Abstract

FORMULATION DEVELOPMENT OF MODEL FAST DISSOLVING ORAL FILM OF A POORLY SOLUBLE DRUG WITH IMPROVED DRUG LOADING USING MIXED SOLVENCY CONCEPT AND ITS EVALUATION

Neha Sonkeshariya* and R. K. Maheshwari

Abstract

The present study was aimed to develop a fast dissolving oral film containing ondansetron hydrochloride dihydrate (as model drug) with enhanced drug loading, which was achieved by improving drug solubility and reducing the total surface area of oral film using mixed solvency concept. HPMC E-5 as film forming polymer, propylene glycol as plasticizer and crospovidone as superdisintegrant were optimized and selected on the basis of thickness, disintegration time and mechanical properties of film. Initially solubility of ondansetron hydrochloride dihydrate was enhanced in aqueous solution by using various solubilizers like niacinamide (NM), sodium citrate (SC), PVP K30, caffeine, HP beta cyclodextrin, PEG 4000, PEG 200, PEG 400, PEG 600, propylene glycol (PG), glycerin etc, individually and as combinations of four and five solubilizers. The maximum solubility of ondansetron hydrochloride dehydrate 13.63% w/v was achieved in 27% w/v mixed solvent system containing 15% v/v propylene glycol + 3% w/v NM + 3% w/v PVP K30 + 3% w/v SC + 3% w/v caffeine. Petriplate method was used for casting the polymeric film. Evaluation of prepared formulation was carried out including thickness, folding endurance test, disintegration time, in-vitro dissolution test, drug content, surface pH test and stability test.

Keywords: Ondansetron hydrochloride dehydrate (O), niacinamide (NM), sodium citrate (SC), propylene glycol (PG), fast dissolving film (FDF).