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. 2021 Feb 18;13(2):273.
doi: 10.3390/pharmaceutics13020273.

Mucoadhesive Gelatin Buccal Films with Propranolol Hydrochloride: Evaluation of Mechanical, Mucoadhesive, and Biopharmaceutical Properties

Marija Jovanović  1 , Nataša Tomić  2 , Sandra Cvijić  3 , Dušica Stojanović  1 , Svetlana Ibrić  3 , Petar Uskoković  1
Affiliations

Mucoadhesive Gelatin Buccal Films with Propranolol Hydrochloride: Evaluation of Mechanical, Mucoadhesive, and Biopharmaceutical Properties

Marija Jovanović et al. Pharmaceutics. .

Abstract

This study processes and characterizes propranolol hydrochloride/gelatin mucoadhesive buccal films. Two types of gelatin are used: Gelatin from porcine skin, type A (GA), and gelatin from bovine skin (GB). The influence of gelatin type on mechanical, mucoadhesive, and biopharmaceutical characteristics of buccal films is evaluated. Fourier-Transfer infrared spectroscopy (FTIR) and differential scanning calorimetry (DSC) analysis show that GA with propranolol hydrochloride (PRH) in the film (GAP) formed a physical mixture, whereas GB with PRH (GBP) form a compound-complex. Results of mechanical testing (tensile test, hardness) revealed that GAP films exhibit higher elastic modulus, tensile strength, and hardness. A mucoahesion test shows that GBP has higher adhesion strength, while GAP shows higher work of adhesion. Both in vitro release study and in silico simulation indicated that processed films can provide effective drug transport through the buccal mucosa. In silico simulation shows improved bioavailability from buccal films, in comparison to the immediate-release tablets-indicating that the therapeutic drug dose can be markedly reduced.

Keywords: buccal films; gelatin; in silico simulation; mucoadhesion; propranolol hydrochloride.

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Scheme of the film preparation.
Figure 2
Figure 2
Mold (left) and the sample of the film (right).
Figure 3
Figure 3
(a) Samples on metal mesh disc; (b) set up for dissolution test.
Figure 4
Figure 4
Fourier-Transfer infrared spectroscopy (FTIR) spectrums of (a) pure gelatin A film (GA), propranolol hydrochloride (PRH), and gelatin A film loaded with PRH (GAP); (b) pure gelatin B film (GB), propranolol hydrochloride (PRH), and gelatin B film loaded with PRH (GBP).
Figure 5
Figure 5
Differential scanning calorimetry (DSC) diagrams of (a) propranolol hydrochloride (PRH); (b) gelatin A and gelatin B powder, (c) pure gelatin A film (GA), gelatin A film loaded with PRH (GAP), pure gelatin B film (GB) and gelatin B film loaded with PRH (GBP).
Figure 6
Figure 6
SEM micrographs of films’ fractured surfaces (a) GA; (b) GB; (c) GAP; (d) GBP.
Figure 7
Figure 7
Tensile stress–strain curves of: (a) Pure gelatin films (GA and GB); (b) films with PRH (GAP and GBP).
Figure 8
Figure 8
Results of Vickers micro-hardness test.
Figure 9
Figure 9
In vitro release study.
Figure 10
Figure 10
Predicted plasma concentration-time profiles for the tested 30 mg PRH buccal films.
Figure 11
Figure 11
Predicted regional absorption profiles for the tested 30 mg PRH formulations and 80 mg PRH IR tablets.
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