HRP20212027T1 - Formulacije polialkilen oksidne asparaginaze i postupci njihove priprave i uporabe - Google Patents
Formulacije polialkilen oksidne asparaginaze i postupci njihove priprave i uporabe Download PDFInfo
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- HRP20212027T1 HRP20212027T1 HRP20212027TT HRP20212027T HRP20212027T1 HR P20212027 T1 HRP20212027 T1 HR P20212027T1 HR P20212027T T HRP20212027T T HR P20212027TT HR P20212027 T HRP20212027 T HR P20212027T HR P20212027 T1 HRP20212027 T1 HR P20212027T1
- Authority
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- Croatia
- Prior art keywords
- preparation
- polyalkylene oxide
- asparaginase
- optionally
- mass
- Prior art date
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- 229960003272 asparaginase Drugs 0.000 title claims 10
- 238000000034 method Methods 0.000 title claims 5
- 239000000203 mixture Substances 0.000 title claims 5
- 238000009472 formulation Methods 0.000 title 1
- 229920001281 polyalkylene Polymers 0.000 title 1
- 238000002360 preparation method Methods 0.000 claims 25
- 229920000233 poly(alkylene oxides) Polymers 0.000 claims 10
- 102000015790 Asparaginase Human genes 0.000 claims 9
- 108010024976 Asparaginase Proteins 0.000 claims 9
- DCXYFEDJOCDNAF-UHFFFAOYSA-M asparaginate Chemical compound [O-]C(=O)C(N)CC(N)=O DCXYFEDJOCDNAF-UHFFFAOYSA-M 0.000 claims 9
- 150000003839 salts Chemical class 0.000 claims 5
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical group [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 4
- 229940061607 dibasic sodium phosphate Drugs 0.000 claims 4
- BNIILDVGGAEEIG-UHFFFAOYSA-L disodium hydrogen phosphate Chemical compound [Na+].[Na+].OP([O-])([O-])=O BNIILDVGGAEEIG-UHFFFAOYSA-L 0.000 claims 4
- 229940045641 monobasic sodium phosphate Drugs 0.000 claims 4
- 229910000403 monosodium phosphate Inorganic materials 0.000 claims 4
- 235000019799 monosodium phosphate Nutrition 0.000 claims 4
- AJPJDKMHJJGVTQ-UHFFFAOYSA-M sodium dihydrogen phosphate Chemical compound [Na+].OP(O)([O-])=O AJPJDKMHJJGVTQ-UHFFFAOYSA-M 0.000 claims 4
- 239000002202 Polyethylene glycol Substances 0.000 claims 3
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims 3
- 239000012141 concentrate Substances 0.000 claims 3
- 125000003827 glycol group Chemical group 0.000 claims 3
- 229920001223 polyethylene glycol Polymers 0.000 claims 3
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims 2
- TWRXJAOTZQYOKJ-UHFFFAOYSA-L Magnesium chloride Chemical compound [Mg+2].[Cl-].[Cl-] TWRXJAOTZQYOKJ-UHFFFAOYSA-L 0.000 claims 2
- 206010028980 Neoplasm Diseases 0.000 claims 2
- WCUXLLCKKVVCTQ-UHFFFAOYSA-M Potassium chloride Chemical compound [Cl-].[K+] WCUXLLCKKVVCTQ-UHFFFAOYSA-M 0.000 claims 2
- 229930006000 Sucrose Natural products 0.000 claims 2
- 201000011510 cancer Diseases 0.000 claims 2
- 238000004108 freeze drying Methods 0.000 claims 2
- 230000006698 induction Effects 0.000 claims 2
- 208000032839 leukemia Diseases 0.000 claims 2
- 238000012423 maintenance Methods 0.000 claims 2
- 230000001613 neoplastic effect Effects 0.000 claims 2
- 239000011780 sodium chloride Substances 0.000 claims 2
- 239000005720 sucrose Substances 0.000 claims 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 2
- 239000008215 water for injection Substances 0.000 claims 2
- HDTRYLNUVZCQOY-UHFFFAOYSA-N α-D-glucopyranosyl-α-D-glucopyranoside Natural products OC1C(O)C(O)C(CO)OC1OC1C(O)C(O)C(O)C(CO)O1 HDTRYLNUVZCQOY-UHFFFAOYSA-N 0.000 claims 1
- OWEGMIWEEQEYGQ-UHFFFAOYSA-N 100676-05-9 Natural products OC1C(O)C(O)C(CO)OC1OCC1C(O)C(O)C(O)C(OC2C(OC(O)C(O)C2O)CO)O1 OWEGMIWEEQEYGQ-UHFFFAOYSA-N 0.000 claims 1
- MSWZFWKMSRAUBD-IVMDWMLBSA-N 2-amino-2-deoxy-D-glucopyranose Chemical compound N[C@H]1C(O)O[C@H](CO)[C@@H](O)[C@@H]1O MSWZFWKMSRAUBD-IVMDWMLBSA-N 0.000 claims 1
- 208000024893 Acute lymphoblastic leukemia Diseases 0.000 claims 1
- 208000031261 Acute myeloid leukaemia Diseases 0.000 claims 1
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 claims 1
- UXVMQQNJUSDDNG-UHFFFAOYSA-L Calcium chloride Chemical compound [Cl-].[Cl-].[Ca+2] UXVMQQNJUSDDNG-UHFFFAOYSA-L 0.000 claims 1
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims 1
- 229930091371 Fructose Natural products 0.000 claims 1
