Patent ID: 7544370

Claim:
A method of producing a multiparticulate formulation of pantoprazole having reduced release under gastric conditions and fast release at neutral pH, said method comprising the steps of: producing a spheroid core comprising about 45% w/w pantoprazole sodium sesquihydrate, as a sole active component in the multiparticulate formulation and about 25% to 30% w/w microcrystalline cellulose, about 4% to 6% w/w polysorbate 80, about 14% to 16% w/w crospovidone, about 0.5 to 2% w/w hydroxypropyl methylcellulose, and about 5% to 8% w/w sodium carbonate a surfactant via extrusion and spheronization, said core further containing about 1 to about 2% w/w water; applying an initial seal coat comprising hydroxypropyl methylcellulose to the spheroid core, applying an enteric coating to the initial seal coated spheroid core, said enteric coating comprising a copolymer of methacrylic acid and methacrylates; and optionally applying a final seal coat to the enteric-coated spheroid core, said final seal coat being about 1 wt % of the multiparticulate; wherein the multiparticulates have an average diameter of about 0.7 mm to about 1.25 mm.