-
- 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
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
Claims (15)
1. Postupak za proizvodnju pripravka od čvrstog sastava koji sadrži rivaroksaban, ili njegovu farmaceutski prihvatljivu sol ili njegov solvat,
naznačen time, da postupak obuhvaća sljedeće:
(a) priprema smjese koja sadrži rivaroksaban, ili njegovu farmaceutski prihvatljivu sol ili njegov solvat, i najmanje jedno farmaceutski prihvatljivo pomoćno sredstvo, pri čemu ona obuhvaća (i) vruće taljeni granulat rivaroksabana s najmanje jednim pomoćnim sredstvom, te prema potrebi miješanje dobivenog granulata s dodatnim pomoćnim sredstvima ili (ii) vruće taljena ekstruzijska krutina rivaroksabana s najmanje jednim pomoćnim sredstvom, te mljevenje ekstrudata i prema potrebi miješanje mljevenog ekstrudata s dodatnim pomoćnim sredstvima; i
(b) pretvaranje navedene smjese u čvrsti farmaceutski sastav, poželjno pomoću kompresije smjese kako bi se dobila tableta;
pri čemu se spomenuti postupak izvodi na temperaturi koja nije viša od 150°C, te pritom najmanje jedno pomoćno sredstvo koje se upotrebljava u koraku (a) obuhvaća najmanje jedno vezivo niskog tališta koje ima talište ispod 120°C i koje je odabrano od poloksamera, polietilenglikola koji imaju prosječnu molekularnu masu ispod 15000, makrogol glicerida i estera od glicerola s masnim kiselinama koje imaju od 10 do 24 atoma ugljika.
2. Postupak prema zahtjevu 1, naznačen time, da se on izvodi na temperaturi koja nije viša od 100°C, a najbolje koja nije viša od 80°C.
3. Postupak prema zahtjevu 1 ili 2, naznačen time, da se on izvodi bez uporabe vode ili organskih otapala.
4. Postupak prema bilo kojem od zahtjeva 1 do 3, naznačen time, da on nadalje obuhvaća mikronizaciju rivaroksabana, posebice koristeći mlazni mlin ili homogenizator s visokim tlakom.
5. Postupak prema bilo kojem od zahtjeva 1 do 4, naznačen time, da najmanje jedno pomoćno sredstvo koje se upotrebljava u koraku (a) obuhvaća najmanje jedno vezivo niskog tališta koje ima talište ispod 100°C, a najbolje ispod 80°C.
6. Postupak prema zahtjevu 5, naznačen time, da navedeni sastav obuhvaća vezivo niskog tališta u količini od 1 do 40 masenih %, posebno od 1 do 30 masenih %, još poželjnije od 5 do 25 masenih %, i najpoželjnije od 10 do 20 masenih %.
7. Postupak prema bilo kojem od zahtjeva 1 do 6, naznačen time, da se navedeno vezivo niskog tališta odabire od poloksamera, polietilenglikola koji imaju prosječnu molekularnu masu u rasponu od 1500 do 10000, makrogol glicerida i estera od glicerina s masnim kiselinama koje imaju od 10 do 24 atoma ugljika.
8. Postupak prema bilo kojem od zahtjeva 1 do 7, naznačen time, da najmanje jedno pomoćno sredstvo koje se upotrebljava u koraku (a), obuhvaća tenzid koji ima talište ispod 120°C, posebno ispod 80°C, a najbolje ispod 65°C.
9. Postupak prema bilo kojem od zahtjeva 1 do 8, naznačen time, da navedeni sastav obuhvaća tenzid u količini od 0,5 do 30 masenih %, još bolje od 1 do 20 masenih %, posebno od 2 do 15 masenih %, još poželjnije od 3 do 10 masenih % i najpoželjnije od 4 do 8 masenih %.
10. Postupak prema zahtjevu 8 ili 9, naznačen time, da se navedeni tenzid odabire od natrijevog dokusata, estera masne kiseline od sorbitana, polisorbata, polioksietilen-alkiletera, poloksamera, triglicerida srednjeg lanca, polioksilglicerida, derivata polioksietilen-ricinusovog ulja i njihovih mješavina.
