Acta Pharm. 66 (2016) 423-431

full paper

Short communication

Evaluation of pancreatin stability through enzyme activity determination

GLEYSSON DE PAULA TERRA, MARCUS VINICIUS DE FARIAS RAMOS, MARCELLO GARCIA TREVISAN and JERUSA SIMONE GARCIA

jerusa.garcia@unifal-mg.edu.br

Federal University of Alfenas – UNIFAL-MG, Institute of Chemistry, Laboratory of Analysis and Characterization of Pharmaceuticals, Alfenas, Minas Gerais, Brazil

Accepted April 12, 2016

Published online May 31, 2016

Pancreatin is a biotechnological product containing an enzyme complex, obtained from porcine pancreas, that is employed in treating pancreatic diseases. Experiments regarding the stability of the pharmaceutical formulation containing pancreatin were performed using standard binary mixtures with 6 excipients in a 1:1 ratio 1 (m/m) and a commercial formulation. To accomplish these goals, samples were stored for 1, 3 and 6 months at 40 ± 1 °C and 75 ± 5 % relative humidity (RH) and 40 ± 1 °C and 0 % RH. Stress testing was also performed. All samples were analyzed to evaluate the α-amylase, lipase and protease activities through UV/Vis spectrophotometry. The results revealed that the excipient proprieties and the storage conditions affected enzyme stability. Humidity was a strong influencing factor in the reduction of α-amylase and protease activities. Stress testing indicated that pH 9.0 and UV light did not induce substantial alterations in enzyme activity.

Keywords: α-amylase, lipase, protease, stress testing, pancreatin, biopharmaceutical, UV/VIS spectrophotometry