Model-based approach to the design of pharmaceutical roller-compaction processes.

This work presents a new model based approach to process design and scale-up within the same equipment of a roller compaction process. The prediction of the operating space is not performed fully in-silico, but uses low-throughput experiments as input. This low-throughput data is utilized in an iterative calibration routine to describe the behavior of the powder in the roller compactor and improves the predictive quality of the mechanistic models at low and high-throughput. The model has been validated with an experimental design of experiments of two ibuprofen formulations. The predicted sweet spots in the operating space are in good agreement with the experimental results.

Model-based NIR spectroscopy implementation for in-line assay monitoring during a pharmaceutical suspension manufacturing process.

The implementation of Process Analytical Technology (PAT) instruments is generally achieved stochastically. Sub-optimal PAT locations could introduce variation in the measurements which is not related to the analyte of interest. For this reason, rational approaches should be considered to establish an optimal sensor placement where relevant measurements are possible and the impact of disturbances is minimized. The aim of this paper is to demonstrate how mechanistic modelling can support appropriate sensor implementation by means of a case study. A PAT method was developed for a bottle filling process of a pharmaceutical formulation with the goal of increasing the yield of the process by gaining process understanding and redefining the endpoint of the process. To ensure proper measurements, an advanced measuring interfacing was assembled. The design of this device was rationalized with the help of a model-based approach using three-dimensional Computational Fluid Dynamics modeling. This allows to maximize the performance of the PAT method and exploit its full benefits.

Characteristics and performance of a "universal" membrane suitable for gas separation, pervaporation, and nanofiltration applications.

The large diversity of membrane separation processes results in a different optimization of membrane materials and structures for each process. In this article, the extent to which a single membrane type can be used in gas separation, pervaporation, and nanofiltration has been investigated. Interpretation of transport and separation properties has led to the conclusion that the membrane SolSep 3360 is a multifunctional membrane fulfilling all requirements for the three separation processes. This can be achieved by keeping a good balance between the thickness of the top layer, sterical hindrance during transport, and the effect of hydrophobicity/hydrophilicity.