Stable digestive enzyme compositions

Details Stable digestive enzyme compositions Stable digestive enzyme compositions

A - Human Necessities

61

K

A61K 9/16 (2006.01) A61K 9/48 (2006.01) A61K 9/50 (2006.01)

Patent

CA 2677989

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.

La présente invention concerne des compositions comprenant au moins une enzyme digestive (par ex., une pancrélipase) et permettant de traiter ou prévenir des troubles associés à des carences en enzymes digestives. Les compositions de la présente invention peuvent comprendre une pluralité de particules enrobées, chacune de ces particules étant constituée d'un noyau enrobé d'un enrobage entérique renfermant au moins un polymère entérique et entre 4 et 10% d'au moins un agent alcalinisant, ou présentant une teneur en humidité inférieure ou égale à environ 3%, une activité hydrique inférieure ou égale à environ 0,6, ou une perte d'activité inférieure ou égale à environ 15% après six mois de test de stabilité accéléré.

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