Department of Pharmaceutical Techonology, HKES's Matoshree Taradevi Rampure Institute of Pharmaceutical Sciences, Kalburgi, Karnataka, India.
Department of Pharmacology, HKES's Matoshree Taradevi Rampure Institute of Pharmaceutical Sciences, Kalburgi, Karnataka, India.
Indian J Dent Res. 2020 Sep-Oct;31(5):685-693. doi: 10.4103/ijdr.IJDR_685_19.
The present work aimed to prepare an oral mucoadhesive gel of dexamethasone sodium phosphate to serve the purpose of treating oral submucous fibrosis by incorporating the drug in a polymeric matrix to facilitate the localisation of the drug at the absorption site, to prolong drug delivery and to provide patient convenience.
The formulations F, F and F were prepared using 2, 2.5 and 3% of carboxymethyl cellulose sodium, formulations F, F and F were prepared using 2, 2.5 and 3% of hydroxypropyl methylcellulose, respectively, and formulations F, F and F were prepared using equal mixtures of carboxymethyl cellulose sodium and hydroxypropyl methylcellulose in the concentrations of 1, 1.25 and 1.50%, respectively. The prepared formulations were subjected for screening of physicochemical parameters, viz, homogeneity, grittiness, viscosity studies, spreadability, extrudability, mucoadhesive strength, pH, drug content uniformity, in vitro drug diffusion, Fourier transform infrared spectroscopy spectral analysis and stability studies.
Among the nine formulations prepared, the formulation F containing 1.25% carboxymethyl cellulose sodium, 1.25% hydroxypropyl methylcellulose having a mucoadhesive strength of 12.600 ± 0.01 g and drug release of 88.473 ± 0.457% was considered as the promising one and was further used for in vivo study.
Oral application of the gel for 4 months in arecoline-induced oral submucous fibrosis rats showed more than 80% reduction in fibrosis. The histopathological results supported these findings.
本研究旨在制备磷酸地塞米松钠的口腔黏附凝胶，通过将药物纳入聚合物基质中以将药物定位在吸收部位，延长药物释放并为患者提供便利，从而治疗口腔黏膜下纤维化。
采用 2%、2.5%和 3%的羧甲基纤维素钠制备制剂 F、F 和 F，分别采用 2%、2.5%和 3%的羟丙基甲基纤维素制备制剂 F、F 和 F，采用羧甲基纤维素钠和羟丙基甲基纤维素浓度分别为 1%、1.25%和 1.50%的等比例混合物制备制剂 F、F 和 F。对制备的制剂进行物理化学参数筛选，即均匀性、砂质、黏度研究、铺展性、挤出性、黏膜黏附强度、pH 值、药物含量均匀性、体外药物扩散、傅里叶变换红外光谱光谱分析和稳定性研究。
在所制备的 9 种制剂中，制剂 F 含有 1.25%羧甲基纤维素钠和 1.25%羟丙基甲基纤维素，黏膜黏附强度为 12.600 ± 0.01 g，药物释放度为 88.473 ± 0.457%，被认为是有前途的制剂，并进一步用于体内研究。
在槟榔碱诱导的口腔黏膜下纤维化大鼠中，口腔应用凝胶 4 个月后，纤维化减少了 80%以上。组织病理学结果支持这些发现。
