Formulation and evaluation of fast-dissolving sublingual films of ondansetron succinate by electrospinning method

Samira Kamranpour,1,* Shahla mirzaeei,2

1. Student Research Committee School of Pharmacy, Kermanshah University of Medical Sciences, Kermanshah, Iran
2. Pharmaceutical Sciences Research Center, School of Pharmacy, Kermanshah University of Medical Sciences, Kermanshah, Iran

Abstract

Introduction

Introduction: drug delivery via sublingual mucous membrane is considered to be a promising alternative to the oral route. this route is useful when rapid onset of action is desired as in the case of antiemetics such as ondansetron. in terms of permeability, the sublingual area of the oral cavity is more permeable than cheek and palatal areas of mouth. the drug absorbed via sublingual blood vessels bypasses the hepatic first-pass metabolic processes giving acceptable bioavailability with low doses and hence decreases the side effects. sublingualdrug delivery system is convenient for paediatric, geriatric, and psychiatric patients with dysphagia. ondansetron hydrochloride, a 5 ht3 antagonist is a powerful antiemetic drug which has oral bioavailability of 60% due to hepatic first pass metabolism and has a short half-life of 5 h. to overcome the above draw back, the present study was carried out to formulate and evaluate fast dissolving films of ondansetron hydrochloride for sublingual administration. fast mouth dissolving films have become popular as a new delivery system because they are easy to administer and sudden-onset of drug action is possible as the nanofibers are taken through the sublingual route.

Methods

Nanofibers solutions were obtained upon the composition of 10% (w/v) betacyclodextrine to 20% pva with ondansetron hydrochloride under magnetic stirring at room temperatures. preparation of the nanofibers was carried out using a customized electrospining system. characterized for morphology, thickness, drug content, infrared (ir) spectroscopy, and in vitro drug release. electrospinning, also referred to as electrostatic spinning, is a process of producing fibers with diameters in the range of 100 nm. the process consists of applying a high voltage direct current to a polymer solution or melt to produce a polymer jet. as the jet travels in air, the jet is elongated under repulsive electrostatic force to produce nanofibers.

Results

The nanofibers were prepared from polymers such as polyvinylalcohol and betacyclodextrine in different ratios . sodium saccharin as sweeteners were also included. the ir spectral studies showed no interaction between drug and polymer or with other additives. satisfactory results were obtained when subjected to physicochemical tests such as uniformity of weight, thickness, surface ph, uniformity of drug content, swelling index. nanofibers were also subjected to in vitro drug release studies.

Conclusion

The aim of this study is to producing sublingual nanofibre of ondansetron in order to rapid onset of action and with due attention to satisfactory results from physicochemical tests, sublingual nanofibre of ondansetron can be an appropriate alternate for conventional dosage form.

Keywords

Ondansetron, nanofibre, electrospinning, polyvinyl alcohol