CR20160061A - Formulación estable líquida de etelcalcetide (amg 461) - Google Patents
Formulación estable líquida de etelcalcetide (amg 461)Info
- Publication number
- CR20160061A CR20160061A CR20160061A CR20160061A CR20160061A CR 20160061 A CR20160061 A CR 20160061A CR 20160061 A CR20160061 A CR 20160061A CR 20160061 A CR20160061 A CR 20160061A CR 20160061 A CR20160061 A CR 20160061A
- Authority
- CR
- Costa Rica
- Prior art keywords
- etelcalcetide
- amg
- stable formulation
- formulation liquid
- liquid
- Prior art date
Links
- 238000009472 formulation Methods 0.000 title abstract 2
- 239000000203 mixture Substances 0.000 title abstract 2
- ANIAZGVDEUQPRI-ZJQCGQFWSA-N etelcalcetide Chemical compound NC(N)=NCCC[C@H](C(N)=O)NC(=O)[C@@H](C)NC(=O)[C@@H](CCCN=C(N)N)NC(=O)[C@@H](CCCN=C(N)N)NC(=O)[C@@H](CCCN=C(N)N)NC(=O)[C@@H](C)NC(=O)[C@@H](CSSC[C@H](N)C(O)=O)NC(C)=O ANIAZGVDEUQPRI-ZJQCGQFWSA-N 0.000 title 1
- 229950006502 etelcalcetide Drugs 0.000 title 1
- 108091022127 etelcalcetide hydrochloride Proteins 0.000 title 1
- 239000007788 liquid Substances 0.000 title 1
- 102000013830 Calcium-Sensing Receptors Human genes 0.000 abstract 1
- 108010050543 Calcium-Sensing Receptors Proteins 0.000 abstract 1
- 229940122985 Peptide agonist Drugs 0.000 abstract 1
- 239000012669 liquid formulation Substances 0.000 abstract 1
- 238000000034 method Methods 0.000 abstract 1
Classifications
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
- F04D—NON-POSITIVE-DISPLACEMENT PUMPS
- F04D25/00—Pumping installations or systems
- F04D25/02—Units comprising pumps and their driving means
- F04D25/06—Units comprising pumps and their driving means the pump being electrically driven
- F04D25/0606—Units comprising pumps and their driving means the pump being electrically driven the electric motor being specially adapted for integration in the pump
-
- 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
- A61K38/08—Peptides having 5 to 11 amino acids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- 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
- A61K9/08—Solutions
-
- 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
-
- 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
- A61P3/12—Drugs for disorders of the metabolism for electrolyte homeostasis
- A61P3/14—Drugs for disorders of the metabolism for electrolyte homeostasis for calcium homeostasis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/18—Drugs for disorders of the endocrine system of the parathyroid hormones
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F01—MACHINES OR ENGINES IN GENERAL; ENGINE PLANTS IN GENERAL; STEAM ENGINES
- F01D—NON-POSITIVE DISPLACEMENT MACHINES OR ENGINES, e.g. STEAM TURBINES
- F01D15/00—Adaptations of machines or engines for special use; Combinations of engines with devices driven thereby
- F01D15/10—Adaptations for driving, or combinations with, electric generators
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Diabetes (AREA)
- Endocrinology (AREA)
- General Engineering & Computer Science (AREA)
- Mechanical Engineering (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Gastroenterology & Hepatology (AREA)
- Immunology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Dermatology (AREA)
- Obesity (AREA)
- Hematology (AREA)
- Rheumatology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Investigating Or Analysing Biological Materials (AREA)
- Peptides Or Proteins (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Inorganic Chemistry (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
Se proporcionan una formulación líquida que comprende un agonista péptido del receptor que detecta calcio y un método para preparar y usar la formulación.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201361840618P | 2013-06-28 | 2013-06-28 | |
| PCT/US2014/044622 WO2014210489A1 (en) | 2013-06-28 | 2014-06-27 | Stable liquid formulation of amg 416 (velcalcetide) |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CR20160061A true CR20160061A (es) | 2016-09-28 |
