FORMULATION AND DEVELOPMENT OF BILAYER FLOATING TABLET OF AMOXICILLIN

Priyanka Jartolia, S. Kondalkar, A. Kondalkar, Muraree Lal
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Abstract

Bilayer floating tablet of amoxicillin was formulated successfully and evaluated under suitable parameters. All the batches of tablet produced were found to exhibit short floating lag times. The tablet of batch F2 exhibited a longer floating lag time of 23 minutes. Relationship between the dependent and independent variables was further elucidated using contour and response surface plots. Dissolution profiles that the tablets of batch F3, F7, and F12 exhibits initial burst phase during the first hour of dissolution. The burst phase was followed by a limited drug release for the rest of the period. Also it was observed during the dissolution studies that tablets of all three batches eroded quickly with increased effervescence. Time required for 50 % drug to get released (T50%) and %CR10hrs were found to be in the range of 0.7 to 8.6 hours and 57.35 ± 3.89 to 99.93 ± 0.07 respectively, value of “Prob > F” less than 0. 05. Response surface plots and Contour plot indicated that at a fixed level of B (35 mg) and low level of A (amount of HPMC), % CR10hrs increases from 68.11 to 90.00 % and T50% decrease from 6.86 to 1.66 as the amount of citric acid (C) increases from 0 to 10 mg. Stability study was performed for optimized formulation and it was found that formulation was stable for 6 week at 25 °C/ 60% RH. KEYWORDS: Bilayer floating tablet, amoxicillin, Evaluated, Multi-layered tablet, Stability
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阿莫西林双层漂浮片的研制
成功研制了阿莫西林双层漂浮片,并在适宜的工艺参数下进行了评价。生产的所有批次的片剂均出现较短的漂浮滞后时间。F2批次片剂的漂浮滞后时间较长,为23分钟。利用等高线图和响应面图进一步阐明了因变量和自变量之间的关系。溶出曲线显示F3、F7、F12批次片剂在溶出的第一个小时内呈现初始爆发阶段。爆发期之后的其余时间是有限的药物释放。在溶出度研究中还观察到,所有三批的片剂都被迅速侵蚀,起泡增加。50%药物释放所需时间(T50%)为0.7 ~ 8.6小时,%CR10hrs为57.35±3.89 ~ 99.93±0.07小时,“Prob > F”值均小于0。05. 响应面图和等高线图显示,在固定水平B (35 mg)和低水平a (HPMC用量)下,随着柠檬酸(C)用量从0 mg增加到10 mg, % CR10hrs从68.11%增加到90.00 %,T50%从6.86降低到1.66。对优化后的配方进行稳定性研究,结果表明,在25℃/ 60% RH条件下,该配方稳定6周。关键词:双层漂浮片,阿莫西林,评价,多层片,稳定性
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