Formulation and evaluation of Oral Thin Film of Esomeprazole and Domperidone Using 32Factorial Design
Abstract
This study focused on the formulation and evaluation of oral thin films (OTFs) containing Esomeprazole, a proton pump inhibitor, and Domperidone, a dopamine antagonist, for the management of gastrointestinal disorders. OTFs were developed to address limitations of conventional oral dosage forms, particularly for patients with swallowing difficulties, and to improve solubility, bioavailability, and patient compliance. Film-forming agents such as Hypromellose, Carbomer 974, and Polyvinyl Alcohol were employed, and key formulation parameters—mechanical strength, disintegration time, and drug release—were optimized. Physicochemical evaluations included thickness, weight variation, folding endurance, swelling index, drug content uniformity, and in-vitro disintegration and dissolution studies. A 3² full factorial design was used, with Hypromellose and Carbomer 974 concentrations as independent variables. Among the formulations, F3 exhibited optimal properties, with rapid disintegration (12 seconds), uniform drug content, and excellent dissolution profiles for both drugs. The findings highlight that OTFs offer a promising platform for delivering Esomeprazole and Domperidone, enabling precise dosing, rapid onset of action, and improved therapeutic efficacy, especially for pediatric and geriatric patients. This approach presents a viable alternative to conventional dosage forms in gastrointestinal therapy
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