HRP20200927T1 - Kompleksi agomelatina i sulfonskih kiselina, postupak njihove proizvodnje i proizvodnje farmaceutskih pripravaka koji ih sadržavaju - Google Patents
Kompleksi agomelatina i sulfonskih kiselina, postupak njihove proizvodnje i proizvodnje farmaceutskih pripravaka koji ih sadržavaju Download PDFInfo
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- C07C233/16—Carboxylic acid amides having carbon atoms of carboxamide groups bound to hydrogen atoms or to acyclic carbon atoms having the nitrogen atom of at least one of the carboxamide groups bound to a carbon atom of a hydrocarbon radical substituted by singly-bound oxygen atoms
- C07C233/17—Carboxylic acid amides having carbon atoms of carboxamide groups bound to hydrogen atoms or to acyclic carbon atoms having the nitrogen atom of at least one of the carboxamide groups bound to a carbon atom of a hydrocarbon radical substituted by singly-bound oxygen atoms with the substituted hydrocarbon radical bound to the nitrogen atom of the carboxamide group by an acyclic carbon atom
- C07C233/18—Carboxylic acid amides having carbon atoms of carboxamide groups bound to hydrogen atoms or to acyclic carbon atoms having the nitrogen atom of at least one of the carboxamide groups bound to a carbon atom of a hydrocarbon radical substituted by singly-bound oxygen atoms with the substituted hydrocarbon radical bound to the nitrogen atom of the carboxamide group by an acyclic carbon atom having the carbon atom of the carboxamide group bound to a hydrogen atom or to a carbon atom of an acyclic saturated carbon skeleton
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- C07C303/02—Preparation of esters or amides of sulfuric acids; Preparation of sulfonic acids or of their esters, halides, anhydrides or amides of sulfonic acids or halides thereof
- C07C303/22—Preparation of esters or amides of sulfuric acids; Preparation of sulfonic acids or of their esters, halides, anhydrides or amides of sulfonic acids or halides thereof from sulfonic acids, by reactions not involving the formation of sulfo or halosulfonyl groups; from sulfonic halides by reactions not involving the formation of halosulfonyl groups
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Claims (16)
1. Kompleksi agomelatina i sultanske kiseline, naznačeni time, da su predstavljeni formulom (I):
[image]
pri čemu je x 0 ili 1, a RSO3H predstavlja 1,5-naftalendisulfonsku kiselinu ili benzensultansku kiselinu.
2. Kompleks agomelatina formule (I) u skladu s patentnim zahtjevom 1, naznačen time, da je to kompleks agomelatin / 1,5-naftalendisulfonske kiseline (2/1).
3. Kompleks agomelatina formule (I) u skladu s patentnim zahtjevom 2, naznačen time, da ima dijagram rendgenske difrakcije praha, izražen u interplanarnoj udaljenosti d, Braggov kut 2 theta (izražen u ° ±0,2) i relativni intenzitet, kako slijedi:
[image]
uključujući oblike čiji kutovi difrakcije odgovaraju vrijednostima unutar ± 0,2 °.
4. Kompleks agomelatina formule (I) u skladu s patentnim zahtjevom 1, naznačen time, da je to kompleks agomelatin / 1,5-naftalendisulfonska kiselina (2/1) monohidrat.
5. Kompleks agomelatina formule (I) u skladu s patentnim zahtjevom 4, naznačen time, da ima dijagram rendgenske difrakcije praha, izražen u interplanarnoj udaljenosti d, Braggov kut 2 theta (izražen u ° ±0,2) i relativni intenzitet, kako slijedi:
[image]
uključujući oblike čiji kutovi difrakcije odgovaraju vrijednostima unutar ± 0,2 °.
6. Kompleks agomelatina formule (I) u skladu s patentnim zahtjevom 1, naznačen time, da je to kompleks agomelatin / benzensulfonska kiselina (2/1).
7. Kompleks agomelatina formule (I) u skladu s patentnim zahtjevom 6, naznačen time, da ima dijagram rendgenske difrakcije praha, izražen u interplanarnoj udaljenosti d, Braggov kut 2 theta (izražen u ° ± 0,2) i relativni intenzitet, kako slijedi:
[image]
uključujući oblike čiji kutovi difrakcije odgovaraju vrijednostima unutar ± 0,2
8. Postupak za dobivanje kompleksa agomelatina i sulfonske kiseline u skladu s bilo kojim od patentnih zahtjeva 1 do 7, naznačen time, da:
- agomelatin i sulfonska kiselina se pomiješaju u organskom ili vodeno-organskom otapalu u željenim omjerima;
- dobivena otopina se miješa i po želji zagrijava na temperaturi ne većoj od vrelišta odabranog otapala;
- smjesa se hladi, uz miješanje, i kokristal se taloži prirodno ili se taloži nakon što je uklonjena u drugo otapalo;
- dobiveni talog se filtrira i suši.
