title: A new perspective on the mechanical evaluation of granular material.
abstract: The mechanical strength of granules is an important parameter to be determined prior to any further downstream formulation processing. It is important to have a good gauge on the granule integrity to forecast any foreseeable powder issues associated with the material processability such as segregation, content uniformity, and material flow-ability. In this study, a systematic methodology has been developed to quantify the integrity of these granules subjected to a low frequency acoustic field to arrive at the Granule Integrity (GI) index. This methodology has been compared to existing well-established bulk characterization techniques reported in the literature such as Heckel analysis, Kawakita analysis, and Young's modulus for four different processed samples. Heckel analysis is more amenable to examine the material deformability while Kawakita analysis is better suited to understand the mechanics of granular material. Individual granule strength measurements to determine Young's modulus often show large variations across the bulk sample. The GI index in conjunction with the Kawakita analysis provides us with more mechanistic insight and understanding into the formation of these granules from a processing perspective. This paper shows the benefits of using the GI index as a practical and direct methodology to characterize the GI of bulk samples in an industrial setting.
authors.affiliation: Material Science Group in Drug Product Science & Technology, Bristol Myers Squibb Company, New Brunswick, NJ, USA. steven.chan@bms.com
authors.forename: Steven H
authors.initials: SH
authors.lastname: Chan
authors.forename: Steve S Y
authors.initials: SS
authors.lastname: Wang
authors.forename: Chiajen
authors.initials: C
authors.lastname: Lai
authors.forename: John
authors.initials: J
authors.lastname: Grosso
mesh_terms: D002626:Chemistry, Pharmaceutical; D055119:Elastic Modulus; D008855:Microscopy, Electron, Scanning; D013607:Tablets; D013678:Technology, Pharmaceutical
chemical_list: D013607:Tablets