Formulation and Characterization of A Domperidone Fast-Dissolving Film (FDF) Dosage Form using A Polymer Combination
DOI:
https://doi.org/10.37287/ijghr.v8i5.2026Keywords:
domperidone, fast-dissolving film, formulation optimization, HPMC E15, maltodextrinAbstract
Domperidone is a dopamine antagonist antiemetic classified as a BCS Class II drug with low solubility and oral bioavailability due to high first-pass metabolism. One approach to enhancing drug release and absorption is through the development of a Fast Dissolving Film (FDF), a thin film that dissolves rapidly in the oral cavity without water and provides a faster onset of action. FDF formulation is influenced by the choice of polymers; HPMC E15 produces a strong and flexible film, while maltodextrin improves solubility and accelerates disintegration, necessitating optimization of the polymer combination to achieve optimal formulation characteristics. To formulate and characterize a fast-dissolving film (FDF) formulation containing domperidone using a combination of hydrophilic polymers. Domperidone is known to have low oral bioavailability due to high first-pass metabolism; therefore, an alternative drug delivery system is needed to improve the speed of onset and therapeutic efficiency. Formula optimization using Design Expert via the I-optimal mixture design method. The independent variables used were the concentrations of HPMC E15 and maltodextrin as polymers, while the dependent variables included fold strength, thickness, disintegration time, and dissolution time. The FDF formulation was prepared using the solvent casting method and evaluated via organoleptic testing, thickness, fold strength, surface pH, content uniformity, and disintegration time. Results: The combination of HPMC E15 and maltodextrin significantly influenced the physical characteristics and drug release from the FDF formulation. The best mathematical model obtained from the optimization was a quartic model. The resulting optimal formulation met the physical evaluation criteria and demonstrated potential as an effective drug delivery system with rapid disintegration and optimal drug release. The domperidone FDF formulation with a combination of HPMC E15 and maltodextrin was successfully developed and possesses characteristics that meet the requirements, as well as the potential to improve bioavailability and the convenience of oral drug administration.
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