In vitro Comparison of Pancreatic Enzyme Preparations Available in the Indian Market

Abstract

Purpose

Pancreatic enzyme replacement therapy (PERT) involves exogenous enzyme supplementation and is used in the treatment of pancreatic exocrine insufficiency. Clinical efficacy of PERT preparations is a function of physical properties and release kinetics that vary between commercially available products. In this study, we evaluated the physical properties, in vitro dissolution, and release kinetics of commercially available pancreatic enzyme preparations available in the Indian market.

Methods

Physical properties such as particle size distribution and water content of the capsules were measured by dynamic light scattering and Karl–Fischer titration method, respectively. An analytical procedure based on the European pharmacopoeia (EP) method was used to determine lipase activity, and a modified United States pharmacopoeia (USP)–based method was used for dissolution studies. Enzyme release was ascertained under gastroduodenal conditions in buffered media.

Results

Considerable variations in physical properties such as particle size and water content were observed between pancreatic enzyme preparations. Some preparations failed to meet the labeled lipase content as per USP standards (>90% label claim) and showed inconsistent release behavior (>5% relative standard deviation).

Conclusion

Differences exist between pancreatic enzyme preparations in terms of physical properties, dissolution, and release behavior that can affect their clinical efficacy. The present study suggests, therefore, that these preparations should not be used interchangeably.

Keywords:

• pancreatic enzyme
• physical properties
• in vitro dissolution
• lipase activity
• release kinetics

Acknowledgments

The authors thank PharmEDGE for providing medical writing support.

Data Sharing Statement

Authors agree to make their data available upon reasonable request.

Ethics Approval and Informed Consent

Not applicable as this is an in vitro study.

Author Contributions

All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

Disclosure

J Enrique Domínguez-Muñoz reports personal fees from Abbott Pharmaceuticals, grants from Viatris, outside the submitted work. Kevin E. Weigl is an employee of Abbott Laboratories GmbH, Hannover, Germany. Kushal D. Sarda is an employee of Abbott India Ltd. None of the remaining authors report any conflicts of interest in this work.

Additional information

Funding

The study was funded by Abbott India Ltd.