Romanian Society of Pharmaceutical Sciences

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DEVELOPMENT OF A DISSOLUTION TEST FOR MELATONIN SUBLINGUAL TABLETS USING A FACTORIAL EXPERIMENTAL DESIGN

LOURDES MAYET-CRUZ, JUAN MANUEL RODRÍGUEZ, HELGI JUNG-COOK *

Departamento de Farmacia, Facultad de Química, Universidad Nacional Autónoma de México. C.P., 04510, Ciudad de México, México

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The main objective of the present study was to develop a dissolution method for melatonin sublingual tablets. A factorial design type 2 was performed using agitation rate, dissolution media and sampling times as critical test parameters. For the experimental design, one commercial batch of the Mexican reference sublingual tablet product (5 mg) was used. The quantification of the drug released was performed using an UV assay at 220 nm. The best results were obtained using USP Apparatus 2 (paddles) at 50 rpm and 500 mL of water as dissolution medium. For the method evaluation, the dissolution profiles of two batches of a reference product and two batches of two commercially available melatonin generic products (5 mg) were evaluated and compared using a model-independent analysis. Results showed the capacity of the method to discern between different products of melatonin sublingual tablets.