Tabletability and compactibility of α-lactose monohydrate powders of different particle size. II: predicted relationships

• Published in: Pharmaceutical development and technology Vol. 28; no. 6; pp. 509 - 519
• Main Authors: Persson, Ann-Sofie, Alderborn, Göran
• Format: Journal Article
• Language: English
• Published: England Taylor & Francis 03.07.2023
• Subjects: compaction pressure; crystalline lactose; porosity; prediction method; Tensile strength; three stage model; three stage model; compaction pressure; porosity; Tensile strength; crystalline lactose; prediction method
• ISSN: 1083-7450; 1097-9867; 1097-9867
• DOI: 10.1080/10837450.2023.2214614

This study aimed to evaluate a material sparing method to predict tabletability and compactibility relationships. Seven α-lactose monohydrate powders with varying particle size were used as test materials. The compressibility of the powders was determined experimentally, whereas tabletability and compactibility profiles were derived both experimentally and predicted. In the prediction method, two experimental compression parameters (Kawakita and Heckel plastic stiffness) and a single tensile strength reference value were used, all necessary data obtained from a single compression experiment. For both predicted and experimental relationships, compaction and tableting parameters (performance indicators) were calculated. The correction for viscoelastic recovery was successful in generating compressibility profiles that corresponded to the series of experimental out-of-die tablet porosities. For both the tabletability and compactibility, the experimental and predicted profiles showed a high degree of similarity. Good correlations were obtained between the predicted and experimental compaction and tableting parameters. It is concluded that the hybrid prediction method is a material sparing method, which can give good approximations of tabletability and compactibility relationships. The prediction method has the potential to be included as a part of a protocol for the characterisation of the tableting performance of particulate solids.