In Brief: Pancreatic Enzyme Replacement Products

Date: October 9, 2017 Issue #:  1531Summary:  Pancreatic enzyme replacement products have been used for years to improve digestion in patients with exocrine pancreatic insufficiency (EPI). These products were initially marketed before formal FDA approval was required; in 1991, however, the FDA told all manufacturers of pancreatic enzyme replacement products that they would have to submit a new drug application by April 2010 in order to keep their products on the market.EPI is a chronic disorder characterized by a deficiency of exocrine pancreatic enzymes, which results in malabsorption, steatorrhea, and weight loss. Irreversible EPI is commonly caused by chronic pancreatitis in adults and by cystic fibrosis in children. The standard treatment for EPI is pancreatic enzyme replacement therapy. Treatment with pancreatic enzyme replacement products has reduced fat malabsorption and steatorrhea.1All pancreatic enzyme replacement products in the US contain a mixture of porcine-derived amylases, lipases, and proteases. All of the products exceptViokace are available in delayed-release capsules containing enteric-coated beads, spheres, microspheres, or microtablets to protect lipase from denaturation by gastric acid.Viokace immediate-release tablets should be taken with a proton pump inhibitor to improve release of pancreatic enzymes in the duodenum.2 Because the rate and extent of dissolution of these products vary, they are not considered i...
Source: The Medical Letter - Category: Drugs & Pharmacology Authors: Tags: Creon pancreatic Enzyme Products Pancreaze pancrelipase Pertzye Viokace Zenpep Source Type: research