title: A protocol for the classification of powder compression characteristics.
abstract: In this paper, a structured protocol for powder compression analysis as a test to assess the mechanical properties of particles in a formulation development programme is presented. First, the sequence of classification steps of the protocol is described, and secondly, the protocol is illustrated using compression data of six powders of two model substances, sodium chloride and mannitol. From powder compression data, a set of compression variables are derived, and by using critical values of these variables, the stages expressed during the compression of the powders are identified and the powders are classified into groups with respect to the expression of particle rearrangement, particle fragmentation and particle plastic deformation during compression. It is concluded that the proposed protocol could, in a satisfactorily way, describe and distinguish between the powders regarding their compression behaviour. Hence, the protocol could be a valuable tool for the formulation scientist to comprehensively assess important functionality-related characteristics of drugs and excipients.
authors.affiliation: Department of Pharmacy, Uppsala University, Uppsala, Sweden. josefina.nordstrom@farmaci.uu.se
authors.forename: Josefina
authors.initials: J
authors.lastname: Nordström
authors.forename: Ingvild
authors.initials: I
authors.lastname: Klevan
authors.forename: Göran
authors.initials: G
authors.lastname: Alderborn
mesh_terms: D002626:Chemistry, Pharmaceutical / Q000379:methods*; D019245:Compressive Strength; D004339:Drug Compounding / Q000379:methods*; D005079:Excipients / Q000737:chemistry; D008353:Mannitol / Q000737:chemistry; D008962:Models, Theoretical; D015999:Multivariate Analysis; D010316:Particle Size; D011208:Powders / Q000737:chemistry*; D025341:Principal Component Analysis / Q000379:methods; D012965:Sodium Chloride / Q000737:chemistry
chemical_list: D005079:Excipients; D011208:Powders; D008353:Mannitol; D012965:Sodium Chloride