Formulation development and In-vitro evaluation of fast dissolving oral films containing ranitidine hydrochloride

Ranitidine Hydrochloride is a histamine receptor antagonist used to treat ulcers of the stomach and intestine. It is also used to treat erosive esophagitis, gastro esophageal disease or GERD, and Zollinger-Ellison syndrome. The present research work was aimed to design, develop and evaluate fast dissolving oral films of ranitidine hydrochloride for oral or buccal delivery. The films were prepared using different polymers like HPMC, SCMC by solvent casting technique. The fast dissolving oral film evaluated for folding endurance, swelling index, surface pH, drug content, drug polymer compatibility (IR Study), and in-vitro drug release. The physical appearance of the films were clear, colorless with smooth surface without any scratches and folding endurance properties were found to be good. The surface pH of all films was found to be in the range of 6. 5 to 6.75 which is close to salivary pH, which indicates that films may have less potential to irritate the oral mucosa. The drug content of all the films was in the range of 94.1 % to 99.03% suggesting that drug was uniformly dispersed throughout all films. Hence it can be inferred that the fast dissolving oral film of Ranitidine Hydrochloride may produce the rapid action thereby improving bioavailability and enhance the absorption by avoiding the first pass effect.