Pharmaceutical formulations containing a compound having an amidine group stabilized by an acid

摘要

A pharmaceutical composition comprising a tablet or capsule or other solid dosage form contains a pharmacologically effective amount of a compound of formula (I), or its salt, a pharmaceutically acceptable solid carrier, and a pharmaceutically acceptable acid in an amount to modify the pH of the composition to a pH of 4. A process of stabilizing the compound of formula (I) against hydrolysis, by adding water during formulation manufacture and contacting the compound during formulation manufacture with a pharmaceutically acceptable acid having a pH of 4 in a saturated aqueous solution is described.