EP3662900A1 — Colonic drug delivery formulation

USPTO Abstract

In a delayed release drug formulation comprising a core containing a drug and optionally and a delayed release coating for intestinal release, release of the drug in the colon is not hindered by the absence of an alkaline middle layer between the core and the outer layer. The delayed release coating comprising and inner coating and optionally an isolation layer. The outer coating comprises a mixture of an enzymatically degradable polysaccharide which is degradable by colonic enzymes selected from the group consisting of starch, amylose, amylopectin, chitosan, chondroitin sulfate, cyclodextrin, dextran, pullulan, carrageenan, scleroglucan, chitin, curdulan, and levan; and a film-forming enteric polymer having a pH threshold at about pH 6 or above, wherein the enzymatically degradable polysaccharide and the enteric polymer are present in the outer coating in a ratio of more than 60:40.