Method for the long term stabilization of labile compounds at room temperature in pharmaceutical preparations containing water

摘要

A stabilized pharmaceutical composition that comprises a pharmaceutical compound that is labile to degradation in the presence of water is disclosed. That composition contains water, an effective amount of labile pharmaceutical compound and a degradation-inhibiting amount of a C₄-C₁₂ polyol that is substantially free of aldehyde or ketone carbonyl groups. The composition exhibits no more than 10 percent degradation of the labile pharmaceutical compound over a period of storage of at least 12 months when stored at ambient room temperature. A method of making the stabilized composition is also disclosed.