HRP20191119T1 - Ko-kristali agomelatina i p-toluensulfonske kiseline, način pripreme i i farmaceutski pripravci koji sadržavaju iste - Google Patents
Ko-kristali agomelatina i p-toluensulfonske kiseline, način pripreme i i farmaceutski pripravci koji sadržavaju iste Download PDFInfo
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- HRP20191119T1 HRP20191119T1 HRP20191119TT HRP20191119T HRP20191119T1 HR P20191119 T1 HRP20191119 T1 HR P20191119T1 HR P20191119T T HRP20191119T T HR P20191119TT HR P20191119 T HRP20191119 T HR P20191119T HR P20191119 T1 HRP20191119 T1 HR P20191119T1
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- agomelatine
- toluenesulfonic acid
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
- C07C233/00—Carboxylic acid amides
- C07C233/01—Carboxylic acid amides having carbon atoms of carboxamide groups bound to hydrogen atoms or to acyclic carbon atoms
- 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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- A—HUMAN NECESSITIES
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- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
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- A61P25/00—Drugs for disorders of the nervous system
- A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/20—Hypnotics; Sedatives
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/22—Anxiolytics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/24—Antidepressants
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/04—Anorexiants; Antiobesity agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
- C07C231/00—Preparation of carboxylic acid amides
- C07C231/22—Separation; Purification; Stabilisation; Use of additives
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
- C07C303/00—Preparation of esters or amides of sulfuric acids; Preparation of sulfonic acids or of their esters, halides, anhydrides or amides
- C07C303/32—Preparation of esters or amides of sulfuric acids; Preparation of sulfonic acids or of their esters, halides, anhydrides or amides of salts of sulfonic acids
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
- C07C309/00—Sulfonic acids; Halides, esters, or anhydrides thereof
- C07C309/01—Sulfonic acids
- C07C309/28—Sulfonic acids having sulfo groups bound to carbon atoms of six-membered aromatic rings of a carbon skeleton
- C07C309/29—Sulfonic acids having sulfo groups bound to carbon atoms of six-membered aromatic rings of a carbon skeleton of non-condensed six-membered aromatic rings
- C07C309/30—Sulfonic acids having sulfo groups bound to carbon atoms of six-membered aromatic rings of a carbon skeleton of non-condensed six-membered aromatic rings of six-membered aromatic rings substituted by alkyl groups
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07B—GENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
- C07B2200/00—Indexing scheme relating to specific properties of organic compounds
- C07B2200/13—Crystalline forms, e.g. polymorphs
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- Bioinformatics & Cheminformatics (AREA)
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- General Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Pharmacology & Pharmacy (AREA)
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- Animal Behavior & Ethology (AREA)
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- Biomedical Technology (AREA)
- Neurosurgery (AREA)
- Pain & Pain Management (AREA)
- Diabetes (AREA)
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- Hematology (AREA)
- Obesity (AREA)
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- Child & Adolescent Psychology (AREA)
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- Heart & Thoracic Surgery (AREA)
- Cardiology (AREA)
- Anesthesiology (AREA)
- Hospice & Palliative Care (AREA)
- Reproductive Health (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Claims (12)
1. Kristalni oblici ko-kristala agomelatina i p-toluensulfonske kiseline, naznačeni time, da imaju formulu (I):
pri čemu n predstavlja 0 ili 1.
2. Ko-kristal agomelatina i monohidrata p-toluensulfonske kiseline formule (I) u skladu s patentnim zahtjevom 1, 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:
uključujući oblike čiji uglovi difrakcije odgovaraju unutar ± 0,2 °.
3. Ko-kristal agomelatina i p-toluensulfonske kiseline formule (I) u skladu s patentnim zahtjevom 1, naznačen time, da ima dijagram rendgenske difrakcije praha, izražen u interplanarnoj udaljenosti d, Braggov kut 2 theta (izražen u ± 0,2 °), i relativni intenzitet, kao što slijedi:
uključujući oblike čiji kutovi difrakcije odgovaraju unutar ± 0,2 °.
4. Postupak za dobivanje ko-kristala agomelatina i p-toluensulfonske kiseline u skladu s bilo kojim patentnim zahtjevom 1 do 3, naznačen time, da:
- agomelatin i monohidrat p-toluensulfonske kiseline su pomiješani u organskom ili vodeno-organskom otapalu u željenim omjerima;
- dobivena otopina se miješa i opcionalno zagrijava na temperaturi koja nije veća od vrelišta odabranog otapala;
- smjesa se ohladi, uz miješanje, i kompleks precipitira prirodno ili se taloži nakon inkorporacije u drugo otapalo;
- dobiveni talog se filtrira i suši;
- po izboru, precipitat se suši grijanjem.