11. Postupak prema bilo kojem od zahtjeva 1 do 10, naznačen time, da navedeni sastav obuhvaća najmanje jedno punilo koje je topivo u vodi i poželjno odabrano od laktoze, manitola, sorbitola, ksilitola i njihovih mješavina, u količini od najmanje 35 masenih %, posebno od 35 do 90 masenih %, još posebnije od 35 do 80 masenih %, poželjno od 40 do 70 masenih %, još poželjnije od 40 do 60 masenih %, te najpoželjnije od 45 do 55 masenih %.
12. Postupak prema bilo kojem od zahtjeva 1 do 11, naznačen time, da navedeni sastav obuhvaća punilo koje je topivo u vodi i punilo koje nije topivo u vodi, gdje su oni u masenom omjeru od 1:10 do 30:1, posebno od 1:1 do 20:1, poželjno od 1:1 do 10:1, još poželjnije od 2:1 do 8:1, te najpoželjnije od 3:1 do 5:1, pri čemu je punilo koje je topivo u vodi, poželjno odabrano od laktoze, manitola, sorbitola, ksilitola i njihovih mješavina i/ili je punilo koje nije topivo u vodi, poželjno odabrano od mikrokristalne celuloze, praškaste celuloze, silikonizirane mikrokristalne celuloze, silicijevog dioksida, krospovidona, natrijeve kroskarmeloze, kalcij-vodikovog fosfata, kalcijevog karbonata, kalcijevog laktata i njihovih mješavina.
13. Postupak prema bilo kojem od zahtjeva 1 do 12, naznačen time, da navedeni sastav obuhvaća dezintegrator u količini od 1 do 20 masenih %, posebno od 2 do 10 masenih %, još poželjnije od 3 do 8 masenih % i najpoželjnije od 4 do 7 masenih %.
14. Postupak prema bilo kojem od zahtjeva 1 do 13, naznačen time, da navedeni sastav obuhvaća sljedeće:
(a) rivaroksaban ili njegovu farmaceutski prihvatljivu sol ili njegov solvat, u količini od 0,1 do 60 masenih %, posebno od 0,5 do 40 masenih %, još poželjnije od 1 do 20 masenih %, i najpoželjnije od 5 do 15 masenih %;
(b) punilo u količini od 30 do 99 masenih %, posebno od 50 do 95 masenih %, još poželjnije od 70 do 90 masenih %, i najpoželjnije od 80 do 87 masenih %;
(c) vezivo u količini od 0,5 do 40 masenih %, posebno od 1 do 20 masenih %, još poželjnije od 2 do 10 masenih %, i najpoželjnije od 3 do 7 masenih %;
(d) dezintegrator u količini od 0 do 20 masenih %, posebno od 2 do 10 masenih %, još poželjnije od 3 do 8 masenih %, i najpoželjnije od 4 do 7 masenih %;
(e) tenzid u količini od 0 do 30 masenih %, posebno od 1 do 10 masenih %, još poželjnije od 1,5 do 5 masenih %, i najpoželjnije od 2 do 3 masena %;
(f) mazivo u količini od 0 do 10 masenih %, posebno od 0,25 do 5 masenih %, i još poželjnije od 0,5 do 2 masena %;
(g) klizno sredstvo u količini od 0 do 10 masenih %, posebno od 0,25 do 5 masenih %, i još poželjnije od 0,5 do 2 masena %;
(h) bojilo u količini od 0 do 1 maseni %, posebno od 0,01 do 0,5 masenih %, i još poželjnije od 0,05 do 0,2 masena %; i
(i) organsku kiselinu u količini od 0 do 15 masenih %, posebno od 1 do 12 masenih %.
