Please use this identifier to cite or link to this item:
Title: Rheology by Design: A Regulatory Tutorial for Analytical Method Validation
Authors: Simões, Ana
Miranda, Margarida 
Cardoso, Catarina 
Veiga, Francisco 
Vitorino, Carla 
Keywords: rheology; method validation; equipment qualification; topical dosage forms; regulatory requirements
Issue Date: 28-Aug-2020
Publisher: MDPI
Project: research grant PD/BDE/135074/2017 assigned by FCT (Fundação para a Ciência e a Tecnologia) and Dendropharma, Investigação e Serviços de Intervenção Farmacêutica, Sociedade Unipessoal Lda, from Drugs R&D Doctoral Program 
PD/BDE/135075/2017 assigned by FCT and Laboratórios Basi from Drugs R&D Doctoral Program. 
Serial title, monograph or event: Pharmaceutics
Volume: 12
Issue: 9
Abstract: The increasing demand for product and process understanding as an active pursuit in the quality guideline Q8 and, more recently, on the draft guideline on quality and equivalence of topical products, has unveiled the tremendous potential of rheology methods as a tool for microstructure characterization of topical semisolid dosage forms. Accordingly, procedure standardization is a dire need. This work aimed at developing and validating a methodology tutorial for rheology analysis. A 1% hydrocortisone cream was used as model cream formulation. Through a risk assessment analysis, the impact of selected critical method variables (geometry, temperature and application mode) was estimated in a broad range of rheological critical analytical attributes-zero-shear viscosity, upper-shear thinning viscosity, lower-shear thinning viscosity, infinite-shear viscosity, rotational yield point, thixotropic relative area, linear viscoelastic region, oscillatory yield point, storage modulus, loss modulus, and loss tangent. The proposed validation of the approach included the rheometer qualification, followed by the validation of numerous operational critical parameters regarding a rheology profile acquisition. The thixotropic relative area, oscillatory yield point, flow point and viscosity related endpoints proved to be highly sensitive and discriminatory parameters. This rationale provided a standard framework for the development of a reliable and robust rheology profile acquisition.
ISSN: 1999-4923
DOI: 10.3390/pharmaceutics12090820
Rights: openAccess
Appears in Collections:FFUC- Artigos em Revistas Internacionais
I&D CQC - Artigos em Revistas Internacionais
I&D CNC - Artigos em Revistas Internacionais

Show full item record

Page view(s)

checked on Sep 25, 2023


checked on Sep 25, 2023

Google ScholarTM




This item is licensed under a Creative Commons License Creative Commons