9. Postupak za pripravu kompleksa agomelatina i sultanske kiseline u skladu s bilo kojim od patentnih zahtjeva 1 do 7, naznačen time, da se dva sastojka zajedno melju.
10. Postupak za pripravu kompleksa agomelatina i sultanske kiseline u skladu s bilo kojim od patentnih zahtjeva 1 do 7, naznačen time, da se dva sastojka miješaju u organskom ili vodeno-organskom otapalu, a zatim zamrzavaju i suše na vrlo niskoj temperaturi.
11. Postupak za pripravu kompleksa agomelatina i sultanske kiseline u skladu s bilo kojim od patentnih zahtjeva 1 do 7, naznačen time, da se praškovi agomelatina i dotične kiseline pomiješaju u miješalici i smjesa se zatim ekstrudira dvostrukim vijkom bez matrice kako bi se dobilo čvrsto zrno izravno na izlazu ekstrudera.
12. Farmaceutski pripravci, naznačeni time, da sadržavaju kao aktivni sastojak jedan od kompleksa agomelatina i sultanske kiseline u skladu s bilo kojim od patentnih zahtjeva 1 do 7, u kombinaciji s jednim ili više inertnih, netoksičnih, farmaceutski prihvatljivih nosača.
13. Upotreba farmaceutskih pripravaka u skladu s patentnim zahtjevom 12, naznačena time, da se koriste u proizvodnji lijekova za liječenje poremećaja melatoninergičkog sustava.
14. Upotreba farmaceutskih pripravaka u skladu s patentnim zahtjevom 12, naznačena time, da se koriste u proizvodnji lijekova za liječenje stresa, poremećaja spavanja, anksioznih poremećaja i posebno generaliziranog anksioznog poremećaja, opsesivno- kompulzivnih poremećaja, poremećaja raspoloženja i posebno bipolarnih poremećaja, velike depresije, sezonskog afektivnog poremećaja, kardiovaskularnih patologija, patologije probavnog sustava, nesanice i umora zbog jet-laga, shizofrenije, napada panike, melankolije, poremećaja apetita, pretilosti, nesanice, boli, psihotičnih poremećaja, epilepsije, dijabetesa, Parkinsonove bolesti, senilne demencije, različitih poremećaja povezanih s normalnim ili patološkim starenjem, migrene, gubitka pamćenja, Alzheimerove bolesti, kao i kod poremećaja cerebralne cirkulacije, te kod seksualnih disfunkcija, kao inhibitora ovulacije i imunomodulatora i u liječenju karcinoma.
15. Kompleksi agomelatina i sulfonske kiseline formule (I) u skladu s bilo kojim od patentnih zahtjeva 1 do 7, naznačeni time, da se liječe poremećaji melatoninergičkog sustava.
