AR096773A1 - Formulación líquida estable - Google Patents

Formulación líquida estable

Info

Publication number
AR096773A1
AR096773A1 ARP140102450A ARP140102450A AR096773A1 AR 096773 A1 AR096773 A1 AR 096773A1 AR P140102450 A ARP140102450 A AR P140102450A AR P140102450 A ARP140102450 A AR P140102450A AR 096773 A1 AR096773 A1 AR 096773A1
Authority
AR
Argentina
Prior art keywords
formulation
amg
liquid formulation
stable liquid
concentration
Prior art date
Application number
ARP140102450A
Other languages
English (en)
Inventor
Maclean Derek
Yin Qun
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=AR096773(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 AR096773A1 publication Critical patent/AR096773A1/es

Links

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)
  • Mechanical Engineering (AREA)
  • General Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (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)
  • Peptides Or Proteins (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Inorganic Chemistry (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

Se proporciona una formulación líquida que comprende un agonista del péptido de receptor sensor de calcio y un método para preparar y usar la formulación. Reivindicación 1: Una formulación farmacéutica que comprende AMG 416 en solución acuosa, donde la formulación tiene un pH de 2,0 a 5,0. Reivindicación 7: La formulación de la reivindicación 1, donde AMG 416 está presente en la formulación a una concentración de 0,1 mg/mL a 20 mg/mL. Reivindicación 13: La formulación de la reivindicación 1, donde la formulación tiene menos de 10% de degradación cuando se almacena a 2 - -8ºC durante 2 años. Reivindicación 15: Una formulación que comprende 2 mg/mL a 20 mg/mL de AMG 416 en solución acuosa, un amortiguador de succinato que mantiene la formulación a un pH de 3,0 a 3,5, y una concentración de cloruro de sodio suficiente para que la formulación sea aproximadamente isotónica.
ARP140102450A 2013-06-28 2014-06-30 Formulación líquida estable AR096773A1 (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
AR096773A1 true AR096773A1 (es) 2016-02-03

Family

ID=51213030

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP140102450A AR096773A1 (es) 2013-06-28 2014-06-30 Formulación líquida estable

Country Status (38)

Country Link
US (4) US9820938B2 (es)
EP (3) EP3246017B1 (es)
JP (1) JP6027708B2 (es)
KR (1) KR102231957B1 (es)
CN (2) CN114376970A (es)
AP (1) AP2015008936A0 (es)
AR (1) AR096773A1 (es)
AU (1) AU2014302122B2 (es)
CA (1) CA2916222C (es)
CL (1) CL2015003738A1 (es)
CR (2) CR20160061A (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
SG11201510647TA (en) 2013-06-28 2016-01-28 Amgen Inc Stable liquid formulation of amg 416 (velcalcetide)
RS60187B1 (sr) 2014-04-03 2020-06-30 Amgen Inc Metoda za pripremanje amg 416
CA2980960C (en) 2015-03-26 2024-05-28 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
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
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
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
CA3178367A1 (en) 2020-05-15 2021-11-18 Rainer Oberbauer 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)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0938557B1 (en) 1996-10-25 2000-09-13 THE GOVERNMENT OF THE UNITED STATES OF AMERICA as represented by the SECRETARY OF THE 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
WO2004105781A2 (en) 2003-06-03 2004-12-09 Novo Nordisk A/S Stabilized pharmaceutical peptide compositions
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
US7265092B2 (en) 2004-09-30 2007-09-04 Kai Pharmaceuticals, Inc. Pharmaceutical formulation
US8987200B2 (en) * 2006-11-16 2015-03-24 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
CA2769525C (en) 2009-07-29 2017-02-21 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
DK2717896T3 (en) * 2011-06-08 2016-12-19 Kai Pharmaceuticals Inc Therapeutics for regulating phoshor serum
EP2776129B2 (en) 2011-11-10 2020-06-17 Kai Pharmaceuticals, Inc. Compositions for use in the treatment of chronic kidney disease-mineral bone disorder characterized by soft tissue calcification
SG11201510647TA (en) 2013-06-28 2016-01-28 Amgen Inc Stable liquid formulation of amg 416 (velcalcetide)
RS60187B1 (sr) * 2014-04-03 2020-06-30 Amgen Inc Metoda za pripremanje amg 416

Also Published As

Publication number Publication date
MA38724A1 (fr) 2017-03-31
US20220042515A1 (en) 2022-02-10
EP3013318B1 (en) 2017-04-19
TW201542239A (zh) 2015-11-16
US11959486B2 (en) 2024-04-16
EP3246017A1 (en) 2017-11-22
CL2015003738A1 (es) 2016-12-09
SI3013318T1 (sl) 2017-11-30
MY180276A (en) 2020-11-26
ZA201600238B (en) 2017-05-31
CN114376970A (zh) 2022-04-22
CA2916222A1 (en) 2014-12-31
MA38724B1 (fr) 2017-11-30
JO3817B1 (ar) 2021-01-31
NZ715403A (en) 2020-10-30
PE20210413A1 (es) 2021-03-04
MX2015017952A (es) 2016-10-28
KR20160043954A (ko) 2016-04-22
EA201690099A1 (ru) 2016-06-30
UY35636A (es) 2015-01-30
PE20160549A1 (es) 2016-06-15
HK1222557A1 (zh) 2017-07-07
US11162500B2 (en) 2021-11-02
HRP20171092T1 (hr) 2017-10-06
BR112015032615A2 (pt) 2017-07-25
JP2016523916A (ja) 2016-08-12
TN2015000569A1 (en) 2017-04-06
US10344765B2 (en) 2019-07-09
AU2014302122B2 (en) 2018-12-06
EA030220B1 (ru) 2018-07-31
EP3013318A1 (en) 2016-05-04
IL243210B (en) 2020-02-27
CA2916222C (en) 2021-05-18
PL3013318T3 (pl) 2018-03-30
CN105764487A (zh) 2016-07-13
PH12015502816A1 (en) 2016-03-21
EP3246017B1 (en) 2021-03-24
JP6027708B2 (ja) 2016-11-16
RS56238B1 (sr) 2017-11-30
PT3013318T (pt) 2017-07-24
US20160220486A1 (en) 2016-08-04
US9820938B2 (en) 2017-11-21
WO2014210489A1 (en) 2014-12-31
ES2633989T3 (es) 2017-09-26
PH12015502816B1 (en) 2016-03-21
CY1120811T1 (el) 2019-12-11
TWI635874B (zh) 2018-09-21
US20190285074A1 (en) 2019-09-19
AU2014302122A1 (en) 2016-01-21
LT3013318T (lt) 2017-09-11
ME02818B (me) 2018-01-20
DK3013318T3 (en) 2017-08-07
UA115373C2 (uk) 2017-10-25
CR20160002A (es) 2018-02-13
IL243210A0 (en) 2016-02-29
HUE034209T2 (en) 2018-02-28
EP3878433A1 (en) 2021-09-15
SG11201510647TA (en) 2016-01-28
AP2015008936A0 (en) 2015-12-31
CR20160061A (es) 2016-09-28
KR102231957B1 (ko) 2021-03-25
US20180080452A1 (en) 2018-03-22

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