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In Silico Product Design Of Pharmaceuticals

Authors: Johan Boetker, Dhara Raijada, Johanna Aho, Milad Khorasani, Soren V. Sogaard, Laerke Arnfast, Adam Bohr, Magnus Edinger, Jorrit J. Water, Jukka Rantanen

Abstract:

The increasing demand for personalized medicine necessitates the production of easily customizable dosage forms. As the number of possible dosage forms may scale toward infinity, their uniqueness requires a versatile production platform and numerical simulation in order to be manufactured efficiently. A mathematical description of these systems is the only feasible approach to manage such diverse properties of different products. However, experimental verification is still essential for evaluation of processability and related concomitant phenomena, such as possible solid state changes that may occur during production and storage.

Keywords

Personalized medicine; Simulation; Rheology; Imaging; Continuous manufacturing; Extrusion.

Citation: Johan Boetker, Dhara Raijada, Johanna Aho, Milad Khorasani, Soren V. Sogaard, Laerke Arnfast, Adam Bohr, Magnus Edinger, Jorrit J. Water, Jukka Rantanen In Silico Product Design Of Pharmaceuticals http://dx.doi.org/10.1016/j.ajps.2016.02.010

Received: 8 October 2015, Accepted: 14 February 2016, Available online: 18 March 2016

Copyright: © 2016 Production and hosting by Elsevier B.V. on behalf of Shenyang Pharmaceutical University. This is an open access article under the CC BY-NC-ND license(http://creativecommons.org/licenses/by-nc-nd/4.0/).

Conclusions

It has been demonstrated that in silico based product design principles can be successfully applied to visualize both deformation and stresses on extruded systems as well as to assess the dissolution rate from the extruded product. Experimental investigations can be used to provide complimentary information on the solid state properties, such as dehydration kinetics of the extruded product, and to establish the means for achieving continuous monitoring and production of the product. In addition, rheological evaluation of molten polymer based products is crucial in determining optimal HME processing conditions. A computational approach combined with experimental investigations conveys several advantages that are indeed required in the pursuit of designing the future manufacturing solutions within the area of personalized medicine. Finally, a PAT approach is a prerequisite for robust quality control of personalized medicines.

Acknowledgements

This study was funded by The Danish Council for Independent Research (DFF), Technology and Production Sciences (FTP), Project 12-126515/0602-02670B (2013–2017) and the Lundbeck Foundation, project R108-A108760.

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