Pancrelipase

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Pancrelipase
Clinical data
AHFS/Drugs.com monograph
MedlinePlus a604035
Legal status ?
Routes Oral
Identifiers
CAS number 53608-75-6 YesY
ATC code A09AA02
DrugBank DB00085
UNII FQ3DRG0N5K YesY
Chemical data
Formula ?
 N (what is this?)  (verify)

Pancrelipases, and in particular, their delayed release formulations (e.g., Creon®, Pancreaze®, Pertzye®, Ultresa®, Zenpep®), are commercial mixtures of porcine-derived pancreatic amylase (a hydrolase acting on starch), pancreatic lipase, and chymotrypsin (a protease) whose therapeutic aim is to improve food digestion in infants, children, and adults who "do not have enough pancreatic enzymes… because they have a condition that affects the pancreas… such as cystic fibrosis… chronic pancreatitis… or a blockage in the passages between the pancreas and the intestine.[1] The three components in the product are digestive enzymes akin to those normally produced by the human pancreas. Longstanding pancreatic enzyme replacement products (PERPs)—some in use for a century or more—fell under a 2006 FDA requirement that pharmaceutical companies with porcine-derived PERP products submit an NDA for each; Creon® (AbbVie Inc.) was the first of the commercial PERP products approved after the FDA directive, reaching market in 2009.[2]

Pancrelipases are generally a first line approach in treatment of exocrine pancreatic insufficiency and other digestive disorders, accompanying cystic fibrosis, complicating surgical pancreatectomy, or resulting from chronic pancreatitis (see above). The formulations are generally hard capsules filled with gastro-resistant granules. Pancrelipases are similar to pancreatins, but with an increased lipase component.[citation needed]

The specific requirement and reasoning for the FDA directive was that manufacturers submit a Risk Evaluation and Mitigation Strategy (REMS) and Medication Guide to ensure patients were adequately informed regarding potential risks associated with administration of high doses of porcine-derived PERP products, especially with regard to "the theroretical risk of transmission of viral disease from pigs to patients", the risk of which (alongside other off-target effects) is reduced by patient adherence to label dosing instructions.[2]

References[edit]

  1. ^ MedlinePlus (2014) Pancrelipase, see [1], accessed 20 July 2014. The full quotation from which this derives also contains a definition of each term preceding each ellipsis: "used to improve digestion of food in children and adults who do not have enough pancreatic enzymes (substances needed to break down food so it can be digested) because they have a condition that affects the pancreas (a gland that produces several important substances including enzymes needed to digest food) such as cystic fibrosis (an inborn disease that causes the body to produce thick, sticky mucus that may clog the pancreas, the lungs, and other parts of the body), chronic pancreatitis (swelling of the pancreas that does not go away), or a blockage in the passages between the pancreas and the intestine."
  2. ^ a b U.S. Food and Drug Administration (2009) FDA Approves Pancreatic Enzyme Replacement Product for Marketing in United States: Creon designed to help those with cystic fibrosis, others with exocrine pancreatic insufficiency, News & Events, FDA News Release, May 7, 2009, see [2], accessed 20 July 2014.