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pps proceeding
Symposium: Polymer Processing in Pharmacy
Poster Presentation
 
 

Melt Rheology of Selected Pharmaceutical Polymers

Troiss Alexander (1), Treffer Daniel (1), Khinast Johannes (2)*

(1) TU Graz - Styria - Austria, (2) TU Graz & RCPE GmbH - Styria - Austria

Hot melt extrusion (HME) is a process with fast increasing importance for the pharmaceutical industry. The significance is due to the fact that HME is a robust production process for solid dispersions. These products comprise active pharmaceutical ingredient, carrier polymer and additives and are an approach to tackle current drug development challenges, such as the improvement of bioavailability of poorly water soluble APIs or modified API release. In process design, it is necessary to understand the thermoplastic melt flow behavior. For example, the extrusion die is designed based on viscosity data for a given formulation, so that the requested target throughput can be reached without exceeding the maximum extrusion pressure. However, in the openly accessible literature very little is published concerning the flow behavior of polymers relevant to pharmaceutical HME. Therefore, the aim of this study is to characterize the rheological properties of selected polymers to provide data for process equipment design. The polymers KollidonŽVA64, Soluplus (BASF SE), EudragitŽE (Evonik Industries AG) and EVA Rowalit R 300-1/28 (Rowak AG) are chosen for detailed analysis. The measurements were carried out using a rotational rheometer. A vacuum compression molding device was used for sample preparation. All analyzed samples showed shear thinning behavior and decreasing viscosity with increasing temperature. The measurements showed excellent reproducibility as the standard deviation between repetitions is lower than 3%. All data were fitted to the Carreau-Yasuda viscosity model, which proved to be a suitable choice for all investigated polymers. The Williams Landel Ferry model was found to provide a good description of the temperature dependence. The applicability of the time-temperature superposition principle was checked using the van Gurp and Palmen analysis. Thus, the study provides reliable data, which can be applied for process development and simulation purposes.