15. Postupak prema bilo kojem od zahtjeva 1 do 14, naznačen time, da je navedeni sastav u obliku tablete ili kapsule ili je u obliku zrnaca ili granula.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP09163177A EP2266541A1 (en) | 2009-06-18 | 2009-06-18 | Solid pharmaceutical composition comprising rivaroxaban |
| EP10156445 | 2010-03-12 | ||
| EP10725746.1A EP2442799B2 (en) | 2009-06-18 | 2010-06-18 | Solid pharmaceutical composition comprising rivaroxaban |
| PCT/EP2010/058680 WO2010146179A2 (en) | 2009-06-18 | 2010-06-18 | Solid pharmaceutical composition comprising rivaroxaban |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| HRP20161617T1 HRP20161617T1 (hr) | 2017-01-13 |
| HRP20161617T4 true HRP20161617T4 (hr) | 2019-06-28 |
Family
ID=42352709
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20161617TT HRP20161617T4 (hr) | 2009-06-18 | 2016-12-01 | Čvrsti farmaceutski sastav koji sadrži rivaroksaban |
Country Status (11)
| Country | Link |
|---|---|
| EP (1) | EP2442799B2 (hr) |
| DK (1) | DK2442799T3 (hr) |
| EA (1) | EA035562B1 (hr) |
| ES (1) | ES2606127T5 (hr) |
| HR (1) | HRP20161617T4 (hr) |
| HU (1) | HUE031177T2 (hr) |
| LT (1) | LT2442799T (hr) |
| PL (1) | PL2442799T5 (hr) |
| PT (1) | PT2442799T (hr) |
| SI (1) | SI2442799T2 (hr) |
| WO (1) | WO2010146179A2 (hr) |
Families Citing this family (20)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20130064888A1 (en) | 2011-08-08 | 2013-03-14 | Roey Solomonovich | Pharmaceutical formulations |
| EP2935255B1 (en) | 2012-12-21 | 2017-08-16 | Farma GRS, d.o.o. | A process for preparation of rivaroxaban |
| EP2808011A1 (en) * | 2013-05-29 | 2014-12-03 | Sandoz Ag | Process for the preparation of a pharmaceutical composition comprising Rivaroxaban |
| RU2016126430A (ru) * | 2013-12-23 | 2018-01-30 | Лабораториос Дель Др. Эстеве, С.А. | Пероральная фармацевтическая композиция |
| WO2015124995A1 (en) | 2014-02-19 | 2015-08-27 | Aurobindo Pharma Ltd | Solid dosage forms of rivaroxaban |
| CN104055743B (zh) * | 2014-06-10 | 2016-01-06 | 吉林省博大制药有限责任公司 | 一种含利伐沙班口服制剂的制备方法 |
| TR201501970A2 (en) * | 2015-02-19 | 2016-09-21 | Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi | Pharmaceutical combinations of dronedarone. |
| WO2016144071A2 (ko) * | 2015-03-06 | 2016-09-15 | 에스케이케미칼 주식회사 | 리바록사반을 포함하는 약학제제 |
| WO2016166733A1 (en) * | 2015-04-17 | 2016-10-20 | Micro Labs Limited | A process for preparing a pharmaceutical composition comprising rivaroxaban |
| US20180214453A1 (en) * | 2015-08-05 | 2018-08-02 | Interquim, S.A. | Rivaroxaban pharmaceutical compositions |
| CN105078915A (zh) * | 2015-08-27 | 2015-11-25 | 江苏中邦制药有限公司 | 一种利伐沙班片及其制备方法 |
| WO2017146709A1 (en) * | 2016-02-25 | 2017-08-31 | Mylan Inc. | A unique high-shear granulation process for improved bioavailability of rivaroxaban |
| EP3263096A1 (en) * | 2016-06-28 | 2018-01-03 | Sanovel Ilac Sanayi ve Ticaret A.S. | Pharmaceutical capsule composition of rivaroxaban |
| BR112019000187A2 (pt) * | 2016-07-05 | 2019-04-24 | Alphamed Formulations Pvt Ltd | composição sólida contendo anticoagulante oral |
| EP3505160A1 (en) | 2017-12-31 | 2019-07-03 | Abdi Ibrahim Ilac Sanayi ve Ticaret A.S. | Preparation of a solid pharmaceutical composition comprising rivaroxaban and production thereof |