Family
ID=51213030
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CR20160002A CR20160002A (es) | 2013-06-28 | 2014-06-27 | Formulación estable líquida de etelcalcetide (amg 461) |
| CR20160061A CR20160061A (es) | 2013-06-28 | 2014-06-27 | Formulación estable líquida de etelcalcetide (amg 461) |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CR20160002A CR20160002A (es) | 2013-06-28 | 2014-06-27 | Formulación estable líquida de etelcalcetide (amg 461) |
Country Status (38)
| Country | Link |
|---|---|
| US (4) | US9820938B2 (es) |
| EP (3) | EP3878433A1 (es) |
| JP (1) | JP6027708B2 (es) |
| KR (1) | KR102231957B1 (es) |
| CN (2) | CN114376970A (es) |
| AP (1) | AP2015008936A0 (es) |
| AR (1) | AR096773A1 (es) |
| AU (1) | AU2014302122B2 (es) |
| CA (1) | CA2916222C (es) |
| CL (1) | CL2015003738A1 (es) |
| CR (2) | CR20160002A (es) |
| CY (1) | CY1120811T1 (es) |
| DK (1) | DK3013318T3 (es) |
| EA (1) | EA030220B1 (es) |
| ES (1) | ES2633989T3 (es) |
| HR (1) | HRP20171092T1 (es) |
| HU (1) | HUE034209T2 (es) |
| IL (1) | IL243210B (es) |
| JO (1) | JO3817B1 (es) |
| LT (1) | LT3013318T (es) |
| MA (1) | MA38724B1 (es) |
| ME (1) | ME02818B (es) |
| MX (1) | MX2015017952A (es) |
| MY (1) | MY180276A (es) |
| PE (2) | PE20160549A1 (es) |
| PH (1) | PH12015502816B1 (es) |
| PL (1) | PL3013318T3 (es) |
| PT (1) | PT3013318T (es) |
| RS (1) | RS56238B1 (es) |
| SG (1) | SG11201510647TA (es) |
| SI (1) | SI3013318T1 (es) |
| SM (1) | SMT201700401T1 (es) |
| TN (1) | TN2015000569A1 (es) |
| TW (1) | TWI635874B (es) |
| UA (1) | UA115373C2 (es) |
| UY (1) | UY35636A (es) |
| WO (1) | WO2014210489A1 (es) |
| ZA (1) | ZA201600238B (es) |
Families Citing this family (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| MA38724B1 (fr) | 2013-06-28 | 2017-11-30 | Amgen Inc | Formulation liquide stable d'amg 416 (velcalcétide) |
| RS60187B1 (sr) | 2014-04-03 | 2020-06-30 | Amgen Inc | Metoda za pripremanje amg 416 |
| ES2806200T3 (es) * | 2015-03-26 | 2021-02-16 | Amgen Inc | Método en fase de disolución para preparar etelcalcetida |
| CN106137979A (zh) * | 2015-03-31 | 2016-11-23 | 深圳翰宇药业股份有限公司 | 一种冻干粉针剂及其制备方法 |
| CN106928321B (zh) * | 2015-12-31 | 2019-07-26 | 深圳翰宇药业股份有限公司 | 一种合成Etelcalcetide的方法 |
| CN106928320B (zh) * | 2015-12-31 | 2021-01-15 | 深圳翰宇药业股份有限公司 | 一种合成Etelcalcetide的方法 |
| CN110054662B (zh) * | 2018-01-18 | 2021-03-02 | 成都圣诺生物制药有限公司 | 一种固相合成Etelcalcetide的方法 |
| CA3178367A1 (en) | 2020-05-15 | 2021-11-18 | Rainer Oberbauer | Methods of treating left ventricle hypertrophy |
| CN111925415A (zh) * | 2020-08-10 | 2020-11-13 | 海南中和药业股份有限公司 | 一种维拉卡肽杂质的制备方法 |
| WO2022034545A1 (en) * | 2020-08-14 | 2022-02-17 | Aurobindo Pharma Limited | Etelcalcetide formulations for parenteral use |
| EP4333805A1 (en) | 2021-05-06 | 2024-03-13 | Amgen Inc. | Etelcalcetide formulations |
Family Cites Families (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0938557B1 (en) | 1996-10-25 | 2000-09-13 | THE GOVERNMENT OF THE UNITED STATES OF AMERICA as represented by the SECRETARY OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES | Methods and compositions for inhibiting inflammation and angiogenesis comprising a mammalian cd97 alpha subunit |
| AT409081B (de) | 2000-02-16 | 2002-05-27 | Gebro Pharma Gmbh | Stabile, nasal, oral oder sublingual anwendbare pharmazeutische zubereitung |
| KR101308912B1 (ko) * | 2003-06-03 | 2013-09-23 | 노보 노르디스크 에이/에스 | 안정화된 약학적 펩티드 조성물 |
| EP1633390B1 (en) | 2003-06-03 | 2012-01-18 | Novo Nordisk A/S | Stabilized pharmaceutical glp-1 peptide compositions |
| US7265092B2 (en) | 2004-09-30 | 2007-09-04 | Kai Pharmaceuticals, Inc. | Pharmaceutical formulation |
| JP5645408B2 (ja) * | 2006-11-16 | 2014-12-24 | カイ ファーマシューティカルズ インコーポレーティッド | 副甲状腺機能亢進症および高カルシウム血症性障害の治療のためのポリカチオン性カルシウムモジュレーターペプチド |
| CA2989778C (en) | 2007-01-19 | 2020-06-30 | Kai Pharmaceuticals, Inc. | Method of modifying peptide compositions |
