A dimensionless variable for the scale up and transfer of a roller compaction formulation

Abstract

Roller compaction is the most commonly employed dry granulation process in the pharmaceutical industry. While this process is increasingly used as an alternative to wet granulation, there are no parameter sets or system of equations to quickly scale up or transfer a formulation between two pieces of equipment. In this work, dimensionless variable was examined as a method to transfer the operating parameters of a formulation between two different pieces of equipment. This work was completed to establish the ground work for the development of a dimensionless relationship relating the operating parameters of the equipment to the porosity of the ribbon. The working hypothesis was three-fold, namely (i) that ribbons of the same porosity made with different equipment will have similar properties, (ii) that it is possible to establish an objective relationship between ribbon porosity and a combination of operating parameters and raw material attributes and (iii) that by expressing such parameter combination as a dimensionless variable, it will be possible to use the same relationship for different pieces of roller compaction equipment. The dimensionless variable RP/RS*HFS*True Density*D² was found to correlate well with the ribbon porosity for the formulations and equipment used in these experiments. Depending on the formulation, the average difference in ribbon porosity between the two units varied between 0.012 and 0.024.

• Dimensionless variable
• operating parameters
• ribbon porosity
• roller compaction
• scale up

Acknowledgements

The authors thank The Fitzpatrick Corporation for donating the IR-220 roller compactor, Alexanderwerk, Inc. for lending the WP 120 × 40 roller compactor and FMC Biopolymer for donating the MCC used in these experiments.

Declaration of interest

The authors report no declarations of interest.