琼脂为天然超级崩解剂的盐酸格拉司琼多孔分散片的研制与评价

C. Sahoo, N. Sahoo, M. Sahu, A. K. Moharana, D. Sarangi
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引用次数: 8

摘要

该研究的主要目的是开发盐酸格拉司琼的口服分散片,这是一种选择性5-HT3受体拮抗剂(一种止吐剂),用于改善患者的依从性,特别是那些患有吞咽困难的儿童和老年人。采用湿造粒法,采用天然超级崩解剂琼脂制备orodispersible片剂。对所制片剂进行重量变化、硬度、脆性、润湿时间、体外分散时间、药物含量和体外溶出度等评价。认为片剂F4批次为整体最佳制剂(体外释药率为99.09%)。短期稳定性研究(40±20℃/75±5% RH)表明,最佳配方的药物含量无明显变化。从红外光谱研究表明,没有药物赋形剂相互作用。关键词:盐酸格拉司琼,孔分散片,FTIR光谱,润湿时间,体外释药研究,稳定性研究
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 Orodispersible Tablets of Granisetron Hydrochloride Using Agar as Natural Super disintegrants
The main aim of the study was to develop orodispersible tablets of Granisetron hydrochloride a selective 5-HT3 receptor antagonist (an antivomiting agent) for improving patient compliance, especially those of paediatric and geriatric categories with difficulties in swallowing. In the wet granulation method orodispersible (ORD) tablets were prepared using natural super disintegrants Agar agar. The prepared batches of tablets were evaluated for weight variation, hardness, friability, wetting time, in vitro dispersion time, drug content and in vitro dissolution studies. The tablet formulation batch F4 was considered as the overall best formulation (with an in vitro drug release study of 99.09%). Short term stability studies (at 40 ± 2oC/75 ± 5% RH) on the best formulation indicated that there no significant changes in drug content. From the FTIR study indicated that there are no drug excipient interactions. Key words : Granisetron hydrochloride, Orodispersible tablets, FTIR spectroscopy, Wetting time, In vitro drug release study, Stability studies.
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