Treatment of Pancreatic Exocrine Insufficiency with Enteric Coated Pancreatin Formulations: An Overview



  • B K Bhattacharyya
  • s Chowdhury
  • S Das
  • S Mukherjee
  • D Bhattacharjee


Pancreatin is a mixture of several digestive enzymes produced by the exocrine cells of the pancreas. It is composed of amylase, lipase and protease. It is used to treat conditions in which pancreatic secretions are deficient, such as surgical pancreatectomy, pancreatitis and cystic fibrosis. Pancreatin products contain the pancreatic enzymes trypsin, amylase and lipase. The patients with pancreatic diseases often suffer from pancreatic exocrine insufficiency. In such condition pancreas does not secrete required amount of digestive enzymes for proper digestion to occur. Severe pancreatic insufficiency occurs in cystic fibrosis, chronic pancreatitis, tumors or after surgical resection. Thus pancreatic exocrine insufficiency may result in clinical manifestation of malnutrition, weight loss and steatorrhea leading towards the increased risk of morbidity and mortality. For the improvement of clinical symptoms, restriction of fat intake and pancreatic enzyme replacement therapy are recommended. The enzyme substitution therapy is very much challenging because the optimal enzyme dose is highly variable to mimic the physiological pattern of pancreatic exocrine secretion. Regulatory authorities have approved several pancreatic enzyme formulations in the form of enteric coated minimicrosphere which are now available commercially. This review focuses on the physiological considerations of   pancreatic exocrine insufficiency and its treatment with enteric coated pancreatin formulations. 


Download data is not yet available.


Metrics Loading ...


Pancreatic exocrine insufficiency, enzyme replacement therapy, fat digestion, enteric coated pancreatin, minimicrosphere, dose




How to Cite

Bhattacharyya BK, Chowdhury s, Das S, Mukherjee S, Bhattacharjee D. Treatment of Pancreatic Exocrine Insufficiency with Enteric Coated Pancreatin Formulations: An Overview. Scopus Indexed [Internet]. 2013 Nov. 30 [cited 2024 May 18];6(3):2125-30. Available from:



Review Articles


Anagnostides A, ChadwickVS, Selden AC and Manton PN (1984). Sham feeding and pancreatic secretion Evidence for direct vagal stimulation of enzyme output. Gastroenterol 87(1): 109-114.

Cahen DL, Gouma DJ, Nio Y, Rauws EA, Boermeester MA, Busch OR, Stoker J, Lameris JS, Dijkgraaf MG, Huibregtse K and Bruno MJ (2007). Endoscopic versus surgical drainage of the pancreatic duct in chronic pancreatitis. N Engl J Med 356: 676-684.

Chowdhury RS and Forsmark CE (2003). Review article: Pancreatic function testing. Aliment Pharmacol Ther 17(6): 733-750.

DiMagno EP, Hendricks JC, Go VLW and Dozois RR (1979). Relationship among canine fasting biliary secretions, pancreatic duct pressure and duodenal phase III motor activity-Boldyreff revisited. Dig Dis Sci 24(9): 689-693.

Dominguez-Munoz JE, Iglesias-Garcia J, Iglesias-Rey M, Figueiras A and Vilarino-Insua M (2005). Effect of administration schedule on the therapeutic efficacy of oral pancreatic enzyme supplements in patients with exocrine pancreatic insufficiency: a randomized three way crossover study. Aliment Pharmacol Ther 21: 993-1000.

Dominguez-Munoz JE (2011). Pancreatic exocrine insufficiency: Diagnosis and treatment. J Gastroenterol Hepatol Suppl. 2: 12-16.

Dutta SK, Bustin MP, Russel RM and Costa BS (1982). Deficiency of fat soluble vitamins in treated patients with pancreatic insufficiency. Ann Intern Med 97: 549-552.

Go VL, Hofmann AF and Summerskill WH (1970). Pancreozymin bioassay in man based on pancreatic enzyme secretion: potency of specific amino acids and other digestive products. J Clin Invest 49(8): 1558-1564.

