Starch Orodispersible Film Loaded with Melatonin for Human Supplementation

Abstract

An innovative pharmaceutical form for administering melatonin, based on starch orodispersible film (ODF), was designed and prepared. The composition of the ODF included starch as the polymer matrix, the active drug melatonin, and a plasticizer. Melatonin, a natural hormone produced by the pineal gland in the brain, can be absorbed by passive diffusion across the mucous membrane, resulting in improved bioavailability when compared to conventional oral administration. This study shows a simple and efficient method for preparing melatonin-loaded orodispersible films with a physically stable and commercially viable matrix, suitable for use in the pharmaceutical industry. The films were prepared by treating the starch with microwave irradiation, followed by plasticization with glycerol, melatonin loading and drying by solvent casting. Mechanical tests showed the films’ robustness, with a modulus of approximately 97 MPa, indicating good handling properties. Moisture uptake analysis showed fast water absorption, reaching about 150% within 2 min, indicating its fast oral disintegration potential. Disintegration tests in artificial saliva and dissolution studies indicated the release of the drug in minutes, indicating the potential properties of the film for oral drug delivery. To the best of our knowledge, there is no melatonin ODF based on starch described in the literature.