Form C obeticolico Crystalline acid; Preparation Process of Form 1 obeticolico acid from the Crystalline Form C; Pharmaceutical composition comprising a Crystalline form of obeticolico acid, useful for the Treatment or prevention of cholestatic liver disease, HEP Atopatia alcoholic and cardiovascular diseases such as atherosclerosis, among others.
The present invention relates to obeticholic acid: or a pharmaceutically acceptable salt, solvate or amino acid conjugate thereof. Obeticholic acid is useful for the treatment or prevention of a FXR mediated disease or condition, cardiovascular disease or cholestatic liver disease, and for reducing HDL cholesterol, for lowering triglycerides in a mammal, or for inhibition of fibrosis. The present invention also relates to processes for the synthesis of obeticholic acid.Composición farmacéutica que comprende la forma 1 de ácido obeticólico que comprende menos que un 1% de ácido cenodesoxicólico y un vehículo farmacéuticamente aceptable; composición farmacéutica que comprende la forma 1 de ácido obeticólico que comprende uno o más compuestos y un vehículo farmacéuticamente aceptable.