Ono Pharmaceutical Co., Ltd.

Ono Pharmaceuticals Co., Ltd.

Akira Takada

Masao Sudo

Masao Sudoh

A method for the preparation of a freeze-dried product of N-[o-(p-pivaloyloxybenzenesulfonylamino)benzoyl]glycine monosodium salt tetra-hydrate dissolved in a mixed solvent of water and ethanol, and the freeze-dried product obtained by the method. According to the present invention, N-[o-(p-pivaloyloxybenzenesulfonylamino)benzoyl]glycine monosodium salt tetra-hydrate is dissolved in a small amount of a mixed solvent of water and ethanol, and therefore it is possible to manufacture high-dosage product by freeze-drying.

Freeze-dried product of N-[o-(p-pivaloyloxy benzenesulfonylamino)benzoyl]glycine monosodium salt tetra-hydrate and a process for the manufacture thereof

Freeze-dried preparation of n[o-(p-pivaloyloxybenzenasulfonylamino) benzoyl] glycine monosodium salt tetrahydrate and process for producing same

A solution of N-&lsqb;o-(p-pivaloyloxybenzenesulfonylamino)benzoyl&rsqb;glycine monosodium salt tetra-hydrate (I) comprising at least one pH adjuster selected from tri-sodium phosphate, a hydrate thereof, sodium hydroxide or potassium hydroxide and a drug product using the solution. According to the invention, the solubility of the compound (I) increases and thereby it is possible to provide a solution thereof and a drug product using it. Moreover, by using a mixture of water and an organic solvent, greatly improved solubility makes it possible to manufacture a solution of higher concentration of the compound (I), and high-dosage drug products using it.

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Mishima-gun, Japan

Akira Takada