HRP20241209T1 - Komprimirani pripravci macitentana, postupci i njihova uporaba - Google Patents
Komprimirani pripravci macitentana, postupci i njihova uporaba Download PDFInfo
- Publication number
- HRP20241209T1 HRP20241209T1 HRP20241209TT HRP20241209T HRP20241209T1 HR P20241209 T1 HRP20241209 T1 HR P20241209T1 HR P20241209T T HRP20241209T T HR P20241209TT HR P20241209 T HRP20241209 T HR P20241209T HR P20241209 T1 HRP20241209 T1 HR P20241209T1
- Authority
- HR
- Croatia
- Prior art keywords
- mass fraction
- diluent
- surfactant
- sugar alcohol
- total
- Prior art date
Links
- 238000002360 preparation method Methods 0.000 title claims 18
- JGCMEBMXRHSZKX-UHFFFAOYSA-N macitentan Chemical compound C=1C=C(Br)C=CC=1C=1C(NS(=O)(=O)NCCC)=NC=NC=1OCCOC1=NC=C(Br)C=N1 JGCMEBMXRHSZKX-UHFFFAOYSA-N 0.000 title claims 5
- 229960001039 macitentan Drugs 0.000 title claims 5
- 238000000034 method Methods 0.000 title claims 3
- 239000003085 diluting agent Substances 0.000 claims 22
- 150000005846 sugar alcohols Chemical class 0.000 claims 20
- 239000004094 surface-active agent Substances 0.000 claims 20
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 claims 5
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims 5
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims 5
- 229940068968 polysorbate 80 Drugs 0.000 claims 5
- 229920000053 polysorbate 80 Polymers 0.000 claims 5
- 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 4
- 229930195725 Mannitol Natural products 0.000 claims 4
- TVXBFESIOXBWNM-UHFFFAOYSA-N Xylitol Natural products OCCC(O)C(O)C(O)CCO TVXBFESIOXBWNM-UHFFFAOYSA-N 0.000 claims 4
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical group [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims 4
- 239000000845 maltitol Substances 0.000 claims 4
- 235000010449 maltitol Nutrition 0.000 claims 4
- VQHSOMBJVWLPSR-WUJBLJFYSA-N maltitol Chemical compound OC[C@H](O)[C@@H](O)[C@@H]([C@H](O)CO)O[C@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O VQHSOMBJVWLPSR-WUJBLJFYSA-N 0.000 claims 4
- 229940035436 maltitol Drugs 0.000 claims 4
- 239000000594 mannitol Substances 0.000 claims 4
- 235000010355 mannitol Nutrition 0.000 claims 4
- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 claims 4
- 239000000811 xylitol Substances 0.000 claims 4
- 235000010447 xylitol Nutrition 0.000 claims 4
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 claims 4
- 229960002675 xylitol Drugs 0.000 claims 4
- 239000011230 binding agent Substances 0.000 claims 3
- 239000000203 mixture Substances 0.000 claims 3
- CSCPPACGZOOCGX-UHFFFAOYSA-N Acetone Chemical compound CC(C)=O CSCPPACGZOOCGX-UHFFFAOYSA-N 0.000 claims 2
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims 2
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical group C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims 2
- 206010064911 Pulmonary arterial hypertension Diseases 0.000 claims 2
- 230000001476 alcoholic effect Effects 0.000 claims 2
- 239000007884 disintegrant Substances 0.000 claims 2
- 239000008187 granular material Substances 0.000 claims 2
- 239000000314 lubricant Substances 0.000 claims 2
- 235000019359 magnesium stearate Nutrition 0.000 claims 2
- 229960001855 mannitol Drugs 0.000 claims 2
- 229940016286 microcrystalline cellulose Drugs 0.000 claims 2
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims 2
- 239000008108 microcrystalline cellulose Substances 0.000 claims 2
- 239000008183 oral pharmaceutical preparation Substances 0.000 claims 2
- 239000007787 solid Substances 0.000 claims 2
- 229960000913 crospovidone Drugs 0.000 claims 1
- 238000005461 lubrication Methods 0.000 claims 1
- 239000000546 pharmaceutical excipient Substances 0.000 claims 1
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 claims 1
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 claims 1
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims 1
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims 1
- 229940069328 povidone Drugs 0.000 claims 1
- 229940079832 sodium starch glycolate Drugs 0.000 claims 1
- 239000008109 sodium starch glycolate Substances 0.000 claims 1
- 229920003109 sodium starch glycolate Polymers 0.000 claims 1
- 239000000126 substance Substances 0.000 claims 1
- 238000005550 wet granulation Methods 0.000 claims 1
Landscapes
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PT2019115632 | 2019-07-05 | ||
| EP19185065 | 2019-07-08 | ||
| PCT/IB2020/056304 WO2021005478A1 (fr) | 2019-07-05 | 2020-07-03 | Compositions de macitentan comprimées, procédés et utilisations de celles-ci |
| EP20750358.2A EP3993777B1 (fr) | 2019-07-05 | 2020-07-03 | Compositions de macitentan comprimé, procédés et utilisations associés |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20241209T1 true HRP20241209T1 (hr) | 2024-11-22 |
Family
ID=82258125
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20241209TT HRP20241209T1 (hr) | 2019-07-05 | 2020-07-03 | Komprimirani pripravci macitentana, postupci i njihova uporaba |
Country Status (8)
| Country | Link |
|---|---|
| ES (1) | ES2988283T3 (fr) |
| HR (1) | HRP20241209T1 (fr) |
| LT (1) | LT3993777T (fr) |
| MA (1) | MA56458B1 (fr) |
| PL (1) | PL3993777T3 (fr) |
| RS (1) | RS66024B1 (fr) |
| SI (1) | SI3993777T1 (fr) |
| SM (1) | SMT202400342T1 (fr) |
-
2020
- 2020-07-03 SI SI202030487T patent/SI3993777T1/sl unknown
- 2020-07-03 ES ES20750358T patent/ES2988283T3/es active Active
- 2020-07-03 MA MA56458A patent/MA56458B1/fr unknown
- 2020-07-03 HR HRP20241209TT patent/HRP20241209T1/hr unknown
- 2020-07-03 RS RS20240975A patent/RS66024B1/sr unknown
- 2020-07-03 SM SM20240342T patent/SMT202400342T1/it unknown
- 2020-07-03 LT LTEPPCT/IB2020/056304T patent/LT3993777T/lt unknown
- 2020-07-03 PL PL20750358.2T patent/PL3993777T3/pl unknown
Also Published As
| Publication number | Publication date |
|---|---|
| ES2988283T3 (es) | 2024-11-19 |
| SI3993777T1 (sl) | 2024-12-31 |
| LT3993777T (lt) | 2024-09-10 |
| MA56458B1 (fr) | 2024-09-30 |
| SMT202400342T1 (it) | 2024-11-15 |
| PL3993777T3 (pl) | 2024-12-16 |
| RS66024B1 (sr) | 2024-11-29 |
| MA56458A (fr) | 2022-05-11 |
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