PROCESS OF PREPARING A SOLID ORAL MODIFIED-RELEASE COMPOSITION COMPRISING BUDESONIDE OR SALTS THEREOF

摘要

The present invention relates to process of preparing a solid oral modified-release composition comprising budesonide or salts thereof. In particular, the present invention relates to solid oral modified-release composition comprising matrix of budesonide or salts thereof with one or more amphiphilic excipients and one or more hydrophilic excipients comprising polymers having low viscosity, and the composition is free of any lipophilic excipient. The invention further relates to use of such composition in the treatment of ulcerative colitis.