Assessment of the Inter-Batch Variability of Microstructure Parameters in Topical Semisolids and Impact on the Demonstration of Equivalence

Assessment of the Inter-Batch Variability of Microstructure Parameters in Topical Semisolids and Impact on the Demonstration of Equivalence

Demonstration of similar microstructure is essential for demonstrating the equivalence of generic topical products since the microstructure of semisolids may affect the drug release. The objective of this study was to compare the microstructure-defining physical parameters of different batches of a...

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Bibliographic Details
Main Authors: Víctor Mangas-Sanjuán, María Pleguezuelos-Villa, Matilde Merino-Sanjuán, Mª Jesús Hernández, Amparo Nácher, Alfredo García-Arieta, Daniel Peris, Irene Hidalgo, Lluís Soler, Marta Sallan, Virginia Merino
Format: Article
Language:English
Published: MDPI AG 2019-10-01
Series:Pharmaceutics
Subjects:
microstructure
rheology
equivalence
generic semisolid formulation
topical drug
inter-batch variability
Online Access:https://www.mdpi.com/1999-4923/11/10/503

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https://www.mdpi.com/1999-4923/11/10/503

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