Patent ID: 7658918

Claim:
A dosage form comprising a plurality of coated particles, said particles comprising a core coated with an enteric coating; wherein the core comprises: 68-90 wt. % of pancrelipase; the enteric coating comprises: 10-20 wt. % of at least one enteric polymer; and 4-10 wt. % of talc; wherein each said wt. % is based on the total weight of the coated particles, wherein the combined lipase, protease, and amylase activities of the dosage form is: 4,500-5,500 IU of lipase activity, 8,000-34,000 IU of protease activity, and 8,000-45,000 IU of amylase activity; or 9,000-11,000 IU of lipase activity, 17,000-67,000 IU of protease activity, and 17,000-90,000 IU of amylase activity; or 13,500-16,500 IU of lipase activity, 26,000-100,000 IU of protease activity, and 26,000-135,000 IU of amylase activity; or 18,000-22,000 IU of lipase activity, 35,000-134,000 IU of protease activity, and 35,000-180,000 IU of amylase activity; wherein said coated particles have a moisture content of about 2% or less, and exhibit a loss of pancrelipase activity of no more than 25% after six months of accelerated stability testing.