Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Tablets – lozenges – or pills
Patent
1994-02-14
1996-03-12
Page, Thurman K.
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Tablets, lozenges, or pills
424462, 424482, 424497, 424489, A61K 920
Patent
active
054984238
ABSTRACT:
In order to correct a melatonin deficiency or distortion in the plasma melatonin level and profile in a human subject, there is administered to a human in which such a deficiency or distortion had been diagnosed, over a predetermined time period including at least part of the nocturnal period, an amount of melatonin in controlled-release form, such that the melatonin is released according to a profile which, taking into account the existing profile, simulates the profile in plasma of a human having a normal endogenous melatonin plasma profile. The invention also relates to a pharmaceutical controlled-release formulation, which comprises melatonin in combination with at least one pharmaceutical carrier, diluent or coating, the formulation being adapted to release melatonin over a predetermined time period, according to a profile which, taking into account the existing profile, simulates the profile in plasma of a human having a normal endogenous melatonin profile. The method of the invention may be e.g. applied to the prevention of sudden infant death syndrome in infants, and then comprises a preliminary screening step in order to determine the plasma melatonin levels, in order to select infants having a deficient plasma melatonin level.
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Page Thurman K.
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