An investigation into applicability of different compression behaviour assessment approaches for multiparticulate units characterization

Abstract

Increasing expectations to understand material properties and process parameters impact on drug product performance resulted in increased efforts towards evaluation of drug/excipients mixtures, particularly during compression. Several research groups introduced material classification methodologies based on compression behaviour. In the present work, the applicability of different compression behaviour assessment approaches: Manufacturability Classification System (MCS), SeDeM Expert System and Compression Behaviour Classification System (CBCS) on multiparticulate units (MPU) characterization was evaluated. MPUs were prepared either by extrusion/spheronization or kneading/granulation and comprehensive sample characterization was conducted. Experimentally determined parameters were mathematically transformed and evaluated in the framework of MCS, SeDeM and CBCS. The investigated approaches were successfully applied for MPU compressibility assessment and were able to discriminate sample characteristics affected by different manufacturing methods. The results obtained provide insight into multiparticulate properties, contribute to understanding of factors governing their compressibility and may serve as useful tool in multiparticulate dosage forms development.