| GR1009619B (el) * | 2018-05-09 | 2019-10-23 | Φαρμαζακ Α.Φ.Ε.Β.Ε. | Φαρμακευτικη συνθεση που περιεχει ριβαροξαβανη και μεθοδος για την παρασκευη αυτης |
| JP2020029455A (ja) * | 2018-08-20 | 2020-02-27 | 大原薬品工業株式会社 | 微粉砕されたリバーロキサバンを含有してなる固形製剤 |
| WO2020101587A1 (en) * | 2018-11-16 | 2020-05-22 | Santa Farma İlaç Sanayi̇ A.Ş. | Oral formulations comprising rivaroxaban |
| EP4208462A1 (en) * | 2020-09-05 | 2023-07-12 | Inventia Healthcare Limited | Rivaroxaban compositions |
| WO2022259118A1 (en) * | 2021-06-10 | 2022-12-15 | Shilpa Medicare Limited | Fast dissolving oral film preparation comprising rivaroxaban |
Family Cites Families (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE19962924A1 (de) | 1999-12-24 | 2001-07-05 | Bayer Ag | Substituierte Oxazolidinone und ihre Verwendung |
| 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 |
| DE102005047561A1 (de) * | 2005-10-04 | 2007-04-05 | Bayer Healthcare Ag | Feste, oral applizierbare pharmazeutische Darreichungsformen mit schneller Wirkstofffreisetzung |
| NZ567092A (en) | 2005-10-04 | 2011-05-27 | Bayer Schering Pharma Ag | Novel polymorphous form and the amorphous form of 5-chloro-N-({ (5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)-phenyl]-1,3-oxazolidine-5-yl}-methyl)-2-thiophene carboxamide |
| DE102007048705A1 (de) | 2007-10-11 | 2009-04-16 | Bayer Healthcare Ag | Amorphe Formulierung |
| WO2010003641A1 (en) * | 2008-07-08 | 2010-01-14 | Ratiopharm Gmbh | Pharmaceutical compositions comprising 5-chloro-n-({(5s)-2-oxo-3-[4-(3-oxo-4-morpholinyl)-phenyl]-1,3-oxazolidin-5-yl}-methyl)-2-thiophencarboxamid |
| EP2317980A2 (en) * | 2008-08-11 | 2011-05-11 | Ratiopharm GmbH | Pharmaceutical compositions of rivaroxaban with modified release properties |
-
2010
- 2010-06-18 SI SI201031344T patent/SI2442799T2/sl unknown
- 2010-06-18 EP EP10725746.1A patent/EP2442799B2/en active Active
- 2010-06-18 HU HUE10725746A patent/HUE031177T2/hu unknown
- 2010-06-18 EA EA201190319A patent/EA035562B1/ru not_active IP Right Cessation
- 2010-06-18 WO PCT/EP2010/058680 patent/WO2010146179A2/en active Application Filing
- 2010-06-18 PL PL10725746T patent/PL2442799T5/pl unknown
- 2010-06-18 PT PT107257461T patent/PT2442799T/pt unknown
- 2010-06-18 DK DK10725746.1T patent/DK2442799T3/da active
- 2010-06-18 ES ES10725746T patent/ES2606127T5/es active Active
- 2010-06-18 LT LTEP10725746.1T patent/LT2442799T/lt unknown
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2016
- 2016-12-01 HR HRP20161617TT patent/HRP20161617T4/hr unknown
Also Published As
| Publication number | Publication date |
|---|---|
| EA201190319A1 (ru) | 2012-06-29 |
| HRP20161617T1 (hr) | 2017-01-13 |
| EP2442799B1 (en) | 2016-09-07 |
| SI2442799T2 (sl) | 2019-08-30 |
| WO2010146179A3 (en) | 2011-04-14 |
| LT2442799T (lt) | 2016-12-27 |
| ES2606127T5 (es) | 2020-02-17 |
| EA035562B1 (ru) | 2020-07-08 |
| SI2442799T1 (sl) | 2017-02-28 |
| EP2442799A2 (en) | 2012-04-25 |
| DK2442799T3 (da) | 2017-01-02 |
| PL2442799T5 (pl) | 2019-09-30 |
| PT2442799T (pt) | 2016-12-07 |
| ES2606127T3 (es) | 2017-03-22 |
| HUE031177T2 (hu) | 2017-07-28 |
| EP2442799B2 (en) | 2019-05-22 |
| WO2010146179A2 (en) | 2010-12-23 |
| PL2442799T3 (pl) | 2017-04-28 |
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