Preparation and Optimization of Ivabradine Hydrochloride Mouth-Dissolving Tablet

Heramb Shahane, Rani Ghosalkar, Kedar Bavaskar, Ashish Jain
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Abstract

The aim of the present work was the preparation and optimization of mouth-dissolving tablets (MDTs) of Ivabradine hydrochloride by using natural super disintegrants. The tablets were prepared using microcrystalline cellulose as diluent and aspartame as a sweetening agent along with Natural super disintegrants. The natural super disintegrants used in this study were Guar Gum and Banana powder. By using natural superdisintegrants we had saved the environment and protected our bodies from the harmful effect of synthetic superdisintegrants. The tablet was prepared by the direct compression method. The 6mm of punch was used and the tablet weight is 110 mg. The tablets were evaluated for weight variation, hardness, friability, wetting time, disintegration time (DT), and dissolution study. Different concentration of superdisintegrants was used in this formulation as 6%, 8%, and 10%. The three batches of guar gum and 3 batches of banana powder were prepared i.e., a Total of six batches were prepared. From the results obtained, it can be concluded that the tablet formulation prepared with 10% banana powder i.e., 10 mg showed fast and higher drug release (98.66%) during in vitro dissolution study. Also, the hardness, friability, dissolution rate, and assay of prepared tablets (batch F6) were found to be acceptable according to standard limits. The result was the F6 batch was optimized batch from all the batches.
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盐酸伊伐布雷定口腔溶解片的制备与优化
本研究的目的是利用天然超级崩解剂制备和优化盐酸伊伐布雷定口腔崩解片(MDTs)。片剂的制备使用了微晶纤维素作为稀释剂,阿斯巴甜作为甜味剂以及天然超级崩解剂。本研究中使用的天然超级崩解剂是瓜尔胶和香蕉粉。通过使用天然超级崩解剂,我们拯救了环境,保护了我们的身体免受合成超级崩解剂的危害。片剂采用直接压片法制备。片剂重量为 110 毫克。对片剂的重量变化、硬度、易碎性、润湿时间、崩解时间(DT)和溶出度进行了评估。该配方中使用了不同浓度的超微崩解剂,分别为 6%、8% 和 10%。共制备了三批瓜尔胶和三批香蕉粉,即六批。从所得结果可以得出结论,在体外溶解研究中,用 10%香蕉粉(即 10 毫克)制备的片剂显示出较快和较高的药物释放率(98.66%)。此外,制备的片剂(批次 F6)的硬度、易碎性、溶出率和化验结果均符合标准限值。结果表明,F6 批次是所有批次中最优化的批次。
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