FORMULATION AND EVALUATION OF TASTE MASKED MOUTH DISSOLVING TABLETS OF ONDANSETRON HYDROCHLORIDE

Prajapati R.H.
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引用次数: 4

Abstract

To overcome difficulty in swallowing tablets or capsules, formulators have considerably dedicated their effort to develop novel drug delivery systems which enhance safety and efficacy of drug molecule and to achieve better patient compliance. One such approach is ‘Mouth Dissolving Tablets’. The purpose of this research was to mask the intensely bitter taste of ondansetron Hcl by complexing with indion204 Resin by the solvent evaporation and to formulate a mouth dissolving tablets of the taste-masked drug. Tablets were formulated by direct compression method using different superdisintegrants like Polyplasdone XL-10 & Sodium starch glycolate (SSG) in different concentration, diluents like Mannitol, Microcrystalline cellulose (MCC 112), sweetening agent Aspartame, Flavoring agents like peppermint and vanilla, lubricant Magnesium Stearate & glidant aerosil. All formulations were evaluated for disintegration time, wetting time, % friability, Content uniformity and in vitro dissolution rate. Formulations with 7% Polyplasdone XL-10 showed the disintegration time 14 seconds and wetting time 25 seconds. In vitro drug release study of taste masked tablet showed complete drug release within 10 minutes & successful masking of taste and rapid disintegration of the formulated tablets in the oral cavity.
盐酸昂丹西琼掩口溶片的研制与评价
为了克服吞咽片剂或胶囊的困难,配方师已经相当努力地开发新的给药系统,以提高药物分子的安全性和有效性,并达到更好的患者依从性。其中一种方法是“口腔溶解药片”。本研究的目的是通过溶剂蒸发法与铟204树脂络合来掩盖盐酸昂丹司琼的强烈苦味,并研制出掩味药的口腔溶片。采用不同浓度的聚plasdone XL-10、淀粉乙醇酸钠(SSG)等超崩解剂、甘露醇、微晶纤维素(MCC 112)等稀释剂、阿斯巴甜等甜味剂、薄荷、香草等调味剂、硬脂酸镁等润滑剂,采用直接压缩法配制片剂。对各制剂的崩解时间、润湿时间、%脆性、含量均匀性和体外溶出度进行了评价。7%聚plasdone XL-10的崩解时间为14秒,润湿时间为25秒。味觉掩蔽片的体外释药试验表明,药物在10分钟内完全释放,味觉掩蔽成功,制剂在口腔内崩解迅速。
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