ENZYME THERAPY FOR PANCREATIC INSUFFICIENCY - PRESENT STATUS AND FUTURE-NEEDS

Pancreatic enzyme extracts have been used for several decades to decre ase maldigestion of macro- and micronutrients due to pancreatic insuff iciency and to alleviate various abdominal symptoms, including the pai n of alcohol-induced chronic pancreatitis and distal intestinal obstru ction. Decreasing nutrient maldigestion and malabsorption in pancreati c insufficiency is of additional critical importance because improveme nt in nutritional status reduces morbidity and mortality. For example, pancreatic sufficient patients with cystic fibrosis (CF) demonstrate a slower decline in pulmonary function. In spite of the recognized imp ortance of pancreatic enzymes, several problems exist with current pre parations, and as newer enzyme preparations are marketed, proper evalu ation becomes critical. There is a clear need to optimize the constitu ents of enzyme preparations, improve manufacturing processes, and find better sources of enzymes. Other issues that need addressing include standardization of the ratios of enzymes (lipase, amylase, protease) i n these products; the stability of the enzymes at room temperature; th e shelf life of the finished product; whether there are significant ba tch-to-batch differences; and the need for a USP reference standard.