Pancreatic
enzyme extracts have been used for several decades to decrease maldigestion of macro- and
micronutrients due to
pancreatic insufficiency and to alleviate various abdominal symptoms, including the
pain of alcohol-induced
chronic pancreatitis and distal
intestinal obstruction. Decreasing nutrient maldigestion and malabsorption in
pancreatic insufficiency is of additional critical importance because improvement 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 importance of pancreatic
enzymes, several problems exist with current preparations, and as newer
enzyme preparations are marketed, proper evaluation becomes critical. There is a clear need to optimize the constituents 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) in these products; the stability of the
enzymes at room temperature; the shelf life of the finished product; whether there are significant batch-to-batch differences; and the need for a USP reference standard.