Exploration of melt granulation technique for the development of entecavir monohydrate tablets using 32 factorial designs

Abstract

This research work aims to fabricate fast-release tablets of entecavir monohydrate using a novel melt granulation technique and optimize the proportion of xylitol and mannitol using a 32 factorial design. entecavir monohydrate, a medication used for treating hepatitis B virus (HBV) infection, was used as a model drug. The fast-release tablets were designed to avoid fluctuations in plasma drug concentration and increase the bioavailability of entecavir monohydrate. The FTIR spectra of pure entecavir monohydrate were compared against polymers which had no interaction. The pre-compression and post-compression parameters were found to be within the desired range. The results of the drug release studies indicate that the formulations were able to release the drug within the desired range of 60-80% within 10 minutes. The study concludes that the melt granulation technique can be used to develop fast-release tablets of entecavir monohydrate with good compressibility, flow characteristics, and mechanical strength.