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.
Type:
Application
Filed:
October 2, 2013
Publication date:
June 19, 2014
Applicant:
APTALIS PHARMA LTD
Inventors:
Giovanni ORTENZI, Marco Marconi, Luigi Mapelli