SOLID PHARMACEUTICAL COMPOSITION FOR THE ORAL ADMINISTRATION OF IBANDRONAIC ACID OR SALTS OR A PHARMACEUTICALLY ACCEPTABLE HYDRATE THEREOF, PROCESS FOR THE PREPARATION OF SAID COMPOSITION BY DIRECT COMPRESSION, PHARMACEUTICAL FORMULATIONS CONTAINING

摘要

The present invention refers to a solid pharmaceutical composition in a unit dose form for the oral administration of ibandronaic acid that is obtained by a direct compression process, the composition including from about 30% to about 37% by weight of ibandronaic acid or a salt or a pharmaceutically acceptable hydrate thereof, at least a diluting agent in an amount ranging from about 55% to about 65% by weight, at least a disintegrating agent in an amount ranging from about 0.5% to 1.5% by weight, and at least a lubricating agent in an amount ranging from about 4.5% to about 5.5% by weight. The invention also comprises a direct compression process for the preparation of said compositions, as well as pharmaceutical coated formulations comprising said compositions and a process for the preparation of the aforementioned coated pharmaceutical formulations.