Stable digestive enzyme compositions
AssigneeAllergan Pharmaceuticals International Limited
InventorsGiovanni Ortenzi, Marco Marconi, Luigi Mapelli
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Abstract
Compositions of the present invention, comprising at least one digestive enzyme (e.g., pancrelipase) are useful for treating or preventing disorders associated with digestive enzyme deficiencies. The compositions of the present invention can comprise a plurality of coated particles, each of which is comprised of a core coated with an enteric coating comprising at least one enteric polymer and 4-10% of at least one alkalinizing agent, or have moisture contents of about 3% or less, water activities of about 0.6 or less, or exhibit a loss of activity of no more than about 15% after six months of accelerated stability testing.
Claims13
A method of treating exocrine pancreatic insufficiency comprising administering to a mammal in need thereof, a pharmaceutical composition comprising a plurality of coated particles, each of which is comprised of a core coated with an enteric coating;
- wherein the core comprises pancrelipase, at least one disintegrant, and at least one polymeric binder, and the enteric coating comprises at least one enteric polymer and 4-10 wt. % talc, based on the total weight of the composition, wherein said composition has a moisture content of about 3% or less.
Dependencies are inferred from the claim text.