- 239000005715 Fructose Substances 0.000 claims 1
- RFSUNEUAIZKAJO-ARQDHWQXSA-N Fructose Chemical compound OC[C@H]1O[C@](O)(CO)[C@@H](O)[C@@H]1O RFSUNEUAIZKAJO-ARQDHWQXSA-N 0.000 claims 1
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims 1
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims 1
- GUBGYTABKSRVRQ-PICCSMPSSA-N Maltose Natural products O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@@H](CO)OC(O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-PICCSMPSSA-N 0.000 claims 1
- 229930195725 Mannitol Natural products 0.000 claims 1
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims 1
- 208000002463 Sveinsson chorioretinal atrophy Diseases 0.000 claims 1
- HDTRYLNUVZCQOY-WSWWMNSNSA-N Trehalose Natural products O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-WSWWMNSNSA-N 0.000 claims 1
- HDTRYLNUVZCQOY-LIZSDCNHSA-N alpha,alpha-trehalose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-LIZSDCNHSA-N 0.000 claims 1
- WQZGKKKJIJFFOK-PHYPRBDBSA-N alpha-D-galactose Chemical compound OC[C@H]1O[C@H](O)[C@H](O)[C@@H](O)[C@H]1O WQZGKKKJIJFFOK-PHYPRBDBSA-N 0.000 claims 1
- MSWZFWKMSRAUBD-UHFFFAOYSA-N beta-D-galactosamine Natural products NC1C(O)OC(CO)C(O)C1O MSWZFWKMSRAUBD-UHFFFAOYSA-N 0.000 claims 1
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 claims 1
- GUBGYTABKSRVRQ-QUYVBRFLSA-N beta-maltose Chemical compound OC[C@H]1O[C@H](O[C@H]2[C@H](O)[C@@H](O)[C@H](O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@@H]1O GUBGYTABKSRVRQ-QUYVBRFLSA-N 0.000 claims 1
- 239000001110 calcium chloride Substances 0.000 claims 1
- 229910001628 calcium chloride Inorganic materials 0.000 claims 1
- 238000007596 consolidation process Methods 0.000 claims 1
- 150000002016 disaccharides Chemical class 0.000 claims 1
- 229930182830 galactose Natural products 0.000 claims 1
- 239000011521 glass Substances 0.000 claims 1
- 229960002442 glucosamine Drugs 0.000 claims 1
- 239000008103 glucose Substances 0.000 claims 1
- 150000004676 glycans Chemical class 0.000 claims 1
- 239000008101 lactose Substances 0.000 claims 1
- 229910001629 magnesium chloride Inorganic materials 0.000 claims 1
- 239000000594 mannitol Substances 0.000 claims 1
- 235000010355 mannitol Nutrition 0.000 claims 1
- 150000002772 monosaccharides Chemical group 0.000 claims 1
- 229920001282 polysaccharide Polymers 0.000 claims 1
- 239000005017 polysaccharide Substances 0.000 claims 1
- 239000001103 potassium chloride Substances 0.000 claims 1
- 235000011164 potassium chloride Nutrition 0.000 claims 1
- 125000000185 sucrose group Chemical group 0.000 claims 1
- ODLHGICHYURWBS-LKONHMLTSA-N trappsol cyclo Chemical compound CC(O)COC[C@H]([C@H]([C@@H]([C@H]1O)O)O[C@H]2O[C@@H]([C@@H](O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O3)[C@H](O)[C@H]2O)COCC(O)C)O[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@@H]3O[C@@H]1COCC(C)O ODLHGICHYURWBS-LKONHMLTSA-N 0.000 claims 1
- 238000011282 treatment Methods 0.000 claims 1
- 238000011269 treatment regimen Methods 0.000 claims 1
- JOYRKODLDBILNP-UHFFFAOYSA-N urethane group Chemical group NC(=O)OCC JOYRKODLDBILNP-UHFFFAOYSA-N 0.000 claims 1
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- 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
- A61K38/43—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
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- A—HUMAN NECESSITIES
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- 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
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- 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
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- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/40—Cyclodextrins; Derivatives thereof
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- 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
- A61K47/54—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 compound
- A61K47/542—Carboxylic acids, e.g. a fatty acid or an amino acid
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- 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
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- 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
