Process knowledge discovery tools in compliance with Quality by Design concept.

Implementation of Experimental Design Methodology in the Compatibility Study of Hydrocortisone With Selected Excipients Used in Solid Dosage Forms

“…The development of the pharmaceutical formulations in accordance with the QbD concept allows gaining knowledge about the drug product and better understanding the impact of physicochemical properties of pharmaceutical raw materials on the final drug product quality [6,12,16]. The Quality by Design concept is a scientific, rational, knowledge-based approach to the drug product development [2,7,15,17,23]. Regarding the current trends in industrial pharmacy, this paper considers the application of experimental design methodology (Design of Experiments (DoE), Experimental Design (ED)) as a tool enabling the implementation of the Quality by Design concept at the formulation studies [1,4,9,13,21].…”