pancrelipase (Aptalis Pharma Inc., 19b3bb)

Ultrase MT20 is an orally administered, porcine-derived pancreatic enzyme replacement therapy (PERT) containing pancrelipase, which is a mixture of lipase, amylase, and protease. It is formulated as delayed-release capsules containing enteric-coated minitablets designed to dissolve at a pH of 5.5 or higher, allowing the enzymes to be released in the duodenum to assist in the digestion of fats, proteins, and carbohydrates. Developed by Eurand and Scandipharm (later acquired by Axcan Pharma, which became Aptalis Pharma, and subsequently acquired by Forest Laboratories and Allergan), Ultrase MT20 was primarily indicated for the treatment of exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis, chronic pancreatitis, or pancreatic surgery. Although widely used, the unapproved formulation of Ultrase MT20 was removed from the US market in 2010 due to FDA mandates requiring all pancreatic enzyme products to obtain approved New Drug Applications (NDAs). A reformulated version was subsequently approved under the brand name Ultresa in 2012, which was later discontinued in 2016.

Brand names

UltresaUltraseUltrase MTUltrase MT 20Ultrase MT20

Other names

lipase + amylase + proteasepancreatic enzymesporcine pancreatic enzymesporcine pancrelipase