16. Kompleksi agomelatina i sulfonske kiseline formule (I) u skladu s bilo kojim od patentnih zahtjeva 1 do 7, naznačeni time, da se koriste za liječenje stresa, poremećaja spavanja, anksioznih poremećaja i posebno generaliziranog anksioznog poremećaja, opsesivno-kompulzivnih poremećaja, poremećaja raspoloženja i posebno bipolarnih poremećaja, velike depresije, sezonskog afektivnog poremećaja, kardiovaskularne patologije, patologije probavnog sustava, nesanice i umora zbog jet- laga, shizofrenije, napada panike, melankolije, poremećaja apetita, pretilosti, nesanice, boli, psihotičnih poremećaja, epilepsije, dijabetesa, Parkinsonove bolesti, senilne demencije, raznih poremećaja povezanih s normalnim ili patološkim starenjem, migrene, gubitka pamćenja, Alzheimerove bolesti, kao i kod poremećaja cerebralne cirkulacije, te kod seksualnih disfunkcija, kao inhibitora ovulacije i imunomodulatora i u liječenju karcinoma.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PCT/CN2013/080337 WO2015013865A1 (en) | 2013-07-29 | 2013-07-29 | Agomelatine sulfonic acids complexes and preparation thereof |
| FR1360124A FR3012142B1 (fr) | 2013-10-17 | 2013-10-17 | Nouveaux complexes d'agomelatine et d'acides sulfoniques, leur procede de preparation et les compositions pharmaceutiques qui les contiennent |
| PCT/FR2014/051944 WO2015015102A2 (fr) | 2013-07-29 | 2014-07-28 | Nouveaux complexes d'agomelatine et d'acides sulfoniques, leur procede de preparation et les compositions pharmaceutiques qui les contiennent |
| EP14758162.3A EP3027588B1 (fr) | 2013-07-29 | 2014-07-28 | Complexes d'agomélatine et d'acides sulfoniques, procédé de leur préparation et compositions pharmaceutiques qui les contiennent |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20200927T1 true HRP20200927T1 (hr) | 2020-09-18 |
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| Application Number | Title | Priority Date | Filing Date |
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| HRP20200927TT HRP20200927T1 (hr) | 2013-07-29 | 2014-07-28 | Kompleksi agomelatina i sulfonskih kiselina, postupak njihove proizvodnje i proizvodnje farmaceutskih pripravaka koji ih sadržavaju |
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| US (1) | US9573891B2 (hr) |
| EP (1) | EP3027588B1 (hr) |
| JP (1) | JP6595990B2 (hr) |
| CN (1) | CN105473547B (hr) |
| AU (1) | AU2014298304B2 (hr) |
| CA (1) | CA2919601C (hr) |
| CY (1) | CY1123214T1 (hr) |
| DK (1) | DK3027588T3 (hr) |
| EA (1) | EA031237B1 (hr) |
| ES (1) | ES2792248T3 (hr) |
| HK (1) | HK1223088A1 (hr) |
| HR (1) | HRP20200927T1 (hr) |
| HU (1) | HUE049928T2 (hr) |
| LT (1) | LT3027588T (hr) |
| ME (1) | ME03741B (hr) |
| MX (1) | MX369303B (hr) |
| NZ (1) | NZ716151A (hr) |
| PL (1) | PL3027588T3 (hr) |
| PT (1) | PT3027588T (hr) |
| RS (1) | RS60440B1 (hr) |
| RU (1) | RU2673080C2 (hr) |
| SG (1) | SG11201600006RA (hr) |
| SI (1) | SI3027588T1 (hr) |
| UA (1) | UA116811C2 (hr) |
| WO (1) | WO2015015102A2 (hr) |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB0706044D0 (en) * | 2007-03-28 | 2007-05-09 | Syngenta Ltd | C0-Crystals |
| WO2009140466A2 (en) * | 2008-05-14 | 2009-11-19 | Dr. Reddy's Laboratories Ltd. | Linezolid co-crystals |
| CN101481321B (zh) * | 2009-02-27 | 2012-04-18 | 上海医药工业研究院 | 阿戈美拉汀卤化氢复合物及其制备方法 |
| CN102690209A (zh) * | 2011-03-23 | 2012-09-26 | 上海医药工业研究院 | 阿戈美拉汀的混晶(形式-ⅷ)、其制备方法、应用和包含其的药物组合物 |
| CN102690210A (zh) * | 2011-03-23 | 2012-09-26 | 上海医药工业研究院 | 阿戈美拉汀的新晶型ⅶ、其制备方法、应用和包含其的药物组合物 |
| PT2517700E (pt) * | 2011-04-28 | 2013-10-14 | Zentiva Ks | Cocristais farmaceuticamente aceitáveis de n-[2-(7-metoxi- 1-naftil)etil]acetamida e métodos para a sua preparação |
| PH12012000132B1 (en) * | 2011-06-09 | 2014-10-20 | Servier Lab | New co-crystals of agomelatine, a process for their preparation and pharmaceutical compositions containing them |
| CN102702041B (zh) * | 2012-05-14 | 2013-08-14 | 上海右手医药科技开发有限公司 | 阿戈美拉汀苯磺酸类复合物及其制备方法 |
| JP2015521179A (ja) * | 2012-05-14 | 2015-07-27 | 上海右手医葯科技▲開▼発有限公司 | アゴメラチン酸基複合体およびその製造方法と用途 |
| CN102718675B (zh) * | 2012-06-07 | 2015-03-25 | 上海右手医药科技开发有限公司 | 阿戈美拉汀甲磺酸复合物及其制备方法 |
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