DPhG-FFQM Quality of Medicines Award 2023
The winners of this year’s prize for promoting drug quality are Sophie Luise Meiser and Jonas Pielenhofer from the working group of Prof. Dr. Peter Langguth, Institute for Biopharmacy and Pharmaceutical Technology at Johannes Gutenberg University, Mainz. Both submitted work in the area of „Quality-by-Design (QbD), Nanotechnology / Clinical Pharmacy“, which was carried out by an interdisciplinary research group.
Pielenhofer accepted the award at the DPhG annual conference in Tübingen on behalf of those involved in the project.
In addition to Prof. Langguth’s working group, Internal Medicine III, the Dermatology Clinic and the Institute of Immunology at Mainz University Medical Center were also involved in the project.
According to the quality-by-design concept, a new nanoparticulate emulsion gel with the very poorly soluble active ingredient imiquimod was developed with the aim of producing an optimized test preparation with reproducible high quality.
The retrospective validation was carried out on 13 batches of the investigational product and impressively demonstrated the validity and robustness of the GMP-compliant production. In a clinical phase I/II study planned as an Investigator Initiated Trial with >80 patients with the indication “actinic dermatosis”, the nano investigational preparation was tested against the comparison preparation and showed the same effectiveness and significantly better tolerability.
We congratulate the award winners on the results of this very interesting project, which, in addition to QbD-based product development and ensuring the quality of medicines, also includes safe use by patients. It is therefore a very good example of how the quality of medicines can be improved through targeted measures.
The project results are summarized in several publications, the following of which were submitted with the application:
„Quality by Design (QbD) approach for a nanoparticulate imiquimod formulation as an investigational medicinal product” und
„Complaint management of a quality defect in a nanoparticulate imiquimod formulation in an investigator initiated academic phase I/II clinical trial”.
Description of the project Link
