A Novel Combination of Esomeprazole and Domperidone in a Unit-dose for Potential Application in Gastroesophageal Reflux Disease

The current study is designed to develop an orodispersible film (ODF) incorporating esomeprazole (EOZ) and domperidone (DPD) using synthetic (polyvinyl alcohol), semisynthetic (hydroxypropylmethyl cellulose, HPMC; hydroxylethyl cellulose, HEC), and natural (xanthan gum) polymers. The solvent casting method was employed to formulate the ODF, which resulted in a homogenous, transparent, and smooth surface film. The prepared formulations were evaluated through Fourier Transform Infrared (FTIR) spectroscopy, mechanical strength, physico-chemical properties, and an in vitro drug release study. The disintegration time, surface pH, tensile strength, percentage elongation, moisture uptake, moisture loss, and loss on drying were observed in the range between 29-53 sec., 5.89-6.63, 13-22 N, 5.3-7.3%, 2.1-3.9%, 0.9-2.2%, 0.04-0.07%, respectively. Maximum concentration of both drugs was released from all the ODF formulations within 5 min during the in vitro drug release study performed in simulated saliva of pH 6.8. During the accelerated stability study, the values of all essential parameters were observed within the standard range. Hence, the combination of EOZ and DPD in an ODF could be a novel approach for the potential treatment of gastroesophageal reflux disease (GERD).