琥珀酸舒马匹坦多孔分散片的设计与评价

Sreenivasa Rao, Patil Kg, Dattatreya B. Udgirkar, P. Patil, K. V. Biradar
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引用次数: 4

摘要

在过去的十年中,对口服分散片(ODT)的需求一直在增长。琥珀酸舒马匹坦用于治疗偏头痛和丛集性头痛。琥珀酸舒马匹坦是一种5-羟色胺受体激动剂,具有广泛的第一次代谢,口服生物利用度为14%。本研究尝试以乙醇酸淀粉钠、交叉卡蜜糖钠和交叉维酮为强力崩解剂,采用直接压缩法制备琥珀酸舒马普坦的体外分散片,提高其溶出率,提高生物利用度。对制备的片剂进行硬度、脆度、平均重量、厚度、体外崩解时间、润湿时间、吸水率、药物含量均匀性、体外溶出度、药物-聚合物相互作用、体外释药、红外光谱研究、短期稳定性和相容性研究等指标的评价。含琥珀酸舒马普坦压缩片的交联棉糖钠超崩解剂在30 min内的体外释药率最高,达到93%,特征吸收带的位置无变化,说明药物与聚合物之间无相互作用。
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Design and Evaluation of Orodispersible Tablets of Sumatriptan Succinate
The demand for Orodispersible tablet (ODT) has been growing during the last decade. Sumatriptan Succinate used in the treatment of migraine and cluster headache. Sumatriptan Succinate is a 5-HT 1 receptor agonist, undergo extensive fi rst pass metabolism with an oral bioavailability of 14%. In present work an attempt has been made to prepare Orodispersible tablets of Sumatriptan Succinate with increased rate of dissolution May leads to increase bioavailability by using sodium starch glycolate, Crosscarmellose sodium and Crospovidone as Superdisintegrants by direct compression methods. The prepared tablets were evaluated for various parameters like hardness, friability, average weight, thickness, in vitro disintegration time, wetting time, water absorption ratio, uniformity of drug content, in vitro dissolution study, drug-polymer interaction, in vitro drug release, IR studies and short term stability and compatibility studies. Superdisintegrant of Croscarmellose sodium containing Sumatriptan Succinate compressed tablets showed highest in vitro drug release of 93% within 30 min. and there is no variation in the position of characteristic absorption bands it reveals that there is no interaction between drug and polymer.
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