ABSTRACT
The stability of amylase and lipase in formulated pancreatin tablets prepared by direct compression using Avicel PH 101 and Zeparox were studied at four temperatures [50, 37, 25 and 4C] for 6 months. Pancreatin-Avicel tablet coated with HPMC and CAP as non-enteric and enteric coats was also investigated. Commercial pancreatin containing tablets from different sources were also selected in this study for comparison. The enzymatic degradation at the selected temperature obeyed the first order reaction kinetics. The degradation rate constants of enzymes in all tablet formulations were markedly decreased with temperature lowering. Zeparox tablets showed the highest degradation values, while those coated with CAP were the most stable formulations. Festavital tablets gave the highest stability data within the commercial brands. After 6 months of storage, amylase suffered greater losses of its activity than lipase, specially at 50 and 37C. At 4C tablets prepared with Avicel exhibited about 96, 21 and 3.6 times decrease in their degradation rate relative to those stored at 50, 37 and 25C, respectively