Patent ID: 8246950

Claim:
A method of treating a disorder associated with digestive enzyme deficiency comprising administering to a mammal in need thereof, a pharmaceutical composition comprising: a plurality of coated particles, the 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 wt. % is based on the total weight of the coated particles, wherein the pharmaceutical composition has combined lipase, protease, and amylase activities of: about 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 about 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 about 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 about 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 the coated particles have a moisture content of about 3% or less, and exhibit a loss of pancrelipase activity of no more than 25% after six months of accelerated stability testing.