The Study of Mixing and Initial Granule Formation During High Shear Granulation of Pharmaceutical Powders
Doctor of Philosophy
Chemical and Biochemical Engineering
Dr. Lauren Briens
Wet granulation is the agglomeration of particles using a liquid binder to form granules. The process is extensively used in the pharmaceutical industry to manufacture tablets, as granulation minimizes segregation, dust, and improves flowability. Granule uniformity is important in pharmaceutical manufacturing, as the tablet must contain a uniform distribution of excipients in the product in order to comply with United States Food and Drug Administration (FDA) regulations. The research presented in this thesis focuses on the influence of formulation and process parameters on granule formation. Sugar spheres were initially used to study segregation during the dry mixing phase of high shear granulation. The effect of formulation, specifically the effect of any hygroscopic components, was studied through drop penetration measurements using heterogeneous powder beds of varying hygroscopicity. The results were compared to theoretical models in the literature and led to improvements in the models through the introduction of a semi-empirical parameter. The effects of both process parameters and formulation were then combined in a final study. The conclusions from this research provide guidance for the selection of process parameters to promote the formation of optimal granule nuclei which can then grow into final granules with specific properties and provide information on the effect of formulation that can be used in development.
Alkhatib, Aveen, "The Study of Mixing and Initial Granule Formation During High Shear Granulation of Pharmaceutical Powders" (2015). Electronic Thesis and Dissertation Repository. 2720.