In-Vitro Comparison of Physical Characteristics, Enzyme Content, and Release Kinetics of Pancreatic Enzyme Preparations Available in Europe and Canada.

Abstract

Introduction: Commercially available pancreatic enzyme replacement therapy (PERT) preparations differ significantly in their physical and enzyme properties, raising concern about the interchangeability of these preparations. The current study aimed to compare various commercially available PERT in Europe and Canada for physical properties, enzyme content, enzyme activities, release characteristics, and compliance with the label claim.

Methods: Particle size was determined using a dynamic image analyzer and represented as Feret Max at 10th (FERET Max D [v, 0.1]), 50th (FERET Max D [v, 0.5]), and 90th percentiles (FERET Max D [v, 0.9]). Particle imaging was performed using scanning electron microscopy and a Quorum sputter coater. Lipase activity was measured according to the European Pharmacopoeia (Ph. Eur) and International Pharmaceutical Federation (FIP) procedures. The measured activity was compared against the label claims to identify the percentage of deviations. Lipase release at different pH (release kinetics) was also determined subsequently.

Results: The particle size of the PERT preparations differed considerably. There were deviations in the actual lipase content from the label claim, ranging from 85.8% (Gastrozym 10000) to 177.5% (Pancreolan 6000). Under the simulated conditions, most PERT preparations released the enzyme lipase at an acidic pH present in the stomach before reaching the duodenum.

Conclusion: PERT preparations available in Europe and Canada exhibit significant differences in terms of physical and enzyme release kinetics. Careful evaluation is needed when interchanging these preparations, as it could impact the therapeutic outcomes.