Formulation and Characterization of Etoricoxib Suppositories for the Management of Hemorrhoids.

Bhavna Sonule, Yogesh Khairnar, Nikhil Mehetre, Suraj Kumar, Lalit Kumar
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Abstract

Objectives: This study aimed to formulate and evaluate etoricoxib suppositories to improve patient compliance and drug efficacy in the management of hemorrhoids.

Materials and methods: Suppositories were prepared using glycerin and gelatin. The prepared suppositories were evaluated for content uniformity, homogenization, hardness, weight variation, disintegration time, texture analysis, and in vitro drug release.

Results: Hardness, weight variation, disintegration time, and content uniformity values were found in the range of 4.00±0.50 to 7.50±0.50 kg/cm3, 1.20±0.03 to 1.31±0.01 g, 11.00 to 19.05 min, and 66.98±0.86 to 80.76±3.60%, respectively. The SB3 gave 91.47±17.74% drug release in 6 h, whereas the SB1 gave 99.08±3.40% drug release in 12 h. Drug release from all formulations of suppositories was supported by zero-order, first-order, and Higuchi plots, except for SB4. The mechanism of drug release from all suppositories was fickian diffusion-based. The SB2 results were found to be more appropriate than those of the other batches.

Conclusion: These results confirm that the prepared formulation has a future scope and should be further explored in in vitro cell lines and animal studies.

依托昔布治疗痔疮栓剂的配方及特性。
目的:研制并评价依托瑞昔布栓剂,提高患者治疗痔疮的依从性和疗效。材料和方法:用甘油和明胶配制栓剂。对制备的栓剂进行含量均匀性、均质性、硬度、重量变化、崩解时间、质构分析和体外药物释放度评价。结果:硬度值为4.00±0.50 ~ 7.50±0.50 kg/cm3,重量变化值为1.20±0.03 ~ 1.31±0.01 g,崩解时间为11.00 ~ 19.05 min,含量均匀度为66.98±0.86 ~ 80.76±3.60%。SB3的6 h释药率为91.47±17.74%,SB1的12 h释药率为99.08±3.40%。除SB4外,所有栓剂的释药率均有零阶、一阶和Higuchi图支持。所有栓剂的药物释放机制均以扩散为基础。发现SB2的结果比其他批次的结果更合适。结论:该制剂具有广阔的应用前景,在体外细胞系和动物实验中有待进一步探索。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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