SI2838892T1 - Izolirana trdna oblika anamorelin monohidroklorida z nizkim molskim razmerjem klorid:anamolerin in nizko vsebnostjo preostalega organskega topila - Google Patents

Izolirana trdna oblika anamorelin monohidroklorida z nizkim molskim razmerjem klorid:anamolerin in nizko vsebnostjo preostalega organskega topila Download PDF

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Publication number
SI2838892T1
SI2838892T1 SI201330963T SI201330963T SI2838892T1 SI 2838892 T1 SI2838892 T1 SI 2838892T1 SI 201330963 T SI201330963 T SI 201330963T SI 201330963 T SI201330963 T SI 201330963T SI 2838892 T1 SI2838892 T1 SI 2838892T1
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Slovenia
Prior art keywords
anamorelin monohydrochloride
organic solvent
chloride
residual organic
molar ratio
Prior art date
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SI201330963T
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English (en)
Inventor
Shin-Itsu Kuwabe
Takehiko Yanagimachi
Hideyuki Yoshiyama
Groot Eleanor De
Rubio Silvina Garcia
Peter Manini
Seemon Pines
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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=SI2838892(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Helsinn Healthcare Sa filed Critical Helsinn Healthcare Sa
Publication of SI2838892T1 publication Critical patent/SI2838892T1/sl

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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)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Obesity (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (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)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Polysaccharides And Polysaccharide Derivatives (AREA)

Claims (5)

  1. Izolirana trdna oblika anamorelin monohidroklorida z nizkim molskim razmerjem klorid:anamolerin in nizko vsebnostjo preostalega organskega topila PATENTNI ZAHTEVKI
    1. Izolirana trdna oblika anamorelin monohidroklorida, kjer ima omenjeni anamorelin monohidroklorid molsko razmerje klorid:anamorelin od 0,9 do 0,99, ki vsebuje preostalo vsebnost organskega topila, ki je manjši od 5000 ppm.
  2. 2. Izolirana oblika anamorelin monohidroklorida po zahtevku 1, kjer je preostala vsebnost organskega topila manjša od 3000 ppm.
  3. 3. Izolirana oblika anamorelin monohidroklorida po zahtevku 1, kjer je preostala vsebnost organskega topila manj kot 1000 ppm.
  4. 4. Farmacevtski sestavek, ki obsega: a) terapevtsko učinkovito količino anamorelin monohidroklorida po zahtevkih 1, 2 ali 3; in b) enega ali več farmacevtsko sprejemljivih ekscipientov.
  5. 5. Metoda izdelave farmacevtske dozirne oblike, ki obsega: a) kombiniranje terapevtsko učinkovite količine anamorelin monohidroklorida po zahtevkih 1, 2 ali 3 z enim ali več farmacevtsko sprejemljivih ekscipientov, da se tvori zmes; in c) obdelavo omenjene zmesi v končno dozirno obliko.
SI201330963T 2012-04-20 2013-04-18 Izolirana trdna oblika anamorelin monohidroklorida z nizkim molskim razmerjem klorid:anamolerin in nizko vsebnostjo preostalega organskega topila SI2838892T1 (sl)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201261636108P 2012-04-20 2012-04-20
PCT/US2013/037159 WO2013158874A1 (en) 2012-04-20 2013-04-18 Methods of producing anamorelin hydrochloride having controlled chloride content
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

Publications (1)

Publication Number Publication Date
SI2838892T1 true SI2838892T1 (sl) 2018-05-31

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ID=48225135

Family Applications (2)

Application Number Title Priority Date Filing Date
SI201330963T SI2838892T1 (sl) 2012-04-20 2013-04-18 Izolirana trdna oblika anamorelin monohidroklorida z nizkim molskim razmerjem klorid:anamolerin in nizko vsebnostjo preostalega organskega topila
SI201331789T SI3290410T1 (sl) 2012-04-20 2013-04-18 Izolirana trdna oblika anamorelin-monohidroklorida z nizkim molarnim razmerjem klorid:anamolerin

