Formulation development and in vivo evaluation of mouth dissolving films containing Palonosetron HCl
Keywords:
Palonosetron, emesis, mouth dissolving oral films, disintegration time, HPMC, PharmacokineticsAbstract
Fast dissolving drug delivery systems have gained patient acceptability and popularity in the recent times. The purpose of this work was to develop mouth dissolving oral films of Palonosetron HCl is an antiemetic drug especially used in the prevention and treatment of chemotherapy-induced nausea and vomiting . An attempt was made to prepare oral dissolving films by solvent casting method. The films were prepared by using different grades of HPMC E3, E6 and E15, maltodextrin DE6 and other polymers by solvent casting method. They were evaluated for physical characteristics such as thickness, uniformity of weight, folding endurance, drug content, surface pH, percentage elongation and tensile strength and results were found to be satisfactory. The formulations were subjected to disintegration and in-vitro drug release test. The in vitro disintegration time of the optimized formulation F13 was10sec and drug release was found to be very fast i.e. 99.52% of within 10 min when compared with innovator product i.e 80.5%. In vivo studies confirmed that their potential as an innovative dosage form to improve the bioavailability and considered to be potentially useful for the treatment of emesis where quick onset of action is desirable. DSC and FTIR data revealed that no interactions takes place between the drug and polymers used in the optimized formulation. From the above results, it can be a good alternative to conventional Palonosetron tablets in the treatment of emesis. In vitro and in vivo evaluation of the films confirmed their potential as an innovative dosage form to improve delivery and quick onset of action of Granisetron Hydrochloride. Therefore, the oral fast dissolving film is considered to be potentially useful for the treatment of emesis disease where quick onset of action is desired, also improved patient compliance.
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