TWI677494B - 製造具有經控制氯含量之阿拉莫林鹽酸鹽(anamorelin hydrochloride)之方法 - Google Patents

製造具有經控制氯含量之阿拉莫林鹽酸鹽(anamorelin hydrochloride)之方法 Download PDF

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Publication number
TWI677494B
TWI677494B TW106105466A TW106105466A TWI677494B TW I677494 B TWI677494 B TW I677494B TW 106105466 A TW106105466 A TW 106105466A TW 106105466 A TW106105466 A TW 106105466A TW I677494 B TWI677494 B TW I677494B
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Taiwan
Prior art keywords
alamorin
monohydrochloride
hydrochloric acid
free base
acetate
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TW106105466A
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English (en)
Chinese (zh)
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TW201722928A (zh
Inventor
桑邊辰逸
Shin-Itsu Kuwabe
柳町岳彥
Takehiko YANAGIMACHI
吉山英幸
Hideyuki YOSHIYAMA
西門 派斯
Seemon Pines
艾勒諾 戴古特
Eleanor DE GROOT
蘇菲娜G 露比歐
Silvina Garcia Rubio
彼得 曼尼
Peter Manini
Original Assignee
日商小野藥品工業股份有限公司
Ono Pharmaceutical Co., Ltd.
瑞士商赫爾辛保健公司
Helsinn Healthcare Sa
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=48225135&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=TWI677494(B) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by 日商小野藥品工業股份有限公司, Ono Pharmaceutical Co., Ltd., 瑞士商赫爾辛保健公司, Helsinn Healthcare Sa filed Critical 日商小野藥品工業股份有限公司
Publication of TW201722928A publication Critical patent/TW201722928A/zh
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    • 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
    • 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
    • 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
    • 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

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  • 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)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
  • Polysaccharides And Polysaccharide Derivatives (AREA)
TW106105466A 2012-04-20 2013-04-18 製造具有經控制氯含量之阿拉莫林鹽酸鹽(anamorelin hydrochloride)之方法 TWI677494B (zh)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201261636108P 2012-04-20 2012-04-20
US61/636,108 2012-04-20

Publications (2)

Publication Number Publication Date
TW201722928A TW201722928A (zh) 2017-07-01
TWI677494B true TWI677494B (zh) 2019-11-21

Family

ID=48225135

Family Applications (2)

Application Number Title Priority Date Filing Date
TW106105466A TWI677494B (zh) 2012-04-20 2013-04-18 製造具有經控制氯含量之阿拉莫林鹽酸鹽(anamorelin hydrochloride)之方法
TW102113767A TWI589572B (zh) 2012-04-20 2013-04-18 製造具有經控制氯含量之阿拉莫林鹽酸鹽(anamorelin hydrochloride)之方法

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TW102113767A TWI589572B (zh) 2012-04-20 2013-04-18 製造具有經控制氯含量之阿拉莫林鹽酸鹽(anamorelin hydrochloride)之方法

Country Status (48)

