Pancreatic enzymes, also known as pancreases, pancrelipases or pancreatins are commercial mixtures of

amylase An amylase () is an enzyme that catalysis, catalyses the hydrolysis of starch (Latin ') into sugars. Amylase is present in the saliva of humans and some other mammals, where it begins the chemical process of digestion. Foods that contain large ...

lipase In biochemistry, lipase ( ) refers to a class of enzymes that catalyzes the hydrolysis of fats. Some lipases display broad substrate scope including esters of cholesterol, phospholipids, and of lipid-soluble vitamins and sphingomyelinases; howe ...

protease A protease (also called a peptidase, proteinase, or proteolytic enzyme) is an enzyme that catalysis, catalyzes proteolysis, breaking down proteins into smaller polypeptides or single amino acids, and spurring the formation of new protein products ...

and

lactase Lactase () is an enzyme produced by many organisms and is essential to the complete digestion of whole milk. It breaks down the sugar lactose into its component parts, galactose and glucose. Lactase is found in the brush border of the small ...

obtained from pigs. The components are

digestive enzyme Digestive enzymes take part in the chemical process of digestion, which follows the mechanical process of digestion. Food consists of macromolecules of proteins, carbohydrates, and fats that need to be broken down chemically by digestive enzymes ...

s similar to those normally produced by the human

pancreas The pancreas (plural pancreases, or pancreata) is an Organ (anatomy), organ of the Digestion, digestive system and endocrine system of vertebrates. In humans, it is located in the abdominal cavity, abdomen behind the stomach and functions as a ...

. They help in the

digestion Digestion is the breakdown of large insoluble food compounds into small water-soluble components so that they can be absorbed into the blood plasma. In certain organisms, these smaller substances are absorbed through the small intestine into th ...

of fats, starches, and proteins. They are used to treat

malabsorption Malabsorption is a state arising from abnormality in absorption of food nutrients across the gastrointestinal (GI) tract. Impairment can be of single or multiple nutrients depending on the abnormality. This may lead to malnutrition and a varie ...

syndrome due to certain pancreatic insufficiencies. These pancreatic problems may be due to

cystic fibrosis Cystic fibrosis (CF) is a genetic disorder inherited in an autosomal recessive manner that impairs the normal clearance of Sputum, mucus from the lungs, which facilitates the colonization and infection of the lungs by bacteria, notably ''Staphy ...

, surgical removal of the pancreas, long-term

pancreatitis Pancreatitis is a condition characterized by inflammation of the pancreas. The pancreas is a large organ behind the stomach that produces digestive enzymes and a number of hormone A hormone (from the Ancient Greek, Greek participle , "se ...

pancreatic cancer Pancreatic cancer arises when cell (biology), cells in the pancreas, a glandular organ behind the stomach, begin to multiply out of control and form a Neoplasm, mass. These cancerous cells have the malignant, ability to invade other parts of ...

, or MODY 5, among others. The preparation is taken by mouth. The treatment is also known as pancreatic enzyme replacement therapy or PERT. Common side effects include

vomiting Vomiting (also known as emesis, puking and throwing up) is the forceful expulsion of the contents of one's stomach through the mouth and sometimes the nose. Vomiting can be the result of ailments like food poisoning, gastroenteritis, pre ...

, abdominal pain,

constipation Constipation is a bowel dysfunction that makes bowel movements infrequent or hard to pass. The Human feces, stool is often hard and dry. Other symptoms may include abdominal pain, bloating, and feeling as if one has not completely passed the ...

, and

diarrhea Diarrhea (American English), also spelled diarrhoea or diarrhœa (British English), is the condition of having at least three loose, liquid, or watery bowel movements in a day. It often lasts for a few days and can result in dehydration d ...

. Other side effects include perianal irritation and high blood uric acid. Use is believed to be safe during

pregnancy Pregnancy is the time during which one or more offspring gestation, gestates inside a woman's uterus. A multiple birth, multiple pregnancy involves more than one offspring, such as with twins. Conception (biology), Conception usually occurs ...

