Manufacturing and Process Scale-Up
Roza Markovski, n/a
Laboratory Manager
IMCD Deutschland GmbH
Cologne, Nordrhein-Westfalen, Germany
Melatonin (MT) is a nocturnally secreted pineal gland hormone with pleiotropic chronobiological effects (1). Orally administered MT, available in immediate-release dosage forms, has poor and variable bioavailability. Immediate release is effective for delayed sleep onset, while modified release systems are designed to provide better control of plasma profiles. Various formulation approaches, including multilayer tablets and multiple-dose systems, often use different modified release polymers (2). Pulsatile or delayed-release formulations that deliver an initial dose for sleep induction followed by delayed release, may better mimic endogenous melatonin secretion (3).