BR112016012179B1 - Composições farmacêuticas que compreendem fumarato de dimetila - Google Patents
Composições farmacêuticas que compreendem fumarato de dimetila Download PDFInfo
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- BR112016012179B1 BR112016012179B1 BR112016012179-1A BR112016012179A BR112016012179B1 BR 112016012179 B1 BR112016012179 B1 BR 112016012179B1 BR 112016012179 A BR112016012179 A BR 112016012179A BR 112016012179 B1 BR112016012179 B1 BR 112016012179B1
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- pharmaceutical composition
- dimethyl fumarate
- tablet
- gastro
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- LDCRTTXIJACKKU-ONEGZZNKSA-N dimethyl fumarate Chemical compound COC(=O)\C=C\C(=O)OC LDCRTTXIJACKKU-ONEGZZNKSA-N 0.000 title claims abstract description 93
- 239000008194 pharmaceutical composition Substances 0.000 title claims abstract description 78
- 229960004419 dimethyl fumarate Drugs 0.000 title claims abstract description 63
- 239000000203 mixture Chemical class 0.000 claims abstract description 56
- 239000011248 coating agent Substances 0.000 claims abstract description 46
- 238000000576 coating method Methods 0.000 claims abstract description 46
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims abstract description 29
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims abstract description 29
- 239000008108 microcrystalline cellulose Substances 0.000 claims abstract description 29
- 229940016286 microcrystalline cellulose Drugs 0.000 claims abstract description 29
- 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 abstract description 27
- 229920002785 Croscarmellose sodium Polymers 0.000 claims abstract description 26
- 229960001681 croscarmellose sodium Drugs 0.000 claims abstract description 26
- 235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 claims abstract description 26
- 238000011282 treatment Methods 0.000 claims abstract description 25
- 239000003085 diluting agent Substances 0.000 claims abstract description 22
- 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 description 37
- 239000008101 lactose Substances 0.000 claims description 34
- 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 description 32
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 29
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 24
- 201000006417 multiple sclerosis Diseases 0.000 claims description 24
- FUFJGUQYACFECW-UHFFFAOYSA-L calcium hydrogenphosphate Chemical compound [Ca+2].OP([O-])([O-])=O FUFJGUQYACFECW-UHFFFAOYSA-L 0.000 claims description 21
- 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 description 20
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- 235000019700 dicalcium phosphate Nutrition 0.000 claims description 15
- 239000008119 colloidal silica Substances 0.000 claims description 13
- 239000000314 lubricant Substances 0.000 claims description 13
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- 239000000377 silicon dioxide Substances 0.000 claims description 7
- GWEVSGVZZGPLCZ-UHFFFAOYSA-N Titan oxide Chemical compound O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 claims description 6
- VBICKXHEKHSIBG-UHFFFAOYSA-N 1-monostearoylglycerol Chemical compound CCCCCCCCCCCCCCCCCC(=O)OCC(O)CO VBICKXHEKHSIBG-UHFFFAOYSA-N 0.000 claims description 5
- DOOTYTYQINUNNV-UHFFFAOYSA-N Triethyl citrate Chemical compound CCOC(=O)CC(O)(C(=O)OCC)CC(=O)OCC DOOTYTYQINUNNV-UHFFFAOYSA-N 0.000 claims description 5
- 229940079593 drug Drugs 0.000 claims description 5
- 239000001069 triethyl citrate Substances 0.000 claims description 5
- 235000013769 triethyl citrate Nutrition 0.000 claims description 5
- VMYFZRTXGLUXMZ-UHFFFAOYSA-N triethyl citrate Natural products CCOC(=O)C(O)(C(=O)OCC)C(=O)OCC VMYFZRTXGLUXMZ-UHFFFAOYSA-N 0.000 claims description 5
