The goal of this study was to improve Melatonin's oral bioavailability and give a faster onset of
action by creating an oral fast dissolving film. Melatonin has a low aqueous solubility, and due to
first-pass metabolism, its oral bioavailability is only about 33%. Melatonin oral rapid dissolving
film was made by solvent casting with HPMC-E5 (film forming polymer), PEG-400
(plasticizer), -cyclodextrin (solubilizing agent), citric acid (saliva stimulating agent), and
mannitol (sweetening agent). For the formulation optimization of oral fast dissolving film of
Melatonin, a two factor three level factorial design (32) was used, with experimental trials
performed on all possible formulations, in which the amount of HPMC-E5 (X1) and amount of
PEG-400 (X2) were selected as independent variables (factor) and varied at three different
levels: low (-1), medium (0), and high (+1) levels. The dependent variables were percent
medication release and disintegration time (response). The thickness, weight variation, folding
endurance, weight variation, surface pH, drug content, disintegration time, and in-vitro drug
release of each formulation were all assessed. According to the findings, oral fast dissolving film
(F6) avoids first pass metabolism, improves oral bioavailability, and has a quick onset of action.
Keywords: Melatonin, oral fast dissolving film, solvent casting method, HPMC-E5
Publication date: 01/11/2022
https://ijbpas.com/pdf/2022/November/MS_IJBPAS_2022_6598.pdf
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https://doi.org/10.31032/IJBPAS/2022/11.11.6598
