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
Application number
MEP-2017-150A
Other languages
German (de)
English (en)
French (fr)
Inventor
Derek Maclean
Qun Yin
Original Assignee
Amgen Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=51213030&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=ME02818(B) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Amgen Inc filed Critical Amgen Inc
Publication of ME02818B publication Critical patent/ME02818B/me

Links

Classifications

    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F04POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
    • F04DNON-POSITIVE-DISPLACEMENT PUMPS
    • F04D25/00Pumping installations or systems
    • F04D25/02Units comprising pumps and their driving means
    • F04D25/06Units comprising pumps and their driving means the pump being electrically driven
    • F04D25/0606Units comprising pumps and their driving means the pump being electrically driven the electric motor being specially adapted for integration in the pump
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/04Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/08Peptides having 5 to 11 amino acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/12Drugs for disorders of the metabolism for electrolyte homeostasis
    • A61P3/14Drugs for disorders of the metabolism for electrolyte homeostasis for calcium homeostasis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/18Drugs for disorders of the endocrine system of the parathyroid hormones
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F01MACHINES OR ENGINES IN GENERAL; ENGINE PLANTS IN GENERAL; STEAM ENGINES
    • F01DNON-POSITIVE DISPLACEMENT MACHINES OR ENGINES, e.g. STEAM TURBINES
    • F01D15/00Adaptations of machines or engines for special use; Combinations of engines with devices driven thereby
    • F01D15/10Adaptations 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.
MEP-2017-150A 2013-06-28 2014-06-27 Stab ilna tečna formulacija amg 416 (velkalcetida) ME02818B (me)

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)

* Cited by examiner, † Cited by third party
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

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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
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ES2729051T3 (es) 2009-07-29 2019-10-30 Kai Pharmaceuticals Inc Agentes terapéuticos para reducir los niveles de hormona paratiroidea
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PL3126373T3 (pl) * 2014-04-03 2020-07-27 Amgen Inc. Sposób wytwarzania amg 416

Also Published As

Publication number Publication date
CA2916222A1 (en) 2014-12-31
MA38724B1 (fr) 2017-11-30
JP6027708B2 (ja) 2016-11-16
SMT201700401T1 (it) 2017-09-07
HUE034209T2 (en) 2018-02-28
KR102231957B1 (ko) 2021-03-25
PH12015502816A1 (en) 2016-03-21
PE20160549A1 (es) 2016-06-15
EP3013318B1 (en) 2017-04-19
UY35636A (es) 2015-01-30
RS56238B1 (sr) 2017-11-30
CR20160002A (es) 2018-02-13
EP3878433A1 (en) 2021-09-15
IL243210A0 (en) 2016-02-29
SI3013318T1 (sl) 2017-11-30
WO2014210489A1 (en) 2014-12-31
MY180276A (en) 2020-11-26
BR112015032615A2 (pt) 2017-07-25
JP2016523916A (ja) 2016-08-12
US9820938B2 (en) 2017-11-21
EP3246017B1 (en) 2021-03-24
PH12015502816B1 (en) 2016-03-21
EP3013318A1 (en) 2016-05-04
US20160220486A1 (en) 2016-08-04
PE20210413A1 (es) 2021-03-04
AP2015008936A0 (en) 2015-12-31
US10344765B2 (en) 2019-07-09
US20220042515A1 (en) 2022-02-10
TWI635874B (zh) 2018-09-21
JO3817B1 (ar) 2021-01-31
MA38724A1 (fr) 2017-03-31
PT3013318T (pt) 2017-07-24
CR20160061A (es) 2016-09-28
CA2916222C (en) 2021-05-18
UA115373C2 (uk) 2017-10-25
CL2015003738A1 (es) 2016-12-09
US11162500B2 (en) 2021-11-02
TN2015000569A1 (en) 2017-04-06
LT3013318T (lt) 2017-09-11
KR20160043954A (ko) 2016-04-22
ES2633989T3 (es) 2017-09-26
AU2014302122A1 (en) 2016-01-21
AU2014302122B2 (en) 2018-12-06
HRP20171092T1 (hr) 2017-10-06
CN105764487A (zh) 2016-07-13
PL3013318T3 (pl) 2018-03-30
ZA201600238B (en) 2017-05-31
CY1120811T1 (el) 2019-12-11
TW201542239A (zh) 2015-11-16
NZ715403A (en) 2020-10-30
AR096773A1 (es) 2016-02-03
HK1222557A1 (en) 2017-07-07
US20180080452A1 (en) 2018-03-22
US11959486B2 (en) 2024-04-16
MX2015017952A (es) 2016-10-28
EA201690099A1 (ru) 2016-06-30
IL243210B (en) 2020-02-27
EA030220B1 (ru) 2018-07-31
CN114376970A (zh) 2022-04-22
EP3246017A1 (en) 2017-11-22
DK3013318T3 (en) 2017-08-07
SG11201510647TA (en) 2016-01-28
US20190285074A1 (en) 2019-09-19

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