Crystalline hydrated dihydroxy open-acid simvastatin calcium salt

摘要

The instant invention provides crystalline hydrates of the calcium salt of dihydroxy open acid simvastatin which are useful for inhibiting HMG-CoA reductase, and for treating and/or reducing the risk for diseases and conditions affected by inhibition of HMG-CoA reductase. A process for making a specific crystalline hydrate of the calcium salt of dihydroxy open acid simvastatin is described. Conventional formulations, including rapid-release, time controlled-release and delayed-release formulations, of the active agents are also provided.