Optimization and development of stable w/o/w cosmetic multiple emulsions by means of the Quality by Design approach

Abstract

The preformulation experiment is the part of a development plan. On the basis of these results, the control strategy can be defined and a stable multiple emulsion can be ensured that meets the relevant stakeholders' quality expectations.

Development of nanostructured lipid carriers containing salicyclic acid for dermal use based on the Quality by Design method

“…The Pareto chart shows the relationships between CMAs or CPPs and CQAs, respectively and it can be used to determine the most critical parameters to be controlled for be during the drug development process. Screening of parameters and defining the critical control points were carried out by the LeanQbD™ software (QbD Works LLC, Fremont, CA, USA) (Kovacs, A. et al, 2016, Pallagi, E. et al, 2015.…”

“…Therefore, the QbD approach is more proactive and refers to a systematic process compared to the mainly empirical methodologies used earlier (Beg, S. et al, 2015, Shah, B. et al, 2015, Xu, X. et al, 2011Xu, X. et al, 2012, Kan, S. et al, 2014, Wang, J. et al, 2015, Kovacs, A et al, 2016. Risk assessment and the Design of Experiments (DoE) techniques within the risk assessment process are key elements of QbD methodology (Fig.1).…”

Initial Risk Assessment as part of the Quality by Design in peptide drug containing formulation development

“…The aim of this study was to evaluate the role of RA in the case of the development of a Liraglutide drug delivery system for oral administration. Based on a careful collection, selection and evaluation of the relevant literature together with the previous developments of the research group in this field [7][23] [24], we aimed to set up a strategic flow chart with proposed RA function and decision steps. The selected pilot study focused on novel Liraglutide loaded PLGA NPs prepared by means of the double emulsion solvent evaporation method and the application of the QbD concept in order to optimize the formulation by evaluating the effect of different formulation and process parameters on the quality of the prepared PLGA NPs.…”

New aspects of developing a dry powder inhalation formulation applying the quality-by-design approach

“…As the output of the RA evaluation, Pareto diagrams [28] were generated showing the ranked parameters according to their potential impact on product quality. Using this software-based evaluation is relatively new in the literature [6,29].…”