DK2838892T3 - Isoleret fast form af anamorelinmonohydrochlorid med lavt chlorid:anamolerin-molforhold og lavt indhold af tilbageværende organisk opløsningsmiddel - Google Patents
Isoleret fast form af anamorelinmonohydrochlorid med lavt chlorid:anamolerin-molforhold og lavt indhold af tilbageværende organisk opløsningsmiddel Download PDFInfo
- Publication number
- DK2838892T3 DK2838892T3 DK13719344.7T DK13719344T DK2838892T3 DK 2838892 T3 DK2838892 T3 DK 2838892T3 DK 13719344 T DK13719344 T DK 13719344T DK 2838892 T3 DK2838892 T3 DK 2838892T3
- Authority
- DK
- Denmark
- Prior art keywords
- anamorelin
- monohydrochloride
- anamorelin monohydrochloride
- composition
- free base
- Prior art date
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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
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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
- 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
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- 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
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- 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
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- 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)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
- Polysaccharides And Polysaccharide Derivatives (AREA)
- Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
Claims (5)
1. Isoleret fast form af anamorelinmonohydrochlorid, hvor nævnte anamorelinmonohydrochlorid har et ch 1 o ri d: an am o rel i n - m o 1 fo rh o 1 d på fra 0,9 til 0,99, og som omfatter et tilbageværende indhold af organisk opløsningsmiddel, der er mindre end 5.000 ppm.
2. Isoleret form af anamorelinmonohydrochlorid ifølge krav 1, hvor det tilbageværende indhold af organisk opløsningsmiddel er mindre end 3.000 ppm.
3. Isoleret form af anamorelinmonohydrochlorid ifølge krav 1, hvor det tilbageværende indhold af organisk opløsningsmiddel er mindre end 1.000 ppm.
4. Farmaceutisk præparat, der omfatter: a) en terapeutisk effektiv mængde af anamorelinmonohydrochloridet ifølge krav 1, 2 eller 3, og b) en eller flere farmaceutisk acceptable excipienser.
5. Fremgangsmåde til fremstilling af en farmaceutisk doseringsform, hvilken fremgangsmåde omfatter: a) kombinering af en terapeutisk effektiv mængde af anamorelinmonohydrochloridet ifølge krav 1, 2 eller 3 med en eller flere farmaceutisk acceptable excipienser til dannelse af en blanding, og c) behandling af nævnte blanding til en færdig doseringsform.
Applications Claiming Priority (2)
| 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 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK2838892T3 true DK2838892T3 (da) | 2018-03-12 |
Family
ID=48225135
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK13719344.7T DK2838892T3 (da) | 2012-04-20 | 2013-04-18 | Isoleret fast form af anamorelinmonohydrochlorid med lavt chlorid:anamolerin-molforhold og lavt indhold af tilbageværende organisk opløsningsmiddel |
| DK19155007.8T DK3517532T3 (da) | 2012-04-20 | 2013-04-18 | Fremgangsmåde til fremstilling af anamorelinhydrochlorid med reguleret chloridindhold |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK19155007.8T DK3517532T3 (da) | 2012-04-20 | 2013-04-18 | Fremgangsmåde til fremstilling af anamorelinhydrochlorid med reguleret chloridindhold |
Country Status (48)
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 |
| GEAP201814459A (en) * | 2014-09-04 | 2018-09-10 | Helsinn Healthcare Sa | Medical treatments based on anamorelin |
| EP4659747A2 (en) | 2015-07-24 | 2025-12-10 | Lumos Pharma, Inc. | 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 |
| CN115569120A (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 |
| WO2005030698A1 (en) * | 2003-09-26 | 2005-04-07 | Ranbaxy Laboratories Limited | Process for the preparation of voglibose |
| US7825138B2 (en) | 2004-06-29 | 2010-11-02 | Helsinn Therapeutics (U.S.), Inc. | Crystal forms of (3R)-1-(2-methylalanyl-D-tryptophyl)-3-(phenylmethyl)-3-piperidinecarboxylic acid 1,2,2-trimethylhydrazide |
| CA2677813A1 (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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2013
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