| EP2264138B2 (en) | 2009-06-19 | 2023-03-08 | The Procter & Gamble Company | Liquid hand dishwashing detergent composition |
| US8999932B2 (en) * | 2009-07-29 | 2015-04-07 | Kai Pharmaceuticals, Inc. | Therapeutic agents for reducing parathyroid hormone levels |
| EP2399604A1 (en) | 2010-06-25 | 2011-12-28 | F. Hoffmann-La Roche AG | Novel antibody formulation |
| WO2012075375A1 (en) * | 2010-12-02 | 2012-06-07 | Lanco Biosciences, Inc. | Delivery of parathyroid hormones by microinjection systems |
| HRP20161566T1 (hr) | 2011-06-08 | 2017-02-24 | Kai Pharmaceuticals, Inc. | Terapijski agensi za reguliranje serumskog fosfora |
| CN109985228A (zh) * | 2011-11-10 | 2019-07-09 | 凯伊药品公司 | 拟钙剂及其使用方法 |
| MA38724B1 (fr) | 2013-06-28 | 2017-11-30 | Amgen Inc | Formulation liquide stable d'amg 416 (velcalcétide) |
| RS60187B1 (sr) * | 2014-04-03 | 2020-06-30 | Amgen Inc | Metoda za pripremanje amg 416 |
-
2014
- 2014-06-27 MA MA38724A patent/MA38724B1/fr unknown
- 2014-06-27 SG SG11201510647TA patent/SG11201510647TA/en unknown
- 2014-06-27 PE PE2015002666A patent/PE20160549A1/es unknown
- 2014-06-27 LT LTEP14742093.9T patent/LT3013318T/lt unknown
- 2014-06-27 EP EP21156687.2A patent/EP3878433A1/en active Pending
- 2014-06-27 MX MX2015017952A patent/MX2015017952A/es active IP Right Grant
- 2014-06-27 PL PL14742093T patent/PL3013318T3/pl unknown
- 2014-06-27 CR CR20160002A patent/CR20160002A/es unknown
- 2014-06-27 ME MEP-2017-150A patent/ME02818B/me unknown
- 2014-06-27 CR CR20160061A patent/CR20160061A/es unknown
- 2014-06-27 HR HRP20171092TT patent/HRP20171092T1/hr unknown
- 2014-06-27 RS RS20170704A patent/RS56238B1/sr unknown
- 2014-06-27 TN TN2015000569A patent/TN2015000569A1/en unknown
- 2014-06-27 SM SM20170401T patent/SMT201700401T1/it unknown
- 2014-06-27 CN CN202111597304.7A patent/CN114376970A/zh active Pending
- 2014-06-27 CA CA2916222A patent/CA2916222C/en active Active
- 2014-06-27 EA EA201690099A patent/EA030220B1/ru not_active IP Right Cessation
- 2014-06-27 WO PCT/US2014/044622 patent/WO2014210489A1/en not_active Ceased
- 2014-06-27 DK DK14742093.9T patent/DK3013318T3/en active
- 2014-06-27 JP JP2016524250A patent/JP6027708B2/ja active Active
- 2014-06-27 KR KR1020167002370A patent/KR102231957B1/ko active Active
- 2014-06-27 US US14/908,481 patent/US9820938B2/en active Active
- 2014-06-27 MY MYPI2015003044A patent/MY180276A/en unknown
- 2014-06-27 EP EP14742093.9A patent/EP3013318B1/en active Active
- 2014-06-27 SI SI201430290T patent/SI3013318T1/sl unknown
- 2014-06-27 ES ES14742093.9T patent/ES2633989T3/es active Active
- 2014-06-27 AU AU2014302122A patent/AU2014302122B2/en active Active
- 2014-06-27 HU HUE14742093A patent/HUE034209T2/en unknown
- 2014-06-27 PE PE2020001772A patent/PE20210413A1/es unknown
- 2014-06-27 TW TW103122433A patent/TWI635874B/zh active
- 2014-06-27 AP AP2015008936A patent/AP2015008936A0/xx unknown
- 2014-06-27 EP EP17160312.9A patent/EP3246017B1/en active Active
- 2014-06-27 PT PT147420939T patent/PT3013318T/pt unknown
- 2014-06-27 UA UAA201600641A patent/UA115373C2/uk unknown
- 2014-06-27 CN CN201480047399.7A patent/CN105764487A/zh active Pending
- 2014-06-29 JO JOP/2014/0204A patent/JO3817B1/ar active
- 2014-06-30 AR ARP140102450A patent/AR096773A1/es not_active Application Discontinuation
- 2014-06-30 UY UY0001035636A patent/UY35636A/es not_active Application Discontinuation
-
2015
- 2015-12-17 IL IL243210A patent/IL243210B/en active IP Right Grant
- 2015-12-17 PH PH12015502816A patent/PH12015502816B1/en unknown
- 2015-12-28 CL CL2015003738A patent/CL2015003738A1/es unknown
-
2016
- 2016-01-12 ZA ZA2016/00238A patent/ZA201600238B/en unknown
-
2017
- 2017-07-19 CY CY171100771T patent/CY1120811T1/el unknown
- 2017-11-02 US US15/802,390 patent/US10344765B2/en active Active
-
2019
- 2019-06-03 US US16/430,322 patent/US11162500B2/en active Active
-
2021
- 2021-08-11 US US17/400,044 patent/US11959486B2/en active Active
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