Zsofia Nemeth

University of Szeged, Hungary

Title: How can the application of the Quality by Design approach assist the design and development process of liposomes?

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Biography

Zsófia Németh graduated as a pharmacist and an English-Hungarian medical translator and interpreter at the University of Szeged in 2018 and is currently a third-year Ph.D. student in the Doctoral School of Pharmaceutical Sciences under Ildikó Csóka’s and Edina Pallagi’s supervision at the University. Her interest in pharmaceutical-, and nanotechnology began in 2015 when she joined the nanomedicine research group of the Institute of Pharmaceutical Technology and Regulatory Affairs and has remained unbroken ever since. In her research work, she follows the Quality by Design quality management model principles and works on developing and investigating liposomal formulations. Her scientific research work is supported by the Gedeon Richter’s Talentum Foundation. In addition to the scientific activities, social interactions are also crucial for Zsófia; thus, she assumes the president’s duties in the János Kabay College for Advanced Studies of the Faculty since September 2019.

Abstract

Although liposomes, nanoscale drug delivery systems, significantly contributed to medical technology progression, specified regulatory authorization processes are still missing in their case. The Quality by Design (QbD) approach maintains the quality of the products by following risk?management-based strategies during the development and manufacturing phases, systematizes the required knowledge and rationalizes the experiments, thus improving the pharmaceutical formulation processes.

This study applies the QbD method to systemize the essential factors of the liposome formulation process. It determines the Quality Target Product Profile (QTPP) of a liposome-based formulation; the Critical Quality Attributes (CQAs) of the vesicles; the potential Material Attributes (MAs); and the Process Parameters (PPs) of the thin?film hydration manufacturing method that might influence the properties of the endproduct.

After the aimed QTPP is created, and the CQAs are defined, the critical factors (CMAs, CPPs) can be chosen from the list of MAs and PPs by performing a Risk Assessment (RA).

In this general case, the quality of phospholipids, the active substance content, the surface modifiers, the ratio between the phospholipids and the cholesterol, the phase transition temperature of the lipophilic phase, the quality of the hydration media and the cryoprotectant were identified as the most affecting CMAs; while the working temperature, the time of sonication and the number of filtrations as the basic CPPs. The effectiveness of the RA?based experimental design can be proved by investigations (size, surface charge, thermodynamic behaviour and structural analyses).

The work shows the critical points of the thin-film hydration technique-based liposome formulation process. Thereby, it presents how the QbD methodology could help achieve the aimed quality of the pharmaceutical products.