Effect of Compaction Pressure on the Enzymatic Activity of Pancreatin in Directly Compressible Formulations

Overview

Journal Pharmaceutics

Publisher MDPI

Date 2023 Sep 28

PMID 37765193

Authors

Daniel Zakowiecki

Peter Edinger

Tobias Hess

Jadwiga Paszkowska

Marcela Staniszewska

Svitlana Romanova

Grzegorz Garbacz

Affiliations

Soon will be listed here.

Abstract

Tableting of biomolecules is a challenging formulation phase due to their sensitivity to various process parameters, such as compression pressure, process dynamics, or the temperature generated. In the present study, pancreatin was employed as a model enzyme mixture, which was formulated in tablet form utilizing the synergistic effects of brittle and plastic excipients (dibasic calcium phosphate and microcrystalline cellulose, respectively). The effect of varying compaction pressure and lubricant concentration on the generated temperature and enzymatic activity was evaluated. The tablets were analyzed for pancreatin content and the activity of two enzymes (protease and amylase) using pharmacopoeial tests. This study indicated that the formulations proposed here allow tableting over a wide range of compaction pressures without adversely affecting pancreatin content and its enzymatic activity.

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