Validation of a static Franz diffusion cell system for in vitro permeation studies

Shiow Fern Ng, Jennifer J. Rouse, Francis D. Sanderson, Victor Meidan, Gillian M. Eccleston

Research output: Contribution to journalArticle

106 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)1432-1441
Number of pages10
JournalAAPS PharmSciTech
Volume11
Issue number3
DOIs
Publication statusPublished - Sep 2010

Fingerprint

artificial membranes
ibuprofen
reproducibility
Membranes
Ibuprofen
drugs
cells
Cutaneous Administration
gels
Pharmaceutical Preparations
Artifacts
Gels
Temperature
In Vitro Techniques
temperature
testing
sampling
methodology
Therapeutics
tissues

Keywords

  • franz cell
  • in vitro diffusion cell
  • reproducibility
  • standardisation
  • validation
  • variability

ASJC Scopus subject areas

  • Pharmaceutical Science

Cite this

Validation of a static Franz diffusion cell system for in vitro permeation studies. / Ng, Shiow Fern; Rouse, Jennifer J.; Sanderson, Francis D.; Meidan, Victor; Eccleston, Gillian M.

In: AAPS PharmSciTech, Vol. 11, No. 3, 09.2010, p. 1432-1441.

Research output: Contribution to journalArticle

Ng, Shiow Fern ; Rouse, Jennifer J. ; Sanderson, Francis D. ; Meidan, Victor ; Eccleston, Gillian M. / Validation of a static Franz diffusion cell system for in vitro permeation studies. In: AAPS PharmSciTech. 2010 ; Vol. 11, No. 3. pp. 1432-1441.
@article{fb9032683c1648d189a0a96e5879f771,
title = "Validation of a static Franz diffusion cell system for in vitro permeation studies",
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.",
keywords = "franz cell, in vitro diffusion cell, reproducibility, standardisation, validation, variability",
author = "Ng, {Shiow Fern} and Rouse, {Jennifer J.} and Sanderson, {Francis D.} and Victor Meidan and Eccleston, {Gillian M.}",
year = "2010",
month = "9",
doi = "10.1208/s12249-010-9522-9",
language = "English",
volume = "11",
pages = "1432--1441",
journal = "AAPS PharmSciTech",
issn = "1530-9932",
publisher = "American Association of Pharmaceutical Scientists",
number = "3",

}

TY - JOUR

T1 - Validation of a static Franz diffusion cell system for in vitro permeation studies

AU - Ng, Shiow Fern

AU - Rouse, Jennifer J.

AU - Sanderson, Francis D.

AU - Meidan, Victor

AU - Eccleston, Gillian M.

PY - 2010/9

Y1 - 2010/9

N2 - 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.

AB - 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.

KW - franz cell

KW - in vitro diffusion cell

KW - reproducibility

KW - standardisation

KW - validation

KW - variability

UR - http://www.scopus.com/inward/record.url?scp=78649907180&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=78649907180&partnerID=8YFLogxK

U2 - 10.1208/s12249-010-9522-9

DO - 10.1208/s12249-010-9522-9

M3 - Article

C2 - 20842539

AN - SCOPUS:78649907180

VL - 11

SP - 1432

EP - 1441

JO - AAPS PharmSciTech

JF - AAPS PharmSciTech

SN - 1530-9932

IS - 3

ER -