Stable solid preparations

摘要

It is intended to provide a process for producing unstable amorphous benzimidazole compounds having a proton pump inhibitor function, and stable solid preparations for medicinal use containing these compounds which are produced by blending such an amorphous benzimidazole compound with a nontoxic base such as a basic inorganic salt, forming an intermediate coating layer on the layer containing the active ingredient and further forming an enteric coating layer or a release-controlling coating layer.

主权项

1. A stable solid dosage form comprising a non-toxic base and an amorphous R-isomer of lansoprazole, or a salt thereof having a proton pump inhibitor (PPI) activity,
wherein the non-toxic base is at least one selected from the group consisting of basic inorganic salts and organic bases, wherein the amorphous R-isomer of lansoprazole or salt thereof, contains 60% or more of an amorphous form.