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. 2022 Nov 26;14(23):5146.
doi: 10.3390/polym14235146.

Characterization of an In Vitro/Ex Vivo Mucoadhesiveness Measurement Method of PVA Films

Laura Müller  1 , Christoph Rosenbaum  1 , Julius Krause  1 , Werner Weitschies  1
Affiliations

Characterization of an In Vitro/Ex Vivo Mucoadhesiveness Measurement Method of PVA Films

Laura Müller et al. Polymers (Basel). .

Abstract

Transmucosal drug delivery systems can be an attractive alternative to conventional oral dosage forms such as tablets. There are numerous in vitro methods to estimate the behavior of mucoadhesive dosage forms in vivo. In this work, a tensile test system was used to measure the mucoadhesion of polyvinyl alcohol films. An in vitro screening of potential influencing variables was performed on biomimetic agar/mucin gels. Among the test device-specific factors, contact time and withdrawal speed were identified as influencing parameters. In addition, influencing factors such as the sample area, which showed a linear relationship in relation to the resulting work, and the liquid addition, which led to an abrupt decrease in adhesion, could be identified. The influence of tissue preparation was investigated in ex vivo experiments on porcine small intestinal tissue. It was found that lower values of Fmax and Wad were obtained on processed and fresh tissue than on processed and thawed tissue. Film adhesion on fresh, unprocessed tissue was lowest in most of the animals tested. Comparison of ex vivo measurements on porcine small intestinal tissue with in vitro measurements on agar/mucin gels illustrates the inter- and intra-individual variability of biological tissue.

Keywords: in vitro–ex vivo correlation; mucoadhesive films; porcine small intestine; tensile studies.

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
(a) Schematic illustration of the structural modifications made on the texture analyzer. 1: probe, 2: film sample, 3: porcine small intestine tissue and 4: microscope stage. (b) Photograph of the device setup in the laboratory.
Figure 2
Figure 2
(a) Schematic force−time−distance diagram of the upper probe movement. (b) Resulting force distance diagram.
Figure 3
Figure 3
Effect of sample area of a PVA film on the work of adhesion (mN×m) and the detachment force (N) measured on a gel of 2% agar and 4% mucin. Mean ± SD, n = 6.
Figure 4
Figure 4
Effect of contact force of a PVA film on the work of adhesion (mN×m) and the detachment force (N) measured on a gel of 2% agar and 4% mucin. Mean ± SD, n = 6.
Figure 5
Figure 5
Influence of contact time of a PVA film on work of adhesion (mN×m) and detachment force (N) measured on a gel of 2% agar and 4% mucin. Mean ± SD, n = 6.
Figure 6
Figure 6
Influence of the withdrawal speed of a PVA film on the work of adhesion (mN×m) and detachment force (N) measured on a gel of 2% agar and 4% mucin. Mean ± SD, n = 6.
Figure 7
Figure 7
Effect of adding wetting liquid (PBS buffer pH 7.4) of a gel of 2% agar and 4% mucin on work of adhesion (mN×m) and detachment force (N) measured with a PVA film. Mean ± SD, n = 6.
Figure 8
Figure 8
Influence of storage time of a gel of 2% agar and 4% mucin on work of adhesion (mN×m) and detachment force (N) measured with a PVA film. Mean ± SD, n = 6.
Figure 9
Figure 9
Differences between the individual tissue samples of the pig small intestines. (a) pig #1; (b) pig #2; (c) pig #3. The intestinal tube was cut longitudinally and divided into approx. 5 cm × 7 cm sections. Food components (about 3 mm) present in pig #1 are marked with arrows.
Figure 10
Figure 10
Intraindividual differences between processed tissue samples from pig #1. (a) Unprocessed tissue; (b) cleaned tissue; (c) thawed tissue.
Figure 11
Figure 11
(a) Work of adhesion in mN×m and (b) maximum detachment force in N required to detach PVA films from differently prepared tissue samples. Shown are the individual data and median, n = 6.
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