Stable pancreatic enzyme compositions
AssigneeAptalis Pharma 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.
Claims30
A dosage form comprising
- a capsule, wherein the capsule comprises hydroxypropylmethylcellulose and a moisture content of about 4% or less, and wherein the capsule is filled with a pharmaceutical composition, said pharmaceutical composition comprising:
- a plurality of coated particles, said coated particles comprising a core comprising at least one digestive enzyme, and said coated particles coated with an enteric coating.
Dependencies are inferred from the claim text.