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