AR081679A1 - Metodos y composiciones para la administracion intratecal de heparan n-sulfatasa, envase - Google Patents
Metodos y composiciones para la administracion intratecal de heparan n-sulfatasa, envaseInfo
- Publication number
- AR081679A1 AR081679A1 ARP110102243A ARP110102243A AR081679A1 AR 081679 A1 AR081679 A1 AR 081679A1 AR P110102243 A ARP110102243 A AR P110102243A AR P110102243 A ARP110102243 A AR P110102243A AR 081679 A1 AR081679 A1 AR 081679A1
- Authority
- AR
- Argentina
- Prior art keywords
- stable formulation
- formulation according
- heparan
- sulfatasa
- pack
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title abstract 9
- 229920002971 Heparan sulfate Polymers 0.000 title 1
- 238000009472 formulation Methods 0.000 abstract 8
- 108010089932 heparan sulfate sulfatase Proteins 0.000 abstract 3
- 239000006172 buffering agent Substances 0.000 abstract 2
- 229920000136 polysorbate Polymers 0.000 abstract 2
- 229950008882 polysorbate Drugs 0.000 abstract 2
- 150000003839 salts Chemical class 0.000 abstract 2
- 239000003381 stabilizer Substances 0.000 abstract 2
- 239000004094 surface-active agent Substances 0.000 abstract 2
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 abstract 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 abstract 1
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 abstract 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 abstract 1
- 229930195725 Mannitol Natural products 0.000 abstract 1
- 229910019142 PO4 Inorganic materials 0.000 abstract 1
- 229920001030 Polyethylene Glycol 4000 Polymers 0.000 abstract 1
- 229920001213 Polysorbate 20 Polymers 0.000 abstract 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 abstract 1
- 229930006000 Sucrose Natural products 0.000 abstract 1
- 125000003275 alpha amino acid group Chemical group 0.000 abstract 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 abstract 1
- 239000008103 glucose Substances 0.000 abstract 1
- 238000007913 intrathecal administration Methods 0.000 abstract 1
- 239000000594 mannitol Substances 0.000 abstract 1
- 235000010355 mannitol Nutrition 0.000 abstract 1
- 239000010452 phosphate Substances 0.000 abstract 1
- 125000002467 phosphate group Chemical group [H]OP(=O)(O[H])O[*] 0.000 abstract 1
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 abstract 1
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 abstract 1
- 229940068977 polysorbate 20 Drugs 0.000 abstract 1
- 108090000623 proteins and genes Proteins 0.000 abstract 1
- 102000004169 proteins and genes Human genes 0.000 abstract 1
- 239000000600 sorbitol Substances 0.000 abstract 1
- 239000005720 sucrose Substances 0.000 abstract 1
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- 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
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Abstract
Reivindicación 1: Una formulación estable para la administración intratecal que comprende una proteína heparan N-sulfatasa (HNS), sal, un agente buffer y un tensioactivo de polisorbato.Reivindicación 6: La formulación estable de acuerdo con cualquiera de las reivindicaciones precedentes, en la cual la proteína HNS comprende una secuencia de aminoácidos de SEC ID Nº 1. Reivindicación 7: La formulación estable de acuerdo con cualquiera de las reivindicaciones precedentes, en la cual la sal es NaCI. Reivindicación 12: La formulación estable de acuerdo con la reivindicación 11, en la cual el tensioactivo de polisorbato es polisorbato 20. Reivindicación 15: La formulación estable de acuerdo con cualquiera de las reivindicaciones precedentes, en la cual el agente buffer es fosfato. Reivindicación 21: La formulación estable de acuerdo con cualquiera de las reivindicaciones precedentes, en la cual la formulación comprende además un agente estabilizador. Reivindicación 22: La formulación estable de acuerdo con la reivindicación 21, en la cual el agente estabilizador es seleccionado del grupo que consiste en sacarosa, glucosa, manitol, sorbitol, PEG 4000 y combinaciones de estos.
Applications Claiming Priority (7)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US35885710P | 2010-06-25 | 2010-06-25 | |
US36078610P | 2010-07-01 | 2010-07-01 | |
US38786210P | 2010-09-29 | 2010-09-29 | |
US201161435710P | 2011-01-24 | 2011-01-24 | |
US201161442115P | 2011-02-11 | 2011-02-11 | |
US201161476210P | 2011-04-15 | 2011-04-15 | |
US201161495268P | 2011-06-09 | 2011-06-09 |
Publications (1)
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