New dosage form for pulsatile delivery of melatonin: Development and testing in animal and human subjects

Aging Male

Volumn 1, Issue 2, 1998, Pages 141-148

  Dittgen, M ^a,b   Hoffmann, H ^a  

^a BAYER PHARMA AG   (Germany)

^b NONE   (Germany)

Author keywords

In vitro dissolution; Melatonin; Oral pulsatile delivery system; Pharmacokinetics in dogs; Pharmacokinetics in humans

Indexed keywords

EID: 0000874359     PISSN: 13685538     EISSN: None     Source Type: Journal    
DOI: 10.3109/13685539809148613     Document Type: Article

References (32)

1. Arendt J. Melatonin and the Mammalian Pineal Gland. London: Chapman & Hall, 1995:161-200
2. Iguchi H, Kato K, Ibayashi H. Age-dependent reduction in serum melatonin concentrations in healthy human subjects. J Clin Endocrinol Metab 1982;55:27-9
3. Waldhauser F, Weiszenbacher G, Tatzer E, Gisinger B, Waldhauser M, Schemper M, Frisch H. Alterations in nocturnal serum melatonin levels in humans with growth and aging. J Clin Endocrinol Metab 1988;66:648-52
4. Haimov I, Laudon M, Zisapel N, Souroujon M, Nof D, Shlitner A, Herer P, Tzischinsky O, Lavie P. Sleep disorders and melatonin rhythms in elderly people. Br Med J 1994;309:167
5. Sudgen D. Psychopharmacological effects of melatonin in mouse and rat. J Pharmacol Exp Ther 1983; 222:587-91
6. Sewerynek E, Melchiorri D, Reiter RJ, Ortiz GG, Lewinski A. Liposaccharide-induced hepatotoxicity is inhibited by the antioxidant melatonin. Eur J Pharmacol 1995;293:327-34
7. Bartsch C, Bartsch H, Lippert TH. Rationales to consider the use of melatonin as a chronooncotherapeutic drug. In Vivo 1995;9:305-10
8. Voordouw BCG, Euser R, Verdonk RER, Alberda BT, de Jong FH, Drogendijk AC, Frauser BCJ, Cohen M. Melatonin and melatonin - progesrin combinations alter pituitary function in women and can inhibit ovulation. J Clin Endocrinol Metab 1992;74:108-17
9. Maestroni GJM. The immunoneuroendocrine role of melatonin. J Pineal Res 1993;14:1-10
10. Brown GM. Melatonin in psychiatric and sleep disorders. CNS Drugs 1995;3:209-26
11. Zhdanova IV, Wurtman RJ, Morabito C, Piotrovska VR, Lynch HJ. Effects of low oral doses of melatonin, given 2-4 hours before habitual bedtime, on sleep in normal young humans. Sleep 1996;19:423-31
12. Garfinkel D, Laudon M, Nof D, Zisapel N. Improvement of sleep quality in elderly people by controlled-release melatonin. Lancet 1995;346: 541-4
13. Petrie K, Dawson AG, Thomson L, Brook R. A double-blind trial of melatonin as a treatment for jet lag in international cabin crew. Biol Psychiatr 1993;33:526-30
14. Dawson D, Encel N, Lushington K. Improving adaption to stimulated night shift timed exposure to bright light versus daytime melatonin administration. Sleep 1995;18:11-21
15. Thalen BE, Kjellman BF, Morkrid L, Wetterberg L. Melatonin in light treatment of patients with seasonal and nonseasonal depression. Acta Psychiatr Scand 1995;92:274-84
16. Haimov I, Lavie P. Potential of melatonin replacement therapy in older patients with sleep disorders. Drugs & Aging 1995;7:75-8
17. Benes L, Brun J, Claustrat B, DeGrande G, Ducloux N, Geoffriau M, Horriere F, Karsenty H, Lagain D. In Touitou Y, Arendt J, Pévet P, eds. Melatonin and the Pineal Gland - From Basic Science to Clinical Application. Amsterdam: Elsevier Science Publishers, 1993:347-50
18. Zisapel N. Melatonin containing compositions. European Patent Application. EP 0 518 468 A1. Neurim Pharm Ltd, Tel Aviv
19. Lewy AJ, Sack RL, Parrott KA, Ayres JW. Sustained release oral compositions containing melatonin. WO 95/03043 US (1994)
20. Lee B-J, Min G-H. Preparation and release characteristics of polymer-reinforced and coated alginate beads. Arch Pharm Res 1995;18:183-8
21. Lee B-J, Parrott KA, Ayres JW, Sack RL. Design and evaluation of an oral controlled release delivery system for melatonin in human subjects. Int J Pharmac 1995;124:119-27
22. Lee B-J, Min G-H. Oral controlled release of melatonin using polymer-reinforced coated alginate beads. Int J Pharmac 1996;144:37-46
23. Aldhous M, Franey C, Wright J, Arendt J. Plasma concentrations of melatonin in man following oral absorption of different preparations. Br J Clin Pharmac 1985;19:517-21
24. Lee B-J, Parrott KA, Ayres JW, Sack RL. Preliminary evaluation of transdermal delivery of melatonin in human subjects. Res Comm Mol Path Pharmacol 1994;85:337-46
25. Dittgen M, Fricke S, Gräeser T, Osterwald H, Oettel M, Lippert TH, Hoffmann H, Fautek J-D. Use of melatonin for the production of a peroral pulsatile form of medication. German Patent Application. DE 44 43 175 A1. Jenapharm GmbH & Co. KG, Jena
26. Fraser S, Cowen P, Franklin M, Franey C, Arendt J. Direct radioimmunoassay for melatonin in plasma J Clin Chem 1983;29:396-7
27. Aldhous M, Arendt J. Radioimmunoassay for 6-sulphatoxymelatonin in urine using an iodinated tracer. Ann Clin Biochem 1988;25:298-303
28. Junginger HE. Oral applications of pulsatile drug delivery. In Gurny R, Junginger HE, Peppas NA, eds. Pulsatile Drug Delivery, Current Applications and Future Trends. Stuttgart: Wissenschaftl Verlagsgesellschaft, 1993;113-34
29. Nowak R, McMillen IC, Redman J, Short RV. The correlation between serum and salivary melatonin concentrations and urinary 6-hydroxymelatonin sulphate excretion rates: two non-invasive techniques for monitoring human circadian rhythmicity. Clin Endocrinol (Oxf) 1987;27: 445-52
30. Mallo C, Zaidan R, Galy G, Vermeulen E, Brun J, Chazot G, Claustrat B. Pharmacokinetics of melatonin in man after intravenous infusion and bolus injection. Eur J Clin Pharmacol 1990;38:297-301
31. Di W, Kadva A, Johnston A, Silman R. Variable bioavailability of oral melatonin. N Engl J Med 1997;333:1028-9
32. Yeleswaram K, McLaughlin LG, Knipe JO, Schabdach D. Pharmacokinetics and oral bioavailability of exogenous melatonin in preclinical animal studies and clinical implications. J Pineal Res 1997; 22:45-51