HRP20180316T1 - Izolirani čvrsti oblik anamorelin monohidroklorida s niskim molarnim odnosom klorida: anamolerina i niskim sadržajem rezidualnog organskog otapala - Google Patents
Izolirani čvrsti oblik anamorelin monohidroklorida s niskim molarnim odnosom klorida: anamolerina i niskim sadržajem rezidualnog organskog otapala Download PDFInfo
- Publication number
- HRP20180316T1 HRP20180316T1 HRP20180316TT HRP20180316T HRP20180316T1 HR P20180316 T1 HRP20180316 T1 HR P20180316T1 HR P20180316T T HRP20180316T T HR P20180316TT HR P20180316 T HRP20180316 T HR P20180316T HR P20180316 T1 HRP20180316 T1 HR P20180316T1
- Authority
- HR
- Croatia
- Prior art keywords
- anamorelin monohydrochloride
- organic solvent
- solid form
- residual organic
- isolated solid
- Prior art date
Links
- VQPFSIRUEPQQPP-MXBOTTGLSA-N anamorelin Chemical compound C([C@@]1(C(=O)N(C)N(C)C)CN(CCC1)C(=O)[C@@H](CC=1C2=CC=CC=C2NC=1)NC(=O)C(C)(C)N)C1=CC=CC=C1 VQPFSIRUEPQQPP-MXBOTTGLSA-N 0.000 title claims 8
- 229950005896 anamorelin Drugs 0.000 title claims 8
- 108010052640 anamorelin Proteins 0.000 title claims 8
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 title claims 7
- 239000003960 organic solvent Substances 0.000 title claims 4
- 239000007787 solid Substances 0.000 title claims 4
- VEXZGXHMUGYJMC-UHFFFAOYSA-M Chloride anion Chemical compound [Cl-] VEXZGXHMUGYJMC-UHFFFAOYSA-M 0.000 title claims 2
- 239000002552 dosage form Substances 0.000 claims 2
- 239000000203 mixture Substances 0.000 claims 2
- 239000000546 pharmaceutical excipient Substances 0.000 claims 2
- 238000000034 method Methods 0.000 claims 1
- 239000008194 pharmaceutical composition Substances 0.000 claims 1
Classifications
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- 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
- C07D401/06—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 carbon chain containing only aliphatic carbon atoms
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
- A61K38/05—Dipeptides
-
- 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
- A61K31/454—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. pimozide, domperidone
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1682—Processes
-
- 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
-
- 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
- C07K—PEPTIDES
- C07K5/00—Peptides containing up to four amino acids in a fully defined sequence; Derivatives thereof
- C07K5/04—Peptides containing up to four amino acids in a fully defined sequence; Derivatives thereof containing only normal peptide links
- C07K5/06—Dipeptides
- C07K5/06008—Dipeptides with the first amino acid being neutral
- C07K5/06017—Dipeptides with the first amino acid being neutral and aliphatic
- C07K5/06034—Dipeptides with the first amino acid being neutral and aliphatic the side chain containing 2 to 4 carbon atoms
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02P—CLIMATE CHANGE MITIGATION TECHNOLOGIES IN THE PRODUCTION OR PROCESSING OF GOODS
- Y02P20/00—Technologies relating to chemical industry
- Y02P20/50—Improvements relating to the production of bulk chemicals
- Y02P20/55—Design of synthesis routes, e.g. reducing the use of auxiliary or protecting groups
Landscapes
- Chemical & Material Sciences (AREA)
- Health & Medical Sciences (AREA)
- Organic Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Gastroenterology & Hepatology (AREA)
- Immunology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Obesity (AREA)
- Hematology (AREA)
- Diabetes (AREA)
- Child & Adolescent Psychology (AREA)
- Genetics & Genomics (AREA)
- Biophysics (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Peptides Or Proteins (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
- Polysaccharides And Polysaccharide Derivatives (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
Claims (5)
1. Izolirani čvrsti oblik anamorelin monohidroklorida, naznačen time što navedeni anamorelin monohidroklorid ima molarni odnos klorida:anamorelina od 0.9 do 0.99, i sadrži rezidualni sadržaj organskog otapala koji je manji od 5000 ppm.
2. Izolirani čvrsti oblik anamorelin monohidroklorida prema patentnom zahtjevu 1, naznačen time što je rezidualni sadržaj organskog rastvarača manji od 3000 ppm.
3. Izolirani čvrsti oblik anamorelin monohidroklorida prema patentnom zahtjevu 1, naznačen time što je rezidualni sadržaj organskog otapala manji od 1000 ppm.
4. Farmaceutski sastav koji sadrži:
a) terapeutski efikasnu količinu anamorelin monohidroklorida prema patentnim zahtjevima 1, 2 ili 3; i
b) jedan ili više farmaceutski prihvatljivih ekscipijenata.
