ME02818B - Stab ilna tečna formulacija amg 416 (velkalcetida) - Google Patents
Stab ilna tečna formulacija amg 416 (velkalcetida)Info
- Publication number
- ME02818B ME02818B MEP-2017-150A MEP2017150A ME02818B ME 02818 B ME02818 B ME 02818B ME P2017150 A MEP2017150 A ME P2017150A ME 02818 B ME02818 B ME 02818B
- Authority
- ME
- Montenegro
- Prior art keywords
- formulation
- formulation according
- concentration
- amo
- fact
- 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 2
- 229950006502 etelcalcetide Drugs 0.000 title claims 2
- 108091022127 etelcalcetide hydrochloride Proteins 0.000 title claims 2
- 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
- 238000000354 decomposition reaction Methods 0.000 claims 2
- 239000011780 sodium chloride Substances 0.000 claims 2
- 239000008181 tonicity modifier Substances 0.000 claims 2
- 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
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)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (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)
- Mechanical Engineering (AREA)
- General Engineering & Computer Science (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Gastroenterology & Hepatology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Immunology (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)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Claims (15)
1. Farmaceutska formulacija koja sadrži AMO 4 16 u vodenom rastvoru, naznačena time što formulacija ima pH od 2.0 do 5.0.
2. Formulacija prema patentnom zahtevu l, naznače na time što formulacija ima pH od 2.5 do 4.5.
3.Formulacija prema patentnom zahtevu l, nazn ačena time što formulacija ima pH od 2.5 do 4.0.
4.Formulacija prema patentnom zahtevu l , naznačena time što formulacija ima pH od 3.0 do 3.5.
5.Formulacija prema patentnom zahtevu l , naznačena time što je pH održavana pomoću farmaceutski prihvat lj ivog pufera.
6.Formulacija prema patentnom zahtevu 5, naznačena time štopufer je sukcinat.
7.Formulacija prema patentnom zahtevu l, naznačena time što AMO 416 je prisutan u formulaciji u koncentraciji od 0.1 mg/mL do 20 mg/mL
8.Formulacija prema patentnom zahtevu l, naznačena time što je AMO 416 prisutan u formulaciji u koncentraciji od l mg/mL do 15 mg/mL.
9.Formulacija prema patentnom zahtevu l, naznačena time što je AMO 416 prisutan u formulaciji u koncentraciji od 2.5 mg/mL do l O mg/mL.
10.Formulacija prema patentnom zahtevu l, koja dalje sadrži farmace utski prihvatljiv modifikator toničnosti.
11.ll. Formulacija prema patentnom zahtevu l O, naznačena time što je modifikator toničnosti prisutan u formulaciji u koncentraciji koja je dovoljna da formulacija bude približno izotonična.
12.Formulacija prema patentnom zahtevu l O, naznačena time što regulator toni čnosti je NaCl.
13.Formulacija prema patentnom zahtevu l, naznačena time što formulacija ima manje od l 0% razlaganja kada je čuvana na 2-8°C tokom 2 godine.
14.Formulacija prema patentnom zahtevu l, naznačena time što formulacija ima manje od l 0% razlaganja kada je čuvana na sobnoj temperaturi tokom 2 godine.
15.Formulacija koja sadrži 2 mg/mL do 20 mg/mL AMG 416 u vodenom rastvoru, sukcinatni pufer koji održava formu laciju na pH od oko 3.0 do 3.5, i dovoljnu koncentraciju natrijum hlorida da bi formu lacija 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 |
|---|---|
| ME02818B true ME02818B (me) | 2018-01-20 |
Family
ID=51213030
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MEP-2017-150A ME02818B (me) | 2013-06-28 | 2014-06-27 | Stab ilna tečna formulacija amg 416 (velkalcetida) |
Country Status (38)
| Country | Link |
|---|---|
| US (4) | US9820938B2 (me) |
| EP (3) | EP3246017B1 (me) |
| JP (1) | JP6027708B2 (me) |
| KR (1) | KR102231957B1 (me) |
| CN (2) | CN105764487A (me) |
| AP (1) | AP2015008936A0 (me) |
| AR (1) | AR096773A1 (me) |
| AU (1) | AU2014302122B2 (me) |
| CA (1) | CA2916222C (me) |
| CL (1) | CL2015003738A1 (me) |
| CR (2) | CR20160002A (me) |
| CY (1) | CY1120811T1 (me) |
| DK (1) | DK3013318T3 (me) |
| EA (1) | EA030220B1 (me) |
| ES (1) | ES2633989T3 (me) |
| HR (1) | HRP20171092T1 (me) |
| HU (1) | HUE034209T2 (me) |
| IL (1) | IL243210B (me) |
| JO (1) | JO3817B1 (me) |
| LT (1) | LT3013318T (me) |
| MA (1) | MA38724B1 (me) |
| ME (1) | ME02818B (me) |
| MX (1) | MX2015017952A (me) |