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 claims description 4
- FSBVERYRVPGNGG-UHFFFAOYSA-N dimagnesium dioxido-bis[[oxido(oxo)silyl]oxy]silane hydrate Chemical compound O.[Mg+2].[Mg+2].[O-][Si](=O)O[Si]([O-])([O-])O[Si]([O-])=O FSBVERYRVPGNGG-UHFFFAOYSA-N 0.000 claims description 4
- AMTWCFIAVKBGOD-UHFFFAOYSA-N dioxosilane;methoxy-dimethyl-trimethylsilyloxysilane Chemical compound O=[Si]=O.CO[Si](C)(C)O[Si](C)(C)C AMTWCFIAVKBGOD-UHFFFAOYSA-N 0.000 claims description 4
- 239000000391 magnesium silicate Substances 0.000 claims description 4
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- 229940083037 simethicone Drugs 0.000 claims description 4
- 239000004408 titanium dioxide Substances 0.000 claims description 4
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 4
- 235000021355 Stearic acid Nutrition 0.000 claims description 3
- 229940037627 magnesium lauryl sulfate Drugs 0.000 claims description 3
- HBNDBUATLJAUQM-UHFFFAOYSA-L magnesium;dodecyl sulfate Chemical compound [Mg+2].CCCCCCCCCCCCOS([O-])(=O)=O.CCCCCCCCCCCCOS([O-])(=O)=O HBNDBUATLJAUQM-UHFFFAOYSA-L 0.000 claims description 3
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 claims description 3
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 claims description 3
- 235000019333 sodium laurylsulphate Nutrition 0.000 claims description 3
- 239000008117 stearic acid Substances 0.000 claims description 3
- 229960004274 stearic acid Drugs 0.000 claims description 3
- OKMWKBLSFKFYGZ-UHFFFAOYSA-N 1-behenoylglycerol Chemical compound CCCCCCCCCCCCCCCCCCCCCC(=O)OCC(O)CO OKMWKBLSFKFYGZ-UHFFFAOYSA-N 0.000 claims description 2
- UFHFLCQGNIYNRP-UHFFFAOYSA-N Hydrogen Chemical compound [H][H] UFHFLCQGNIYNRP-UHFFFAOYSA-N 0.000 claims description 2
- CERQOIWHTDAKMF-UHFFFAOYSA-N Methacrylic acid Chemical compound CC(=C)C(O)=O CERQOIWHTDAKMF-UHFFFAOYSA-N 0.000 claims description 2
- 239000001506 calcium phosphate Substances 0.000 claims description 2
- 229910000389 calcium phosphate Inorganic materials 0.000 claims description 2
- 235000011010 calcium phosphates Nutrition 0.000 claims description 2
- 239000000378 calcium silicate Substances 0.000 claims description 2
- 229910052918 calcium silicate Inorganic materials 0.000 claims description 2
- 235000012241 calcium silicate Nutrition 0.000 claims description 2
- CJZGTCYPCWQAJB-UHFFFAOYSA-L calcium stearate Chemical compound [Ca+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O CJZGTCYPCWQAJB-UHFFFAOYSA-L 0.000 claims description 2
- 235000013539 calcium stearate Nutrition 0.000 claims description 2
- 239000008116 calcium stearate Substances 0.000 claims description 2
- OYACROKNLOSFPA-UHFFFAOYSA-N calcium;dioxido(oxo)silane Chemical compound [Ca+2].[O-][Si]([O-])=O OYACROKNLOSFPA-UHFFFAOYSA-N 0.000 claims description 2
- 239000001913 cellulose Substances 0.000 claims description 2
- MVPICKVDHDWCJQ-UHFFFAOYSA-N ethyl 3-pyrrolidin-1-ylpropanoate Chemical compound CCOC(=O)CCN1CCCC1 MVPICKVDHDWCJQ-UHFFFAOYSA-N 0.000 claims description 2
- 229940049654 glyceryl behenate Drugs 0.000 claims description 2
- FETSQPAGYOVAQU-UHFFFAOYSA-N glyceryl palmitostearate Chemical compound OCC(O)CO.CCCCCCCCCCCCCCCC(O)=O.CCCCCCCCCCCCCCCCCC(O)=O FETSQPAGYOVAQU-UHFFFAOYSA-N 0.000 claims description 2
- 229940046813 glyceryl palmitostearate Drugs 0.000 claims description 2
- 239000008172 hydrogenated vegetable oil Substances 0.000 claims description 2
- 229940059904 light mineral oil Drugs 0.000 claims description 2
- 229910052919 magnesium silicate Inorganic materials 0.000 claims description 2
- 235000019792 magnesium silicate Nutrition 0.000 claims description 2
- 229940099273 magnesium trisilicate Drugs 0.000 claims description 2
- 229910000386 magnesium trisilicate Inorganic materials 0.000 claims description 2
