CONTROLLED-RELEASE PHARMACEUTICAL COMPOSITION INCLUDING TAMSULOSIN OR THE PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, AND ORAL PREPARATION INCLUDING SAME

摘要

The present invention relates to a controlled-release pharmaceutical composition including tamsulosin or the pharmaceutically acceptable salts thereof as an active ingredient, and to an oral preparation including same, and more particularly, to a pharmaceutical composition comprising a core that includes tamsulosin or the pharmaceutically acceptable salts thereof, a controlled-release polymer coating layer formed on the core, and a plurality of microspheres including an enteric polymer outer layer formed on the controlled-release polymer coating layer, wherein the controlled-release polymer coating layer has a first and second group of microspheres, the average thicknesses of which are different; and to an oral preparation including same. The controlled-release pharmaceutical composition according to the present invention may increase the therapeutic effects for patients when orally administered, as the degree of release of the active ingredient according to pH changes in the digestive tract and the control of the release pattern of the active ingredient in the small intestine are facilitated, the effective plasma concentration of the active ingredient may be maintained for a certain period of time, and the bitter taste may be suppressed for a certain period of time even though the composition is exposed to the oral cavity.