Solution of N-[o-(p-pivaloyloxybenzenesulfonylamino)benzoyl] glycine monosodium salt tetra-hydrate and drug product thereof
AssigneeOno Pharmaceutical Co., Ltd.
InventorsAkira Takada, Masao Sudoh
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Abstract
A solution of N-[o-(p-pivaloyloxybenzenesulfonylamino)benzoyl]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.
Claims15
A freeze-dried product prepared using a solution, said solution comprising N-[o-(p-pivaloyloxybenzenesulfonylamino)benzoyl]glycine monosodium salt tetra-hydrate of formula (I)
- and at least one pH adjuster selected from tri-sodium phosphate, a hydrate thereof, sodium hydroxide or potassium hydroxide, wherein the pH of the solution is 7.0-9.0.
Dependencies are inferred from the claim text.