DK3013318T3 - Stabil væskeformulering af amg 416 (velcalcetid) - Google Patents
Stabil væskeformulering af amg 416 (velcalcetid) Download PDFInfo
- Publication number
- DK3013318T3 DK3013318T3 DK14742093.9T DK14742093T DK3013318T3 DK 3013318 T3 DK3013318 T3 DK 3013318T3 DK 14742093 T DK14742093 T DK 14742093T DK 3013318 T3 DK3013318 T3 DK 3013318T3
- Authority
- DK
- Denmark
- Prior art keywords
- formulation
- amg
- degradation
- concentration
- another embodiment
- Prior art date
Links
Classifications
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- 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)
- Proteomics, Peptides & Aminoacids (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Gastroenterology & Hepatology (AREA)
- Immunology (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)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Peptides Or Proteins (AREA)
- Inorganic Chemistry (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Claims (15)
1. Farmaceutisk formulering, der omfatter AMG 416 i vandig opløsning, hvor formuleringen har en pH-værdi på 2,0 til 5,0.
2. Formulering ifølge krav 1, hvor formuleringen haren pH-værdi på 2,5 til 4,5.
3. Formulering ifølge krav 1, hvor formuleringen haren pH-værdi på 2,5 til 4,0.
4. Formulering ifølge krav 1, hvor formuleringen haren pFI-værdi på 3,0 til 3,5.
5. Formulering ifølge krav 1, hvor pH-værdien fastholdes ved hjælp afen farmaceutisk acceptabel buffer.
6. Formulering ifølge krav 5, hvor bufferen er succinat.
7. Formulering ifølge krav 1, hvor AMG 416 forekommer i formuleringen i en koncentration på 0,1 mg/ml til 20 mg/ml.
8. Formulering ifølge krav 1, hvor AMG 416 forekommer i formuleringen i en koncentration på 1 mg/ml til 15 mg/ml.
9. Formulering ifølge krav 1, hvor AMG 416 forekommer i formuleringen i en koncentration på 2,5 mg/ml til 10 mg/ml.
10. Formulering ifølge krav 1, der yderligere omfatter en farmaceutisk acceptabel tonicitetsmodifikator.
11. Formulering ifølge krav 10, hvor tonicitetsmodifikatoren forekommer i formuleringen i en koncentration, der er tilstrækkelig til, at formuleringen er tilnærmelsesvis isotonisk.
12. Formulering ifølge krav 10, hvor tonicitetsmodifikatoren er NaCI.
13. Formulering ifølge krav 1, hvor formuleringen har en nedbrydning på mindre end 10 % ved opbevaring ved 2-8 °C i 2 år.
14. Formulering ifølge krav 1, hvor formuleringen har en nedbrydning på mindre end 10 % ved opbevaring ved stuetemperatur i 2 år.
15. Formulering, der omfatter 2 mg/ml til 20 mg/ml AMG 416 i vandig opløsning, en succinatbuffer, der opretholder formuleringen ved en pH-værdi på ca. 3,0 til 3,5, og en tilstrækkelig koncentration af natriumchlorid til formuleringen til, at den er tilnærmelsesvis isotonisk.
