Stable digestive enzyme compositions
AssigneeEurand Pharmaceuticals Ltd.
InventorsGiovanni Ortenzi, Marco Marconi, Luigi Mapelli
Life of this patent
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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.
Claims15
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.
Dependencies are inferred from the claim text.