Patent ID: 6696084
Filing Date: 2004-02-24
Classification: A61K,A61P

Abstract:
A process for the preparation of small particles or microparticles containing fenofibrate and a phospholipid surface stabilizing substance comprising the steps of:a) mixing at high shear an admixture of fenofibrate and a phospholipid in an aqueous carrier in the absence of an organic solvent and optionally in the presence of one or more than one surface active substances within a temperature range at or above the melting point of the fenofibrate to form a heated suspension containing the fenofibrate, then b) homogenizing said heated suspension in a pressure range and within said temperature range to form a heated homogenate containing the fenofibrate then c) spray drying the heated homogenate to form dried small particles containing the fenofibrate wherein one or more bulking agents is added at any stage of either of steps (a) or (b) and wherein at least one surface active agent is a phospholipid.