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SI201331789T SI3290410T1 (sl) 2012-04-20 2013-04-18 Izolirana trdna oblika anamorelin-monohidroklorida z nizkim molarnim razmerjem klorid:anamolerin

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US (8) US20140018391A1 (sl)
EP (3) EP3290410B1 (sl)
JP (3) JP6109925B2 (sl)
KR (2) KR102141323B1 (sl)
CN (3) CN103857669B (sl)
AP (1) AP2014008013A0 (sl)
AR (1) AR090725A1 (sl)
AU (1) AU2013249197B2 (sl)
BR (1) BR112014025972A8 (sl)
CA (2) CA2869893C (sl)
CL (1) CL2014002817A1 (sl)
CO (1) CO7131356A2 (sl)
CR (1) CR20140530A (sl)
CY (1) CY1120276T1 (sl)
DK (2) DK3517532T3 (sl)
DO (1) DOP2014000235A (sl)
EA (1) EA031581B1 (sl)
EC (1) ECSP14027739A (sl)
ES (2) ES2820354T3 (sl)
GE (1) GEP20186902B (sl)
HK (2) HK1202863A1 (sl)
HR (1) HRP20180316T1 (sl)
HU (2) HUE035697T2 (sl)
IL (1) IL235064B (sl)
JO (1) JO3353B1 (sl)
LT (1) LT2838892T (sl)
MA (1) MA37524B1 (sl)
MD (1) MD4615C1 (sl)
ME (1) ME02966B (sl)
MX (1) MX354793B (sl)
MY (1) MY170068A (sl)
NI (1) NI201400124A (sl)
NO (1) NO2877697T3 (sl)
NZ (1) NZ700833A (sl)
PE (1) PE20150084A1 (sl)
PH (1) PH12014502351A1 (sl)
PL (2) PL3290410T3 (sl)
PT (2) PT2838892T (sl)
RS (1) RS56869B1 (sl)
SG (2) SG10201608488RA (sl)
SI (2) SI2838892T1 (sl)
TN (1) TN2014000421A1 (sl)
TW (2) TWI589572B (sl)
UA (1) UA116207C2 (sl)
UY (1) UY34753A (sl)
WO (1) WO2013158874A1 (sl)
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Families Citing this family (5)

* Cited by examiner, † Cited by third party
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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
AP2017009772A0 (en) * 2014-09-04 2017-02-28 Helsinn Healthcare Sa Medical treatments based on anamorelin
MA43294A1 (fr) 2015-07-24 2020-04-30 Newlink Genetics Corp Sels et promédicaments de 1-méthyl -d-tryptophane
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)

