Development and Optimization of β-Cyclodextrin-Based Domperidone MouthDissolving Films using a Quality by Design Framework

Abstract

The present study was designed to formulate and optimize Domperidone mouth-dissolving films using β-cyclodextrin solid dispersion and a Quality by Design approach. Domperidone is a poorly water-soluble antiemetic drug; therefore, β-cyclodextrin was selected as a complexing agent to improve its apparent solubility and support rapid drug release from the oral film matrix. Domperidone is an antiemetic drug that is poorly water-soluble. Consequently, β-cyclodextrin was chosen as a complexing agent to enhance its apparent solubility and facilitate the rapid release of the drug from the oral film matrix. Hydroxypropyl methylcellulose E15 served as the film-forming polymer, polyethylene glycol 400 functioned as the plasticizer, Tween-80 acted as the surfactant/wetting agent, and citric acid was utilized as the saliva-stimulating ingredient. Factorial designs 3² were utilized, employing HPMC E15 concentration and PEG-400 concentration as independent formulation variables. The prepared films were evaluated for morphological appearance, film thickness, folding endurance, surface pH, disintegration time, drug content and in vitro drug release. Domperidone showed maximum absorbance at 286 nm in phosphate buffer pH 6.8, which was used for analytical estimation. The prepared films were soft, semi-transparent, and nonsticky that showed acceptable handling properties. Disintegration time ranged from 31 to 68 seconds, folding endurance from 162 to 376 folds, drug content from 96.8% to 99.1%, film thickness from 0.114 to 0.189 mm and drug release at 15 minutes from 79.5% to 98.2%. All formulations released more than 75% Domperidone within 15 minutes. Formulation F6, containing 750 mg HPMC E15 and 20% PEG-400 was selected as the optimized formulation because it showed rapid disintegration, maximum drug release, acceptable folding endurance, uniform drug content and suitable film thickness. The research demonstrates that βcyclodextrin solid dispersion, in conjunction with factorial design optimization, is effective for the formulation of Domperidone mouth-dissolving films