Abstract
In recent years, the “quality by design” (QbD) approach has been used for developing pharmaceutical formulations. This is particularly important for complex dosage forms such as topical semisolid products. The first step for developing a product using this efficient approach is defining the quality target product profile (QTPP), a list of quality attributes (QAs) that are required to be present in the final product. These quality attributes are affected by the ingredients used as well as manufacturing procedure parameters. Hence, critical material attributes (CMAs) and critical process parameters (CPPs) need to be specified. Possible failure modes of a topical semisolid product can be determined based on the physiochemical properties of ingredients and manufacturing procedures. In this review, we have defined and specified QTPP, QAs, CMAs and CPPs that are required for developing a topical semisolid product based on the QbD approach.
Highlights
The skin is the largest organ of human body and the primary site of action of topical products
ICH Q8 defines quality target product profile (QTPP) as “A prospective summary of the quality characteristics of a drug product that ideally will be achieved to ensure the desired quality, taking into account safety and efficacy of the drug product”. These quality requirements are called quality attributes, and in order to accurately characterize the different components of QTPP, i.e., physicochemical properties, it is imperative to understand which of these can potentially be the critical quality attributes (CQAs) of a formulation
Design of experiment (DoE) is one such structured method that takes into account the effects of the critical material attributes (CMAs) and critical process parameters (CPPs) on the CQAs of the final dosage form [9,10]
Summary
The skin is the largest organ of human body and the primary site of action of topical products. The ICH guideline Q8 definition for QbD is “A systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management” [6] This modern aspect of product design starts with defining a list of quality requirements named the quality target product profile (QTPP). ICH Q8 defines QTPP as “A prospective summary of the quality characteristics of a drug product that ideally will be achieved to ensure the desired quality, taking into account safety and efficacy of the drug product” These quality requirements are called quality attributes, and in order to accurately characterize the different components of QTPP, i.e., physicochemical properties, it is imperative to understand which of these can potentially be the critical quality attributes (CQAs) of a formulation. We will investigate how correct identification and testing of these QAs using standardized methods and sensitive techniques can influence the physical and chemical stability and therapeutic performance of the product in order to mitigate performance failure in topical dermatological products
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
