ABSTRACT:
Oral thin films (OTFs) signify a groundbreaking advancement in drug delivery systems, characterised by their swift disintegration and user-friendly administration, improved patient compliance, and capacity to enhance the bioavailability of pharmaceuticals characterised by limited solubility in aqueous environments. The current study concentrated on development and assessment of OTFs incorporating esomeprazole as well as domperidone for the effective management of gastrointestinal disorders. Both drugs exhibit limited aqueous solubility and variable oral bioavailability, which can compromise their therapeutic performance when administered through conventional oral dosage forms. The developed OTFs were intended to provide fast disintegration in the oral cavity, the effective release of medication and enhanced patient outcomes convenience, especially for children, older adults, and individuals with swallowing difficulties. A systematic formulation approach was employed to optimize the concentrations of Film-forming polymers, plasticisers, and additional functional additives to obtain films with suitable mechanical characteristics and desirable drug liberation characteristics. The prepared films were subjected to comprehensive physicochemical characterization, including assessment of appearance, folding endurance, thickness, weight consistency, swelling index, drug content, surface pH, as well as disintegration duration. The optimized formulations demonstrated satisfactory mechanical integrity and disintegrated rapidly within 12–32 seconds. Analysis of drug content verified a consistent distribution of the active pharmaceutical ingredients, with esomeprazole content ranging from 93.54% to 99.12% and domperidone content from 96.42% to 99.83%. In vitro dissolution studies revealed efficient releasing of drug from optimized films, with cumulative releases of 97.53% for esomeprazole and 98.87% for domperidone within 25 minutes, indicating the suitability of the formulation for rapid therapeutic action. Compatibility studies using analytical techniques validated the lack of substantial drug–excipient interactions, while thermal analysis demonstrated adequate stability of both drugs throughout the formulation process. Overall, the findings establish that oral thin films comprising esomeprazole and domperidone represent auspicious alternative to conventional oral dosage forms via providing fast drug release, enhanced patient adherence and the possibility to improve therapeutic efficacy. Further pharmacokinetic and clinical investigations are recommended to substantiate the in vivo performance and medicinal benefits of the optimized formulation.