Development of Zingiber officinale in oral dissolving films: Effect of polymers on in vitro, in vivo parameters and clinical efficacy

Abstract

Oral dissolving drug delivery system offers a solution for those patients having difficulty in swallowing tablets/capsules,etc. Zingiber officinale, has been used for medicinal purpose since antiquity to treat motion sickness, pregnancy, and cancer-chemotherapy-induced vomiting, mild stomach upset, cough, chronic bronchial problems, and low-grade infections of all kinds and anorexia condition. This work investigates the possibility of developing Zingiber officinale oral dissolving films allowing fast, reproducible dissolution in oral cavity; thus bypassing first pass metabolism. The oral dissolving films were prepared by solvent-casting method. Prepared films were evaluated for film-forming properties, physico-mechanical properties, palatability, microbial limit test, accelerated stability studies, and clinical efficacy test. The different polymers such as hydroxypropyl methylcellulose 5cps, maltodextrin, pullulan, and polyvinyl alcohol were explored individually and in combination with each other for the formation of film. Among all polymers, maltodextrin and HPMC 5 cps alone and in combination showed excellent film-forming properties as well as very good physico-mechanical properties. The films resulted into excellent palatability along with least disintegrating time. But at accelerated stability studies, only HPMC 5 cps was found to be stable when compared with other formulations. So, it was concluded that HPMC 5 cps is the best film forming as well as stable polymer with respect to Zingiber officinale oral dissolving film.