HRP20171092T1 - Stabilna tekuća formulacija amg 416 (velkalcetid) - Google Patents
Stabilna tekuća formulacija amg 416 (velkalcetid) Download PDFInfo
- Publication number
- HRP20171092T1 HRP20171092T1 HRP20171092TT HRP20171092T HRP20171092T1 HR P20171092 T1 HRP20171092 T1 HR P20171092T1 HR P20171092T T HRP20171092T T HR P20171092TT HR P20171092 T HRP20171092 T HR P20171092T HR P20171092 T1 HRP20171092 T1 HR P20171092T1
- Authority
- HR
- Croatia
- Prior art keywords
- formulation
- amg
- concentration
- present
- velcalcetide
- Prior art date
Links
- 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 claims 7
- 229950006502 etelcalcetide Drugs 0.000 title claims 7
- 108091022127 etelcalcetide hydrochloride Proteins 0.000 title claims 7
- 239000012669 liquid formulation Substances 0.000 title 1
- 238000009472 formulation Methods 0.000 claims 27
- 239000000203 mixture Substances 0.000 claims 27
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical group [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 4
- 239000007864 aqueous solution Substances 0.000 claims 2
- 239000000872 buffer Substances 0.000 claims 2
- 230000015556 catabolic process Effects 0.000 claims 2
- 238000006731 degradation reaction Methods 0.000 claims 2
- 239000003607 modifier Substances 0.000 claims 2
- 239000011780 sodium chloride Substances 0.000 claims 2
- 239000003795 chemical substances by application Substances 0.000 claims 1
- 239000008194 pharmaceutical composition Substances 0.000 claims 1
- 239000008362 succinate buffer Substances 0.000 claims 1
- 150000003890 succinate salts Chemical group 0.000 claims 1
- 230000001256 tonic effect Effects 0.000 claims 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)
- Hematology (AREA)
- Obesity (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)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
Claims (15)
1. Farmaceutska formulacija koja sadrži AMG 416 u vodenoj otopini, pri čemu formulacija ima pH od 2.0 do 5.0.
2. Formulacija iz patentnog zahtjeva 1, pri čemu formulacija ima pH od 2.5 do 4.5.
3. Formulacija iz patentnog zahtjeva 1, pri čemu formulacija ima pH od 2.5 do 4.0.
4. Formulacija iz patentnog zahtjeva 1, pri čemu formulacija ima pH od 3.0 do 3.5.
5. Formulacija iz patentnog zahtjeva 1, pri čemu se pH održava farmaceutski prihvatljivim puferom.
6. Formulacija iz patentnog zahtjeva 5, pri čemu je pufer sukcinat.
7. Formulacija iz patentnog zahtjeva 1, pri čemu je AMG 416 prisutan u formulaciji u koncentraciji od 0.1 mg/mL do 20 mg/mL.
8. Formulacija iz patentnog zahtjeva 1, pri čemu je AMG 416 prisutan u formulaciji u koncentraciji od 1 mg/mL do 15 mg/mL.
9. Formulacija iz patentnog zahtjeva 1, pri čemu je AMG 416 prisutan u formulaciji u koncentraciji od 2.5 mg/mL do 10 mg/mL.
10. Formulacija iz patentnog zahtjeva 1, nadalje sadrži farmaceutski prihvatljivi modifikator tonusa.
11. Formulacija iz patentnog zahtjeva 10, pri čemu je modifikator tonusa prisutan u formulaciji u koncentraciji dovoljnoj za približno izotoničnu formulaciju.
12. Formulacija iz patentnog zahtjeva 10, pri čemu je tonifikator NaCl.
13. Formulacija iz patentnog zahtjeva 1, pri čemu formulacija ima manje od 10% raspadanja kada se čuva na 2-8°C tijekom 2 godine.
14. Formulacija iz patentnog zahtjeva 1, pri čemu formulacija ima manje od 10% raspadanja kada se čuva na sobnoj temperaturi tijekom 2 godine.
