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

ORCID
0000-0003-3935-4263
Affiliation
Chemische Fabrik Budenheim KG, Rheinstrasse 27, 55257 Budenheim, Germany(T.H.)
Zakowiecki, Daniel;
Affiliation
Chemische Fabrik Budenheim KG, Rheinstrasse 27, 55257 Budenheim, Germany(T.H.)
Edinger, Peter;
ORCID
0000-0002-3950-9010
Affiliation
Chemische Fabrik Budenheim KG, Rheinstrasse 27, 55257 Budenheim, Germany(T.H.)
Hess, Tobias;
ORCID
0000-0003-1230-8128
Affiliation
Physiolution Polska sp. z o.o., Skarbowcow 81/7, 53-025 Wroclaw, Poland(G.G.)
Paszkowska, Jadwiga;
ORCID
0000-0002-6865-5471
Affiliation
Physiolution Polska sp. z o.o., Skarbowcow 81/7, 53-025 Wroclaw, Poland(G.G.)
Staniszewska, Marcela;
Affiliation
Physiolution Polska sp. z o.o., Skarbowcow 81/7, 53-025 Wroclaw, Poland(G.G.)
Romanova, Svitlana;
ORCID
0000-0003-4511-0329
Affiliation
Physiolution Polska sp. z o.o., Skarbowcow 81/7, 53-025 Wroclaw, Poland(G.G.)
Garbacz, Grzegorz

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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