HRP20210312T1 - Tetrahidrat h3 liganda, postupak za njegovo pripremanje i farmaceutski pripravci koji ga sadrže - Google Patents
Tetrahidrat h3 liganda, postupak za njegovo pripremanje i farmaceutski pripravci koji ga sadrže Download PDFInfo
- Publication number
- HRP20210312T1 HRP20210312T1 HRP20210312TT HRP20210312T HRP20210312T1 HR P20210312 T1 HRP20210312 T1 HR P20210312T1 HR P20210312T T HRP20210312T T HR P20210312TT HR P20210312 T HRP20210312 T HR P20210312T HR P20210312 T1 HRP20210312 T1 HR P20210312T1
- Authority
- HR
- Croatia
- Prior art keywords
- disorders
- form according
- sleep
- tetrahydrate
- tetrahydrate form
- Prior art date
Links
- 150000004685 tetrahydrates Chemical class 0.000 title claims 12
- 238000000034 method Methods 0.000 title claims 2
- 239000003446 ligand Substances 0.000 title 1
- 239000008194 pharmaceutical composition Substances 0.000 title 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 10
- 208000035475 disorder Diseases 0.000 claims 10
- 230000003935 attention Effects 0.000 claims 6
- 208000010877 cognitive disease Diseases 0.000 claims 5
- 150000001875 compounds Chemical class 0.000 claims 5
- 208000007590 Disorders of Excessive Somnolence Diseases 0.000 claims 3
- 208000018737 Parkinson disease Diseases 0.000 claims 3
- 206010041349 Somnolence Diseases 0.000 claims 3
- 208000001797 obstructive sleep apnea Diseases 0.000 claims 3
- 230000002265 prevention Effects 0.000 claims 3
- 201000009032 substance abuse Diseases 0.000 claims 3
- 231100000736 substance abuse Toxicity 0.000 claims 3
- 208000011117 substance-related disease Diseases 0.000 claims 3
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 3
- CSCPPACGZOOCGX-UHFFFAOYSA-N Acetone Chemical compound CC(C)=O CSCPPACGZOOCGX-UHFFFAOYSA-N 0.000 claims 2
- 208000007848 Alcoholism Diseases 0.000 claims 2
- 206010012289 Dementia Diseases 0.000 claims 2
- 208000019022 Mood disease Diseases 0.000 claims 2
- 206010001584 alcohol abuse Diseases 0.000 claims 2
- 208000025746 alcohol use disease Diseases 0.000 claims 2
- 238000002425 crystallisation Methods 0.000 claims 2
- 230000008025 crystallization Effects 0.000 claims 2
- 238000001035 drying Methods 0.000 claims 2
- 206010016256 fatigue Diseases 0.000 claims 2
- 238000001914 filtration Methods 0.000 claims 2
- 238000004519 manufacturing process Methods 0.000 claims 2
- 201000003631 narcolepsy Diseases 0.000 claims 2
- 208000019116 sleep disease Diseases 0.000 claims 2
- ACQXFQGMLFJXEI-KRWDZBQOSA-N 4-[4-[3-[(3s)-3-methylpiperidin-1-yl]propoxy]phenyl]-1-oxidopyridin-1-ium Chemical compound C1[C@@H](C)CCCN1CCCOC1=CC=C(C=2C=C[N+]([O-])=CC=2)C=C1 ACQXFQGMLFJXEI-KRWDZBQOSA-N 0.000 claims 1
- 208000024827 Alzheimer disease Diseases 0.000 claims 1
- 206010003550 Asthenic conditions Diseases 0.000 claims 1
- 208000006096 Attention Deficit Disorder with Hyperactivity Diseases 0.000 claims 1
- 208000036864 Attention deficit/hyperactivity disease Diseases 0.000 claims 1
- 206010003805 Autism Diseases 0.000 claims 1
- 208000020706 Autistic disease Diseases 0.000 claims 1
- 208000019888 Circadian rhythm sleep disease Diseases 0.000 claims 1
- 206010067889 Dementia with Lewy bodies Diseases 0.000 claims 1
- 201000002832 Lewy body dementia Diseases 0.000 claims 1
- 208000001145 Metabolic Syndrome Diseases 0.000 claims 1
- 206010028813 Nausea Diseases 0.000 claims 1
- 208000008589 Obesity Diseases 0.000 claims 1
- 208000006199 Parasomnias Diseases 0.000 claims 1
