EA202191646A1 - Лиофилизированная композиция пегаспаргазы - Google Patents

Лиофилизированная композиция пегаспаргазы

Info

Publication number
EA202191646A1
EA202191646A1 EA202191646A EA202191646A EA202191646A1 EA 202191646 A1 EA202191646 A1 EA 202191646A1 EA 202191646 A EA202191646 A EA 202191646A EA 202191646 A EA202191646 A EA 202191646A EA 202191646 A1 EA202191646 A1 EA 202191646A1
Authority
EA
Eurasian Patent Office
Prior art keywords
pegaspargase
composition
present
stable
lyophilized composition
Prior art date
Application number
EA202191646A
Other languages
English (en)
Inventor
Татагата Мукхерджи
Правин Кумар Агарвал
Санджай Сингх
Original Assignee
Дженнова Биофармасьютикалз Лимитед
Ин/Ин]
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 Дженнова Биофармасьютикалз Лимитед, Ин/Ин] filed Critical Дженнова Биофармасьютикалз Лимитед
Publication of EA202191646A1 publication Critical patent/EA202191646A1/ru

Links

Classifications

    • 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
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/50—Hydrolases (3) acting on carbon-nitrogen bonds, other than peptide bonds (3.5), e.g. asparaginase
    • 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
    • A61K47/26—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
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/14—Hydrolases (3)
    • C12N9/78—Hydrolases (3) acting on carbon to nitrogen bonds other than peptide bonds (3.5)
    • C12N9/80—Hydrolases (3) acting on carbon to nitrogen bonds other than peptide bonds (3.5) acting on amide bonds in linear amides (3.5.1)
    • C12N9/82—Asparaginase (3.5.1.1)
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y305/00—Hydrolases acting on carbon-nitrogen bonds, other than peptide bonds (3.5)
    • C12Y305/01—Hydrolases acting on carbon-nitrogen bonds, other than peptide bonds (3.5) in linear amides (3.5.1)
    • C12Y305/01001—Asparaginase (3.5.1.1)
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Organic Chemistry (AREA)
  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Molecular Biology (AREA)
  • General Engineering & Computer Science (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • General Chemical & Material Sciences (AREA)
  • Inorganic Chemistry (AREA)
  • Biotechnology (AREA)
  • Microbiology (AREA)
  • Biomedical Technology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

Настоящее изобретение относится к новой, экономически целесообразной, стабильной при хранении лиофилизированной композиции пегаспаргазы. Композиция содержит пегаспаргазу, криопротектор, наполнитель, буфер и может по выбору содержать другие фармацевтически приемлемые вспомогательные вещества, включая, но не ограничиваясь солью. Композиция настоящего изобретения стабильна в течение длительных периодов времени в значительном диапазоне температур, без присутствия какого-либо значительного количества примесей. Настоящее изобретение также относится к экономически целесообразному и масштабируемому способу лиофилизации для получения стабильной при хранении композиции пегаспаргазы.
EA202191646A 2018-12-24 2019-05-20 Лиофилизированная композиция пегаспаргазы EA202191646A1 (ru)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN201821048859 2018-12-24
PCT/IN2019/050402 WO2020136666A1 (en) 2018-12-24 2019-05-20 A lyophilized composition of pegaspargase

Publications (1)

Publication Number Publication Date
EA202191646A1 true EA202191646A1 (ru) 2022-01-14

Family

ID=71129290

Family Applications (1)

Application Number Title Priority Date Filing Date
EA202191646A EA202191646A1 (ru) 2018-12-24 2019-05-20 Лиофилизированная композиция пегаспаргазы

Country Status (13)

Country Link
US (1) US20220080033A1 (ru)
EP (1) EP3867369A4 (ru)
JP (2) JP2022514942A (ru)
KR (1) KR20210107014A (ru)
AU (1) AU2019412580A1 (ru)
BR (1) BR112021011956A2 (ru)
CL (1) CL2021001379A1 (ru)
CO (1) CO2021008047A2 (ru)
EA (1) EA202191646A1 (ru)
MX (1) MX2021007654A (ru)
PE (1) PE20220492A1 (ru)
WO (1) WO2020136666A1 (ru)
ZA (1) ZA202103379B (ru)

