Solution of N-o-(p-pivaloyloxybenzenesulfonylamino)benzoyl glycine monosodium salt tetra-hydrate and drug product thereof

摘要

A solution of N-o-(p-pivaloyloxybenzenesulfonylamino)benzoylglycine 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.