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, said formulation comprising solid lipid particles, said solid lipid particles being: - between 50 μm and 1200 μm in size, - strictly hydrophobic, - free from water, organic solvent, surfactant compounds and polymers, and comprising: - at least one digestive enzyme, - a strictly hydrophobic, non-hygroscopic waxy matrix, and in said solid lipid particles the at least one digestive enzyme: - is homogeneously distributed in every 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, said formulation having a melting point between 20 and 65 °C.