Aptalis Pharma Limited

Allergan Pharmaceuticals International Limited

Societe Des Produits Nestle S.a.

Eurand Pharmaceuticals, Ltd.

Giovanni Ortenzi

Luigi Giovanni Mapelli

Marco Marconi

Luigi Boltri

Christian Stollberg

Giuseppe De Franza

Danilo Clementi

Luigi Ghidorsi

Massimo Latino

The present invention is directed to a pharmaceutical composition or dosage form having a stable, low (diluted) digestive enzyme content comprising at least one digestive enzyme and at least one carrier, or a dosage form thereof. The invention is also directed to a process of preparation of the composition or the dosage form. In addition the invention is directed to the treatment and prevention of disorders or conditions associated with a digestive enzyme deficiency in a patient in need thereof, comprising administering to said patient a pharmaceutically acceptable amount of the composition having a stable low digestive enzyme content or dosage form thereof.

Stable low digestive enzyme content formulation

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.

Stable digestive enzyme compositions

Methods for screening pancrelipase for RNA virus contamination comprise removing free viral RNA from the pancrelipase, denaturing any viruses in the pancrelipase to release encapsidated RNA into the pancrelipase milieu, and detecting this released RNA. Removal of free viral RNA may comprise treating pancrelipase with RNase and DNase or precipitating the protein fraction of pancrelipase with a salt that precipitates the protein fraction while leaving nucleic acids such as RNA in solution. Pancrelipase substantially devoid of free nucleic acid is also provided.

Methods for removing viral contaminants from pancreatic extracts

The invention is directed to a process for measuring the amount of digestive enzymes released from a solid composition in a dissolution medium by fluorescence spectroscopy. The invention is also directed to a combined method for measuring both the dissolution and gastroresistance of a solid compositions comprising pancrelipase.

Method for dissolution testing of solid compositions containing digestive enzymes

Methods of producing stable pancreatic enzyme compositions

Stable pancreatic enzyme compositions

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Monza, Italy

Giovanni Ortenzi