Quality by Design: Development of the Quality Target Product Profile (QTPP) for Semisolid Topical Products.
CMAs
CPPs
QTPP
QbD
critical material attributes
critical process parameters
quality by design
quality target product profile
topical formulation
Journal
Pharmaceutics
ISSN: 1999-4923
Titre abrégé: Pharmaceutics
Pays: Switzerland
ID NLM: 101534003
Informations de publication
Date de publication:
23 Mar 2020
23 Mar 2020
Historique:
received:
03
03
2020
revised:
19
03
2020
accepted:
19
03
2020
entrez:
27
3
2020
pubmed:
27
3
2020
medline:
27
3
2020
Statut:
epublish
Résumé
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.
Identifiants
pubmed: 32210126
pii: pharmaceutics12030287
doi: 10.3390/pharmaceutics12030287
pmc: PMC7150996
pii:
doi:
Types de publication
Journal Article
Review
Langues
eng
Déclaration de conflit d'intérêts
The authors declare no conflict of interest.
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