- A61K47/69—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 conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
- A61K47/6921—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 conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit the form being a particulate, a powder, an adsorbate, a bead or a sphere
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- 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
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
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- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
- A61P35/02—Antineoplastic agents specific for leukemia
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
- A61P35/04—Antineoplastic agents specific for metastasis
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- 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)
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
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- C12N9/96—Stabilising an enzyme by forming an adduct or a composition; Forming enzyme conjugates
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- 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)
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- 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
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- Gastroenterology & Hepatology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
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Claims (16)
1. Rekonstituirani liofilizirani pripravak, naznačen time, da sadrži:
polialkilen oksidnu asparaginazu u koncentraciji od 100 do 5000 IU po ml navedenog pripravka;
dibazični natrijev fosfat u koncentraciji od 0,1 do 0,8% po masi;
monobazični natrijev fosfat u koncentraciji od 0,01 do 0,5% po masi;
sol u koncentraciji od 0,05 do 1% po masi; i
šećer u koncentraciji od 0,1 do 25% po masi,
pri čemu polialkilen oksidna asparaginaza sadrži asparaginazu kovalentno vezanu s polialkilen oksidnom skupinom.
2. Pripravak prema patentnom zahtjevu 1, naznačen time, da:
a. koncentracija dibazičnog natrijevog fosfata iznosi od 0,1 do 0,5% po masi ili 0,2 do 0,3% po masi; i
b. koncentracija monobazičnog natrijevog fosfata iznosi od 0,01 do 0,1% po masi ili 0,05 do 0,07% po masi.
3. Pripravak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da koncentracija šećera iznosi od 0,5 do 20% po masi, od 1 do 10% po masi ili od 4 do 5% po masi.
4. Pripravak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da sol je natrijev klorid, kalijev klorid, kalcijev klorid, magnezijev klorid, ili njihova kombinacija, s time da je sol opcionalno natrijev klorid.
5. Pripravak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da šećer je monosaharid, disaharid ili polisaharid; s time da je šećer opcionalnosaharoza, manitol, maltoza, trehaloza, 2-hidroksipropil-beta-ciklodekstrin (β-HPCD), laktoza, glukoza, fruktoza, galaktoza, glukozamin, ili njihove kombinacije, te nadalje opcionalno, šećer je saharoza.
6. Pripravak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da koncentracija polialkilen oksidne asparaginaze iznosi:
a. 500 do 1000 IU po ml navedenog pripravka;
b. 700 do 800 IU po ml navedenog pripravka; ili
c. 750 IU po ml navedenog pripravka.
7. Pripravak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da polialkilen oksidna skupina sadrži polietilen glikolnu skupinu, pri čemu opcionalno:
a. polietilen glikolna skupina ima molekularnu masu u rasponu od 2000 do 10000 daltona; ili
b. polietilen glikolna skupina ima molekularnu masu od 5000 daltona.
8. Pripravak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da je veznik uretanski ili sukcinatni veznik.
9. Pripravak prema bilo kojem od patentnih zahtjeva 1 do 8, naznačen time, da pripravak nadalje sadrži natrijev hidroksid ili klorovodičnu kiselinu.
10. Liofilizirani pripravak stabilan za pohranu, naznačen time, da sadrži:
polialkilen oksidnu asparaginazu;
pufer koji sadrži dibazični natrijev fosfat i monobazični natrijev fosfat;
sol; i
šećer,
pri čemu je liofilizirani pripravak stabilan za pohranu sposoban za formiranje pripravka prema bilo kojem od patentnih zahtjeva 1 do 9 rekonstituiranjem liofiliziranog pripravka stabilnog za pohranus vodom za injekciju (WFI).
