State Key Laboratory of Oral Diseases & National Center for Stomatology & National Clinical Research Center for Oral Diseases & Research Unit of Oral Carcinogenesis and Management & Chinese Academy of Medical Sciences, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, Sichuan, China.
J Mater Chem B. 2024 Mar 20;12(12):3015-3021. doi: 10.1039/d3tb02976j.
Oral ulceration (OU), a prevalent oral mucosal condition causing significant pain and hindering eating and speaking, adversely impacts the patient's quality of life. Topical medications are preferred for their minimal side effects and convenient administration. However, existing formulations generally present discomfort and insufficient drug retention due to the thick formulations and poor adhesion, which considerably restrict their therapeutic effectiveness. In this study, a thin and lightweight double-layer oral film based on FDA approved excipients with excellent adhesion under wet oral conditions and outstanding biocompatibility is successfully developed by a simple method. It consists of an adhesive layer for anchoring to delivery drugs and a hydrophobic layer to isolate the saliva for unidirectional drug delivery. The double-layer oral film with extremely thin appearance (only 0.11 mm thick) offers excellent adhesion (up to 150 min on an SD rat oral ulceration), which was also matched with its drug release time (87.47% release in 2 h). Animal experiments confirmed that the double-layer oral film carrying dexamethasone sodium phosphate achieved satisfactory efficacy in the SD rat oral ulcer model. Hence, this biologically friendly double-layer thin oral film holds great promise for clinical application in topical drug therapy for oral mucosal conditions.
口腔溃疡（OU）是一种常见的口腔黏膜疾病，会导致严重的疼痛，影响进食和说话，降低患者的生活质量。局部用药因其副作用小、使用方便而受到青睐。然而，现有的制剂由于配方较厚、附着力差，通常会引起不适，且药物保留不足，这极大地限制了它们的治疗效果。在这项研究中，我们成功开发了一种基于 FDA 批准辅料的薄而轻的双层口腔膜，该辅料在湿润的口腔环境下具有极好的附着力和出色的生物相容性，其制备方法简单。该双层口腔膜由一个用于锚定药物输送的粘性层和一个用于隔离唾液的疏水性层组成，具有极薄的外观（仅 0.11 毫米厚），能提供极好的附着力（在 SD 大鼠口腔溃疡模型上可长达 150 分钟），同时也与药物释放时间相匹配（2 小时内释放 87.47%）。动物实验证实，携带地塞米松磷酸钠的双层口腔膜在 SD 大鼠口腔溃疡模型中具有令人满意的疗效。因此，这种生物友好型双层薄口腔膜有望在口腔黏膜疾病的局部药物治疗的临床应用中得到应用。
