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Review
. 2020 Mar 23;12(3):287.
doi: 10.3390/pharmaceutics12030287.

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

Sarika Namjoshi  1 , Maryam Dabbaghi  1 , Michael S Roberts  1   2   3 , Jeffrey E Grice  1 , Yousuf Mohammed  1
Affiliations
Review

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

Sarika Namjoshi et al. Pharmaceutics. .

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.

Keywords: CMAs; CPPs; QTPP; QbD; critical material attributes; critical process parameters; quality by design; quality target product profile; topical formulation.

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
The quality by design (QbD) approach for the development of topical semisolid products. critical process parameters (CPPs) and critical material attributes (CMAs) govern the individualized QTPP for a product.
See this image and copyright information in PMC

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