Implementation of Patient Reported Outcome Measures (PROMs) in QbD based formulation development in ophthalmology

Abstract

Development of drug delivery systems for chronic disorders needs a complex thinking in order to ensure the quality of the product. A multidisciplinary approach of pharmaceutical technology, regulatory and behavioral sciences on the basis of the Quality by Design methodology can be a proper tool for this to handle formulators’, patients’, and also doctors’ needs in therapy planning in case of chronic ophthalmologic disorders. According to the present state-of-the-art”, patient perceptions are collected in the form of the “Patient Reported Outcome Measurements” during the clinical trials, but no feedback is given to the formulation development in order to take these aspects into consideration when designing a new product. This work aims to link the key performance indicators from patients’ point of view to the pharmaceutical development and show a new approach to product development by evaluating the patient and formulator aspect as critical quality attributes within the classical Quality by Design workflow. This study can be the basis of the formulation design and development of a new ophthalmic formulation as it revealed the patient critical needs and requirement.