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      A Melatonin Preparation with a Pulsatile Liberation Pattern: A New Form of Melatonin in Replacement Therapy

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          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: C<sub>max1</sub> 20.7 (A), 16.4 (B), 9.7 (C). Capsules B and C released a second MLT pulse after about 3.5 h with C<sub>max2</sub> 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.

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          Variable bioavailability of oral melatonin.

          Megan K. W. Di Quinzio, A Kadva, Ian Johnston … (1997)
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            Improvement of sleep quality in elderly people by controlled-release melatonin

            D. Garfinkel, M Laudon, D Nof … (1995)
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              A double-blind trial of melatonin as a treatment for jet lag in international cabin crew.

              Keith Petrie, Alexander Dawson, Leonard J. Thompson … (1993)
              This study investigated the efficacy of oral melatonin in alleviating jet lag in flight crew after a series of international flights. The optimal time for taking melatonin in this group was also investigated. In a double-blind placebo-controlled trial, 52 international cabin crew were randomly assigned to three groups; early melatonin (5 mg started 3 days prior to arrival until 5 days after return home); late melatonin (placebo for 3 days then 5 mg melatonin for 5 days); and placebo. Daily ratings showed a trend in jet lag, mood, and sleepiness measures toward an improved recovery in the late melatonin group and a worse recovery in the early melatonin group as compared to placebo. Retrospective ratings made 6 days after arrival showed the late melatonin group reported significantly less jet lag and sleep disturbance following the flight compared to placebo. The late melatonin group also showed a significantly faster recovery of energy and alertness than the early melatonin group, which reported a worse overall recovery than placebo. These findings show melatonin may have potential benefits for international aircrew.
              Article 0 comments Cited 32 times – based on 0 reviews     Review now
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                Author and article information

                Journal
                Journal ID (publisher-id): BSI
                Journal ID (nlm-ta): Neurosignals
                Journal ID (doi): 10.1159/issn.1424-862X
                Title: Neurosignals
                Publisher: S. Karger AG
                ISSN (Print): 1424-862X
                ISSN (Electronic): 1424-8638
                Publication date Subscription-year: 1999
                Publication date (Print): April 1999
                Publication date (Electronic): 19 March 1999
                Volume: 8
                Issue: 1-2
                Pages: 96-104
                Affiliations
                aDepartment of Clinical Pharmacology University Hospital Jena and bJenapharm GmbH & Co KG, Jena, Germany
                Article
                Publisher ID: 14576 Other ID: Biol Signals Recept 1999;8:96–104
                DOI: 10.1159/000014576
                PubMed ID: 10085470
                SO-VID: 64392b15-5b09-4b21-9888-98a6ab9c7c90
                Copyright © © 1999 S. Karger AG, Basel
                License:

                Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher. Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug. Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.

                History
                Page count
                Figures: 5, Tables: 1, References: 38, Pages: 9
                Categories
                Subject: Part II: Clinical Applications<br>Invited Lectures

                ScienceOpen disciplines: Geriatric medicine,Neurology,Cardiovascular Medicine,Neurosciences,Clinical Psychology & Psychiatry,Public health
                Keywords: Pulsatile liberation,Pharmacokinetics,Melatonin
                Data availability:
                ScienceOpen disciplines: Geriatric medicine, Neurology, Cardiovascular Medicine, Neurosciences, Clinical Psychology & Psychiatry, Public health
                Keywords: Pulsatile liberation, Pharmacokinetics, Melatonin

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