PE20160549A1 - Formulacion liquida estable de etelcalcetida (amg 416) - Google Patents

Formulacion liquida estable de etelcalcetida (amg 416)

Info

Publication number
PE20160549A1
PE20160549A1 PE2015002666A PE2015002666A PE20160549A1 PE 20160549 A1 PE20160549 A1 PE 20160549A1 PE 2015002666 A PE2015002666 A PE 2015002666A PE 2015002666 A PE2015002666 A PE 2015002666A PE 20160549 A1 PE20160549 A1 PE 20160549A1
Authority
PE
Peru
Prior art keywords
amg
liquid formulation
ethelcalcetida
stable liquid
formulation
Prior art date
Application number
PE2015002666A
Other languages
English (en)
Inventor
Qun Yin
Derek Maclean
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=***_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=PE20160549(A1) "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 PE20160549A1 publication Critical patent/PE20160549A1/es

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)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (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)
  • 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)
  • Peptides Or Proteins (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Inorganic Chemistry (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Abstract

Se proporcionan una formulacion liquida que comprende un agonista peptidico del receptor de deteccion de calcio y un metodo de preparacion y uso de la formulacion, donde dicho agonista es velcalcetida AMG 416 de formula I
PE2015002666A 2013-06-28 2014-06-27 Formulacion liquida estable de etelcalcetida (amg 416) PE20160549A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US201361840618P 2013-06-28 2013-06-28

Publications (1)

Publication Number Publication Date
PE20160549A1 true PE20160549A1 (es) 2016-06-15

Family

ID=51213030

Family Applications (2)

Application Number Title Priority Date Filing Date
PE2020001772A PE20210413A1 (es) 2013-06-28 2014-06-27 Formulacion liquida estable que comprende etelcalcetida (amg416), un agente tamponante y agente de tonicidad
PE2015002666A PE20160549A1 (es) 2013-06-28 2014-06-27 Formulacion liquida estable de etelcalcetida (amg 416)

Family Applications Before (1)

Application Number Title Priority Date Filing Date
PE2020001772A PE20210413A1 (es) 2013-06-28 2014-06-27 Formulacion liquida estable que comprende etelcalcetida (amg416), un agente tamponante y agente de tonicidad

Country Status (38)

Country Link
US (4) US9820938B2 (es)
EP (3) EP3246017B1 (es)
JP (1) JP6027708B2 (es)
KR (1) KR102231957B1 (es)
CN (2) CN105764487A (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)
HK (1) HK1222557A1 (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) PE20210413A1 (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)
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)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3246017B1 (en) 2013-06-28 2021-03-24 Amgen Inc. Stable liquid formulation of amg 416 hcl (etelcalcetide)
EP4219526A3 (en) 2014-04-03 2023-08-30 Amgen, Inc. Method for preparing 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
JP2023525884A (ja) 2020-05-15 2023-06-19 アムジェン インコーポレイテッド 左室肥大の処置方法
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)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE69703121D1 (de) 1996-10-25 2000-10-19 Us Health Verfahren und zusammensetzungen zur verhinderung von entzündungen und angiogenese enthaltend säugetieren cd97 alpha untereinheit
AT409081B (de) 2000-02-16 2002-05-27 Gebro Pharma Gmbh Stabile, nasal, oral oder sublingual anwendbare pharmazeutische zubereitung
JP4936884B2 (ja) * 2003-06-03 2012-05-23 ノボ・ノルデイスク・エー/エス 安定化された薬学的ペプチド組成物
WO2004105781A2 (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
EP2086321B1 (en) 2006-11-16 2016-08-31 Kai Pharmaceuticals, Inc. Polycationic calcium modulator peptides for the treatment of hyperparathyroidism and hypercalcemic disorders
KR102274003B1 (ko) * 2007-01-19 2021-07-08 카이 파마슈티컬즈 안정성 및 전달 효율을 증가시키기 위한 펩타이드 조성물의 변형
EP2264138B2 (en) 2009-06-19 2023-03-08 The Procter & Gamble Company Liquid hand dishwashing detergent composition
EP2459208B1 (en) 2009-07-29 2016-09-28 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
AU2012267470C1 (en) 2011-06-08 2017-09-21 Kai Pharmaceuticals, Inc. Therapeutic agents for regulating serum phosphorus
CA2854911C (en) 2011-11-10 2019-09-24 Kai Pharmaceuticals, Inc. Calcimimetics and methods for their use
EP3246017B1 (en) 2013-06-28 2021-03-24 Amgen Inc. Stable liquid formulation of amg 416 hcl (etelcalcetide)
EP4219526A3 (en) * 2014-04-03 2023-08-30 Amgen, Inc. Method for preparing amg 416

Also Published As

Publication number Publication date
US11959486B2 (en) 2024-04-16
CY1120811T1 (el) 2019-12-11
JP2016523916A (ja) 2016-08-12
MX2015017952A (es) 2016-10-28
UA115373C2 (uk) 2017-10-25
US10344765B2 (en) 2019-07-09
US20180080452A1 (en) 2018-03-22
TN2015000569A1 (en) 2017-04-06
IL243210A0 (en) 2016-02-29
JP6027708B2 (ja) 2016-11-16
PL3013318T3 (pl) 2018-03-30
EP3246017A1 (en) 2017-11-22
EP3246017B1 (en) 2021-03-24
KR102231957B1 (ko) 2021-03-25
CR20160061A (es) 2016-09-28
HRP20171092T1 (hr) 2017-10-06
TWI635874B (zh) 2018-09-21
CA2916222A1 (en) 2014-12-31
RS56238B1 (sr) 2017-11-30
DK3013318T3 (en) 2017-08-07
HUE034209T2 (en) 2018-02-28
US9820938B2 (en) 2017-11-21
AU2014302122A1 (en) 2016-01-21
KR20160043954A (ko) 2016-04-22
SI3013318T1 (sl) 2017-11-30
BR112015032615A2 (pt) 2017-07-25
US11162500B2 (en) 2021-11-02
CN105764487A (zh) 2016-07-13
CA2916222C (en) 2021-05-18
PH12015502816A1 (en) 2016-03-21
EP3878433A1 (en) 2021-09-15
SG11201510647TA (en) 2016-01-28
ZA201600238B (en) 2017-05-31
LT3013318T (lt) 2017-09-11
US20160220486A1 (en) 2016-08-04
US20190285074A1 (en) 2019-09-19
PE20210413A1 (es) 2021-03-04
ME02818B (me) 2018-01-20
ES2633989T3 (es) 2017-09-26
MY180276A (en) 2020-11-26
US20220042515A1 (en) 2022-02-10
EP3013318B1 (en) 2017-04-19
NZ715403A (en) 2020-10-30
MA38724B1 (fr) 2017-11-30
CR20160002A (es) 2018-02-13
PT3013318T (pt) 2017-07-24
JO3817B1 (ar) 2021-01-31
AR096773A1 (es) 2016-02-03
HK1222557A1 (zh) 2017-07-07
CL2015003738A1 (es) 2016-12-09
MA38724A1 (fr) 2017-03-31
UY35636A (es) 2015-01-30
PH12015502816B1 (en) 2016-03-21
EA030220B1 (ru) 2018-07-31
EA201690099A1 (ru) 2016-06-30
AU2014302122B2 (en) 2018-12-06
WO2014210489A1 (en) 2014-12-31
AP2015008936A0 (en) 2015-12-31
IL243210B (en) 2020-02-27
CN114376970A (zh) 2022-04-22
TW201542239A (zh) 2015-11-16
EP3013318A1 (en) 2016-05-04

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