Gorelick F, Pandol SJ and Topazian M (2003). Pancreatic physiology, acute and chronic pancreatitis. Gastrointestinal Teaching Project, American Gastroenterologic association, USA.

Hammer HF (2010). Pancreatic exocrine insufficiency: diagnostic evalution and replacement therapy with pancreatic enzymes. Dig Dis 28(2): 339 – 343.

Hofmann A F and Borgslrom B (1963). Hydrolysis of Long chain monoglycerides in micellar solution by pancreatic lipase. Biochim Biophys Acta 70: 317-331.

Kalivianakis M, Minich DM, Bijleveld CM, Van Aalderen WM, Stellanrd F, Laseur M, Vonk RJ and Verkade HJ (1999). Fat malabsorption in cystic fibrosis patients receiving enzyme replacement therapy is due to impaired intestinal uptake of long-chain fatty-acids. Am J Clin Nutr 69: 127-134.

Kato H, Nakao A, Kishimoto W, Nonami T, Harada A, Hayakawa T and Takagi H (1993). 13c labeled trioctanoin breath test for exocrine pancreatic function test in patients after pancreatoduodenectomy. Am J Gastroenterol 88: 64-69.

Keller J and Layer P (2005). Human pancreatic exocrine response to nutrients in health and disease. Gut 54: 1-28.

Kilberg MS, Stevens BR and Novak DA (1993). Recent advances in mammalian amino acid transport. Annu Rev Nutr 13: 137-165.

Kimmich G A (1990). Membrane potentials and mechanism of intestinal Na +- dependent sugar transport. J Membr Biol 114 (1): 1- 27.

Konturek S J, Dubiel J and Gabrys B (1969). Effect of acid infusion into various levels of the intestine on gastric and pancreatic secretion in the cat. Gut 10(9): 749-753.

Kreiss C, Schwizer W, Erlacher U, Borovicka J, Lochner-Kuery C, muller R, Jansen JB and Fried M (1996). Role of antrum in regulation of pancreaticobiliary secretion in humans. Am J Physiol 207(5 Pt 1): G844 – G851.

Kuhel DG, Zheng S, Tso P and Hui DY (2000). Adenovirus-mediated human pancreatic lipase gene transfer to rat bile: gene therapy of fat malabsorption. Am J Physiol Gastrointest Liver Physiol 279: G1031-G1036.

Kuhnelt P, Mundlos S and Adler G (1991). Einfluss der pelletgrobe eines pankrearenzym praparates auf die duodenale lipolytische aktivitat. Z Gastroenterol 29: 417-421.

Lankisch PG, Lembcke B, Goke B and Creutzfeldt W (1986a). Therapy of pancreatogenic steatorrhoea: Does acid protection of pancreatic enzymes offer any advantage? Z Gastroenterol 24: 753-757.

Lankisch PG, Lembcke B, Wemken G and Creutzfeldt W (1986b). Functional reserve capacity of exocrine pancreas. Digestion 35:175-181.

Layer P, Keller J and Lankisch PG (2001). Pancreatic enzyme replacement therapy. Curr Gastroenterol Rep 3: 101-108.

Layer P, Go VL and DiMagno EP (1986). Fate of pancreatic enzymes during small intestinal aboral transit in humans. Am J Physiol 251: G475-G480.

Leeds JS, Oppong K and Sanders DS (2011). The role of fecal elastase-1 in detecting exocrine pancreatic disease. Nat Rev Gastroenterol Hepatol 8(7): 405-415.

Liddle RA, Goldfine ID, Rosen MS, Taplitz RA and Williams JA (1985). Cholecystokinin bioactivity in human plasma. Molecular forms, responses to feeding and relationship to gall bladder contraction. J Clin Invest 75(4): 1144-1152.

Maeda H, Danel C and Crystal RG (1994). Adenovirus-mediated transfer of human lipase complementary DNA to the gall bladder. Gastroenterol 106: 1638-1644.

