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Evaluation of Pancreatin Stability Through Enzyme Activity Determination

Evaluation of Pancreatin Stability Through Enzyme Activity Determination

Gleysson De Paula Terra, Marcus Vinícius De Farias, Marcello Garcia Trevisan, Jerusa Simone Garcia

Acta Pharm. 2016 Sep 1;66(3):423-31.

PMID: 27383890

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.

Chemicals Related in the Paper:

Catalog Number	Product Name	Structure	CAS Number	Price
AP8049476-C	Pancreatin from porcine pancreas		8049-47-6	Price

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