SUSTAINED RELEASE BEHAVIOR OF FAMOTIDINE FROM FLOATING GELUCIRE FORMULATIONS

The aim of the present study was to prepare floating sustained release formulations of famotidine (FM) using a blend of Gelucire 43/01 (GL 43/01) and Gelucire 44/14 (GL 44/14) in different concentrations. These formulations were intended to be retained in the stomach and prolong the drug release to improve bioavailability and reduce frequency of administration. Granules and beads were prepared by melt-granulation technique and melt-solidification technique, respectively. The formulations were evaluated for surface morphology, flowability, in-vitro floating ability, and in-vitro drug release. In case of beads, process yield, drug loading, encapsulation efficiency, and particle size were also investigated. Differential scanning calorimetry (DSC) and infrared spectroscopy (IR) were used to investigate the possibility of drug-lipid interactions. The obtained beads had smooth surfaces, while the granules showed rough surfaces. Both formulations showed free flowing properties and excellent floating characteristics. There was no interaction between the drug and Gelucires used in the formulation. In-vitro drug release of FM from the prepared granules and beads was studied in 0.1 N HCI (pH 1.2) for up to 12 hrs. The drug released in a sustained manner in pH 1.2 from both formulations with no significant difference between granules and beads.