Comparative Quality Analysis of Three Marketed Melatonin Containing Products in Spain for the Improvement of Sleep
Ana María Castilla Olea
TECNALIA, Basque Research and Technology Alliance (BRTA), Parque Tecnológico de Álava, c/Leonardo Da Vinci no. 11, 01510 Miñano, Spain.
Jaime de Algorta
Medical Department, Exeltis Healthcare, Spain.
Idoia Arriaga-Ibañez
TECNALIA, Basque Research and Technology Alliance (BRTA), Parque Tecnológico de Álava, c/Leonardo Da Vinci no. 11, 01510 Miñano, Spain.
Ilia Villate-Beitia
Nano Bio Cel Research Group, Laboratory of Pharmacy and Pharmaceutical Technology. Faculty of Pharmacy, University of the Basque Country (UPV/EHU), Paseo de la Universidad 7, 01006 Vitoria-Gasteiz, Spain, Networking Research Centre of Bioengineering, Biomaterials and Nanomedicine (CIBER-BBN), Institute of Health Carlos III, 01006 Vitoria-Gasteiz, Spain and Bioaraba, NanoBioCel Research Group, 01009 Vitoria-Gasteiz, Spain.
Idoia Gallego
Nano Bio Cel Research Group, Laboratory of Pharmacy and Pharmaceutical Technology. Faculty of Pharmacy, University of the Basque Country (UPV/EHU), Paseo de la Universidad 7, 01006 Vitoria-Gasteiz, Spain, Networking Research Centre of Bioengineering, Biomaterials and Nanomedicine (CIBER-BBN), Institute of Health Carlos III, 01006 Vitoria-Gasteiz, Spain and Bioaraba, NanoBioCel Research Group, 01009 Vitoria-Gasteiz, Spain.
Çağla Defterali
Medical Department, Exeltis Healthcare, Spain.
Jose-Luis Pedraz *
Nano Bio Cel Research Group, Laboratory of Pharmacy and Pharmaceutical Technology. Faculty of Pharmacy, University of the Basque Country (UPV/EHU), Paseo de la Universidad 7, 01006 Vitoria-Gasteiz, Spain, Networking Research Centre of Bioengineering, Biomaterials and Nanomedicine (CIBER-BBN), Institute of Health Carlos III, 01006 Vitoria-Gasteiz, Spain and Bioaraba, NanoBioCel Research Group, 01009 Vitoria-Gasteiz, Spain.
*Author to whom correspondence should be addressed.
Abstract
Background: Exogenous melatonin may effectively improve the sleep-wake cycle and sleep quality in subjects with age or disease related decrease in endogenous melatonin production or response. A controlled release melatonin-based medication, Circadin® has been developed and licensed for insomnia; in addition to several food supplements available on the market. However, the quality and release profile of these melatonin containing products may vary.
Aims: The current study aimed to compare three melatonin containing products, all of them marketed in Spain: a licensed medicine prolonged release tablet, Circadin® 2 mg, and two food supplements, Aquilea® 1,95mg and Oniria® 1,98 mg.
Materials and Methods: Three batches of each product were analyzed for melatonin content, inter-batch variability and dissolution profile.
Results: Our results confirm a large gap in quality control of the two melatonin containing food supplements, where Aquilea® and Oniria® showed poorer quality control as demonstrated by high variability between batches in melatonin content compared to Circadin®. Moreover, the extended release characteristics of Circadin® were evident in its profile, which exhibited an initial release of 70% at the 4-hour mark, followed by a consistent and sustained release lasting up to 8 hours.
Conclusion: In terms of the dissolution profile, only Circadin® provides the prolonged release profile as indicated in the specifications, with proven efficacy and safety for the improvement of sleep-onset, sleep maintenance and quality throughout the whole night.
Keywords: Insomnia, melatonin, food supplement, quality control