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US (8) US20140018391A1 (enExample)
EP (3) EP3517532B1 (enExample)
JP (3) JP6109925B2 (enExample)
KR (2) KR102141323B1 (enExample)
CN (3) CN110041304A (enExample)
AP (1) AP2014008013A0 (enExample)
AR (1) AR090725A1 (enExample)
AU (1) AU2013249197B2 (enExample)
BR (1) BR112014025972A8 (enExample)
CA (2) CA2869893C (enExample)
CL (1) CL2014002817A1 (enExample)
CO (1) CO7131356A2 (enExample)
CR (1) CR20140530A (enExample)
CY (1) CY1120276T1 (enExample)
DK (2) DK3517532T3 (enExample)
DO (1) DOP2014000235A (enExample)
EA (1) EA031581B1 (enExample)
EC (1) ECSP14027739A (enExample)
ES (2) ES2820354T3 (enExample)
GE (2) GEP20186902B (enExample)
HK (1) HK1248694A1 (enExample)
HR (1) HRP20180316T1 (enExample)
HU (2) HUE035697T2 (enExample)
IL (1) IL235064B (enExample)
JO (1) JO3353B1 (enExample)
LT (1) LT2838892T (enExample)
MA (1) MA37524B1 (enExample)
MD (1) MD4615C1 (enExample)
ME (1) ME02966B (enExample)
MX (1) MX354793B (enExample)
MY (1) MY170068A (enExample)
NI (1) NI201400124A (enExample)
NO (1) NO2877697T3 (enExample)
NZ (1) NZ700833A (enExample)
PE (1) PE20150084A1 (enExample)
PH (1) PH12014502351B1 (enExample)
PL (2) PL2838892T3 (enExample)
PT (2) PT2838892T (enExample)
PY (1) PY1316881A (enExample)
RS (1) RS56869B1 (enExample)
SG (2) SG11201406478XA (enExample)
SI (2) SI2838892T1 (enExample)
TN (1) TN2014000421A1 (enExample)
TW (2) TWI677494B (enExample)
UA (1) UA116207C2 (enExample)
UY (1) UY34753A (enExample)
WO (1) WO2013158874A1 (enExample)
ZA (1) ZA201408508B (enExample)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
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
KR102234319B1 (ko) 2014-09-04 2021-04-01 헬신 헬쓰케어 에스.에이. 아나모렐린 기반의 의학적 치료
PE20180928A1 (es) 2015-07-24 2018-06-08 Newlink Genetics Corp Sales y profarmacos de 1-metil-d-triptofano
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
JP7854809B2 (ja) * 2019-08-30 2026-05-07 ヘルシン ヘルスケア ソシエテ アノニム 安定性が改善されたアナモレリン錠剤の製造方法

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008100448A2 (en) * 2007-02-13 2008-08-21 Helsinn Therapeutics (U.S.), Inc. Method of treating cell proliferative disorders using growth hormone secretagogues
WO2010099522A1 (en) * 2009-02-27 2010-09-02 Helsinn Therapeutics (U.S.), Inc. Enhanced migraine treatments based on ghrelin mimetics

Family Cites Families (4)

* Cited by examiner, † Cited by third party
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
EP2298760B1 (en) 2004-06-29 2015-08-05 Helsinn Healthcare S.A. Crystal forms of (3R)-1-(2-methylalanyl-D-tryptophyl)-3-(phenylmethyl)-3-piperidinecarboxylic acid 1,2,2-trimethylhydrazide
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

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008100448A2 (en) * 2007-02-13 2008-08-21 Helsinn Therapeutics (U.S.), Inc. Method of treating cell proliferative disorders using growth hormone secretagogues
WO2010099522A1 (en) * 2009-02-27 2010-09-02 Helsinn Therapeutics (U.S.), Inc. Enhanced migraine treatments based on ghrelin mimetics

