Pilot Equivalence Study Comparing Different Batches of Topical 0.025% Capsaicin Emulsion: Product Microstructure, Release, and Permeation Evaluation

Pilot Equivalence Study Comparing Different Batches of Topical 0.025% Capsaicin Emulsion: Product Microstructure, Release, and Permeation Evaluation

The European Medical Agency (EMA) has issued a draft guideline on the quality and equivalence of topical products. The equivalence for complex semisolid formulations involves several steps: the same quantitative content, the same microstructure, the same release, and permeation profile. In this pape...

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Bibliographic Details
Main Authors: Francesc Navarro-Pujol, Sanja Bulut, Charlotte Hessman, Kostas Karabelas, Carles Nieto, Francisco Fernandez-Campos
Format: Article
Language:English
Published: MDPI AG 2021-12-01
Series:Pharmaceutics
Subjects:
extended pharmaceutical equivalence
equivalence topical products
capsaicin
in vitro release
in vitro permeation
rheology
Online Access:https://www.mdpi.com/1999-4923/13/12/2083

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