Pharmaceutical development of ondansetron tablets.

R E Leak, J D Woodford
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Abstract

Ondansetron tablets contain ondansetron base as the hydrochloride dihydrate, lactose, microcrystalline cellulose, starch and magnesium stearate. Tablets sampled at the beginning and end of the compression process have good content uniformity and drug content, showing that there is no segregation or loss of the drug substance during tabletting. The release of drug substance is related to the tablet disintegration time. Tablets with disintegration times of 3 and 10 min release 85% of the drug substance in approximately 6 and 20 min respectively. Satisfactory bioavailability has been demonstrated. The tablets have good stability, and have a shelf life of 2 years when stored below 30 degrees C.

昂丹西琼片剂的研制。
昂丹司琼片剂含有昂丹司琼碱盐酸盐二水合物、乳糖、微晶纤维素、淀粉和硬脂酸镁。在压缩过程开始和结束时取样的片剂具有良好的含量均匀性和药物含量,表明压片过程中没有分离或损失原料药。药物的释放与崩解时间有关。崩解时间为3 min和10 min的片剂分别在约6 min和20 min内释放85%的原料药。令人满意的生物利用度已被证明。片剂稳定性好,在30℃以下保存,保质期2年。
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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