STABLE FORMULATIONS OF THIADIAZOLE DERIVATIVE

摘要

The disclosure relates to a pharmaceutical composition comprising N-{ 4-(2,2-dimethyl-propiony1)-(5R)-5-[(2-ethylamino-ethanesulfonylamino)-methyl]-5-phenyl-4,5-dihydro-[1,3 ,4]thiadiazol-2-yl} -2,2-dimethyl-propionamide, a buffer and/or salt selected from tartrate, phosphate, citrate, mesylate, sodium phosphate, and sodium sulfate, and a pharmaceutically acceptable carrier, diluent, or excipient in aqueous solution wherein the pH of said composition is less than 5.4 and greater than 2.0 and contains no more than 2.0% N{ 4-(2,2-dimethyl-propiony1)-(5S)-5-[(2-ethylamino-ethanesulfonylamino)-methyl]-5-phenyl-4,5-dihydro-[1,3,4]thiadiazol-2-yl} -2,2-dimethyl-propionamide and is stable to chiral conversion.