采用doe法制备辛伐他汀快速崩解片

Urvashi B. Patel, Harshil M. Patel, Chainesh N. Shah
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引用次数: 0

摘要

为提高辛伐他汀的体外溶出度,采用DoE法,利用design Expert软件进行32全因子设计优化。以丙二醇(PG)为液体载体,Avicel PH-102为载体材料,Aerosil为包衣材料,阿斯巴甜为甜味剂,Kyron 314为超级崩解剂。利用新建立的32全因子设计数学模型,制定了各种液固粉末体系,并计算了载体材料和涂层材料的用量。对所制备的液固批进行重量变化、药物含量均匀性、硬度、脆性、崩解度和溶出度试验。液固体系也进行了DSC, FT-IR测试。从设计数据的检查点分析结果来看,SMLCFDT10在较短的润湿时间(124.682秒)和崩解时间(31.843秒)下具有较高的释药率(89.257%)。辛伐他汀液体固体致密剂与其他增强溶解度的技术相比,提高了溶解度和溶解速度。因此,本研究工作可能有助于利用液体固体技术配制快速崩解片,通过快速吸收实现快速起效,最大限度地提高疗效,减少剂量和给药频率,从而提高患者的依从性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
FORMULATION AND EVALUATION OF FAST DISINTEGRATING TABLETS OF SIMVASTATIN USING LIQUISOLID TECHNOLOGY BY USING DOE APPROACH
To obtain an enhanced in-vitro dissolution rate of simvastatin by using Liquisolid technique and Liquisolid tablets were optimized by DoE approach 32 full factorial design using Design Expert Software.Theliquisolid tablets were formulated by using propylene glycol (PG), as liquid vehicle, Avicel PH-102 as a carrier material, Aerosil as a coating material, and aspartame as sweetener and Kyron 314 as a superdisintegrant. The new mathematical model 32 full factorial design was utilized to formulate various liquisolid powder systems and to calculate amount of carrier material and coating material. All prepared liquisolid batches were subjected to weight variation, drug content uniformity, hardness, friability test, and disintegration test and dissolution tests. Liquisolid systems were also tested for DSC, FT-IR. From result of check point analysis of design data, , SMLCFDT10 shows higher Drug release (89.257 %) at less wetting time (124.682 sec.) and disintegrating time (31.843 sec). Simvasatin liquisolid compacts enhance aqueous solubility and dissolution rate in compare to other solubility enhancement technique. Hence, this research work may be useful to formulate fast disintegrating Tablets using Liquisolid Technique which may give rapid onset of action by rapid absorption, maximize efficacy, reduce dose and dose frequency & hence increase patient Compliance.
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