CPS Formulations, DR. Reddy's Laboratories Limited, Bachupally, Hyderabad-500090, India.
Acta Pharm. 2010 Sep;60(3):267-80. doi: 10.2478/v10007-010-0025-8.
The present study is aimed to develop dextromethorphan hydrobromide (DXM) oral disintegrating tablets (ODT) with acceptable palatability to help patients of all age groups. The bitter taste of the drug was masked by binding the drug to ion exchange resin. The effect of the particle size of resin on drug loading was studied. In vitro and in vivo disintegration time and in vitro drug release studies were performed. Drug loading increased significantly with a decrease in the particle size of the resin. DSC and XRPD studies reveal that the molecular state of the drug changed from crystalline to amorphous form. The dissolution efficiency calculated for optimized ODT and conventional directly compressed tablet were almost comparable, indicating free dissociation of the drug from the resinate. The bitter taste of DXM can be masked by binding with ion exchange resin and the resinate can be successfully formulated into oral disintegrating tablets.
本研究旨在开发可接受口感的右美沙芬氢溴酸盐(DXM)口腔崩解片(ODT),以帮助所有年龄段的患者。通过将药物与离子交换树脂结合来掩盖药物的苦味。研究了树脂粒径对载药量的影响。进行了体外和体内崩解时间以及体外药物释放研究。药物载药量随着树脂粒径的减小而显著增加。DSC 和 XRPD 研究表明药物的分子状态从结晶态变为无定形态。计算优化的 ODT 和常规直接压片的溶出效率几乎相当,表明药物从树脂酸盐中自由解离。通过与离子交换树脂结合可以掩盖 DXM 的苦味,并且可以成功地将树脂酸盐制成口腔崩解片。