15. Formulacija sadrži 2 mg/mL do 20 mg/mL AMG 416 u vodenoj otopini, sukcinatni pufer koji održava formulaciju na pH iznad 3.0 do 3.5 i dovoljnu koncentraciju natrijevog klorida kako bi formulacija bila približno izotonična.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201361840618P | 2013-06-28 | 2013-06-28 | |
| EP14742093.9A EP3013318B1 (en) | 2013-06-28 | 2014-06-27 | Stable liquid formulation of amg 416 (velcalcetide) |
| PCT/US2014/044622 WO2014210489A1 (en) | 2013-06-28 | 2014-06-27 | Stable liquid formulation of amg 416 (velcalcetide) |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20171092T1 true HRP20171092T1 (hr) | 2017-10-06 |
Family
ID=51213030
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20171092TT HRP20171092T1 (hr) | 2013-06-28 | 2017-07-17 | Stabilna tekuća formulacija amg 416 (velkalcetid) |
Country Status (38)
| Country | Link |
|---|---|
| US (4) | US9820938B2 (hr) |
| EP (3) | EP3246017B1 (hr) |
| JP (1) | JP6027708B2 (hr) |
| KR (1) | KR102231957B1 (hr) |
| CN (2) | CN105764487A (hr) |
| AP (1) | AP2015008936A0 (hr) |
| AR (1) | AR096773A1 (hr) |
| AU (1) | AU2014302122B2 (hr) |
| CA (1) | CA2916222C (hr) |
| CL (1) | CL2015003738A1 (hr) |
| CR (2) | CR20160002A (hr) |
| CY (1) | CY1120811T1 (hr) |
| DK (1) | DK3013318T3 (hr) |
| EA (1) | EA030220B1 (hr) |
| ES (1) | ES2633989T3 (hr) |
| HK (1) | HK1222557A1 (hr) |
| HR (1) | HRP20171092T1 (hr) |
| HU (1) | HUE034209T2 (hr) |
| IL (1) | IL243210B (hr) |
| JO (1) | JO3817B1 (hr) |
| LT (1) | LT3013318T (hr) |
| MA (1) | MA38724B1 (hr) |
| ME (1) | ME02818B (hr) |
| MX (1) | MX2015017952A (hr) |
| MY (1) | MY180276A (hr) |
| PE (2) | PE20160549A1 (hr) |
| PH (1) | PH12015502816B1 (hr) |
| PL (1) | PL3013318T3 (hr) |
| PT (1) | PT3013318T (hr) |
| RS (1) | RS56238B1 (hr) |
| SG (1) | SG11201510647TA (hr) |
| SI (1) | SI3013318T1 (hr) |
| TN (1) | TN2015000569A1 (hr) |
| TW (1) | TWI635874B (hr) |
| UA (1) | UA115373C2 (hr) |
| UY (1) | UY35636A (hr) |
| WO (1) | WO2014210489A1 (hr) |
| ZA (1) | ZA201600238B (hr) |
Families Citing this family (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| SI3013318T1 (sl) | 2013-06-28 | 2017-11-30 | Amgen Inc. | Stabilna tekoča oblika amg 416 (velkalcetid) |
| KR102397271B1 (ko) | 2014-04-03 | 2022-05-16 | 암젠 인코포레이티드 | Amg 416의 제조 방법 |
| WO2016154580A1 (en) * | 2015-03-26 | 2016-09-29 | 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 |
| US20230201313A1 (en) | 2020-05-15 | 2023-06-29 | 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 |
| JP2024517801A (ja) | 2021-05-06 | 2024-04-23 | アムジエン・インコーポレーテツド | エテルカルセチド製剤 |
Family Cites Families (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CA2270154A1 (en) | 1996-10-25 | 1998-04-30 | The Government Of The United States Of America As Represented By The Sec Retary, 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 |
| KR101293507B1 (ko) | 2003-06-03 | 2013-08-06 | 노보 노르디스크 에이/에스 | 안정화된 약학적 펩티드 조성물 |
| US7265092B2 (en) | 2004-09-30 | 2007-09-04 | Kai Pharmaceuticals, Inc. | Pharmaceutical formulation |
| AU2007325387B2 (en) * | 2006-11-16 | 2014-04-03 | Kai Pharmaceuticals, Inc. | Polycationic calcium modulator peptides for the treatment of hyperparathyroidism and hypercalcemic disorders |
