<abstract xmlns="http://www.w3.org/1999/xhtml"><p> 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 (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.</p></abstract>

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 (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.

Evaluation of pancreatin stability through enzyme activity determination

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

Acta Pharmaceutica

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 License.

{"article-title":"Evaluation of pancreatin stability through enzyme activity determination"}

Pancreatin is a biotechnological product containing an enzyme complex, obtained from porcine pancreas, that is employed in treating pancreatic diseases....

Evaluation of pancreatin stability through enzyme activity determination

Published Online: Jun 29, 2016

Page range: 423 - 431

Accepted: Jan 11, 2016

DOI: https://doi.org/10.1515/acph-2016-0037

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

© by Jerusa Simone Garcia

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 License.

Evaluation of pancreatin stability through enzyme activity determination

Published Online: Jun 29, 2016

Page range: 423 - 431

Accepted: Jan 11, 2016

DOI: https://doi.org/10.1515/acph-2016-0037

Keywordsα-amylase, lipase, protease, stress testing, pancreatin stability, biopharmaceutical, UV/VIS spectrophotometry

© by Jerusa Simone Garcia

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 License.

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