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Combined Size and Density Fractionation of Soils for Investigations of Organo-Mineral Interactions

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Quantification of mass transfer during spheronisation.

Martin Koester¹, Markus Thommes

¹Institute of Pharmaceutics and Biopharmaceutics, Heinrich-Heine-University, Universitaetsstrasse 1, 40225, Duesseldorf, Germany. markus.thommes@uni-duesseldorf.de

AAPS Pharmscitech

|March 15, 2012

Summary

This study reveals that mass transfer between pellets is a key mechanism in spheronisation, a pharmaceutical process. The novel mass transfer fraction (MTF) parameter quantifies this phenomenon, showing significant material involvement in pellet formation.

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Area of Science:

Pharmaceutical Technology
Materials Science

Background:

Extrusion spheronisation is a standard pharmaceutical technique for producing spherical pellets.
Existing models often overlook particle adhesion and mass transfer during spheronisation.
This study addresses the neglected mechanism of mass transfer between pellets.

Purpose of the Study:

To quantify the mass transfer occurring between pellets during the spheronisation process.
To introduce and validate a new parameter, the mass transfer fraction (MTF).
To investigate the influence of formulation components and water content on mass transfer.

Main Methods:

Systematic variation of pelletisation aids (microcrystalline cellulose, kappa-carrageenan), drugs (acetaminophen, ibuprofen), and water content.
Definition and application of the novel "mass transfer fraction" (MTF) parameter.
Quantification of mass transfer dynamics during the spheronisation of pharmaceutical granules.

Main Results:

The mass transfer fraction (MTF) ranged from 0.10 to 0.52 across all formulations, indicating substantial material exchange.
Pelletisation aids demonstrated similar MTF values irrespective of the drug incorporated.
Microcrystalline cellulose formulations showed an increased MTF with higher water content.

Conclusions:

Mass transfer between pellets is a critical, previously underestimated, mechanism in the spheronisation process.
The MTF parameter provides a quantifiable measure for assessing mass transfer during pellet formation.
Formulation composition and hydration significantly influence the extent of mass transfer in spheronisation.