- 208000013738 Sleep Initiation and Maintenance disease Diseases 0.000 claims 1
- 206010040981 Sleep attacks Diseases 0.000 claims 1
- 208000006011 Stroke Diseases 0.000 claims 1
- 208000007271 Substance Withdrawal Syndrome Diseases 0.000 claims 1
- 201000004810 Vascular dementia Diseases 0.000 claims 1
- 206010048010 Withdrawal syndrome Diseases 0.000 claims 1
- 201000000690 abdominal obesity-metabolic syndrome Diseases 0.000 claims 1
- 208000015802 attention deficit-hyperactivity disease Diseases 0.000 claims 1
- 230000002490 cerebral effect Effects 0.000 claims 1
- 230000007278 cognition impairment Effects 0.000 claims 1
- 230000006735 deficit Effects 0.000 claims 1
- 230000003001 depressive effect Effects 0.000 claims 1
- 206010012601 diabetes mellitus Diseases 0.000 claims 1
- 208000002173 dizziness Diseases 0.000 claims 1
- 206010015037 epilepsy Diseases 0.000 claims 1
- 208000013403 hyperactivity Diseases 0.000 claims 1
- 210000000987 immune system Anatomy 0.000 claims 1
- 208000035231 inattentive type attention deficit hyperactivity disease Diseases 0.000 claims 1
- 206010022437 insomnia Diseases 0.000 claims 1
- 238000012423 maintenance Methods 0.000 claims 1
- 238000002844 melting Methods 0.000 claims 1
- 230000008018 melting Effects 0.000 claims 1
- 230000036651 mood Effects 0.000 claims 1
- 230000008693 nausea Effects 0.000 claims 1
- 235000020824 obesity Nutrition 0.000 claims 1
- 230000007170 pathology Effects 0.000 claims 1
- 239000000546 pharmaceutical excipient Substances 0.000 claims 1
- 239000000825 pharmaceutical preparation Substances 0.000 claims 1
- 238000000634 powder X-ray diffraction Methods 0.000 claims 1
- 230000000506 psychotropic effect Effects 0.000 claims 1
- 230000029058 respiratory gaseous exchange Effects 0.000 claims 1
- 230000028327 secretion Effects 0.000 claims 1
Classifications
-
- 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
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/445—Non condensed piperidines, e.g. piperocaine
- A61K31/4523—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
- A61K31/4545—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a six-membered ring with nitrogen as a ring hetero atom, e.g. pipamperone, anabasine
-
- 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
-
- 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
- A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D401/00—Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom
- C07D401/02—Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom containing two hetero rings
- C07D401/12—Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom containing two hetero rings linked by a chain containing hetero atoms as chain links
-
- 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
Landscapes
- Chemical & Material Sciences (AREA)
- Health & Medical Sciences (AREA)
- Organic Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Biomedical Technology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Neurosurgery (AREA)
- Neurology (AREA)
- Psychiatry (AREA)
- Epidemiology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Hydrogenated Pyridines (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Plural Heterocyclic Compounds (AREA)
- Pyridine Compounds (AREA)
Claims (10)
1. Tetrahidratni oblik spoja formule (A):
[image]
(A) : (3S)-4-{4-[3-(3-metilpiperidin-1-il)propoksi]fenil}piridin 1-oksid, dihidroklorid
