SI2838892T1 - Isolated solid form of anamorelin monohydrochloride with low molar ratio chloride: anamolerin and low content of the remaining organic solvent - Google Patents
Isolated solid form of anamorelin monohydrochloride with low molar ratio chloride: anamolerin and low content of the remaining organic solvent Download PDFInfo
- 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
- Authority
- SI
- Slovenia
- Prior art keywords
- anamorelin monohydrochloride
- organic solvent
- chloride
- residual organic
- molar ratio
- Prior art date
Links
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 title claims abstract 10
- 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 abstract 10
- 229950005896 anamorelin Drugs 0.000 title claims abstract 10
- 108010052640 anamorelin Proteins 0.000 title claims abstract 10
- VEXZGXHMUGYJMC-UHFFFAOYSA-M Chloride anion Chemical compound [Cl-] VEXZGXHMUGYJMC-UHFFFAOYSA-M 0.000 title claims abstract 4
- 239000003960 organic solvent Substances 0.000 title claims 5
- 239000007787 solid Substances 0.000 title claims 3
- 239000000203 mixture Substances 0.000 claims abstract 3
- 239000008194 pharmaceutical composition Substances 0.000 claims abstract 2
- 239000002552 dosage form Substances 0.000 claims 2
- 239000000546 pharmaceutical excipient Substances 0.000 claims 2
- 238000004519 manufacturing process Methods 0.000 claims 1
Classifications
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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
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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)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Immunology (AREA)
- Gastroenterology & Hepatology (AREA)
- Diabetes (AREA)
- Obesity (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Hematology (AREA)
- Child & Adolescent Psychology (AREA)
- Genetics & Genomics (AREA)
- Molecular Biology (AREA)
- Biophysics (AREA)
- Biochemistry (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)
- Polysaccharides And Polysaccharide Derivatives (AREA)
- Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
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 |
|---|---|
| SI2838892T1 true SI2838892T1 (en) | 2018-05-31 |
Family
ID=48225135
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| SI201330963T SI2838892T1 (en) | 2012-04-20 | 2013-04-18 | Isolated solid form of anamorelin monohydrochloride with low molar ratio chloride: anamolerin and low content of the remaining organic solvent |
| SI201331789T SI3290410T1 (sl) | 2012-04-20 | 2013-04-18 | Izolirana trdna oblika anamorelin-monohidroklorida z nizkim molarnim razmerjem klorid:anamolerin |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| SI201331789T SI3290410T1 (sl) | 2012-04-20 | 2013-04-18 | Izolirana trdna oblika anamorelin-monohidroklorida z nizkim molarnim razmerjem klorid:anamolerin |
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 |
| HUE046894T2 (hu) | 2014-09-04 | 2020-04-28 | Helsinn Healthcare Sa | Anamorelinen alapuló gyógyászati kezelések |
| CA2992016C (en) | 2015-07-24 | 2019-10-22 | Newlink Genetics Corporation | 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 |
| CN115569119A (zh) * | 2019-08-30 | 2023-01-06 | 赫尔森保健股份公司 | 具有改善稳定性的阿拉莫林片剂的生产方法 |
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 |
| 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 |
| MX2009008561A (es) * | 2007-02-13 | 2010-01-15 | Helsinn Therapeutics Us Inc | Metodo para tratar trastornos proliferativos celulares utilizando secretagogos. |
| 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 US US13/865,649 patent/US20140018391A1/en not_active Abandoned
- 2013-04-18 LT LTEP13719344.7T patent/LT2838892T/lt unknown
- 2013-04-18 AP AP2014008013A patent/AP2014008013A0/xx unknown
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