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 |
|---|---|
| DK3013318T3 true DK3013318T3 (da) | 2017-08-07 |
Family
ID=51213030
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK14742093.9T DK3013318T3 (da) | 2013-06-28 | 2014-06-27 | Stabil væskeformulering af amg 416 (velcalcetid) |
Country Status (38)
| Country | Link |
|---|---|
| US (4) | US9820938B2 (da) |
| EP (3) | EP3878433A1 (da) |
| JP (1) | JP6027708B2 (da) |
| KR (1) | KR102231957B1 (da) |
| CN (2) | CN114376970A (da) |
| AP (1) | AP2015008936A0 (da) |
| AR (1) | AR096773A1 (da) |
| AU (1) | AU2014302122B2 (da) |
| CA (1) | CA2916222C (da) |
| CL (1) | CL2015003738A1 (da) |
| CR (2) | CR20160061A (da) |
| CY (1) | CY1120811T1 (da) |
| DK (1) | DK3013318T3 (da) |
| EA (1) | EA030220B1 (da) |
| ES (1) | ES2633989T3 (da) |
| HK (1) | HK1222557A1 (da) |
| HR (1) | HRP20171092T1 (da) |
| HU (1) | HUE034209T2 (da) |
| IL (1) | IL243210B (da) |
| JO (1) | JO3817B1 (da) |
| LT (1) | LT3013318T (da) |
| MA (1) | MA38724B1 (da) |
| ME (1) | ME02818B (da) |
| MX (1) | MX2015017952A (da) |
| MY (1) | MY180276A (da) |
| PE (2) | PE20210413A1 (da) |
| PH (1) | PH12015502816A1 (da) |
| PL (1) | PL3013318T3 (da) |
| PT (1) | PT3013318T (da) |
| RS (1) | RS56238B1 (da) |
| SG (1) | SG11201510647TA (da) |
| SI (1) | SI3013318T1 (da) |
| TN (1) | TN2015000569A1 (da) |
| TW (1) | TWI635874B (da) |
| UA (1) | UA115373C2 (da) |
| UY (1) | UY35636A (da) |
| WO (1) | WO2014210489A1 (da) |
| ZA (1) | ZA201600238B (da) |
Families Citing this family (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| PE20210413A1 (es) | 2013-06-28 | 2021-03-04 | Amgen Inc | Formulacion liquida estable que comprende etelcalcetida (amg416), un agente tamponante y agente de tonicidad |
| PL3126373T3 (pl) | 2014-04-03 | 2020-07-27 | Amgen Inc. | Sposób wytwarzania amg 416 |
| US10858389B2 (en) | 2015-03-26 | 2020-12-08 | Amgen Inc. | Solution phase method for preparing etelcalcetide |
| 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 |
| 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 |
| 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 |
| 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 |
| WO2021231960A1 (en) | 2020-05-15 | 2021-11-18 | Amgen Inc. | 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 |
| US20240207354A1 (en) | 2021-05-06 | 2024-06-27 | Amgen Inc. | Etelcalcetide formulations |
Family Cites Families (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2001510987A (ja) | 1996-10-25 | 2001-08-07 | アメリカ合衆国 | 哺乳動物のＣＤ９７αサブユニットを含む炎症および脈管形成を阻害するための方法および組成物 |
| AT409081B (de) | 2000-02-16 | 2002-05-27 | Gebro Pharma Gmbh | Stabile, nasal, oral oder sublingual anwendbare pharmazeutische zubereitung |
| CN102940879B (zh) * | 2003-06-03 | 2017-06-06 | 诺沃挪第克公司 | 稳定化的药物肽组合物 |
| CA2527743A1 (en) | 2003-06-03 | 2004-12-09 | Novo Nordisk A/S | Stabilized pharmaceutical peptide compositions |
| US7265092B2 (en) | 2004-09-30 | 2007-09-04 | Kai Pharmaceuticals, Inc. | Pharmaceutical formulation |
| KR101552843B1 (ko) * | 2006-11-16 | 2015-09-14 | 카이 파마슈티컬즈 | 부갑상선 기능항진증 및 고칼슘혈증 장애의 치료를 위한 폴리양이온성 칼슘 조절제 펩타이드 |
| CN101675067B (zh) * | 2007-01-19 | 2013-09-11 | 凯制药公司 | 肽组合物的修饰以提高稳定性和递送效率 |
| ES2412707T5 (es) | 2009-06-19 | 2023-06-12 | Procter & Gamble | Composición detergente líquida para lavado de vajillas a mano |
| 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 |
| PL2717896T3 (pl) | 2011-06-08 | 2017-05-31 | Kai Pharmaceuticals, Inc. | Środki lecznicze do regulowania poziomu fosforu w surowicy krwi |
| CN104168955A (zh) * | 2011-11-10 | 2014-11-26 | 凯伊药品公司 | 拟钙剂及其使用方法 |
