Sponsor: Industrial cooperation project, F.Hoffmann-La Roche
Contact person: Marie Brunotte
Summary of the overall project:
The production of tablets, the most commonly used dosage form, is carried out using rotary presses with the aim of achieving high production capacity while precisely maintaining the critical quality attributes of the tablet properties, in particular strength, disintegration time and release kinetics. The challenge of efficient production is that less time is available for the compaction process of the powder between pressing tools with higher production speeds. Depending on the material and its properties, the desired physicochemical and mechanical properties of the tablets depend not only on the compression pressure but also to varying degrees on the loading and unloading speed and the time of maximum loading. In addition to deviations in the critical quality attributes, this can also lead to drastic effects such as tablet defects due to delamination or capping.
As part of this project, compression data are systematically and meaningfully evaluated in order to characterize the effects of compression kinetics on material deformation behavior and product properties. Various pure materials combinations of actives and excipients are systematically investigated for the deformation mechanisms that occur and the susceptibility to kinetic compression parameters, using a compaction simulator. In addition, a method for transferring the process parameters of the compaction simulator to rotary tablet presses is to be developed. The aim is to overcome measurement and evaluation challenges, to depict the material-process-product property relationships in a categorization system, and to develop an algorithm for user-friendly evaluation of experimental data.
Goals and tasks of iPAT:
Project partner: F.Hoffmann-La Roche