Stable pharmaceutical composition in the form of tablet containing bisoprolol fumarate as active substance

摘要

The present invention relates to a stable pharmaceutical composition in the form of a tablet containing bisoprolol fumarate as active substance wherein the invented pharmaceutical composition is characterized in that it is comprised of a mixture of bisoprolol fumarate and at least 40 percent by weight, based on the tablet total weight, of a mixture of microcrystalline cellulose and lactose obtained by dry spraying and containing at 5 up to 80 percent by weight of microcrystalline cellulose, based on said dry sprayed mixture total weight and optionally at least one pharmaceutically acceptable adjuvant, molded into the tablet by direct molding process. The invention also relates to a process for preparing the above-indicated pharmaceutical composition wherein the preparation process is characterized by mixing bisoprolol fumarate with fraction of dry sprayed mixture of microcrystalline cellulose and lactose being added successively to the mixture being mixed whereupon the obtained mixture can be further mixed with at least one pharmaceutically acceptable adjuvant and optionally with the last fraction of the dry sprayed mixture of microcrystalline cellulose and lactose and the obtained mixture is then molded to form a tablet. So obtained tablet can be optionally coated with a coating restricting or eliminating penetration of atmosphere components into the tablet and enabling release of bisoprolol fumarate at the point of its absorption by an organism.