2. Tetrahidratni oblik prema zahtjevu 1, koji pokazuje vrh topljenja od 191°C, mjereno postupkom kapilarne cijevi.
3. Tetrahidratni oblik prema bilo kojem od patentnih zahtjeva 1 ili 2, koji ima sadržaj vode od 15,3±0,7 mas.%.
4. Tetrahidratni oblik prema bilo kojem od prethodnih zahtjeva, koji pokazuje linije na rendgenskom difraktogramu praha: 2-Theta° (d u Angströmima) = 9,7 (9,1), 12,5 (7,1), 14,6 (6,1), 15,2 (5,8), 16,5 (5,4), 19,0 (4,7), 19,5 (4,6), 22,0 (4,1), 24,3 (3,7), 24,8 (3,6), 26,2 (3,4), 28,4 (3,1).
5. Postupak za pripremanje tetrahidratnog oblika prema bilo kojem od prethodnih zahtjeva, koji sadrži slijedeće faze:
- otapanje spoja (A) u vodi;
- koncentriranje do kristalizacije;
- filtriranje; i
- sušenje.
6. Postupak za pripremanje tetrahidratnog oblika prema bilo kojem od patentnih zahtjeva 1 do 4, naznačen time što sadrži slijedeće faze:
- otapanje spoja (A) u vodi;
- dodavanje acetona i snižavanje temperature do kristalizacije;
- filtriranje; i
- sušenje.
7. Farmaceutski pripravak naznačen time što sadrži tetrahidratni oblik prema bilo kojem od patentnih zahtjeva 1 do 4, zajedno s najmanje jednom farmaceutski prihvatljivom pomoćnom tvari.
8. Tetrahidratni oblik prema bilo kojem od patentnih zahtjeva 1 do 4 za uporabu kod humanog pacijenta u liječenju i/ili prevenciji Alzheimerove bolesti; poremećaja pažnje; budnosti i pamćenja; kognitivnih deficita u psihijatrijskim patologijama; poremećaja raspoloženja, pozornosti ili kognitivnih poremećaja kod starijih osoba; depresivnih ili asteničnih stanja; Parkinsonove bolesti; opstruktivne apneje tijekom sna; demencije s Levijevim tjelešcima; vaskularne demencije; vrtoglavice; mučnine tijekom vožnje; pretilosti; dijabetesa i metaboličkog sindroma; poremećaja sna; stresa; psihotropnih poremećaja; epilepsije; depresije; narkolepsije sa ili bez katapleksije; poremećaja hipotalamohipofizne sekrecije, cerebralne cirkulacije i/ili imunološkog sistema; prekomjerne dnevne pospanosti i umora povezanih s Parkinsonovom bolešću, opstruktivne apneje tijekom sna ili demencije i/ili za olakšavanje rada noću ili prilagođavanje vremenskoj razlici kod zdravih ljudi; poremećaja nedostatka pažnje; poremećaja zbog zlouporabe supstanci, naročito zlouporabe alkohola; prevencije sindroma povlačenja povezanih sa zlouporabom supstanci; umora nakon moždanog udara, poremećaja raspoloženja, kognitivnih poremećaja i poremećaja pozornosti; kognitivnih poremećaja kod autizma; poremećaja pažnje i pozornosti kod poremećaja s deficitom pažnje i hiperaktivnošću (ADHD) kod djece ili odraslih.
9. Tetrahidratni oblik prema bilo kojem od patentnih zahtjeva 1 do 4, za uporabu u liječenju i/ili prevenciji poremećaja sna, poželjno nesanice, poremećaja ulaska u san i održavanja spavanja, isprekidanosti sna, parasomnije, poremećenog disanja tijekom spavanja, cirkadijalne disritmije, narkolepsije s ili bez katapleksije, prekomjerne dnevne pospanosti uključujući "napade sna", poželjno prekomjerne dnevne pospanosti povezane s Parkinsonovom bolešću, opstruktivne apneje tijekom sna ili demencije; poremećaja zbog zlouporabe supstanci, poželjno zlouporabe alkohola, poremećaja raspoloženja, kognitivnih poremećaja i poremećaja pozornosti povezanih s moždanim udarom; kognitivnih poremećaja i poremećaja pažnje kod ADHD.
