Solid pharmaceutical fixed dose compositions comprising irbesartan and amlodipine, their preparation and their therapeutic application

A stable solid oral pharmaceutical fixed dose composition in the form of a monolayer tablet comprising irbesartan, amlodipine besilate and pharmaceutically acceptable excipients, wherein the irbesartan is present as coated granules embedded in an extragranular matrix comprising amlodipine besilate, wherein the amlodipine besilate is not in granular form, and wherein the composition has less than 1.50% (w/w) of total impurities for amlodipine and less than 0.50% (w/w) of total impurities for irbesartan after 6 months at 40° C./75% relative humidity.