- 235000019793 magnesium trisilicate Nutrition 0.000 claims description 2
- XAEFZNCEHLXOMS-UHFFFAOYSA-M potassium benzoate Chemical compound [K+].[O-]C(=O)C1=CC=CC=C1 XAEFZNCEHLXOMS-UHFFFAOYSA-M 0.000 claims description 2
- 239000004300 potassium benzoate Substances 0.000 claims description 2
- 235000010235 potassium benzoate Nutrition 0.000 claims description 2
- 229940103091 potassium benzoate Drugs 0.000 claims description 2
- 229940045902 sodium stearyl fumarate Drugs 0.000 claims description 2
- QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical group [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 claims description 2
- XOOUIPVCVHRTMJ-UHFFFAOYSA-L zinc stearate Chemical compound [Zn+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O XOOUIPVCVHRTMJ-UHFFFAOYSA-L 0.000 claims description 2
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- XJCRCPKBJWRZAX-UHFFFAOYSA-L disodium;dibenzoate Chemical compound [Na+].[Na+].[O-]C(=O)C1=CC=CC=C1.[O-]C(=O)C1=CC=CC=C1 XJCRCPKBJWRZAX-UHFFFAOYSA-L 0.000 claims 1
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- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical class [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 abstract description 11
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- 150000003839 salts Chemical class 0.000 abstract description 8
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical class [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 abstract description 7
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Landscapes
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Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP13382504 | 2013-12-12 | ||
| EP13382504.2 | 2013-12-12 | ||
| PCT/EP2014/076767 WO2015086467A1 (en) | 2013-12-12 | 2014-12-05 | Pharmaceutical compositions comprising dimethyl fumarate |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| BR112016012179A2 BR112016012179A2 (https=) | 2017-08-08 |
| BR112016012179B1 true BR112016012179B1 (pt) | 2023-04-18 |
Family
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| BR112016012179-1A BR112016012179B1 (pt) | 2013-12-12 | 2014-12-05 | Composições farmacêuticas que compreendem fumarato de dimetila |
Country Status (31)
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| US (2) | US20160310457A1 (https=) |
| EP (2) | EP3656379A1 (https=) |
| JP (3) | JP6581088B2 (https=) |
| KR (2) | KR102335289B1 (https=) |
| CN (2) | CN114159421B (https=) |
| AR (1) | AR098746A1 (https=) |
| AU (2) | AU2014363792B2 (https=) |
| BR (1) | BR112016012179B1 (https=) |
| CA (2) | CA2932054C (https=) |
| CL (1) | CL2016001415A1 (https=) |
| CY (1) | CY1124336T1 (https=) |
| DK (1) | DK3079666T3 (https=) |
| EA (1) | EA201600457A1 (https=) |
| ES (1) | ES2860551T3 (https=) |
| HR (1) | HRP20210468T1 (https=) |
| HU (1) | HUE054408T2 (https=) |
| IL (2) | IL287109B (https=) |
| LT (1) | LT3079666T (https=) |
| MX (2) | MX375144B (https=) |
| MY (1) | MY179355A (https=) |
| NZ (2) | NZ720287A (https=) |
| PH (2) | PH12016501043B1 (https=) |
| PL (1) | PL3079666T3 (https=) |
| PT (1) | PT3079666T (https=) |
| RS (1) | RS61658B1 (https=) |
| SG (3) | SG10201802815UA (https=) |
| SI (1) | SI3079666T1 (https=) |
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| TW (2) | TWI704915B (https=) |
| UA (2) | UA120428C2 (https=) |
| WO (1) | WO2015086467A1 (https=) |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| US10098863B2 (en) | 2014-02-28 | 2018-10-16 | Banner Life Sciences Llc | Fumarate esters |
| US9636318B2 (en) | 2015-08-31 | 2017-05-02 | Banner Life Sciences Llc | Fumarate ester dosage forms |
| US9326947B1 (en) | 2014-02-28 | 2016-05-03 | Banner Life Sciences Llc | Controlled release fumarate esters |
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