Mmt. Ohare et al., STATED VERSUS ACTUAL LIPASE ACTIVITY IN PANCREATIC-ENZYME SUPPLEMENTS- IMPLICATIONS FOR CLINICAL USE, Journal of pediatric gastroenterology and nutrition, 21(1), 1995, pp. 59-63
We have carried out an independent investigation of the lipase activit
y of several pancreatin preparations, including high-lipase preparatio
ns of pancreatin that have recently become available. Six preparations
from three pharmaceutical companies, Cilag, Duphar, and Merck, were a
nalyzed during the recommended shelf life of the preparation and inclu
ded a standard and a high-lipase preparation from each manufacturer. A
ll preparations studied showed lipase activity in excess of that which
was stated on the packets, and in some cases it was more than twofold
. This has important implications for patients and prescribers since c
hanges in apparent enzyme requirements may reflect differences in the
potency of batches with time. As it is impossible to evaluate capsule
requirements with each new batch prescribed, the presence or relief of
symptoms of malabsorption will probably continue to be the way in whi
ch most patients monitor their enzyme supplementation on a regular bas
is. We believe that clinicians need to be aware of the extent of possi
ble intrinsic variation between individual prescriptions before attemp
ting to define possible dose/symptom relationships.