Inter‐ and intralaboratory variation of in vitro diffusion cell measurements: An international multicenter study using quasi‐standardized methods and materials

Chilcott, Robert P.; Barai, Namrata D.; Beezer, Anthony E.; Brain, Sally Innis; Brown, Marc; Bunge, Annette L.; Burgess, S.E.; Cross, Sheree E.; Dalton, Christopher H.; Dias, M; Farinha, A.; Finnin, Barrie C.; Gallagher, Simon; Green, D. M.; Gunt, Hemali B.; Gwyther, Robert; Heard, Charles Martin; Jarvis, C. A.; Kamiyama, Fumio; Kasting, Gerald B.; Ley, Eugene E.; Lim, S. T.; Mcnaughton, Graham Stephen; Morris, Andrew; Nazemi, Mohammed Husein; Pellett, Mark; Plessis, Jeanetta du; Quan, Ying‐Shu; Raghavan, Srini; Roberts, Michael S.; Romonchuk, Wayne J.; Roper, Clive; Schenk, Denis; Simonsen, Lene; Simpson, A. H. R. W.; Traversa, B. D.; Trottet, Lionel; Watkinson, Adam C.; Wilkinson, Simon C.; Williams, Faith M.; Yamamoto, Akira; Hadgraft, Jonathan

doi:10.1002/jps.20229

Cited by 61 publications

(37 citation statements)

References 16 publications

(21 reference statements)

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“…GlaxoSmithKline cells with steeper side arms showed slower dye dispersion within the 60.0±4. 6 22 For laboratories with CV less than 5%, 10% and 20% (12) side arm. Inadequate mixing in the side arm hinders receptor phase homogeneity yielding high variability when sampling.…”

Section: Discussionmentioning

confidence: 99%

“…A 10-mg mass of finely ground potassium permanganate powder was gently deposited into each receptor cell. The times taken for the dye to spread uniformly throughout the main receptor cell chamber and sidearm at arbitrary low (1.5, 3), medium (5, 7), high (10,11) and very high (12,14) speeds were recorded.…”

Section: Stirrer Efficiency and Dye Spreading Measurementsmentioning

confidence: 99%

“…Methylparaben was the test penetrant, while a minimally prescriptive protocol was employed to obtain mean flux values. Interestingly, the CV between laboratories was 35% (12). These variabilities have been explained as being caused by differential experimental setup and operator training, as the synthetic membranes are of precise manufacture (12).…”

Section: Introductionmentioning

confidence: 99%

“…Interestingly, the CV between laboratories was 35% (12). These variabilities have been explained as being caused by differential experimental setup and operator training, as the synthetic membranes are of precise manufacture (12). Current regulatory guidelines offer only partial standardisation of in vitro skin absorption studies (13).…”

Section: Introductionmentioning

confidence: 99%

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Validation of a Static Franz Diffusion Cell System for In Vitro Permeation Studies

et al. 2010

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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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Section: Discussionmentioning

confidence: 99%

Section: Stirrer Efficiency and Dye Spreading Measurementsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Validation of a Static Franz Diffusion Cell System for In Vitro Permeation Studies

et al. 2010

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“…Also, that model was developed based on the Flynn database that contains human skin permeability results collected from many research groups using diverse experimental conditions. As it was shown in several studies [11][12][13], the difference between permeability data measured in various laboratories can exceed by an order of magnitude, therefore the prediction potential of this model is not proved yet.…”

Section: Introductionmentioning

confidence: 94%