Process of preparing active pharmaceutical ingredient salts

摘要

The invention relates to a process of preparing a salt of an active pharmaceutical ingredient, the process comprising providing a blend of an active pharmaceutical ingredient and a salt forming substance, mixing the blend, optionally in the presence of added water, to react the active pharmaceutical ingredient with the salt forming substance to provide the salt of the active pharmaceutical ingredient; wherein when the active pharmaceutical ingredient is acidic, the salt forming substance is a base and the pKa difference between the acidic active pharmaceutical ingredient and the base is greater than 1, typically greater than 2 or preferably greater than 3; or when the active pharmaceutical ingredient is basic, the salt forming substance is an acid and the pKa difference between the basic active pharmaceutical ingredient and the acid is greater than 1, typically greater than 2 or preferably greater than 3,