A Novel Oral Film Formulation for Jujuboside: Response Surface Optimization of Preparation Parameters and Performance Evaluation.

Jujuboside is an active saponin with anxiolytic and sedative effects, but its oral bioavailability is extremely low. This study prepared an oral film to achieve rapid absorption through the oral mucosa. Using jujuboside as the raw material, the mass ratio of vinyl alcohol polymer to microbial polysaccharide, the ratio of propylene glycol to glycerol and the amount of cellulose ether were selected as influencing factors. On the basis of single-factor experiments, the response surface method was employed to optimize the preparation process of jujuboside oral films, and the effects of these factors on disintegration time and flexibility of the films were investigated. Meanwhile, the content uniformity of jujuboside A and γ-aminobutyric acid in the films was determined by high-performance liquid chromatography. Results showed that the optimized jujuboside oral film had complete molding, a smooth surface, good flexibility, a disintegration time of 25 s in simulated oral environment, and acceptable content uniformity of jujuboside A and γ-aminobutyric acid. The oral film can disintegrate rapidly and release the drug in the oral cavity, and is designed for oromucosal delivery. This oral film is convenient to take, particularly suitable for children, the elderly and patients with dysphagia, providing a new strategy for the clinical application of jujuboside.