INTESTINAL-RELEASE FORMULATION OF A DIGESTIVE ENZYME, METHOD OF PRODUCTION AND GALENIC PREPARATION

摘要

The invention relates to a formulation of at least one digestive enzyme, the formulation comprising solid lipid particles, the solid lipid particles being:between 50 μm and 1200 μm in size,strictly hydrophobic,free of water, of organic solvent, of surfactant compound and of polymer, and comprising:at least one digestive enzyme,a strictly hydrophobic, non-hygroscopic waxy matrix, in which said at least one digestive enzyme:has homogeneous distribution in each solid lipid particle of the formulation,is distributed without a distribution gradient towards the interior of the waxy matrix, andrepresents between 0.1% and 90% of the mass of the formulation, the formulation having a melting point of between 20° C. and 65° C.