5. Postupak za pripravu ko-kristala agomelatina i p-toluensulfonske kiseline u skladu s bilo kojim patentnim zahtjevom 1 do 3, naznačen time, da se dva sastojka melju zajedno.
6. Postupak za pripravu ko-kristala agomelatina i p-toluensulfonske kiseline u skladu s bilo kojim patentnim zahtjevom 1 do 3, naznačen time, da se dva sastojka pomiješaju u organskom ili vodeno-organskom otapalu, a zatim zamrznu i osuše na vrlo niskoj temperaturi.
7. Postupak za pripravu ko-kristala agomelatina i p-toluensulfonske kiseline u skladu s bilo kojim patentnim zahtjevom 1 do 3, naznačen time, da se prašci agomelatina i predmetne kiseline miješaju u miješalici i zatim se smjesa ekstrudira ekstruzijom s dva vijka bez kalupa kako bi se dobilo čvrsto zrno izravno na izlazu iz ekstrudera.
8. Farmaceutski pripravci, naznačeni time, da kao aktivni sastojak sadržavaju jedan od ko-kristala agomelatina i p-toluensulfonske kiseline u skladu s bilo kojim patentnim zahtjevom 1 do 3, u kombinaciji s jednim ili više inertnih, netoksičnih i farmaceutski prihvatljivih nosača.
9. Upotreba farmaceutskih pripravaka u skladu s patentnim zahtjevom 8, naznačena time, da se oni koriste za proizvodnju lijekova za liječenje poremećaja melatoninergičkog sustava.
10. Upotreba farmaceutskih pripravaka u skladu s patentnim zahtjevom 8, naznačena time, da se koriste za proizvodnju lijekova za liječenje stresa, poremećaja spavanja, anksioznih poremećaja i posebno generaliziranog anksioznog poremećaja, opsesivno kompulzivnih poremećaja, poremećaja raspoloženja, a posebno bipolarnih poremećaja, velike depresije, sezonskog afektivnog poremećaja, kardiovaskularnih patologija , patologije probavnog sustava, nesanica i umora uslijed vremenske razlike, shizofrenije, napadaja 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 poremećaja moždane cirkulacije, kao i kod seksualnih disfunkcija, kao inhibitori ovulacije i imunomodulatori te u liječenju karcinoma.
11. Ko-kristali agomelatina i p-toluensulfonske kiseline formule (I) u skladu s bilo kojim patentnim zahtjevom 1 do 3, naznačeni time, da se koriste za liječenje poremećaja melatoninergičkog sustava.
12. Ko-kristali agomelatina i p-toluensulfonske kiseline formule (I) u skladu s bilo kojim od patentnih zahtjeva 1 do 3, naznačeni time, da se koriste za liječenje stresa, poremećaja spavanja, anksioznih poremećaja i posebno generaliziranog anksioznog poremećaja, opsesivno kompulzivnih poremećaja, poremećaja raspoloženja, a naročito bipolamog poremećaja, velike depresije, sezonskog afektivnog poremećaja, kardiovaskularne patologije, patologije probavnog sustava, nesanice i umora uslijed vremenske razlike, shizofrenije, napadaja 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 poremećaja moždane cirkulacije, kao i kod seksualnih disfunkcija, kao inhibitori ovulacije i imunomodulatori te u liječenju karcinoma.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PCT/CN2013/080472 WO2015013903A1 (en) | 2013-07-31 | 2013-07-31 | NEW AGOMELATINE p-TOLUENESULFONIC ACID CO-CRYSTAL FORMS AND PREPARATION THEREOF |
| FR1360121A FR3012141B1 (fr) | 2013-10-17 | 2013-10-17 | Nouvelles formes de co-cristaux d'agomelatine et d'acide p-toluenesulfonique, leur procede de preparation et les compositions pharmaceutiques qui les contiennent |
| EP14749937.0A EP3036218B1 (fr) | 2013-07-31 | 2014-07-30 | Co-cristaux d'agomelatine et d'acide p-toluenesulfonique, leur procede de preparation et les compositions pharmaceutiques qui les contiennent |