11. Postupak za pripravu liofiliziranog pripravka poliakilen oksidne asparaginaze, naznačen time, da postupak obuhvaća liofilizaciju vodenog koncentrata pripravka koji sadrži:
(i) polialkilen oksidnu asparaginazu koja sadrži polialkilen oksidnu skupinu kovalentno vezanu s asparaginazom pomoću veznika;
(ii) pufer koji sadrži dibazični natrijev fosfat i monobazični natrijev fosfat;
(iii) sol; i
(iv) šećer,
na način koji je dostatan kako bi se proizveo liofilizirani pripravak stabilan za pohranu polialkilen oksidne asparaginaze u skladu s patentnim zahtjevom 10,
dok opcionalno pritom postupak nadalje obuhvaća uvođenje vodenog koncentrata pripravka u spremnik za jediničnu dozu i liofilizaciju vodenog koncentrata pripravka u spremniku za jediničnu dozu, pri čemu opcionalno, spremnik za jediničnu dozu je fijala, kao što je zabrtvljena staklena fijala.
12. Pripravak prema bilo kojem od patentnih zahtjeva 1 do 10, naznačen time, da je za uporabu u postupku liječenja pojedinca od neoplastičnog stanja.
13. Pripravak za uporabu prema patentnom zahtjevu 12, naznačen time, da neoplastično stanje je rak, dok je rak opcionalno leukemija, a opcionalno leukemija je:
(i) akutna limfoblastična leukemija (ALL), ili
(ii) akutna mijeloična leukemija (AML).
14. Pripravak za uporabu prema patentnom zahtjevu 12 ili zahtjevu 13, naznačen time, da se pojedincu određuje režim liječenja koji uključuje indukcijsku fazu, fazu konsolidacije i fazu održavanja,
gdje opcionalno postupak obuhvaća davanje jednostruke jedinice za doziranje pojedincu u indukcijskoj fazi i višestrukih jedinica za doziranje za vrijeme faze održavanja,
te nadalje opcionalno pritom se višestruke jedinice za doziranje daju pojedincu putem primjene jedinice za doziranje kod pojedinca svaka tri tjedna ili svaka dva tjedna.
15. Pripravak za uporabu prema bilo kojem od patentnih zahtjeva 12 do 14, naznačen time, da:
a. pojedinac je maloljetna osoba; ili
b. pojedinac je odrasla osoba.
16. Komplet, naznačen time, da sadrži jedan ili više spremnika za jedinično doziranje, od kojih svaki sadrži liofilizirani pripravak stabilan za pohranu u skladu s patentnim zahtjevom 10.
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US201662344249P | 2016-06-01 | 2016-06-01 | |
US201662344252P | 2016-06-01 | 2016-06-01 | |
US201662344256P | 2016-06-01 | 2016-06-01 | |
EP17831465.4A EP3463308B1 (en) | 2016-06-01 | 2017-06-01 | Formulations of polyalkylene oxide-asparaginase and methods of making and using the same |
PCT/US2017/035461 WO2018017190A2 (en) | 2016-06-01 | 2017-06-01 | Formulations of polyalkylene oxide-asparaginase and methods of making and using the same |
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US (2) | US20190240300A1 (hr) |
EP (2) | EP3463308B1 (hr) |
JP (2) | JP7109427B2 (hr) |
KR (3) | KR20230162139A (hr) |
CN (1) | CN109640961B (hr) |
AU (1) | AU2017299374B2 (hr) |
BR (1) | BR112018074823B1 (hr) |
CA (1) | CA3026070A1 (hr) |
CL (1) | CL2018003418A1 (hr) |
CO (1) | CO2018013753A2 (hr) |
CY (1) | CY1124980T1 (hr) |
DK (1) | DK3463308T3 (hr) |
ES (1) | ES2905874T3 (hr) |
HR (1) | HRP20212027T1 (hr) |
HU (1) | HUE057856T2 (hr) |
IL (1) | IL263349B1 (hr) |
LT (1) | LT3463308T (hr) |
MX (2) | MX2018014916A (hr) |
MY (1) | MY198474A (hr) |
PH (1) | PH12018502540A1 (hr) |
PL (1) | PL3463308T3 (hr) |
PT (1) | PT3463308T (hr) |
RS (1) | RS62979B1 (hr) |
RU (1) | RU2758796C2 (hr) |
SG (1) | SG11201810685WA (hr) |
SI (1) | SI3463308T1 (hr) |
UA (1) | UA123020C2 (hr) |
WO (1) | WO2018017190A2 (hr) |
ZA (2) | ZA201807943B (hr) |
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KR20230165799A (ko) * | 2021-04-06 | 2023-12-05 | 재즈 파마슈티칼즈 아일랜드 리미티드 | L-아스파라기나제의 제제 |
CN114392237B (zh) * | 2021-12-28 | 2024-02-02 | 上海允英生物医药科技有限公司 | 一种冻干病毒制剂及其制备方法 |
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