abstract |
A melatonin composition has a dry granulation including a melatonin powder with a median melatonin particle size of 5 µm to 40 µm, a carboxylic acid powder, and a powder of a hydrogel-forming polymer. The dry granulation is combined with pharmaceutical excipients in a dry orally ingestible pharmaceutical dosage form adapted to absorb water upon ingestion and form a hydrogel including soluble melatonin and soluble carboxylic acid in the hydrogel, the carboxylic acid being in an amount sufficient to impart a pH of 4.4 or less to the hydrogel after ingestion. |