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Open AccessReview

Quality by Design: Development of the Quality Target Product Profile (QTPP) for Semisolid Topical Products

1
Therapeutics Research Group, The University of Queensland Diamantina Institute, The University of Queensland, Woolloongabba, Brisbane 4102, Australia
2
School of Pharmacy and Medical Sciences, University of South Australia, Adelaide 5000, Australia
3
Therapeutics research Centre, Basil Hetzel Institute for Translational Health Research, The Queen Elizabeth Hospital, Adelaide 5011, Australia
*
Author to whom correspondence should be addressed.
These authors contributed equally to this work.
Pharmaceutics 2020, 12(3), 287; https://doi.org/10.3390/pharmaceutics12030287 (registering DOI)
Received: 3 March 2020 / Revised: 19 March 2020 / Accepted: 19 March 2020 / Published: 23 March 2020
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. View Full-Text
Keywords: quality by design; QbD; quality target product profile; QTPP; topical formulation; critical material attributes; CMAs; critical process parameters; CPPs quality by design; QbD; quality target product profile; QTPP; topical formulation; critical material attributes; CMAs; critical process parameters; CPPs
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MDPI and ACS Style

Namjoshi, S.; Dabbaghi, M.; Roberts, M.S.; Grice, J.E.; Mohammed, Y. Quality by Design: Development of the Quality Target Product Profile (QTPP) for Semisolid Topical Products. Pharmaceutics 2020, 12, 287.

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