| MY (1) | MY180276A (me) |
| PE (2) | PE20160549A1 (me) |
| PH (1) | PH12015502816B1 (me) |
| PL (1) | PL3013318T3 (me) |
| PT (1) | PT3013318T (me) |
| RS (1) | RS56238B1 (me) |
| SG (1) | SG11201510647TA (me) |
| SI (1) | SI3013318T1 (me) |
| SM (1) | SMT201700401T1 (me) |
| TN (1) | TN2015000569A1 (me) |
| TW (1) | TWI635874B (me) |
| UA (1) | UA115373C2 (me) |
| UY (1) | UY35636A (me) |
| WO (1) | WO2014210489A1 (me) |
| ZA (1) | ZA201600238B (me) |
Families Citing this family (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CA2916222C (en) | 2013-06-28 | 2021-05-18 | Amgen Inc. | Stable liquid formulation of amg 416 (etelcalcetide) |
| 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 |
| EP4149507A1 (en) | 2020-05-15 | 2023-03-22 | 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 |
|---|---|---|---|---|
| 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 |
| BRPI0410972C1 (pt) * | 2003-06-03 | 2021-05-25 | Novo Nordisk As | método para aumentar a vida de armazenagem de uma composição farmacêutica, composição farmacêutica, e, método para tratamento de hiperglicemia |
| PL1633390T3 (pl) | 2003-06-03 | 2012-06-29 | Novo Nordisk As | Stabilizowane kompozycje farmaceutyczne peptydu glp-1 |
| US7265092B2 (en) | 2004-09-30 | 2007-09-04 | Kai Pharmaceuticals, Inc. | Pharmaceutical formulation |
| CN101668421B (zh) | 2006-11-16 | 2014-05-21 | 凯制药公司 | 用于治疗甲状旁腺功能亢进和高钙血症的聚阳离子钙调节肽 |
| WO2008089491A2 (en) | 2007-01-19 | 2008-07-24 | 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 |
| ES2729051T3 (es) | 2009-07-29 | 2019-10-30 | Kai Pharmaceuticals Inc | Agentes terapéuticos para reducir los niveles de hormona paratiroidea |
| 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 |
| WO2012170955A1 (en) | 2011-06-08 | 2012-12-13 | Kai Pharmaceuticals, Inc. | Therapeutic agents for regulating serum phosphorus |
| AU2012335009B2 (en) | 2011-11-10 | 2017-08-31 | Kai Pharmaceuticals, Inc. | Calcimimetics and methods for their use |
| CA2916222C (en) | 2013-06-28 | 2021-05-18 | Amgen Inc. | Stable liquid formulation of amg 416 (etelcalcetide) |
| PL3126373T3 (pl) * | 2014-04-03 | 2020-07-27 | Amgen Inc. | Sposób wytwarzania amg 416 |
-
2014
- 2014-06-27 CA CA2916222A patent/CA2916222C/en active Active
- 2014-06-27 CR CR20160002A patent/CR20160002A/es unknown
- 2014-06-27 MX MX2015017952A patent/MX2015017952A/es active IP Right Grant
- 2014-06-27 KR KR1020167002370A patent/KR102231957B1/ko active Active
- 2014-06-27 RS RS20170704A patent/RS56238B1/sr unknown
- 2014-06-27 EA EA201690099A patent/EA030220B1/ru not_active IP Right Cessation
- 2014-06-27 TW TW103122433A patent/TWI635874B/zh active
- 2014-06-27 HU HUE14742093A patent/HUE034209T2/en unknown
- 2014-06-27 PL PL14742093T patent/PL3013318T3/pl unknown
- 2014-06-27 US US14/908,481 patent/US9820938B2/en active Active
- 2014-06-27 SG SG11201510647TA patent/SG11201510647TA/en unknown
- 2014-06-27 ME MEP-2017-150A patent/ME02818B/me unknown
- 2014-06-27 MA MA38724A patent/MA38724B1/fr unknown
- 2014-06-27 WO PCT/US2014/044622 patent/WO2014210489A1/en not_active Ceased
- 2014-06-27 CN CN201480047399.7A patent/CN105764487A/zh 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 TN TN2015000569A patent/TN2015000569A1/en unknown
- 2014-06-27 CR CR20160061A patent/CR20160061A/es 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 JP JP2016524250A patent/JP6027708B2/ja active Active
- 2014-06-27 PE PE2015002666A patent/PE20160549A1/es unknown
- 2014-06-27 DK DK14742093.9T patent/DK3013318T3/en active
- 2014-06-27 ES ES14742093.9T patent/ES2633989T3/es active Active
- 2014-06-27 EP EP21156687.2A patent/EP3878433A1/en active Pending
- 2014-06-27 AU AU2014302122A patent/AU2014302122B2/en active Active
- 2014-06-27 PE PE2020001772A patent/PE20210413A1/es unknown
- 2014-06-27 LT LTEP14742093.9T patent/LT3013318T/lt unknown
- 2014-06-27 HR HRP20171092TT patent/HRP20171092T1/hr unknown
- 2014-06-27 PT PT147420939T patent/PT3013318T/pt unknown
- 2014-06-27 SI SI201430290T patent/SI3013318T1/sl unknown
- 2014-06-27 MY MYPI2015003044A patent/MY180276A/en unknown
- 2014-06-27 AP AP2015008936A patent/AP2015008936A0/xx unknown
- 2014-06-27 SM SM20170401T patent/SMT201700401T1/it unknown
- 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
-
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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