Effect of different polymer excipients on the dissolution behavior and crystalline morphology of amorphous loratadine
Objective To investigate the influence of different polymer excipients on the dissolution behavior and crystallization of amorphous loratadine.Methods The dissolution of amorphous loratadine in different concentrations solutions of povidone K30(PVP-K30),polyethylene glycol 4000(PEG 4000)or hydroxypropyl methylcellulose(HPMC)was investigated by ultraviolet spectropho-tometer.The crystal morphology and growth of amorphous loratadine in water and 3 kinds of polymer solutions were observed by po-larizing microscope.Results Different kinds of polymers showed different solubilization effect on amorphous loratadine.The higher the concentration of polymer was,the stronger its solubilization effect.And PEG 4000 showed the strongest solubilization.Different kinds of polymers showed different inhibitory effects on the growth of loratadine crystals.Conclusion The type and concentration of polymer excipients have different effects on the solubility and crystal morphology of amorphous loratadine.This study provides theo-retical guidance for the stability study of amorphous drugs and the development of preparations.