AR124700A1 - Formulaciones líquidas de proteínas y métodos de preparación de las mismas - Google Patents

Formulaciones líquidas de proteínas y métodos de preparación de las mismas

Info

Publication number
AR124700A1
AR124700A1 ARP220100149A ARP220100149A AR124700A1 AR 124700 A1 AR124700 A1 AR 124700A1 AR P220100149 A ARP220100149 A AR P220100149A AR P220100149 A ARP220100149 A AR P220100149A AR 124700 A1 AR124700 A1 AR 124700A1
Authority
AR
Argentina
Prior art keywords
liquid formulation
eflapegrastim
concentration
liquid
formulation
Prior art date
Application number
ARP220100149A
Other languages
English (en)
Inventor
Hyung Kyu Lim
Sang Yun Kim
Sung Hee Hong
Original Assignee
Hanmi Pharm Ind Co Ltd
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
Application filed by Hanmi Pharm Ind Co Ltd filed Critical Hanmi Pharm Ind Co Ltd
Publication of AR124700A1 publication Critical patent/AR124700A1/es

Links

Classifications

    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/19—Cytokines; Lymphokines; Interferons
    • A61K38/193—Colony stimulating factors [CSF]
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/56—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
    • A61K47/59—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
    • A61K47/60—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • 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
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Immunology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Dermatology (AREA)
  • Zoology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Peptides Or Proteins (AREA)

Abstract

Se proporciona una formulación líquida de proteínas y un método de preparación de la misma. Según una formulación líquida que contiene una alta concentración de eflapegrastim y un método de preparar la misma, la formulación líquida puede tener una excelente solubilidad y estabilidad, puede tener una alta concentración de proteína y puede inyectarse de un modo conveniente para el paciente debido a la reducción de la irritación / dolor en el sitio de administración o del malestar del paciente. Reivindicación 1: Una formulación líquida de eflapegrastim que comprende eflapegrastim y un material de tampón, en donde una concentración del eflapegrastim es de aproximadamente 11 mg/ml a aproximadamente 66 mg/ml; un índice de comodidad de uso para el paciente (CP) de la formulación líquida, representado por la ecuación 1, es de 10 o menos; [Ecuación 1] Índice de comodidad para el paciente (CP) = Osm (mOsm/kg) / 100 + MGF (N) en donde, en la ecuación 1, Osm indica el valor de osmolaridad de la formulación líquida, y MGF indica un valor de fuerza máxima de deslizamiento cuando la formulación líquida se inyecta con una jeringa de calibre 29 (29G) a una velocidad de 2.835 mm/s; una osmolaridad de la formulación líquida es de aproximadamente 100 mOsm/kg a aproximadamente 800 mOsm/kg; una fuerza máxima de deslizamiento (MGF) de la formulación líquida es de 5 N o menos cuando se inyecta con una jeringa de calibre 29 (29G) a una velocidad de aproximadamente 2.835 mm/s, o de 7 N o menos a una velocidad de aproximadamente 4.725 mm/s; y una tasa restante de eflapegrastim después de su almacenamiento a una temperatura de 23ºC a 27ºC y una humedad relativa de aproximadamente el 55% al 65% es del 95% o más, medida por cromatografía de líquidos de alta resolución en fase inversa (RP-HPLC) o cromatografía de líquidos de alta resolución de exclusión por tamaño molecular (SE-HPLC). Reivindicación 20: Una formulación líquida de eflapegrastim que comprende eflapegrastim, un material tampón y un tensioactivo, en donde una concentración del eflapegrastim es de aproximadamente 11 mg/ml a aproximadamente 66 mg/ml; una concentración del material tampón es de aproximadamente 5 mM a aproximadamente 100 mM; y una concentración del tensioactivo tras la concentración de la formulación líquida es de aproximadamente el 0.001% a aproximadamente el 5% (m/v) de la formulación líquida total, y una concentración del tensioactivo tras la concentración de la formulación líquida es de aproximadamente el 0.001% a aproximadamente el 5% (m/v) de la formulación líquida total.
ARP220100149A 2021-01-27 2022-01-26 Formulaciones líquidas de proteínas y métodos de preparación de las mismas AR124700A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
KR1020210011802A KR102375269B1 (ko) 2021-01-27 2021-01-27 단백질 액상 제제 및 이의 제조방법

Publications (1)

Publication Number Publication Date
AR124700A1 true AR124700A1 (es) 2023-04-26

Family

ID=80936291

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP220100149A AR124700A1 (es) 2021-01-27 2022-01-26 Formulaciones líquidas de proteínas y métodos de preparación de las mismas

Country Status (12)

Country Link
US (1) US20240082355A1 (es)
EP (1) EP4284340A1 (es)
JP (1) JP2024505211A (es)
KR (1) KR102375269B1 (es)
CN (1) CN116782882A (es)
AR (1) AR124700A1 (es)
AU (1) AU2022213961A1 (es)
CA (1) CA3206349A1 (es)
IL (1) IL304528A (es)
MX (1) MX2023008804A (es)
TW (1) TW202231295A (es)
WO (1) WO2022164204A1 (es)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11684655B2 (en) 2019-05-31 2023-06-27 Spectrum Pharmaceuticals, Inc. Methods of treating neutorpenia using G-CSF protein complex

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR100356140B1 (ko) * 1999-07-08 2002-10-19 한미약품공업 주식회사 인간 과립구 콜로니 자극인자 변이체 및 이의 생산 방법
US8420081B2 (en) * 2007-11-30 2013-04-16 Abbvie, Inc. Antibody formulations and methods of making same
EP2525787B1 (en) * 2010-01-19 2017-03-15 Hanmi Science Co., Ltd. Liquid formulations for long-acting g-csf conjugate
WO2013173687A1 (en) * 2012-05-18 2013-11-21 Genentech, Inc. High-concentration monoclonal antibody formulations
BR112016025126B1 (pt) * 2014-05-07 2024-02-15 Takeda Pharmaceutical Company Limited Composição aquosa compreendendo anticorpo neutralizante de gmcsf, e uso da mesma
KR20200112881A (ko) * 2018-01-24 2020-10-05 비욘드스프링 파마수티컬스, 인코포레이티드. 플리나불린의 투여를 통해 혈소판감소증을 감소시키는 조성물 및 방법
JP2021512121A (ja) * 2018-02-01 2021-05-13 ビヨンドスプリング ファーマシューティカルズ，インコーポレイテッド プリナブリンおよびｇ−ｃｓｆ製剤の投与による化学療法誘発性好中球減少症を軽減するための組成物および方法

Also Published As

Publication number Publication date
EP4284340A1 (en) 2023-12-06
AU2022213961A1 (en) 2023-08-10
TW202231295A (zh) 2022-08-16
CA3206349A1 (en) 2022-08-04
IL304528A (en) 2023-09-01
WO2022164204A1 (en) 2022-08-04
US20240082355A1 (en) 2024-03-14
MX2023008804A (es) 2023-08-04
CN116782882A (zh) 2023-09-19
KR102375269B1 (ko) 2022-03-17
JP2024505211A (ja) 2024-02-05

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