Meites S and Rogols S (1971). Amylase isozymes. CRC Crit Rev Clin Lab Sci 2(1):103-138.

Montalto G, Soresi M, Carroccio A, Scafidi E, barbagallo CM, Ippolito S and Notarbartolo A (1994). Lipoproteins and chronic pancreatitis. Pancreas 9: 137-138.

Mossner J and Keim V (2011). Pancreatic enzyme therapy. Deutsches Arzteblatt Int 108(34-35): 578-582.

Nakajima K, Oshida H, Muneyuki T and Kakei M (2012). Pancrelipase: an evidence-based review of its use for treating pancreatic exocrine insufficiency. Core Evidence 7: 77-91.

Pandol SJ (2010). Gross anatomic considerations. In the exocrine pancreas. Sam Rafael (CA): Morgan and Claypool Life Sciences,USA.

Pasquali C, Fogar P, Sperti C, Basso D, De Paoli M and Pedrazzoli S (1996). Efficacy of a pancreatic enzyme formulation in the treatment of steatorrhea in patients with chronic pancreatitis. Currr Ther Res-Clin Expmtl 57: 358-365.

Raimondo M and DiMagno EP (1994). Lipolytic activity of bacterial lipase suvives better than that of porcine lipase in human gastric and duodenal content. Gastroenterol 107: 231-235.

Riediger H, Adam U, Fischer E, Keck T, Pfeffer F, Hopt UT and Makowiec F (2007). Long term outcome after resection for chronic pancreatitis in 224 patients. J Gastrointest Surg 11: 949-960.

Rivers JP and Hassam AG (1975). Defective essential fatty acids metabolism in cystic fibrosis. Lancet 2: 642-643.

Roberts IM (1989). Enzyme therapy for malabsorption in exocrine pancreatic insufficiency. Pancreas 4: 496-503.

Safdi M, Bekal P, Martin S, Saeed ZA, Burton F and Toskes PP (2006). The effects of oral pancreatic enzymes (Creon 10 capsules) on steartorrhea: a multicenter, placebo-controlled, parallel group trial in subjects with chronic pancreatitis. Pancreas 33: 156-162.

Sikkens E.C.M, Cahen DL, Eijck C, Kuipers EJ and Bruno JM (2012). The daily practice of pancreatic enzyme replacement therapy after pancreatic surgery: A northern European Survey 16: 1487-1492.

Song Y, Li P, Lee KY, Chang TM and Chey WY (1999). Canine pancreatic juice stimulates the release of secretin and pancreatic secretion in the dog. Am J Physiol 277(3 pt 1): G731-735.

Smith RS (1965). Iron deficiency and iron overload. Archives on Diseases of Childhood 40: 343-349.

Stead RJ, Skypala I, Hodson ME and Batten JC (1987). Enteric coated microminispheres of pancreatin in the treatment of cystic fibrosis: comparison with a standard enteric coated preparations. Thorax 42: 533-537.

Suzuki A, Mizumoto A, Sarr MG and DiMagno EP (1997). Bacterial lipase and high-fat diet in canine exocrine pancreatic insufficiency: a new therapy of steatorrhea. Gastroenterol 112: 2048-2055.

Whitcomb DC and Lowe ME (2007). Human pancreatic digestive enzymes. Dig Dis Sci 52(1): 1-17.

Wright EM, Martin MG and Turk E (2003). Intestinal absorption in health and disease-sugars. Bert Pract Res Clin Gastroenterol 17(6): 943-956.

Ziarno M (2008). In vitro cholesterol uptake by Lactobacillus acidophilus isolates. Acta Sci Pol Technol Aliment 7(3): 65-74.

Zimmerman DW, Sarr MG, Smith CD, Nicholson CP, Dalton RR Barr D, Perkins JD and DiMagno EP (1992). Cyclic interdigestive pancreatic exocrine secretion: is it mediated by neural or hormonal mechanisms? Gastroenterol 102(4pt1): 1378-1384.