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1. WO2020136666 - A LYOPHILIZED COMPOSITION OF PEGASPARGASE

Publication Number WO/2020/136666
Publication Date 02.07.2020
International Application No. PCT/IN2019/050402
International Filing Date 20.05.2019
IPC
C12N 9/82 2006.01
CCHEMISTRY; METALLURGY
12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
9Enzymes, e.g. ligases (6.); Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating, or purifying enzymes
14Hydrolases (3.)
78acting on carbon to nitrogen bonds other than peptide bonds (3.5)
80acting on amide bonds in linear amides
82Asparaginase
A61K 47/60 2017.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
50the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
51the non-active ingredient being a modifying agent
56the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
59obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
60the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
A61K 38/50 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
38Medicinal preparations containing peptides
16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
43Enzymes; Proenzymes; Derivatives thereof
46Hydrolases (3)
50acting on carbon-nitrogen bonds, other than peptide bonds (3.5), e.g. asparaginase
A61K 31/00 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
CPC
A61K 38/50
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
38Medicinal preparations containing peptides
16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
43Enzymes; Proenzymes; Derivatives thereof
46Hydrolases (3)
50acting on carbon-nitrogen bonds, other than peptide bonds (3.5), e.g. asparaginase
A61K 47/60
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
50the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
51the non-active ingredient being a modifying agent
56the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
59obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
60the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
A61K 9/19
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
14Particulate form, e.g. powders, ; Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
19lyophilised ; , i.e. freeze-dried, solutions or dispersions
C12N 9/82
CCHEMISTRY; METALLURGY
12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
9Enzymes; Proenzymes; Compositions thereof
14Hydrolases (3)
78acting on carbon to nitrogen bonds other than peptide bonds (3.5)
80acting on amide bonds in linear amides ; (3.5.1)
82Asparaginase ; (3.5.1.1)
C12Y 305/01001
CCHEMISTRY; METALLURGY
12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
YENZYMES
305Hydrolases acting on carbon-nitrogen bonds, other than peptide bonds (3.5)
01in linear amides (3.5.1)
01001Asparaginase (3.5.1.1)
Applicants
  • GENNOVA BIOPHARMACEUTICALS LIMITED [IN]/[IN]
Inventors
  • MUKHERJEE, Tathagata
  • AGARWAL, Praveen Kumar
  • SINGH, Sanjay
Agents
  • ARVIND, Chitra
Priority Data
20182104885924.12.2018IN
Publication Language English (EN)
Filing Language English (EN)
Designated States
Title
(EN) A LYOPHILIZED COMPOSITION OF PEGASPARGASE
(FR) COMPOSITION LYOPHILISÉE DE PEGASPARGASE
Abstract
(EN)
The present invention relates to a novel, economically viable, storage stable, lyophilized composition of pegaspargase. The composition comprises pegaspargase, a cryoprotectant, a bulking agent, a buffer and may optionally contain other pharmaceutically acceptable excipients including but not limited to a salt. The composition of the present invention is stable for extended periods over significant range of temperatures, without the presence of any significant amount of impurities. The present invention also relates to an economically viable and scalable lyophilization process for the production of the storage stable composition of pegaspargase.
(FR)
La présente invention concerne une nouvelle composition lyophilisée de pegaspargase stable au stockage et viable économiquement. La composition comprend de la pegaspargase, un cryoprotecteur, un agent de charge, un tampon et peut éventuellement contenir d'autres excipients pharmaceutiquement acceptables comprenant, mais sans y être limités, un sel. La composition de la présente invention est stable pendant des périodes prolongées sur une grande plage de températures, sans la présence d'une quantité significative d'impuretés. La présente invention concerne également un procédé de lyophilisation économiquement viable et évolutif pour la production de la composition de pegaspargase stable au stockage.
Also published as
Latest bibliographic data on file with the International Bureau