Leak R E, Woodford J D
Glaxo Group Research Ltd., Ware, Hertfordshire, U.K.
Eur J Cancer Clin Oncol. 1989;25 Suppl 1:S63-6.
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.
昂丹司琼片含有作为二水合盐酸盐的昂丹司琼碱、乳糖、微晶纤维素、淀粉和硬脂酸镁。在压片过程开始和结束时取样的片剂具有良好的含量均匀度和药物含量，表明在压片过程中药物没有分离或损失。药物的释放与片剂崩解时间有关。崩解时间为3分钟和10分钟的片剂分别在约6分钟和20分钟内释放85%的药物。已证明具有令人满意的生物利用度。该片剂具有良好的稳定性，在30摄氏度以下储存时保质期为2年。
