Development of a transdermal delivery system for melatonin Public Deposited

http://ir.library.oregonstate.edu/concern/graduate_thesis_or_dissertations/6969z352w

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  • Melatonin is an neurohormone secreted by the pineal gland. Several therapeutic possibilities for melatonin administration have been suggested. However, clinical studies with melatonin have been limited by lack of a delivery system capable of mimicking the physiological release pattern of melatonin. There is an increasing recognition that the skin can serve as a port of administration for systemically active drug. The stability, solubility, skin-vehicle partition coefficient, and in vitro percutaneous penetration of melatonin in a series of buffered propylene glycol-water mixtures (10, 20, 40, and 80%; v/v) over a pH range of 3.3-8.7 were examined. Stability, solubility, and partition coefficient studies were conducted at 25°C while diffusion analysis was performed at 30°C. Melatonin is more stable in acidic solution than in alkaline solution. Higher percent of propylene glycol does not affect the melatonin stability at pH 3.3 but could stabilize melatonin at pH 8.7. The solubility of melatonin in propylene glycol-water mixtures is minimally affected by pH and ranged from 2.2 mg/ml for 10% propylene glycol to over 25 mg/ml for 80% propylene glycol. Hairless mouse skin was used to determine the skin-vehicle partition coefficient, and for percutaneous penetration studies. Melatonin was able to move across hairless mouse skin in these studies (donor phase, PG-water mixtures; receptor phase, normal saline). Flux from PG-water solutions ranged from 6.08 to 0.56 μg /cm /hr while flux from gel preparations ranged from 0.23 to 0.07 μg /cm /hr. Percutaneous delivery of melatonin is feasible and the existence of a transdermal delivery system should facilitate clinical studies in human subjects.
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