Enhancing dissolution of domperidone by spray-drying: effect of different storage conditions on stability

Abstract

Background: Domperidone is an antidopaminergic drug that facilitates a function of the digestive smooth muscle. Depending on the Biopharmaceutical Classification System, domperidone is classified as class II with poor solubility and high permeability. Method/results: Solid dispersions were prepared by spray-drying with a polymer. The characterization of prepared solid dispersions was analyzed by scanning electron microscope, Fourier transform infrared spectroscopy, x-ray diffraction and differential scanning calorimeter. In vitro dissolution behavior was carried out in gastric juice (pH 1.2) and these results were compared with pure domperidone (active pharmaceutical ingredient). The dissolution rate was improved due to the influence of polymers. Stability assays were conducted by the same pre-experiment. Storage conditions of the solid dispersions were as follows: 25°C relative humidity 25% and 65°C relative humidity 80%. Conclusion: In this study, the goal is to improve the dissolution rate of domperidone by solid dispersions and to confirm stability of the prepared solid dispersions. It suggests that the content of polymers added in solid dispersions can affect the dissolution behavior and change dissolution rate of drug.