title: Quality by design (QbD) approaches for the compression step of tableting.
abstract: BACKGROUND
  Although tableting is one of the most commonly used processes in drug manufacturing, the tablet formation process is still not fully understood, nor can it be fully controlled.
  
  
  METHODS
  In this paper, recent approaches to correlate tablet mechanical properties with process parameters are discussed, covering (mainly) the last 5 years. These approaches are the basis for a future of rational formulation strategies, which may lead to optimum tablet properties within a shorter timescale, in contrast to the present empirical approach. The reader will on one hand gain an insight into current parameterization of the tableting process and evaluation strategies and on the other hand will gain an impression of the difficulties connected to the interpretation of a physically complex process and its impact on predictive modeling.
  
  
  CONCLUSIONS
  The main consolidated findings are that even when using multivariate statistical approaches, it cannot be expected to find a global evaluation method that fully explains the mechanism of tableting, but that careful sequential evaluation is required. For further improvement, there is a need to use more complex models and alternative technologies, in order to increase both tablet quality and productivity.
authors.affiliation: University of Tromsoe, Department of Pharmacy, Drug Transport and Delivery Research Group, N-9037 Tromsoe, Norway. ingunn.tho@uit.no
authors.forename: Ingunn
authors.initials: I
authors.lastname: Tho
authors.forename: Annette
authors.initials: A
authors.lastname: Bauer-Brandl
mesh_terms: D004339:Drug Compounding; D011312:Pressure; D013607:Tablets; D013718:Tensile Strength
chemical_list: D013607:Tablets