| PCT/FR2014/051972 WO2015015118A2 (fr) | 2013-07-31 | 2014-07-30 | NOUVELLES FORMES DE CO-CRISTAUX D'AGOMELATINE ET D'ACIDE p-TOLUENESULFONIQUE, LEUR PROCEDE DE PREPARATION ET LES COMPOSITIONS PHARMACEUTIQUES QUI LES CONTIENNENT |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20191119T1 true HRP20191119T1 (hr) | 2019-10-18 |
Family
ID=51300781
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20191119TT HRP20191119T1 (hr) | 2013-07-31 | 2014-07-30 | Ko-kristali agomelatina i p-toluensulfonske kiseline, način pripreme i i farmaceutski pripravci koji sadržavaju iste |
Country Status (24)
| Country | Link |
|---|---|
| US (1) | US9663451B2 (hr) |
| EP (1) | EP3036218B1 (hr) |
| JP (1) | JP6525996B2 (hr) |
| AU (1) | AU2014298230C1 (hr) |
| CA (1) | CA2918228C (hr) |
| CY (1) | CY1122959T1 (hr) |
| DK (1) | DK3036218T3 (hr) |
| EA (1) | EA031053B1 (hr) |
| ES (1) | ES2734562T3 (hr) |
| HK (1) | HK1223348A1 (hr) |
| HR (1) | HRP20191119T1 (hr) |
| HU (1) | HUE044798T2 (hr) |
| LT (1) | LT3036218T (hr) |
| ME (1) | ME03388B (hr) |
| MX (1) | MX369301B (hr) |
| NZ (1) | NZ716153A (hr) |
| PL (1) | PL3036218T3 (hr) |
| PT (1) | PT3036218T (hr) |
| RS (1) | RS58778B1 (hr) |
| RU (1) | RU2695609C2 (hr) |
| SG (1) | SG11201600005VA (hr) |
| SI (1) | SI3036218T1 (hr) |
| UA (1) | UA117023C2 (hr) |
| WO (1) | WO2015015118A2 (hr) |
Family Cites Families (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US7498466B2 (en) * | 2004-02-13 | 2009-03-03 | Les Laboratoires Servier | Process for the synthesis and crystalline form of agomelatine |
| 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 |
| 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 |
| 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 |
-
2014
- 2014-07-30 HK HK16111559.2A patent/HK1223348A1/zh unknown
- 2014-07-30 JP JP2016530589A patent/JP6525996B2/ja not_active Expired - Fee Related
- 2014-07-30 HR HRP20191119TT patent/HRP20191119T1/hr unknown
- 2014-07-30 SG SG11201600005VA patent/SG11201600005VA/en unknown
- 2014-07-30 HU HUE14749937 patent/HUE044798T2/hu unknown
- 2014-07-30 SI SI201431215T patent/SI3036218T1/sl unknown
- 2014-07-30 LT LTEP14749937.0T patent/LT3036218T/lt unknown
- 2014-07-30 RU RU2016106954A patent/RU2695609C2/ru active
- 2014-07-30 NZ NZ716153A patent/NZ716153A/en not_active IP Right Cessation
- 2014-07-30 DK DK14749937.0T patent/DK3036218T3/da active
- 2014-07-30 WO PCT/FR2014/051972 patent/WO2015015118A2/fr active Application Filing
- 2014-07-30 MX MX2016001218A patent/MX369301B/es active IP Right Grant
- 2014-07-30 ES ES14749937T patent/ES2734562T3/es active Active
- 2014-07-30 EA EA201600143A patent/EA031053B1/ru not_active IP Right Cessation
- 2014-07-30 PL PL14749937T patent/PL3036218T3/pl unknown
- 2014-07-30 CA CA2918228A patent/CA2918228C/fr not_active Expired - Fee Related
- 2014-07-30 EP EP14749937.0A patent/EP3036218B1/fr active Active
- 2014-07-30 US US14/908,253 patent/US9663451B2/en not_active Expired - Fee Related
- 2014-07-30 UA UAA201601716A patent/UA117023C2/uk unknown
- 2014-07-30 PT PT14749937T patent/PT3036218T/pt unknown
- 2014-07-30 ME MEP-2019-153A patent/ME03388B/me unknown
- 2014-07-30 RS RS20190633A patent/RS58778B1/sr unknown
- 2014-07-30 AU AU2014298230A patent/AU2014298230C1/en not_active Ceased
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2019
- 2019-07-01 CY CY20191100686T patent/CY1122959T1/el unknown
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