10. Tetrahidratni oblik za uporabu prema zahtjevu 8 ili 9, naznačen time što navedena uporaba sadrži davanje navedenog tetrahidrata spoja (A) čovjeku u dozi u rasponu između 10 i 90 µg u odnosu na bazu spoja (A) svakodnevno.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP17305310.9A EP3378858A1 (en) | 2017-03-21 | 2017-03-21 | Tetrahydrate of h3 ligand, its process of preparation and pharmaceutical compositions comprising the same |
| PCT/EP2018/056999 WO2018172344A1 (en) | 2017-03-21 | 2018-03-20 | Tetrahydrate of h3 ligand, its process of preparation and pharmaceutical compositions comprising the same |
| EP18711350.1A EP3601252B1 (en) | 2017-03-21 | 2018-03-20 | Tetrahydrate of h3 ligand, its process of preparation and pharmaceutical compositions comprising the same |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20210312T1 true HRP20210312T1 (hr) | 2021-04-02 |
Family
ID=58488932
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20210312TT HRP20210312T1 (hr) | 2017-03-21 | 2021-02-24 | Tetrahidrat h3 liganda, postupak za njegovo pripremanje i farmaceutski pripravci koji ga sadrže |
Country Status (21)
| Country | Link |
|---|---|
| US (1) | US11078183B2 (hr) |
| EP (2) | EP3378858A1 (hr) |
| JP (1) | JP7235671B2 (hr) |
| KR (1) | KR102608265B1 (hr) |
| CN (1) | CN110891948B (hr) |
| AU (1) | AU2018238260B2 (hr) |
| BR (1) | BR112019019643A2 (hr) |
| CA (1) | CA3056490A1 (hr) |
| CY (1) | CY1124114T1 (hr) |
| DK (1) | DK3601252T3 (hr) |
| ES (1) | ES2868024T3 (hr) |
| HR (1) | HRP20210312T1 (hr) |
| HU (1) | HUE053710T2 (hr) |
| IL (1) | IL269360B2 (hr) |
| LT (1) | LT3601252T (hr) |
| MA (1) | MA48971B1 (hr) |
| PL (1) | PL3601252T3 (hr) |
| PT (1) | PT3601252T (hr) |
| RS (1) | RS61511B1 (hr) |
| WO (1) | WO2018172344A1 (hr) |
| ZA (1) | ZA201906202B (hr) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP3378477A1 (en) * | 2017-03-21 | 2018-09-26 | BIOPROJET Pharma | New therapeutical use of h3-ligands |
Family Cites Families (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR101060971B1 (ko) * | 2002-05-14 | 2011-09-01 | 제노바 리미티드 | 안트라닐산 유도체 수화물의 제조 방법 |
| EP1820797A4 (en) | 2004-12-01 | 2009-10-28 | Banyu Pharma Co Ltd | SUBSTITUTED PYRIDONE DERIVATIVE |
| EP1717235A3 (en) | 2005-04-29 | 2007-02-28 | Bioprojet | Phenoxypropylpiperidines and -pyrrolidines and their use as histamine H3-receptor ligands |
| MX345145B (es) | 2011-12-08 | 2017-01-17 | Taisho Pharmaceutical Co Ltd | Derivado de fenilpirrol. |
| US20150045553A1 (en) | 2011-12-27 | 2015-02-12 | Taisho Pharmaceutical Co., Ltd | Phenyltriazole derivative |
| EP3378477A1 (en) * | 2017-03-21 | 2018-09-26 | BIOPROJET Pharma | New therapeutical use of h3-ligands |