| EP3248985B1 (en) | 2007-01-19 | 2019-10-23 | Kai Pharmaceuticals, Inc. | Modifications of peptide compositions to increase stability and delivery efficiency |
| EP2264138B2 (en) | 2009-06-19 | 2023-03-08 | The Procter & Gamble Company | Liquid hand dishwashing detergent composition |
| PL2459208T3 (pl) * | 2009-07-29 | 2017-05-31 | Kai Pharmaceuticals, Inc. | Środki lecznicze zmniejszające poziom parathormonu |
| 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 |
| RS55503B1 (sr) * | 2011-06-08 | 2017-05-31 | Kai Pharmaceuticals Inc | Terapijska sredstva za regulisanje fosfora u serumu |
| CN104168955A (zh) | 2011-11-10 | 2014-11-26 | 凯伊药品公司 | 拟钙剂及其使用方法 |
| SI3013318T1 (sl) | 2013-06-28 | 2017-11-30 | Amgen Inc. | Stabilna tekoča oblika amg 416 (velkalcetid) |
| KR102397271B1 (ko) * | 2014-04-03 | 2022-05-16 | 암젠 인코포레이티드 | Amg 416의 제조 방법 |
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2014
- 2014-06-27 SI SI201430290T patent/SI3013318T1/sl unknown
- 2014-06-27 MA MA38724A patent/MA38724B1/fr unknown
- 2014-06-27 PL PL14742093T patent/PL3013318T3/pl unknown
- 2014-06-27 ME MEP-2017-150A patent/ME02818B/me unknown
- 2014-06-27 MY MYPI2015003044A patent/MY180276A/en unknown
- 2014-06-27 ES ES14742093.9T patent/ES2633989T3/es active Active
- 2014-06-27 PE PE2015002666A patent/PE20160549A1/es unknown
- 2014-06-27 SG SG11201510647TA patent/SG11201510647TA/en unknown
- 2014-06-27 TN TN2015000569A patent/TN2015000569A1/en unknown
- 2014-06-27 DK DK14742093.9T patent/DK3013318T3/en active
- 2014-06-27 CN CN201480047399.7A patent/CN105764487A/zh active Pending
- 2014-06-27 UA UAA201600641A patent/UA115373C2/uk unknown
- 2014-06-27 AU AU2014302122A patent/AU2014302122B2/en active Active
- 2014-06-27 MX MX2015017952A patent/MX2015017952A/es active IP Right Grant
- 2014-06-27 RS RS20170704A patent/RS56238B1/sr unknown
- 2014-06-27 CR CR20160002A patent/CR20160002A/es unknown
- 2014-06-27 EP EP17160312.9A patent/EP3246017B1/en active Active
- 2014-06-27 HU HUE14742093A patent/HUE034209T2/en unknown
- 2014-06-27 EA EA201690099A patent/EA030220B1/ru not_active IP Right Cessation
- 2014-06-27 EP EP21156687.2A patent/EP3878433A1/en active Pending
- 2014-06-27 JP JP2016524250A patent/JP6027708B2/ja active Active
- 2014-06-27 LT LTEP14742093.9T patent/LT3013318T/lt unknown
- 2014-06-27 CR CR20160061A patent/CR20160061A/es unknown
- 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 CN CN202111597304.7A patent/CN114376970A/zh active Pending
- 2014-06-27 WO PCT/US2014/044622 patent/WO2014210489A1/en active Application Filing
- 2014-06-27 AP AP2015008936A patent/AP2015008936A0/xx unknown
- 2014-06-27 CA CA2916222A patent/CA2916222C/en active Active
- 2014-06-27 KR KR1020167002370A patent/KR102231957B1/ko active IP Right Grant
- 2014-06-27 PT PT147420939T patent/PT3013318T/pt unknown
- 2014-06-27 TW TW103122433A patent/TWI635874B/zh active
- 2014-06-27 PE PE2020001772A patent/PE20210413A1/es unknown
- 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
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2015
- 2015-12-17 PH PH12015502816A patent/PH12015502816B1/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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