title: Ion-exchange complex of famotidine: sustained release and taste masking approach of stable liquid dosage form.
abstract: A stable controlled release resinate-complex for the highly bitter taste famotidine (FAM) was developed to allow once-daily administration and improve patient compliance especially in pediatric and geriatric medicine. The drug-resinate complexes were prepared in different drug to resin (Amberlite IRP-69) ratios by weight (1:1, 1:2, 1:3, 1:4, 1:5 and 1:6). The optimized drug-resinate complex resulted from 1:6 drug to resin ratio experienced maximum drug loading and sustained release property. Hence, it was subjected to physicochemical characterizations by differential scanning colorimetry (DSC), x-ray diffractometry (XRD), Fourier transform infrared spectroscopy (FTIR) and scanning electron microscope (SEM). The optimized complex was further dispensed in the prepared syrup and the suspension was subjected to accelerated stability study, as mentioned in the International Conference on Harmonization (ICH) guidelines. Furthermore, the gustatory properties of the complex were evaluated on humans. The syrup complied successfully with ICH guidelines and sufficiently alleviated the bitterness of famotidine.
authors: Department of Pharmaceutics, Faculty of Pharmacy, Mansoura University.
authors: Reham Mokhtar
authors: RM
authors: Aman
authors: Mahasen Mohamed
authors: MM
authors: Meshali
authors: Galal Mahmoud
authors: GM
authors: Abdelghani
mesh_terms: D000328:Adult; D003692:Delayed-Action Preparations; D004304:Dosage Forms; D004355:Drug Stability; D015738:Famotidine / Q000008:administration & dosage* / Q000737:chemistry*; D005260:Female; D006635:Histamine H2 Antagonists / Q000008:administration & dosage* / Q000737:chemistry*; D006801:Humans; D007474:Ion Exchange; D008297:Male; D019999:Pharmaceutical Solutions; D013649:Taste / Q000187:drug effects; D055815:Young Adult
chemical_list: D003692:Delayed-Action Preparations; D004304:Dosage Forms; D006635:Histamine H2 Antagonists; D019999:Pharmaceutical Solutions; D015738:Famotidine