Dept. 3 - Formulation and Packaging Technology

Special focus is on the development of strategies for formulating poorly soluble active ingredients (API) and biomolecular drugs. To improve the bioavailability of poorly soluble API they are, for instance, processed into nanoscale suspensions or incorporated into colloidal carriers. The che­mical stability of the drug and the physicochemical integrity of the for­mulations are controlled to ensure storage stability and applicability at the intended site of administration.

Biomolecular drugs such as proteins are excellent candidates for the development of personalized medicines. Due to the complex and delicate structure of those macromolecules and their sensitivity towards processing, the development of stable and patient-convenient drug products is an important but challenging goal.

The fundamental comprehension of the respective formulation, its ingredients and their mutual interactions as well as a profound under­standing of the manufacturing processes from an engineering point of view will provide strategies for developing effective and cost-efficient medicines.

The spectrum of available techniques includes production methods (e.g. milling, high pressure homogenization, spray drying, lyophilization, granulation, tabletting), physicochemical and process characterization (e.g. particle size analysis, X-ray scattering, calorimetry, microscopy, HPLC, μ-PIV), the evaluation of pharmaceutical product properties such as drug release and cell culture permeation experiments, as well as theoretical approaches like molecular modeling and computational fluid dynamics.

left: Analysis of multi-layer tableting with a compaction simulator; right: Stirred media mill (visualization of milling bead movement)

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