Study to compare the enzyme activity, acid resistance and dissolution characteristics of currently available pancreatic enzyme preparations

Abstract

An in vitro study of currently available pancreatic enzyme preparations was carried out to compare the three main types of product available, these being simple pancreatin preparations, enteric coated tablets and enteric coated granules. Two products from each of these types were analysed to compare their enzyme contents. The enteric coated preparations were tested for acid resistance and their pH dissolution profiles were also investigated. The measured enzyme contents were generally higher than the declared values but products' enzyme declarations remain valid for comparison. As the BP declaration for protease does not include total protease this value may be misleading. Acid resistance and pH dissolution profiles varied both between the types of preparation and between the actual products tested. The enteric coated granule preparations were more resistant to acid and released their enzyme more rapidly once the pH threshold of dissolution was reached. Of the two enteric coated granule preparations, Creon (Duphar) was more resistant to acid and released its enzyme from a slightly lower pH value.