Farid Ragwa M, Wen Ming Ming
Department of Pharmaceutics, Faculty of Pharmacy & Drug Manufacturing, Pharos University in Alexandria, Canal Mahmoudaya, Smouha, Alexandria, Egypt.
Curr Drug Deliv. 2017;14(1):123-135. doi: 10.2174/1567201813666160316122548.
Recurrent aphthous ulcer (RAU) is one of the most common ulcerative diseases of the oral mucosa which is recurrent, painful and slow to heal. Treatment is primarily for pain relief and promotion of healing to shorten the disease duration or reduce the rate of recurrence.
Development of a new design of topical buccal bilayer mucoadhesive films containing sodium alginate and gellan gum loaded with low dose of 1 mg prednisolone sodium phosphate to reduce the treatment period and decrease side effects of systemic treatment.
Films were prepared by solvent casting technique and evaluated to ensure optimum film characteristics, and in vivo efficiency.
The bilayer films were thin, flexible with good water uptake, mucoadhesive and mechanical properties. In vitro drug release was sustained and showed anomalous non-Fickian kinetics. SEM confirmed the development of bilayer formation. Fourier Transform Infrared Spectroscopy and Differential Scanning Calorimetery indicated no chemical interaction between the layers. In vivo study in rabbits with induced oral ulceration showed complete ulcer healing within 4-5 days by once daily treatment of the studied film. Histological examination indicated no inflammation on treatment sites compared to inflamed tissue on the control sites.
The results suggested that buccal application of the developed bilayer mucoadhesive films loaded with only 1mg of prednisolone provided mucoadhesive and convenient application and was able to promote RAU healing with shorter treatment duration.
复发性阿弗他溃疡（RAU）是口腔黏膜最常见的溃疡性疾病之一，具有复发性、疼痛性且愈合缓慢。治疗主要是为了缓解疼痛和促进愈合，以缩短病程或降低复发率。
研发一种新型的含藻酸钠和结冷胶的局部颊部双层黏膜黏附膜，负载低剂量1mg泼尼松龙磷酸钠，以缩短治疗周期并减少全身治疗的副作用。
采用溶剂浇铸技术制备薄膜，并进行评估以确保最佳的薄膜特性和体内疗效。
双层膜薄、柔韧，具有良好的吸水性、黏膜黏附性和机械性能。体外药物释放具有持续性，呈现非菲克扩散的异常动力学。扫描电子显微镜证实了双层结构的形成。傅里叶变换红外光谱和差示扫描量热法表明各层之间无化学相互作用。对诱导口腔溃疡的家兔进行的体内研究表明，每天一次使用所研究的薄膜治疗，4-5天内溃疡完全愈合。组织学检查表明，与对照部位的炎症组织相比，治疗部位无炎症。
结果表明，颊部应用仅负载1mg泼尼松龙的新型双层黏膜黏附膜具有黏膜黏附性且应用方便，能够在较短治疗时间内促进RAU愈合。
