Related Experiment Video
Updated: Aug 14, 2026

In Vitro Bioluminescence Assay to Characterize Circadian Rhythm in Mammary Epithelial Cells
Published on: September 28, 2017
A melatonin preparation with a pulsatile liberation pattern: a new form of melatonin in replacement therapy
A Hoffmann1, K Farker, M Dittgen
1Department of Clinical Pharmacology University Hospital Jena, Jena, Germany. ahoffmann@landggraf.med.uni-jena.de
Abstract:
Using melatonin (MLT) as a circadian synchroniser in humans to treat rhythm disorders, it is desirable to have controlled-release dosage forms. Following in vitro liberation tests, one fast-release form containing 5 mg MLT (capsule A) and two oral pulsatile-dosage forms containing 10 mg MLT each (capsules B and C) were studied in a randomised, single-dose, threefold cross-over study in 15 healthy male volunteers after investigation of capsule B in dogs. Mean peak concentrations of MLT in serum (pmol/ml) were reached between 0.5 h and 0.75 h: Cmax1 20.7 (A), 16.4 (B), 9.7 (C). Capsules B and C released a second MLT pulse after about 3.5 h with Cmax2 of 13.0 and 17.5 pmol/ml, respectively. The time course of the renally excreted main metabolite 6-sulphatoxymelatonin (aMT6s) correlates with that of changes in MLT serum concentrations. The kinetic profile of the delivery system is adjusted to the pattern of sleep maintenance disturbances.
Related Concept Videos
Sleep-Wake Cycles
NREM Sleep
NREM sleep comprises four progressive stages that seamlessly merge:
Management of Insomnia
Chronopharmacokinetics: Circadian Rhythms and Influence on Drug Response
The time of drug administration is an important factor to consider, as it can influence the toxic dose of a drug. For example, a study conducted by Prins et al. in 1997 examined the effects of the timing of...
Modified-Release Drug Delivery Systems: Rate-Programmed II
Ophthalmic Drug Delivery Systems
Insulin Formulations: Types and Delivery
Short-acting insulins are divided into rapid-acting...

