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M. Sc. Maximilian Zäh

M. Sc. Maximilian Zäh Foto von M. Sc. Maximilian Zäh

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+49(231)755-6186

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Fakultät Bio- und Chemieingenieurwesen
Emil-Figge-Str. 70
44227 Dortmund

Raum G2-114a

Thermodynamic Aspects in the Solubilisation of Biopharmaceutics

Abstract:

 

Many biopharmaceutical substances are administered to the patient as liquid formulations. When it comes to long-term stability, liquid dosage forms reach their limits. To increase stability, drying methods are used that reduce the water content in the formulation and at the same time increase the stability of the biopharmaceutical. Freeze-drying offers a particularly gentle method. This project deals with the characterization of the freeze-drying process and the influence of additives on the stability and solubilization of the biopharmaceuticals in the dried formulation. [1]

max_zaeh_project

Figure 1: example of an antibody and the stabilisation theories, with equilibrium driven approach and kinetic approach

Description:

 

Two different stabilisation theories are discussed for the stabilisation of biopharmaceuticals. A kinetic and an equilibrium-based approach can be assumed. In the kinetic approach, the degradation of the biopharmaceuticals is related to the viscosity of the freeze-dried formulation. In the equilibrium-based approach, the interactions between biopharmaceuticals and additives are identified as decisive factors for solubilization and increased stability. [2]

Both approaches will be investigated in this project and the knowledge gained will be used to accelerate and improve the development of new formulations.

References:

[1] A. Arsiccio, R. Pisano:
“The Preservation of Lyophilized Human Growth Hormone Activity: how Do Buffers and Sugars Interact?”
Pharmaceutical research, 2018, 35, 131.
[2] Chang, L.L.; Shepherd, D.; Sun, J.; Ouellette, D.; Grant, K.L.; Tang, X.C.; Pikal, M.J.l:
“Mechanism of protein stabilization by sugars during freeze-drying and storage: native structure preservation, specific interaction, and/or immobilization in a glassy matrix? ”
Journal of Pharmaceutical Sciences, 2005, 94, 1427–1444.

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Funding:

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