A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 31/198 (2006.01) A61K 9/19 (2006.01) A61P 11/00 (2006.01) A61P 43/00 (2006.01) A61K 9/14 (2006.01)
Patent
CA 2416600
A process for producing a freeze-dried preparation which comprises freeze- drying N-[o-(p-pivaloyloxybenzenesulfonylamino)benzoyl]glycine monosodium salt tetrahydrate dissolved in a mixed solvent comprising water and ethanol; and a freeze-dried preparation obtained by the process. By the process, a high-dose preparation can be produced through freeze-drying because N-[o-(p- pivaloyloxybenzenesulfonylamino)benzoyl]glycine monosodium salt tetrahydrate can be dissolved in a small amount of the mixed solvent comprising water and ethanol.
L'invention concerne un procédé permettant la production d'une préparation lyophilisée. Ce procédé consiste à lyophiliser du tétrahydrate monosodique de N-[o-(p-pivaloyloxybenzènesulfonylamino)benzoyl]glycine dissout dans un mélange de solvant comprenant de l'eau et de l'éthanol, ainsi qu'une préparation lyophilisée obtenue par ce procédé. Ce procédé permet de préparer par lyophilisation un produit présentant une forte concentration, en dissolvant du tétrahydrate monosodique de N-[o-(p-pivaloyloxybenzènesulfonylamino)benzoyl]glycine dans une faible quantité de mélange de solvant composé d'eau et d'éthanol.
Sudo Masao
Takada Akira
Ono Pharmaceutical Co. Ltd.
Riches Mckenzie & Herbert Llp
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