Bilayer Mucoadhesive Buccal Film for Mucosal Ulcers Treatment: Development, Characterization, and Single Study Case.

Thais F R Alves,Patricia Severino,Norberto Aranha,Katiusca Da Silva Pontes,Alesssandra C Rios,Decio L Portella,Eliana B Souto,Rogeria De Souza Nunes,Marco V Chaud,Joyce K M Gonsalves

doi:10.3390/pharmaceutics12070657

Thais F R Alves, Patricia Severino + Show 8 more

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https://doi.org/10.3390/pharmaceutics12070657

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Abstract

The formation of mucosal ulcers is an end result of epithelial damage, and it occurs due to some specific causes, such as trauma, aphthous stomatitis, lichen planus and lichenoid reactions, cytotoxic effects of chemotherapy and radiation, and drug-induced hypersensitivity reactions and malignant settings. This study focused on films for target drug delivery with respect to the treatment of the diseases of the oral mucosa, specifically mucositis. The results of a single clinical study as a pre-experimental design was performed and followed up to the outcome until 30 days. The polymeric film was prepared in a mucoadhesive bilayer structure: the basal layer with lidocaine HCl had a faster release than the apical layer with benzydamine HCl and N-acetyl-cysteine. Fourier Transform Infrared Spectroscopy (FTIR), Differential Scanning Calorimetry (DSC), and SEM characterized the physical–chemical and morphological properties. The cell viability and cytotoxicity were evaluated in cell line MCF7. The transport mechanism of the solvent (swelling) and the drugs in the basal or apical layer (drug release) was explained with mathematical models. To evaluate the effect of movement inside the mouth, the folding endurance was determined. The mucoadhesive bilayer film is biologically safe and stimulates cellular proliferation. A single study in vivo demonstrated the therapeutic effect of the mucoadhesive bilayer film in buccal mucositis.

Highlights

IntroductionAntineoplastic drugs are cytotoxic; they can induce the formation of intractable ulcerative lesions that provide a primary portal of entry for the secondary infection of buccal flora despite the use of a variety of medicines to prevent them
The formation of mucosal ulcers is an end result of epithelial damage, and it occurs due to some specific causes, such as trauma, aphthous stomatitis, lichen planus and lichenoid reactions, cytotoxic effects of chemotherapy and radiation, and drug-induced hypersensitivity reactions and malignant settings [1,2].Antineoplastic drugs are cytotoxic; they can induce the formation of intractable ulcerative lesions that provide a primary portal of entry for the secondary infection of buccal flora despite the use of a variety of medicines to prevent them
This study focused on films for target drug delivery to the treatment of illness of buccal mucosa, mucositis

Summary

Introduction

Antineoplastic drugs are cytotoxic; they can induce the formation of intractable ulcerative lesions that provide a primary portal of entry for the secondary infection of buccal flora despite the use of a variety of medicines to prevent them. The mucosal injury progresses from its initiation (1) to a primary damage response, (2) signal amplification, (3) ulceration, and (4) when conditions are favorable for healing [3,4]. The initiation phase is asymptomatic where there is a direct lesion in the DNA of the basal cells of the epithelium and the appearance of oxidative radicals. In the signal amplification phase, the enzymes can be activated directly by radiotherapy and chemotherapy or indirectly by the oxidative radicals formed in the previous phase, inducing tumor cell apoptosis. During the phase of amplification, a series of feedback cycles is observed, further aggravating cellular injury due to the exacerbated production of inflammatory cytokines and the direct destruction of mucosal target cells

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