Dr. Karsten Flügel

Contents

Abstract

The formation of amorphous solid dispersions (ASDs) is a common technique to overcome poor solubility of new drugs. Although some preparation methods to generate ASDs (e.g. hot-melt extrusion, spray drying) are well known for decades and are already well established in the pharmaceutical industry, the downstream processing of the obtained intermediates is often neglected in literature. This work is focusing on the downstream processing of hot-melt extrudates into immediate release tablets as the final dosage form.
 

Description

During the hot-melt extrusion process the drug is incorporated into a molten polymeric carrier and processed through a die. To generate immediate release tablets from hot-melt extruded ASDs, the obtained hot extrudates need to be cooled, milled, mixed with suitable excipients and compressed into tablets. Some of these processes, however, cause a very high energy input into the material and therefore are potentially able to alter the amorphous state or induce crystallization. The aim of this research is to investigate the impact of such processes on the properties of the intermediates such as physical stability, dissolution behavior and mechanical properties as well as to systematically evaluate excipient selection for direct compression.

Curriculum Vitae