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  • Design and evaluation of ta...
    Malladi, Madhusudhan; Jukanti, Raju; Nair, Rashmi; Wagh, Sanjay; Padakanti, Hari; Mateti, Ashok

    Acta pharmaceutica (Zagreb, Croatia), 09/2010, Volume: 60, Issue: 3
    Journal Article

    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. Cilj rada bio je pripraviti raspadajuće tablete dekstrometorfan hidrobromida (DXM) za oralnu primjenu (ODT) prihvatljivog okusa s namjerom da se pomogne pacijentima svih dobnih skupina. Gorki okus ljekovite tvari maskiran je vezanjem lijeka na ionskoizmjenjivačku smolu. Proučavan je utjecaj veličine čestica smole na količinu ljekovite tvari koja se može na nju vezati, vrijeme raspadanja in vitro i in vivo, te oslobađanje lijeka in vitro. Količina vezanog lijeka značajno se povećava sa smanjenjem veličine čestica smole. DSC i XRPD studije pokazuju da prilikom vezanja kristalinični oblik lijeka prelazi u amorfni. Oslobađanje ljekovite tvari izračunato za optimizirane ODT i izravno komprimirane tablete vrlo je slično, što ukazuje na slobodno oslobađanje lijeka iz smole. Gorki okus DXM može se maskirati vezanjem ljekovite tvari na ionsko-izmjenjivačku smolu iz koje se mogu pripraviti raspadajuće tablete za oralnu primjenu.