Pharmaceutical Compositions Comprising A Pancreatic Enzyme Preparation With Viral Infectivity Reduced Below A Significant Level And Methods Of Preparing And Using The Same

A solid oral dosage form comprising

• a pancreatic enzyme preparation (PEP) having reduced viral infectivity, wherein (i) the PEP comprises from about 1,000 to about 60,000 USP units lipases, from about 3,000 to about 360,000 USP units proteases, and from about 3,000 to about 360,000 USP units amylases, and (ii) the PEP has been pre-treated with beta-propiolactone (BPL) and has a viral infectivity of porcine parvovirus (PPV) of at least 1 log below that of a PEP not treated with BPL, and
• optionally, one or more pharmaceutically acceptable excipients.

A solid oral dosage form comprising

• a pancreatic enzyme preparation (PEP) having reduced viral infectivity, wherein (i) the PEP comprises from about 1,000 to about 60,000 USP units lipases, from about 3,000 to about 360,000 USP units proteases, and from about 3,000 to about 360,000 USP units amylases, and (ii) the PEP has a PPV infectivity below about 100 FFID50/g PEP, and
• optionally, one or more pharmaceutically acceptable excipients.

15-32. (canceled)

A method of preparing a pancreatic enzyme preparation (PEP) comprising the step of (a) reacting beta-propiolactone (BPL) with a preparation containing one or more pancreatic enzymes for a sufficient time to reduce a viral infectivity in the preparation.