HRP20211660T1 - Postupci i pripravci za dostavu aril-sulfataze-a u središnji živčani sustav - Google Patents
Postupci i pripravci za dostavu aril-sulfataze-a u središnji živčani sustav Download PDFInfo
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- HRP20211660T1 HRP20211660T1 HRP20211660TT HRP20211660T HRP20211660T1 HR P20211660 T1 HRP20211660 T1 HR P20211660T1 HR P20211660T T HRP20211660T T HR P20211660TT HR P20211660 T HRP20211660 T HR P20211660T HR P20211660 T1 HRP20211660 T1 HR P20211660T1
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- Croatia
- Prior art keywords
- formulation
- buffer
- use according
- saline
- polysorbate
- Prior art date
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- 239000000203 mixture Substances 0.000 title claims 24
- 238000000034 method Methods 0.000 title claims 2
- 102100022146 Arylsulfatase A Human genes 0.000 title 1
- 108010036867 Cerebroside-Sulfatase Proteins 0.000 title 1
- 238000009472 formulation Methods 0.000 claims 23
- 239000000872 buffer Substances 0.000 claims 19
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 18
- 239000011780 sodium chloride Substances 0.000 claims 9
- 102000009133 Arylsulfatases Human genes 0.000 claims 5
- 108060007951 sulfatase Proteins 0.000 claims 5
- 229920001213 Polysorbate 20 Polymers 0.000 claims 4
- 238000007913 intrathecal administration Methods 0.000 claims 4
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 claims 4
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 claims 4
- 229940068977 polysorbate 20 Drugs 0.000 claims 4
- 239000012266 salt solution Substances 0.000 claims 4
- 229910019142 PO4 Inorganic materials 0.000 claims 3
- 238000001990 intravenous administration Methods 0.000 claims 3
- 239000010452 phosphate Substances 0.000 claims 3
- 229920001296 polysiloxane Polymers 0.000 claims 3
- 229920000136 polysorbate Polymers 0.000 claims 3
- 229950008882 polysorbate Drugs 0.000 claims 3
- 239000004094 surface-active agent Substances 0.000 claims 3
- 150000001413 amino acids Chemical group 0.000 claims 2
- 239000005388 borosilicate glass Substances 0.000 claims 2
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 claims 2
- 229940071643 prefilled syringe Drugs 0.000 claims 2
- QTBSBXVTEAMEQO-UHFFFAOYSA-M Acetate Chemical compound CC([O-])=O QTBSBXVTEAMEQO-UHFFFAOYSA-M 0.000 claims 1
- KRKNYBCHXYNGOX-UHFFFAOYSA-K Citrate Chemical compound [O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KRKNYBCHXYNGOX-UHFFFAOYSA-K 0.000 claims 1
- HNDVDQJCIGZPNO-YFKPBYRVSA-N L-histidine Chemical compound OC(=O)[C@@H](N)CC1=CN=CN1 HNDVDQJCIGZPNO-YFKPBYRVSA-N 0.000 claims 1
- 201000011442 Metachromatic leukodystrophy Diseases 0.000 claims 1
- 229920001219 Polysorbate 40 Polymers 0.000 claims 1
- 229920001214 Polysorbate 60 Polymers 0.000 claims 1
- 239000007983 Tris buffer Substances 0.000 claims 1
- 239000003708 ampul Substances 0.000 claims 1
- 239000006172 buffering agent Substances 0.000 claims 1
- 230000002490 cerebral effect Effects 0.000 claims 1
- 210000001175 cerebrospinal fluid Anatomy 0.000 claims 1
- 239000003795 chemical substances by application Substances 0.000 claims 1
- 210000004978 chinese hamster ovary cell Anatomy 0.000 claims 1
- 239000003085 diluting agent Substances 0.000 claims 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 1
- 239000002552 dosage form Substances 0.000 claims 1
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 claims 1
- 210000005260 human cell Anatomy 0.000 claims 1
- 238000002650 immunosuppressive therapy Methods 0.000 claims 1
- 238000007914 intraventricular administration Methods 0.000 claims 1
- 239000012931 lyophilized formulation Substances 0.000 claims 1
- 125000002467 phosphate group Chemical group [H]OP(=O)(O[H])O[*] 0.000 claims 1
- 239000000088 plastic resin Substances 0.000 claims 1
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims 1
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims 1
- 235000010483 polyoxyethylene sorbitan monopalmitate Nutrition 0.000 claims 1
- 239000000249 polyoxyethylene sorbitan monopalmitate Substances 0.000 claims 1
- 239000001818 polyoxyethylene sorbitan monostearate Substances 0.000 claims 1
- 235000010989 polyoxyethylene sorbitan monostearate Nutrition 0.000 claims 1
- 229940101027 polysorbate 40 Drugs 0.000 claims 1
- 229940113124 polysorbate 60 Drugs 0.000 claims 1
- 229920000053 polysorbate 80 Polymers 0.000 claims 1
- 229940068968 polysorbate 80 Drugs 0.000 claims 1
- 239000003381 stabilizer Substances 0.000 claims 1
- KDYFGRWQOYBRFD-UHFFFAOYSA-L succinate(2-) Chemical compound [O-]C(=O)CCC([O-])=O KDYFGRWQOYBRFD-UHFFFAOYSA-L 0.000 claims 1
- LENZDBCJOHFCAS-UHFFFAOYSA-N tris Chemical compound OCC(N)(CO)CO LENZDBCJOHFCAS-UHFFFAOYSA-N 0.000 claims 1
Classifications
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- A61K38/465—Hydrolases (3) acting on ester bonds (3.1), e.g. lipases, ribonucleases
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- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- C07K14/575—Hormones
- C07K14/65—Insulin-like growth factors, i.e. somatomedins, e.g. IGF-1, IGF-2
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- 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)
- C12N9/24—Hydrolases (3) acting on glycosyl compounds (3.2)
- C12N9/2402—Hydrolases (3) acting on glycosyl compounds (3.2) hydrolysing O- and S- glycosyl compounds (3.2.1)
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- C12N9/2437—Cellulases (3.2.1.4; 3.2.1.74; 3.2.1.91; 3.2.1.150)
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- C12Y301/06—Sulfuric ester hydrolases (3.1.6)
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- C12Y302/01045—Glucosylceramidase (3.2.1.45), i.e. beta-glucocerebrosidase
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- C12Y310/01001—N-Sulfoglucosamine sulfohydrolase (3.10.1.1)
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Applications Claiming Priority (8)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US35885710P | 2010-06-25 | 2010-06-25 | |
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