Formulation and evaluation of fast dissolving tablets of cinnarizine using superdisintegrant blends and subliming material

Formulation and evaluation of fast dissolving tablets of cinnarizine using superdisintegrant blends and subliming material
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DOI:
10.4103/2231-4040.90885
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发表时间:
2011-10-01
影响因子:
1.4
通讯作者:
Dharamsi, Abhay
Dharamsi, Abhay
中科院分区:
其他
文献类型:
--
作者:
Basu, Biswajit;Bagadiya, Abhishek;Dharamsi, Abhay

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本研究旨在研制桂利嗪速溶片。超级崩解剂的组合,即,淀粉羟乙酸钠(SSG)和交联羧甲基纤维素钠(CCS)与樟脑一起沿着用作升华材料。加入优化浓度的樟脑以帮助片剂的孔隙率。应用3(2)全因子设计来研究两个制剂变量的综合效应:SSG和CCS的量。采用红外光谱法研究药物与聚合物之间的物理化学相互作用。红外光谱表明药物与聚合物之间没有相互作用。在本研究中,采用直接压片法制备片剂。使用平面多冲压片机将粉末混合物压制成片剂。通过将片剂暴露于60 ℃的真空干燥器12小时,樟脑从片剂升华。评价所有制剂的特性,例如平均重量、硬度、润湿时间、脆碎度、含量均匀度、分散时间(DT)和溶出速率。发现优化的片剂处方(F 9)具有良好的硬度(3.30 +/- 0.10 kg/cm(2))、润湿时间(42.33 +/- 4.04秒)、DT(34.67 +/- 1.53秒)和16分钟内累积药物释放不低于99%。
The aim of this investigation was to develop fast dissolving tablet of cinnarizine. A combination of super disintegrants, i.e., sodium starch glycolate (SSG) and crosscarmellose sodium (CCS) were used along with camphor as a subliming material. An optimized concentration of camphor was added to aid the porosity of the tablet. A 3(2) full factorial design was applied to investigate the combined effect of two formulation variables: Amount of SSG and CCS. Infrared (IR) spectroscopy was performed to identify the physicochemical interaction between drug and polymer. IR spectroscopy showed that there is no interaction of drug with polymer. In the present study, direct compression was used to prepare the tablets. The powder mixtures were compressed into tablet using flat face multi punch tablet machine. Camphor was sublimed from the tablet by exposing the tablet to vacuum drier at 60 degrees C for 12 hours. All the formulations were evaluated for their characteristics such as average weight, hardness, wetting time, friability, content uniformity, dispersion time (DT), and dissolution rate. An optimized tablet formulation (F 9) was found to have good hardness of 3.30 +/- 0.10 kg/cm(2) , wetting time of 42.33 +/- 4.04 seconds, DT of 34.67 +/- 1.53 seconds, and cumulative drug release of not less than 99% in 16 minutes.