Formulation And Evaluation of Mucoadhesive Bilayer Tablet
Abstract
Introduction: Domperidone is widely used as an antiemetic and gastroprokinetic agent; however, its therapeutic effectiveness is limited because of poor oral bioavailability, extensive first-pass metabolism, and the requirement for frequent administration. Objective: The present study was carried out to formulate and evaluate a Mucoadhesive Bilayer Tablet of Domperidone for sustained drug release and enhancement of oral bioavailability. To overcome these limitations, a mucoadhesive bilayer tablet approach was selected. Material and Methods: The formulation consisted of two functional layers: a drug-containing mucoadhesive layer and an impermeable backing layer. The mucoadhesive layer was designed to adhere to mucosal surfaces, prolong residence time, and provide sustained release, while the backing layer ensured unidirectional drug delivery and minimized drug loss. Three formulations (F1, F2, and F3) were prepared using wet granulation and direct compression techniques. Various excipients including HPMC K100M, chitosan, lactose monohydrate, citric acid, sodium saccharine, magnesium stearate, talc, and ethyl cellulose were incorporated to optimize swelling behavior, mucoadhesion, and release characteristics. Pre-formulation studies including solubility analysis, melting point determination, FTIR compatibility study, and calibration curve preparation confirmed drug purity and compatibility with selected excipients. Results and Discussion: FTIR analysis demonstrated preservation of characteristic peaks without evidence of chemical interaction. The prepared formulations were evaluated for physical and performance parameters such as hardness, thickness, friability, content uniformity, surface pH, swelling index, and in-vitro dissolution. The tablets demonstrated acceptable physical characteristics and good compressibility. Among all formulations, batch F3 showed superior performance, with 98% content uniformity, acceptable hardness, controlled swelling behavior, and 87.83% cumulative drug release over 8 hours, indicating effective sustained release. Conclusion: The study concluded that mucoadhesive bilayer tablets represent an effective strategy for improving Domperidone delivery by enhancing residence time, controlling release, reducing dosing frequency, and potentially improving patient compliance and therapeutic effectiveness.
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