DOSAGE UNIT COMPRISING RAMIPRIL AND BISOPROLOL HEMIFUMARATE, PROCESS FOR THE PREPARATION THEREOF AND METHOD OF TREATING HYPERTENSION

摘要

The present invention relates to a dosage unit comprising ramipril or a pharmaceutically acceptable salt thereof and bisoprolol hemifumarate as active ingredients, wherein particles of said active ingredients are separated from each other in the dosage unit by that at least one of the two active ingredients is in form of granules or coated compacts, and wherein the dosage unit is in tablet or capsule form. The invention also relates to a process for the preparation of said dosage unit, a method of treating hypertension using the same and to the use of bisoprolol hemifumarate and ramipril or salts thereof for the preparation of said dosage unit. The invention allows to obtain a dosage unit comprising ramipril and bisoprolol hemifumarate as active ingredients, characterised with the stability of the active ingredients, the bioavailability similar to that measured in case of simultaneous administration of two corresponding mono compositions and the dissolution profile which does not change during storage.