Studies on design development and evaluation of mouth dissolving film of anti emetic drug

Abstract

Materials and Method newlineMouth dissolving thin films of selected drug candidates namely Ramosetron hydrochloride and fixed dose combination of Doxylamine succinate and Pyridoxine hydrochloride were prepared using solvent casting technique. The Ramosetron Hcl mouth dissolving film was prepared using HPMC E15 as film forming agent, honey as film modifier and PEG400 as plasticizer. The 32 factorial design was used for the study. The Mouth dissolving sublingual films of Doxylamine succinate and Pyridoxine hydrochloride were prepared with the help of film forming agents namely HPMC E15, HPMC E5 and plasticizers PEG 400. The 23 factorial design was used in the study. The film forming agents chosen for the study were based on the desired films forming ability and drug release property. The prepared films were evaluated for their weight, thickness, folding endurance, tensile strength, disintegration time, dissolution behavior and assay. The formulations prepared were studied and optimized using Design Expert software 11.0 Trial version of Stat ease Inc. newlineResult and Discussion newlineDesign of experiment was found to be a useful tool to study the effect of polymer and plasticizer concentration on film forming capability, disintegration time and dissolution behavior of the mouth dissolving films. The optimized mouth dissolving film of Ramosetron hydrochloride batch R1 was found to disintegrate in 57.0± 2.16 s and release 104.39±1.05 % drug in 9min while the mouth dissolving sublingual film of Doxylamine succinate and Pyridoxine hydrochloride was found to disintegrate in 72.56±2.61 s and release 97.21±1.59 % of Doxylamine succinate and 99.09±2.81 % of Pyridoxine hydrochloride in 21 min. .Conclusion newlineThe mouth dissolving films of Ramosetron hydrochloride were found to be a promising convenient alternative to provide desired action and drug release to a distressed cancer patients suffering from chemotherapy or radiation induced emesis. The development of mouth dissolving sublingual films of combination of Doxylamine succinate and Pyrid