(533a) Pharmaceutical Process Modeling: Mechanistic Insights of the Impacts of Roller Compaction Process Variables and Material Properties on Product Attributes

Roller compaction (RC) is a dry granulation process that improves powder flowability prior to tableting by increasing material solid fraction (SF) followed by a milling step to produce larger agglomerates. Most of RC process work in pharmaceutical industry is performed empirically which is time consuming and expensive. Recent advances in material characterization, computational resources, and numerical simulation tools have provided the opportunity to develop fast and accurate predictive models for process development and scale-up. However, quantitative understanding of the impacts of RC major process variables, and input powder properties on product attributes is still limited due to complex material behavior. In this talk, a mechanistic model is presented which correlates the SF of compacted material with process variables, and powder compressibility and flow properties. Predictive capability of this model was demonstrated by comparing experimentally generated, and numerically calculated SF of various compacted pharmaceutical materials. Provided that the pertinent process variables and powder flow parameters are used in the equations, this model can be used to predict compacted material’s SF at any RC scale and for any given pharmaceutical material. Alternatively, this approach can be used by both pharmaceutical industrial scientists and practitioners to significantly reduce the costs of process development and scale-up.