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Publication number Publication date
NZ700833A (en) 2016-01-29
PL2838892T3 (pl) 2018-05-30
US9956261B2 (en) 2018-05-01
WO2013158874A1 (en) 2013-10-24
ME02966B (me) 2018-07-20
US10576122B2 (en) 2020-03-03
BR112014025972A2 (pt) 2017-06-27
CA2869893C (en) 2019-03-05
SG10201608488RA (en) 2016-12-29
AR090725A1 (es) 2014-12-03
US20190000914A1 (en) 2019-01-03
EA031581B1 (ru) 2019-01-31
CR20140530A (es) 2015-03-25
HK1202863A1 (en) 2015-10-09
MD4615B1 (ro) 2019-01-31
ZA201408508B (en) 2020-01-29
GEP20186902B (en) 2018-10-25
HRP20180316T1 (hr) 2018-04-06
KR20150013115A (ko) 2015-02-04
US9872883B2 (en) 2018-01-23
UA116207C2 (uk) 2018-02-26
CA3031652A1 (en) 2013-10-24
SI2838892T1 (en) 2018-05-31
JP2018076375A (ja) 2018-05-17
US20140018391A1 (en) 2014-01-16
PL3290410T3 (pl) 2021-01-11
US20150072934A1 (en) 2015-03-12
JP2015514779A (ja) 2015-05-21
MX2014012178A (es) 2015-08-05
CY1120276T1 (el) 2019-07-10
CL2014002817A1 (es) 2015-08-14
SI3290410T1 (sl) 2020-11-30
CN103857669A (zh) 2014-06-11
PT2838892T (pt) 2018-02-28
MY170068A (en) 2019-07-03
US10300105B2 (en) 2019-05-28
NO2877697T3 (enExample) 2018-10-13
JO3353B1 (ar) 2019-03-13
MX354793B (es) 2018-03-21
CA3031652C (en) 2020-10-27
IL235064A0 (en) 2014-12-31
KR20190044697A (ko) 2019-04-30
US20200276259A1 (en) 2020-09-03
TW201348224A (zh) 2013-12-01
US9981002B2 (en) 2018-05-29
LT2838892T (lt) 2018-03-12
ES2820354T3 (es) 2021-04-20
EP2838892B1 (en) 2017-12-06
US20160229889A1 (en) 2016-08-11
AP2014008013A0 (en) 2014-10-31
SG11201406478XA (en) 2014-11-27
PE20150084A1 (es) 2015-01-23
UY34753A (es) 2013-11-29
US9403867B2 (en) 2016-08-02
EP3517532A1 (en) 2019-07-31
ECSP14027739A (es) 2015-12-31
TW201722928A (zh) 2017-07-01
MA37524A1 (fr) 2016-06-30
TWI589572B (zh) 2017-07-01
US10905737B2 (en) 2021-02-02
PY1316881A (es) 2016-06-01
EP3290410B1 (en) 2020-07-01
GEAP201813634A (en) 2018-06-25
AU2013249197A1 (en) 2014-10-30
CN110041398A (zh) 2019-07-23
HK1248694A1 (en) 2018-10-19
JP6109925B2 (ja) 2017-04-05
NI201400124A (es) 2015-09-21
MA37524B1 (fr) 2017-04-28
DK2838892T3 (en) 2018-03-12
PT3517532T (pt) 2021-11-08
RS56869B1 (sr) 2018-04-30
PH12014502351A1 (en) 2015-01-12
BR112014025972A8 (pt) 2021-06-22
JP6616853B2 (ja) 2019-12-04
HUE035697T2 (en) 2018-05-28
CA2869893A1 (en) 2013-10-24
EA201401151A1 (ru) 2015-06-30
MD4615C1 (ro) 2019-08-31
KR101972998B1 (ko) 2019-04-29
JP6284665B2 (ja) 2018-02-28
DK3517532T3 (da) 2022-01-03
MD20140122A2 (ro) 2015-05-31
US20160237115A1 (en) 2016-08-18
US20190231843A1 (en) 2019-08-01
US20160235804A1 (en) 2016-08-18
KR102141323B1 (ko) 2020-08-05
CN110041304A (zh) 2019-07-23
JP2017101082A (ja) 2017-06-08
PH12014502351B1 (en) 2015-01-12
HUE050865T2 (hu) 2021-01-28
CO7131356A2 (es) 2014-12-01
CN103857669B (zh) 2019-06-28
EP2838892A1 (en) 2015-02-25
EP3517532B1 (en) 2021-10-13
TN2014000421A1 (en) 2016-03-30
AU2013249197B2 (en) 2017-04-06
ES2658862T3 (es) 2018-03-12
EP3290410A1 (en) 2018-03-07
IL235064B (en) 2019-09-26
DOP2014000235A (es) 2015-01-31

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