| DK3598975T3 (da) * | 2018-07-27 | 2020-11-02 | Bioprojet Soc Civ | Hidtil ukendte kombinationer af en H3-antagonist og en noradrenalin-genoptagelseshæmmer, og de terapeutiske anvendelser deraf |
-
2017
- 2017-03-21 EP EP17305310.9A patent/EP3378858A1/en not_active Withdrawn
-
2018
- 2018-03-20 RS RS20210249A patent/RS61511B1/sr unknown
- 2018-03-20 EP EP18711350.1A patent/EP3601252B1/en active Active
- 2018-03-20 CA CA3056490A patent/CA3056490A1/en active Pending
- 2018-03-20 PT PT187113501T patent/PT3601252T/pt unknown
- 2018-03-20 CN CN201880028499.3A patent/CN110891948B/zh active Active
- 2018-03-20 BR BR112019019643A patent/BR112019019643A2/pt unknown
- 2018-03-20 LT LTEP18711350.1T patent/LT3601252T/lt unknown
- 2018-03-20 ES ES18711350T patent/ES2868024T3/es active Active
- 2018-03-20 HU HUE18711350A patent/HUE053710T2/hu unknown
- 2018-03-20 MA MA48971A patent/MA48971B1/fr unknown
- 2018-03-20 AU AU2018238260A patent/AU2018238260B2/en active Active
- 2018-03-20 JP JP2019552006A patent/JP7235671B2/ja active Active
- 2018-03-20 WO PCT/EP2018/056999 patent/WO2018172344A1/en unknown
- 2018-03-20 KR KR1020197027549A patent/KR102608265B1/ko active IP Right Grant
- 2018-03-20 US US16/496,013 patent/US11078183B2/en active Active
- 2018-03-20 PL PL18711350T patent/PL3601252T3/pl unknown
- 2018-03-20 DK DK18711350.1T patent/DK3601252T3/da active
-
2019
- 2019-09-15 IL IL269360A patent/IL269360B2/en unknown
- 2019-09-19 ZA ZA2019/06202A patent/ZA201906202B/en unknown
-
2021
- 2021-02-24 HR HRP20210312TT patent/HRP20210312T1/hr unknown
- 2021-03-04 CY CY20211100186T patent/CY1124114T1/el unknown
Also Published As
| Publication number | Publication date |
|---|---|
| EP3378858A1 (en) | 2018-09-26 |
| CN110891948B (zh) | 2022-11-11 |
| ZA201906202B (en) | 2020-10-28 |
| JP2020511507A (ja) | 2020-04-16 |
| CA3056490A1 (en) | 2018-09-27 |
| RS61511B1 (sr) | 2021-03-31 |
| CY1124114T1 (el) | 2022-05-27 |
| IL269360B (en) | 2022-10-01 |
| IL269360A (en) | 2019-11-28 |
| RU2019129432A3 (hr) | 2021-07-01 |
| IL269360B2 (en) | 2023-02-01 |
| DK3601252T3 (da) | 2021-03-08 |
| US20200024256A1 (en) | 2020-01-23 |
| EP3601252B1 (en) | 2021-02-17 |
| JP7235671B2 (ja) | 2023-03-08 |
| AU2018238260B2 (en) | 2021-07-22 |
| PL3601252T3 (pl) | 2021-08-02 |
| US11078183B2 (en) | 2021-08-03 |
| HUE053710T2 (hu) | 2021-07-28 |
| ES2868024T3 (es) | 2021-10-21 |
| PT3601252T (pt) | 2021-03-31 |
| EP3601252A1 (en) | 2020-02-05 |
| KR102608265B1 (ko) | 2023-11-30 |
| MA48971A (fr) | 2020-02-05 |
| KR20200008995A (ko) | 2020-01-29 |
| CN110891948A (zh) | 2020-03-17 |
| MA48971B1 (fr) | 2021-03-31 |
| BR112019019643A2 (pt) | 2020-04-14 |
| AU2018238260A1 (en) | 2019-10-10 |
| WO2018172344A1 (en) | 2018-09-27 |
| RU2019129432A (ru) | 2021-03-18 |
| LT3601252T (lt) | 2021-04-26 |
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