PHARMACEUTICAL CONTROLLED RELEASE BEADS COMPRISING FUROSEMIDE AND A FORMULATION CONTAINING SAID CONTROLLED RELEASE BEADS

摘要

The present invention relates to controlled release beads comprising a core of an insoluble or soluble inert material provided with a layer of furosemide dispersed in a hydrophilic polymer and a specific outer membrane for controlled release of the furosemide whereby the membrane comprises 1) a film former selected from ethyl cellulose and copolymerisates of acrylic and methacrylic acid esters and 2) at least one hydrophilic polymer selected from polyvinylpyrrolidone, hydroxypropyl cellulose and polyalkylene glycols; in that the amount of the outer membrane is between 35 and 65 % (w/w) based on the dry layered core; and in that the release profile of furosemide is not more than 30 % after 60 minutes, not more than 44 % after 120 minutes and more than 80 % after 360 minutes. The present invention also refers to a process for the preparation of said controlled release beads, a pharmaceutical formulation comprising said beads and the use of said beads for treatment of cardiovascular diseases such as hypertension, congestive heart failure and oedema.