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Agglomeration tendency in dry pharmaceutical granular systems.

Emilie DesRosiers Lachiver¹, Nicolas Abatzoglou, Louis Cartilier

¹Department of Chemical Engineering, Université de Sherbrooke, Sherbrooke, Que., Canada.

European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V

|June 27, 2006

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Dry pharmaceutical mixture agglomeration is influenced by mixing time and ingredient concentrations. Calcium carbonate and magnesium stearate promote agglomeration, while Xylitol aids in deagglomeration.

Area of Science:

Pharmaceutical Sciences
Materials Science
Chemical Engineering

Background:

Pharmaceutical powder mixtures can exhibit agglomeration, affecting product quality and performance.
Understanding agglomeration dynamics is crucial for optimizing dry powder formulation processes.

Purpose of the Study:

To statistically evaluate the agglomeration tendency of dry pharmaceutical mixtures.
To investigate the influence of Xylitol (Xylitab 100), precipitated calcium carbonate (CCP), and magnesium stearate (MgSt) concentrations and mixing time on agglomeration.

Main Methods:

Utilized a Ro-Tap tester to mix pharmaceutical components at various concentrations.
Quantitatively measured the weight and size of formed agglomerates.
Applied an experimental design for statistical analysis of results.

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Main Results:

Xylitol (Xylitab 100) did not significantly influence agglomerate formation but promoted deagglomeration.
Precipitated calcium carbonate (CCP) and magnesium stearate (MgSt) showed a tendency to form agglomerates over time.
Agglomerate fracture occurred when cohesive forces were overcome by gravity and inertia at a critical size.

Conclusions:

Mixing time and ingredient concentrations significantly impact the agglomeration tendency of three-component pharmaceutical mixtures.
The interplay between CCP and MgSt favors agglomeration, while Xylitol aids in breaking down these agglomerates.
These findings provide quantitative insights into controlling powder flow and processing characteristics.