A Method for Improving Handling Properties of Ranitidine HCl

Ranitidine is widely used H₂receptor antagonist in clinical practice; however its deliquescent character is major challenge during formulation. In this study we have explored one of the possible uses of ion exchange resins to reduce hygroscopicity of ranitidine through complexation with commercially available resin Indion 234 and thereby improve handling properties.

Ranitidine, resin and resinate (complex of resin and ranitidine) was exposed to 75% relative humidity at 40°C and the plot of % moisture content (obtained by weight gain) Vs time was used to determine the hygroscopic nature. The effect of drug content of resinates on moisture uptake was also studied. The moisture content was also determined by Karl Fischer titration. Thermogravimetric analysis and differential thermal analysis (TG - DTA) plots were used to compare drying characteristics of ranitidine, resin and resinate. Resinate showed less equilibrium moisture content and moisture uptake rate compared to ranitidine and resin. Moreover the ranitidine content and moisture uptake showed inverse relationship. To conclude that resinates of ranitidine have less moisture uptake rate and moisture content than resin and ranitidine alone and can be used to improve handling of ranitidine.