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: - of size between 50 μm and 1200 μm, - 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 a homogeneous distribution in each solid lipid particle of the formulation, - is distributed without a distribution gradient towards the interior of the waxy matrix, and - represents between 0.1% and 90% of the mass of the formulation, the formulation having a melting point between 20 ° C and 65 ° C.