. Pancreatic enzymes have been used as medications since at least the 1800s. They are on the

World Health Organization's List of Essential Medicines The WHO Model List of Essential Medicines (aka Essential Medicines List or EML), published by the World Health Organization (WHO), contains the medications considered to be most effective and safe to meet the most important needs in a health s ...

. In 2022, it was the 253rd most commonly prescribed medication in the United States, with more than one million prescriptions.

Medical uses

Pancrelipases are generally a first line approach in treatment of

exocrine pancreatic insufficiency Exocrine pancreatic insufficiency (EPI) is the inability to properly digest food due to a lack or reduction of digestive enzymes made by the pancreas. EPI can occur in humans and is prevalent in many conditions such as cystic fibrosis, Shwach ...

and other digestive disorders, accompanying

, complicating surgical pancreatectomy, or resulting from chronic pancreatitis. The

formulation Formulation is a term used in various senses in various applications, both the material and the abstract or formal. Its fundamental meaning is the putting together of components in appropriate relationships or structures, according to a formula ...

s are generally hard capsules filled with gastro-resistant granules. Pancrelipases and pancreatins are similar, except pancrelipases has an increased lipase component. Pancreatin is a mixture of several digestive

enzyme An enzyme () is a protein that acts as a biological catalyst by accelerating chemical reactions. The molecules upon which enzymes may act are called substrate (chemistry), substrates, and the enzyme converts the substrates into different mol ...

s produced by the exocrine cells of the

. It is composed of

and

. This mixture is used to treat conditions in which pancreatic secretions are deficient, such as surgical pancreatectomy,

and

. It has been claimed to help with food allergies, celiac disease, autoimmune disease, cancer and weight loss. Pancreatin is sometimes called "pancreatic acid", although it is neither a single chemical substance nor an acid. A similar mixture of enzymes is sold as pancrelipase, which contains more active lipase enzyme than does pancreatin. The trypsin found in pancreatin works to hydrolyze proteins into oligopeptides; amylase hydrolyzes starches into oligosaccharides and the disaccharide maltose; and lipase hydrolyzes triglycerides into fatty acids and glycerols. Pancreatin is an effective enzyme supplement for replacing missing pancreatic enzymes, and aids in the digestion of foods in cases of pancreatic insufficiency. Pancreatin reduces the absorption of iron from food in the duodenum during digestion. Some

contact lens Contact lenses, or simply contacts, are thin lenses placed directly on the surface of the eyes. Contact lenses are ocular prosthetic devices used by over 150 million people worldwide, and they can be worn to correct vision or for cosmetic ...

-cleaning solutions contain porcine pancreatin extractives to assist in the intended protein-removal process.

Side effects

High doses over a long period of time are associated with fibrosing colonopathy. Due to this association a maximum dose of 10,000 IU of lipase per kilogram per day is recommended. Though never reported there is a theoretical risk of a viral infection as they are from pigs.

Society and culture

Brand names

Brand names include Creon, Pancreaze, Pertzye, Sollpura (LiprotamaseDid not make it past Phase 3 trials), Ultresa, and Zenpep. In some countries, Creon is marketed by Viatris after Upjohn merged with Mylan to create Viatris.

Legal status

United States

Longstanding pancreatic enzyme replacement products (PERPs)—some in use for a century or more—fell under a 2006

FDA The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...

requirement that pharmaceutical companies with porcine-derived PERP products submit a

New Drug Application The Food and Drug Administration's (FDA) New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing. Some 30% or less of initial ...

(NDA) for each; ''Creon'' (AbbVie Inc.), the first of the commercial PERP products approved after the FDA directive, reached market in 2009. 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 are adequately informed regarding potential risks associated with administration of high doses of porcine-derived PERP products, especially with regard to "the theoretical 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.

Shortages and alternatives

Due to its non-constant supply, being sourced from pigs, there have been several pancreatin shortages in different markets. This has led for alternative sources of enzymes to be studied and commercialised, mainly being of bacterial or fungal origin.

Notes

References

{{DEFAULTSORT:Pancreatic Enzymes Medication Enzymes Drugs developed by AbbVie World Health Organization essential medicines Wikipedia medicine articles ready to translate Enzymes used as drugs