Validation of a Static Franz Diffusion Cell System for <Emphasis Type="Italic">In Vitro</Emphasis> Permeation Studies |
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Authors: | Shiow-Fern Ng Jennifer J Rouse Francis D Sanderson Victor Meidan Gillian M Eccleston |
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Institution: | (1) Faculty of Pharmacy, Universiti Kebangsaan Malaysia, Kuala Lumpur, 50300, Malaysia;(2) Strathclyde Institute of Pharmacy and BioMedical Sciences, University of Strathclyde, Glasgow, G4 0NR, Scotland, UK;(3) Pharmaceutical Development, GlaxoSmithKline, Harlow, CM19 5AW, UK |
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Abstract: | Over the years, in vitro Franz diffusion experiments have evolved into one of the most important methods for researching transdermal drug administration.
Unfortunately, this type of testing often yields permeation data that suffer from poor reproducibility. Moreover, this feature
frequently occurs when synthetic membranes are used as barriers, in which case biological tissue-associated variability has
been removed as an artefact of total variation. The objective of the current study was to evaluate the influence of a full-validation
protocol on the performance of a tailor-made array of Franz diffusion cells (GlaxoSmithKline, Harlow, UK) available in our
laboratory. To this end, ibuprofen was used as a model hydrophobic drug while synthetic membranes were used as barriers. The
parameters investigated included Franz cell dimensions, stirring conditions, membrane type, membrane treatment, temperature
regulation and sampling frequency. It was determined that validation dramatically reduced derived data variability as the
coefficient of variation for steady-state ibuprofen permeation from a gel formulation was reduced from 25.7% to 5.3% (n = 6). Thus, validation and refinement of the protocol combined with improved operator training can greatly enhance reproducibility
in Franz cell experimentation. |
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