Alves Thais F R, Rios Alesssandra C, da Silva Pontes Katiusca, Portella Decio L, Aranha Norberto, Severino Patricia, Souto Eliana B, Gonsalves Joyce K M, de Souza Nunes Rogeria, Chaud Marco V
Laboratory of Biomaterials and Nanotechnology (LaBNUS), University of Sorocaba, Sorocaba 18023-000, Sao Paulo, Brazil.
Department of Surgery Plastic, School of Medicine, Pontifical Catholic University, Sorocaba 18030-070, Sao Paulo, Brazil.
Pharmaceutics. 2020 Jul 11;12(7):657. doi: 10.3390/pharmaceutics12070657.
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 -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.
黏膜溃疡的形成是上皮损伤的最终结果，它是由一些特定原因引起的，如创伤、复发性阿弗他口炎、扁平苔藓和苔藓样反应、化疗和放疗的细胞毒性作用、药物引起的超敏反应以及恶性病变。本研究聚焦于用于口腔黏膜疾病，特别是口腔黏膜炎治疗的靶向给药薄膜。作为一项预实验设计，进行了一项单一临床研究，并随访至30天观察结果。制备的聚合物薄膜为黏膜黏附双层结构：含盐酸利多卡因的基层比含盐酸苄达明和N-乙酰半胱氨酸的顶层释放速度更快。采用傅里叶变换红外光谱（FTIR）、差示扫描量热法（DSC）和扫描电子显微镜（SEM）对其理化性质和形态特性进行了表征。在MCF7细胞系中评估了细胞活力和细胞毒性。用数学模型解释了溶剂（溶胀）和基层或顶层药物（药物释放）的转运机制。为评估口腔内运动的影响，测定了折叠耐久性。该黏膜黏附双层薄膜具有生物安全性并能刺激细胞增殖。一项单一的体内研究证明了该黏膜黏附双层薄膜对颊部口腔黏膜炎的治疗效果。
