2010
DOI: 10.18433/j3ws33
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A New Discriminative Criterion for the Development of Franz Diffusion Tests for Transdermal Pharmaceuticals

Abstract: -PURPOSE.In vitro skin/membrane permeation profiling of topical pharmaceuticals is an important overall quality attribute in the evaluation of product consistency and it is also used for IVIVR (in vitro -in vivo relationship) purposes in product development and change control. Franz diffusion cell (FDC) experiments are emerging as a generally accepted methodology in this field, where the choice of operational conditions requires a data-supported justification towards the discriminating power of the test. A res… Show more

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Cited by 50 publications
(23 citation statements)
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“…This was performed by plotting three standard curves, each constructed by the five different hormone concentrations of the work solutions (i.e., 14,17,20,23, and 26 µg mL −1 for T in T emuls ; 35, 42.5, 50, 57.5, and 65 µg mL −1 for P in P emuls ; 14, 17, 20, 23, and 26 µg mL −1 for E2 in E emuls , and Biest; 56, 68, 80, 92, and 104 µg mL −1 for E3 in Biest). For this purpose, the data for each concentration range after fitting by the ordinary least-squares method were statistically evaluated; this method accounted for homoscedasticity (Cochran's test), residues' normality (Shapiro-Wilk test), and the lack of fit test (analysis of variance, ANOVA).…”
Section: Linearitymentioning
confidence: 99%
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“…This was performed by plotting three standard curves, each constructed by the five different hormone concentrations of the work solutions (i.e., 14,17,20,23, and 26 µg mL −1 for T in T emuls ; 35, 42.5, 50, 57.5, and 65 µg mL −1 for P in P emuls ; 14, 17, 20, 23, and 26 µg mL −1 for E2 in E emuls , and Biest; 56, 68, 80, 92, and 104 µg mL −1 for E3 in Biest). For this purpose, the data for each concentration range after fitting by the ordinary least-squares method were statistically evaluated; this method accounted for homoscedasticity (Cochran's test), residues' normality (Shapiro-Wilk test), and the lack of fit test (analysis of variance, ANOVA).…”
Section: Linearitymentioning
confidence: 99%
“…The validated methods were then employed for in vitro drug release tests, where biorelevant media were prepared according to the procedure described by Baert et al 14 To select the most suitable medium for each product/emulsion, the following compositions were used: 0.01 M phosphate buffered saline, pH 7.4 (NaCl-138.0 mM; KCl-2.7 mM; KH 2 PO 4 -1.43 mM; Na 2 HPO 4 -8.57 mM); artificial human sweat (NaCl-49.96 mM; CaCl 2 -0.15 mM; MgSO 4 -1.0 mM; KH 2 PO 4 -7.5 mM); simulated body fluid (NaCl-136.8 mM; KCl-3.0 mM; CaCl 2 -2.5 mM; MgCl 2 -1.5 mM; Na 2 SO 4 -0.5 mM; NaHCO 3 -4.2 mM; KH 2 PO 4 -1.0 mM). The solubility of these compositions was also determined with additional measurements using bovine serum albumin (BSA) or hydroxypropyl-β-cyclodextrin (HPBCD) as the medium, resulting in a total of nine different media samples.…”
Section: Selection Of Receptor Medium For In Vitro Release Testsmentioning
confidence: 99%
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“…The preparation of the receptor media were according to Baert et al (2010) 17 and the exact compositions of the same (aqueous solutions) are described in Table 1.…”
Section: Selection Of Receptor Media For In Vitro Drug Release Testingmentioning
confidence: 99%
“…In order to develop a new formulation, it is necessary to assess the quality of the bio-active molecules. Among the specific tests conducted for the quality assessment of transdermal emulsions, 17 the in vitro drug release carried out in Franz-type diffusion cell is widely used. Such a test can estimate the release of drugs from semisolid systems into synthetic skin and predict the percutaneous systemic absorption of topically applied active compounds.…”
Section: Introductionmentioning
confidence: 99%