5. Postupak za pripremu farmaceutskog oblika doze koji sadrži:
a) spajanje terapeutski efikasne količine anamorelin monohidroklorida prema patentnim zahtjevima 1, 2 ili 3 s jednim ili više farmaceutski prihvatljivih ekscipijenata da bi se formirala smjesa; i
c) obradu navedene smjese u gotov oblik doze.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201261636108P | 2012-04-20 | 2012-04-20 | |
EP13719344.7A EP2838892B1 (en) | 2012-04-20 | 2013-04-18 | Isolated solid form of anamorelin monohydrochloride with low molar ratio of chloride:anamolerin and low content of residual organic solvent |
PCT/US2013/037159 WO2013158874A1 (en) | 2012-04-20 | 2013-04-18 | Methods of producing anamorelin hydrochloride having controlled chloride content |
Publications (1)
Publication Number | Publication Date |
---|---|
HRP20180316T1 true HRP20180316T1 (hr) | 2018-04-06 |
Family
ID=48225135
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20180316TT HRP20180316T1 (hr) | 2012-04-20 | 2018-02-21 | Izolirani čvrsti oblik anamorelin monohidroklorida s niskim molarnim odnosom klorida: anamolerina i niskim sadržajem rezidualnog organskog otapala |
Country Status (47)
Families Citing this family (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JO3353B1 (ar) | 2012-04-20 | 2019-03-13 | Ono Pharmaceutical Co | شكل صلب معزول من أحادي هيدروكلوريد أناموريلين بنسبة مولارية منخفضة من الكلوريد: أناموريلين ومحتوى منخفض من مذيب عضوي متبقي |
ES2761777T3 (es) | 2014-09-04 | 2020-05-21 | Helsinn Healthcare Sa | Tratamiento médico a base de anamorelina |
NZ736978A (en) | 2015-07-24 | 2019-06-28 | Newlink Genetics Corp | Salts and prodrugs of 1-methyl-d-tryptophan |
CN108239141A (zh) * | 2016-12-23 | 2018-07-03 | 江苏先声药业有限公司 | 一种阿拉莫林的制备方法 |
US20220323430A1 (en) | 2019-08-30 | 2022-10-13 | Helsinn Healthcare Sa | Methods of manufacturing anamorelin tablets having improved stability |
Family Cites Families (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
UA73530C2 (uk) * | 1999-11-10 | 2005-08-15 | Ново Нордіск А/С | Сполука з властивостями вивільнювати гормон росту |
WO2005030698A1 (en) * | 2003-09-26 | 2005-04-07 | Ranbaxy Laboratories Limited | Process for the preparation of voglibose |
KR101324340B1 (ko) | 2004-06-29 | 2013-10-31 | 헬신 세라퓨틱스 (유.에스.) 인크. | (3r)-1-(2-메틸알라닐-d-트립토필)-3-(페닐메틸)-3-피페리딘카르복실산 1,2,2-트리메틸하이드라지드의 결정 형태 |
EP2134341B1 (en) * | 2007-02-13 | 2015-06-17 | Helsinn Healthcare S.A. | Method of treating cell proliferative disorders using growth hormone secretagogues |
UA105657C2 (uk) * | 2009-02-27 | 2014-06-10 | Хелсінн Терапьютікс (Ю.Ес.), Інк. | Поліпшені способи лікування мігрені на основі анамореліну |
JO3353B1 (ar) | 2012-04-20 | 2019-03-13 | Ono Pharmaceutical Co | شكل صلب معزول من أحادي هيدروكلوريد أناموريلين بنسبة مولارية منخفضة من الكلوريد: أناموريلين ومحتوى منخفض من مذيب عضوي متبقي |
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2013
- 2013-04-15 JO JOP/2013/0101A patent/JO3353B1/ar active
- 2013-04-17 AR ARP130101264A patent/AR090725A1/es not_active Application Discontinuation
- 2013-04-18 NZ NZ700833A patent/NZ700833A/en unknown
- 2013-04-18 PL PL13719344T patent/PL2838892T3/pl unknown
- 2013-04-18 KR KR1020197011485A patent/KR102141323B1/ko active IP Right Grant
- 2013-04-18 MA MA37524A patent/MA37524B1/fr unknown
- 2013-04-18 EP EP17192651.2A patent/EP3290410B1/en active Active
- 2013-04-18 WO PCT/US2013/037159 patent/WO2013158874A1/en active Application Filing
- 2013-04-18 EP EP19155007.8A patent/EP3517532B1/en active Active
- 2013-04-18 SG SG10201608488RA patent/SG10201608488RA/en unknown
- 2013-04-18 SG SG11201406478XA patent/SG11201406478XA/en unknown
- 2013-04-18 CA CA3031652A patent/CA3031652C/en active Active
- 2013-04-18 DK DK13719344.7T patent/DK2838892T3/en active
- 2013-04-18 ES ES17192651T patent/ES2820354T3/es active Active
- 2013-04-18 CN CN201380003026.5A patent/CN103857669B/zh active Active
- 2013-04-18 HU HUE17192651A patent/HUE050865T2/hu unknown
