Amelie Mattusch, M.Sc.

Contents

Abstract

For many pharmaceutical applications a rapid dissolution of an active pharmaceutical ingredient (API) is desired, since only dissolved API molecules can diffuse through living tissue and reach their target site [1]. Therefore, the understanding of the basic dissolution process is crucial for an enhanced drug formulation development in a targeted manner.
 

Description

The dissolution itself is defined as the drug release into the surrounding fluid. Therefore, this is a critical quality attribute with respect to the implementation of Quality-by-Design concepts during the drug development phase and for formulation aspects of the drug product. Dissolution is a heterogeneous process, which can be described by different phases (Fig. 1) and is either driven by limitations in the surface reaction layer or the diffusion layer [1,2]. The impact factors defining the dominant mechanism are not fully enlightened so far. However, the influence of the hydrodynamics of the surrounding fluid is crucial in this context [3].

Within the scope of this work a new apparatus for a sensitive and robust determination of the dissolution behavior is constructed. Using this flow channel device, the limitations and mechanisms of the drug dissolution can be investigated and characterized. Also the dissolution shall be described based on hydrodynamics and material properties.
 

References

1. Siepmann, J. et al., Mathematical modeling of drug dissolution, Int J Pharm 453: 12-24 (2013)
2. Paus, R., Solubility and Dissolution of Pharmaceuticals, dissertation (2015)
3. Higuchi, W.I., Diffusional models unseful in biopharmaceutics, J Pharm Sci 56: 315-324 (1967)

Curriculum Vitae