| PE20210413A1 (es) | 2013-06-28 | 2021-03-04 | Amgen Inc | Formulacion liquida estable que comprende etelcalcetida (amg416), un agente tamponante y agente de tonicidad |
| PL3126373T3 (pl) * | 2014-04-03 | 2020-07-27 | Amgen Inc. | Sposób wytwarzania amg 416 |
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2014
- 2014-06-27 PE PE2020001772A patent/PE20210413A1/es unknown
- 2014-06-27 RS RS20170704A patent/RS56238B1/sr unknown
- 2014-06-27 ES ES14742093.9T patent/ES2633989T3/es active Active
- 2014-06-27 CR CR20160061A patent/CR20160061A/es unknown
- 2014-06-27 AP AP2015008936A patent/AP2015008936A0/xx unknown
- 2014-06-27 EP EP21156687.2A patent/EP3878433A1/en active Pending
- 2014-06-27 UA UAA201600641A patent/UA115373C2/uk unknown
- 2014-06-27 EP EP17160312.9A patent/EP3246017B1/en active Active
- 2014-06-27 LT LTEP14742093.9T patent/LT3013318T/lt unknown
- 2014-06-27 MY MYPI2015003044A patent/MY180276A/en unknown
- 2014-06-27 ME MEP-2017-150A patent/ME02818B/me unknown
- 2014-06-27 SI SI201430290T patent/SI3013318T1/sl unknown
- 2014-06-27 AU AU2014302122A patent/AU2014302122B2/en active Active
- 2014-06-27 CA CA2916222A patent/CA2916222C/en active Active
- 2014-06-27 MX MX2015017952A patent/MX2015017952A/es active IP Right Grant
- 2014-06-27 HU HUE14742093A patent/HUE034209T2/en unknown
- 2014-06-27 PE PE2015002666A patent/PE20160549A1/es unknown
- 2014-06-27 PL PL14742093T patent/PL3013318T3/pl unknown
- 2014-06-27 CN CN202111597304.7A patent/CN114376970A/zh active Pending
- 2014-06-27 EP EP14742093.9A patent/EP3013318B1/en active Active
- 2014-06-27 US US14/908,481 patent/US9820938B2/en active Active
- 2014-06-27 EA EA201690099A patent/EA030220B1/ru not_active IP Right Cessation
- 2014-06-27 CR CR20160002A patent/CR20160002A/es unknown
- 2014-06-27 JP JP2016524250A patent/JP6027708B2/ja active Active
- 2014-06-27 TW TW103122433A patent/TWI635874B/zh active
- 2014-06-27 MA MA38724A patent/MA38724B1/fr unknown
- 2014-06-27 TN TN2015000569A patent/TN2015000569A1/en unknown
- 2014-06-27 PT PT147420939T patent/PT3013318T/pt unknown
- 2014-06-27 DK DK14742093.9T patent/DK3013318T3/da active
- 2014-06-27 SG SG11201510647TA patent/SG11201510647TA/en unknown
- 2014-06-27 CN CN201480047399.7A patent/CN105764487A/zh active Pending
- 2014-06-27 KR KR1020167002370A patent/KR102231957B1/ko active IP Right Grant
- 2014-06-27 WO PCT/US2014/044622 patent/WO2014210489A1/en active Application Filing
- 2014-06-29 JO JOP/2014/0204A patent/JO3817B1/ar active
- 2014-06-30 UY UY0001035636A patent/UY35636A/es not_active Application Discontinuation
- 2014-06-30 AR ARP140102450A patent/AR096773A1/es not_active Application Discontinuation
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2015
- 2015-12-17 PH PH12015502816A patent/PH12015502816A1/en unknown
- 2015-12-17 IL IL243210A patent/IL243210B/en active IP Right Grant
- 2015-12-28 CL CL2015003738A patent/CL2015003738A1/es unknown
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2016
- 2016-01-12 ZA ZA2016/00238A patent/ZA201600238B/en unknown
- 2016-09-12 HK HK16110762.7A patent/HK1222557A1/zh unknown
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2017
- 2017-07-17 HR HRP20171092TT patent/HRP20171092T1/hr unknown
- 2017-07-19 CY CY171100771T patent/CY1120811T1/el unknown
- 2017-11-02 US US15/802,390 patent/US10344765B2/en active Active
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2019
- 2019-06-03 US US16/430,322 patent/US11162500B2/en active Active
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2021
- 2021-08-11 US US17/400,044 patent/US11959486B2/en active Active
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