- 2013-04-18 AP AP2014008013A patent/AP2014008013A0/xx unknown
- 2013-04-18 MD MDA20140122A patent/MD4615C1/ro active IP Right Grant
- 2013-04-18 LT LTEP13719344.7T patent/LT2838892T/lt unknown
- 2013-04-18 DK DK19155007.8T patent/DK3517532T3/da active
- 2013-04-18 US US13/865,649 patent/US20140018391A1/en not_active Abandoned
- 2013-04-18 PL PL17192651T patent/PL3290410T3/pl unknown
- 2013-04-18 UA UAA201412382A patent/UA116207C2/uk unknown
- 2013-04-18 CN CN201910323598.0A patent/CN110041304A/zh active Pending
- 2013-04-18 MY MYPI2014703092A patent/MY170068A/en unknown
- 2013-04-18 ES ES13719344.7T patent/ES2658862T3/es active Active
- 2013-04-18 ME MEP-2018-47A patent/ME02966B/me unknown
- 2013-04-18 BR BR112014025972A patent/BR112014025972A8/pt not_active Application Discontinuation
- 2013-04-18 PE PE2014001624A patent/PE20150084A1/es not_active Application Discontinuation
- 2013-04-18 GE GEAP201313634A patent/GEP20186902B/en unknown
- 2013-04-18 SI SI201331789T patent/SI3290410T1/sl unknown
- 2013-04-18 RS RS20180192A patent/RS56869B1/sr unknown
- 2013-04-18 TW TW106105466A patent/TWI677494B/zh active
- 2013-04-18 CA CA2869893A patent/CA2869893C/en active Active
- 2013-04-18 HU HUE13719344A patent/HUE035697T2/en unknown
- 2013-04-18 SI SI201330963T patent/SI2838892T1/en unknown
- 2013-04-18 EA EA201401151A patent/EA031581B1/ru unknown
- 2013-04-18 PT PT137193447T patent/PT2838892T/pt unknown
- 2013-04-18 JP JP2015507175A patent/JP6109925B2/ja active Active
- 2013-04-18 TW TW102113767A patent/TWI589572B/zh active
- 2013-04-18 EP EP13719344.7A patent/EP2838892B1/en active Active
- 2013-04-18 AU AU2013249197A patent/AU2013249197B2/en active Active
- 2013-04-18 CN CN201910323606.1A patent/CN110041398A/zh active Pending
- 2013-04-18 PT PT191550078T patent/PT3517532T/pt unknown
- 2013-04-18 KR KR1020147018116A patent/KR101972998B1/ko active IP Right Grant
- 2013-04-18 MX MX2014012178A patent/MX354793B/es active IP Right Grant
- 2013-04-19 UY UY0001034753A patent/UY34753A/es active IP Right Grant
- 2013-07-29 NO NO13823572A patent/NO2877697T3/no unknown
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2014
- 2014-10-07 IL IL235064A patent/IL235064B/en active IP Right Grant
- 2014-10-08 TN TN2014000421A patent/TN2014000421A1/fr unknown
- 2014-10-20 PH PH12014502351A patent/PH12014502351B1/en unknown
- 2014-10-20 CL CL2014002817A patent/CL2014002817A1/es unknown
- 2014-10-20 NI NI201400124A patent/NI201400124A/es unknown
- 2014-10-20 DO DO2014000235A patent/DOP2014000235A/es unknown
- 2014-11-12 US US14/539,318 patent/US9403867B2/en active Active
- 2014-11-18 EC ECIEPI201427739A patent/ECSP14027739A/es unknown
- 2014-11-19 CR CR20140530A patent/CR20140530A/es unknown
- 2014-11-19 ZA ZA2014/08508A patent/ZA201408508B/en unknown
- 2014-11-20 CO CO14255094A patent/CO7131356A2/es unknown
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2015
- 2015-04-02 HK HK15103359.2A patent/HK1202863A1/xx unknown
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2016
- 2016-04-21 US US15/135,147 patent/US9872883B2/en active Active
- 2016-04-21 US US15/135,051 patent/US9981002B2/en active Active
- 2016-04-21 US US15/135,107 patent/US9956261B2/en active Active
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2017
- 2017-03-08 JP JP2017043785A patent/JP6284665B2/ja active Active
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2018
- 2018-01-30 JP JP2018013782A patent/JP6616853B2/ja active Active
- 2018-02-21 HR HRP20180316TT patent/HRP20180316T1/hr unknown
- 2018-03-05 CY CY20181100270T patent/CY1120276T1/el unknown
- 2018-04-26 US US15/963,284 patent/US10300105B2/en active Active
- 2018-06-28 HK HK18108293.7A patent/HK1248694A1/zh unknown
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2019
- 2019-04-14 US US16/383,623 patent/US10576122B2/en active Active
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2020
- 2020-01-24 US US16/751,836 patent/US10905737B2/en active Active
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