* Cited by examiner, † Cited by third party
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UA73530C2 (uk) * 1999-11-10 2005-08-15 Ново Нордіск А/С Сполука з властивостями вивільнювати гормон росту
CN1882526A (zh) * 2003-09-26 2006-12-20 兰贝克赛实验室有限公司 制备伏格列波糖的方法
EP1768976B1 (en) 2004-06-29 2017-04-26 Helsinn Healthcare S.A. Crystal forms of (3r)-1-(2-methylalanyl-d-tryptophyl)-3-(phenylmethyl)-3-piperidinecarboxylic acid 1,2,2-trimethylhydrazide
WO2008100448A2 (en) 2007-02-13 2008-08-21 Helsinn Therapeutics (U.S.), Inc. 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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UY34753A (es) 2013-11-29
ES2820354T3 (es) 2021-04-20
EP3517532A1 (en) 2019-07-31
HK1202863A1 (en) 2015-10-09
PE20150084A1 (es) 2015-01-23
SG11201406478XA (en) 2014-11-27
MD20140122A2 (ro) 2015-05-31
TN2014000421A1 (en) 2016-03-30
JO3353B1 (ar) 2019-03-13
PT3517532T (pt) 2021-11-08
GEP20186902B (en) 2018-10-25
NZ700833A (en) 2016-01-29
CN110041398A (zh) 2019-07-23
ECSP14027739A (es) 2015-12-31
BR112014025972A8 (pt) 2021-06-22
LT2838892T (lt) 2018-03-12
SG10201608488RA (en) 2016-12-29
US20190000914A1 (en) 2019-01-03
US10576122B2 (en) 2020-03-03
CN103857669B (zh) 2019-06-28
EP3517532B1 (en) 2021-10-13
HUE035697T2 (en) 2018-05-28
PT2838892T (pt) 2018-02-28
BR112014025972A2 (pt) 2017-06-27
US9403867B2 (en) 2016-08-02
US20190231843A1 (en) 2019-08-01
PL3290410T3 (pl) 2021-01-11
AP2014008013A0 (en) 2014-10-31
CA2869893C (en) 2019-03-05
CN110041304A (zh) 2019-07-23
CA3031652A1 (en) 2013-10-24
US9981002B2 (en) 2018-05-29
ME02966B (me) 2018-07-20
NO2877697T3 (sl) 2018-10-13
CA2869893A1 (en) 2013-10-24
US10300105B2 (en) 2019-05-28
US9872883B2 (en) 2018-01-23
NI201400124A (es) 2015-09-21
EP2838892B1 (en) 2017-12-06
TWI589572B (zh) 2017-07-01
AR090725A1 (es) 2014-12-03
JP6616853B2 (ja) 2019-12-04
CR20140530A (es) 2015-03-25
UA116207C2 (uk) 2018-02-26
RS56869B1 (sr) 2018-04-30
IL235064A0 (en) 2014-12-31
US20200276259A1 (en) 2020-09-03
WO2013158874A1 (en) 2013-10-24
EP3290410A1 (en) 2018-03-07
US20160237115A1 (en) 2016-08-18
AU2013249197A1 (en) 2014-10-30
US20150072934A1 (en) 2015-03-12
AU2013249197B2 (en) 2017-04-06
KR20150013115A (ko) 2015-02-04
CA3031652C (en) 2020-10-27
JP2015514779A (ja) 2015-05-21
MY170068A (en) 2019-07-03
US20160229889A1 (en) 2016-08-11
EA201401151A1 (ru) 2015-06-30
HUE050865T2 (hu) 2021-01-28
PH12014502351B1 (en) 2015-01-12
ES2658862T3 (es) 2018-03-12
KR102141323B1 (ko) 2020-08-05
PL2838892T3 (pl) 2018-05-30
DK2838892T3 (en) 2018-03-12
JP2017101082A (ja) 2017-06-08
KR101972998B1 (ko) 2019-04-29
HRP20180316T1 (hr) 2018-04-06
TWI677494B (zh) 2019-11-21
HK1248694A1 (zh) 2018-10-19
MX2014012178A (es) 2015-08-05
SI3290410T1 (sl) 2020-11-30
EP2838892A1 (en) 2015-02-25
US10905737B2 (en) 2021-02-02
MX354793B (es) 2018-03-21
DK3517532T3 (da) 2022-01-03
US9956261B2 (en) 2018-05-01
MD4615C1 (ro) 2019-08-31
US20160235804A1 (en) 2016-08-18
PH12014502351A1 (en) 2015-01-12
KR20190044697A (ko) 2019-04-30
CO7131356A2 (es) 2014-12-01
CN103857669A (zh) 2014-06-11
EP3290410B1 (en) 2020-07-01
CY1120276T1 (el) 2019-07-10
MD4615B1 (ro) 2019-01-31
ZA201408508B (en) 2020-01-29
MA37524B1 (fr) 2017-04-28
JP6284665B2 (ja) 2018-02-28
IL235064B (en) 2019-09-26
TW201722928A (zh) 2017-07-01
DOP2014000235A (es) 2015-01-31
TW201348224A (zh) 2013-12-01
MA37524A1 (fr) 2016-06-30
US20140018391A1 (en) 2014-01-16
JP2018076375A (ja) 2018-05-17
JP6109925B2 (ja) 2017-04-05
EA031581B1 (ru) 2019-01-31
CL2014002817A1 (es) 2015-08-14

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