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011003633A1 (en) * 2009-07-06 2011-01-13 Alize Pharma Ii Pegylated l-asparaginase
CN105796507B (zh) * 2014-12-29 2019-01-18 江苏众红生物工程创药研究院有限公司 含聚乙二醇化门冬酰胺酶的药物组合物及其制备方法
EP3463308B1 (en) * 2016-06-01 2021-12-01 Servier IP UK Limited Formulations of polyalkylene oxide-asparaginase and methods of making and using the same

Also Published As

Publication number Publication date
KR20210107014A (ko) 2021-08-31
EP3867369A4 (en) 2022-09-14
PE20220492A1 (es) 2022-04-07
CO2021008047A2 (es) 2021-06-30
ZA202103379B (en) 2022-07-27
JP2022514942A (ja) 2022-02-16
AU2019412580A1 (en) 2021-06-17
US20220080033A1 (en) 2022-03-17
WO2020136666A1 (en) 2020-07-02
JP2024028905A (ja) 2024-03-05
BR112021011956A2 (pt) 2021-09-08
EP3867369A1 (en) 2021-08-25
MX2021007654A (es) 2021-09-21
CL2021001379A1 (es) 2022-01-14

Similar Documents

Publication Publication Date Title
EA201992074A1 (ru) Фармацевтическая композиция, содержащая селексипаг
CY1118676T1 (el) Βελτιωμενη συνθεση ανασυσταμενου επιφανειοδραστικου η οποια περιεχει αναλογα της επιφανειοδραστικης πρωτεϊνης β (sp-b) και της επιφανειοδραστικης πρωτεϊνης c (sp-c)
EA202190906A1 (ru) Рекомбинантное получение препаратов пептидов коллагена и их применение
SG11201807765PA (en) Antibody-containing preparation
EA201591276A1 (ru) Фармацевтическая композиция с улучшенной биодоступностью
EA201991798A1 (ru) Стабильные при хранении составы
EA202090500A1 (ru) Кристаллические формы иммуномодуляторов
CU20200045A7 (es) Derivados de indol-2-carboxamidas sustituidos con pirazolo-piperidina activos contra el virus de la hepatitis b (vhb)
EA202090536A1 (ru) Кристаллические формы 3-замещенного 1,2,4-оксадиазола
EA202190960A1 (ru) Конденсированные пирролины, которые действуют как ингибиторы убиквитин-специфической протеазы 30 (usp30)
EA201991701A1 (ru) Состав на основе моноклонального антитела к rsv
RU2013105700A (ru) Твердые формы ромидепсина и их применение
EA201500783A1 (ru) Способы получения дикетопиперазинов и соединений, содержащих дикетопиперазины
MX2020007945A (es) Proteinas f del rsv estabilizadas y usos de las mismas.
EA202092569A1 (ru) Модифицированные фитазы
EA202192925A1 (ru) Твердые формы ингибитора glyt1
EA202092464A1 (ru) Способы получения стабильных композиций на основе белков
EA201990998A1 (ru) Фармацевтические составы и способы их получения
MX2020009935A (es) Formulaciones acuosas y estables de anticuerpos anti-tau.
MX2021012939A (es) Formulaciones de factor ix liofilizadas.
EA201891905A1 (ru) Стабильная жидкая композиция гонадотропина
CU20210038A7 (es) Compuestos derivados sustituidos de 6,7-dihidro- 4h-pirazolo pirazinindol-2' carboxamidas activas contra el virus de la hepatitis b (vhb)
EA202191646A1 (ru) Лиофилизированная композиция пегаспаргазы
EA201892020A1 (ru) Индольные производные и их применение в качестве ингибиторов протеинкиназы
EA202090164A1 (ru) Изотретиноиновые перорально-слизистые композиции и способы их применения