TRANSDERMAL MELATONIN DELIVERY SYSTEM FOR INSOMNIA TREATMENT
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Abstract
Melatonin, a pineal gland hormone can play an important role on circadian rhythms and worked as an internal sleep facilitator in human. Recently, melatonin was used as a drug for treatment of insomnia. The transdermal drug delivery is a good alternative for melatonin delivery because of its variable oral absorption, short half-life, highly first pass metabolism, and a favorable partition coefficient. Recently, transdermal delivery of melatonin is prepared as solutions, patches, nanovesicles and nanoparticles, and hydrogels. Many studies are successful in development and evaluation of transdermal melatonin delivery system with high drug released, high drug permeated, and high permeation rate with short lag time. Furthermore, vehicles and penetration enhancers have a major effect on melatonin permeation via the skin. Some clinical trials that studied the effectiveness of transdermal melatonin patch showed that the patch can increase plasma melatonin level for an extended duration. However, these clinical trials were performed in few numbers of subjects, thus the study in a larger number of subject is still necessary. In conclusion, transdermal melatonin delivery may be a more effective way in the treatment of insomnia.
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References
Aeschbach D, Lockyer BJ, Dijk DJ, Lockley SW, Nuwayser ES, Nichols LD, Czeisler CA. 2009. Use of transdermal melatonin delivery to improve sleep maintenance during daytime. Clin. Pharmacol. Ther. 86(4): 378-382.
Andega S, Kanikkannan N, Singh M. 2001. Comparison of the effect of fatty alcohols on the permeation of melatonin between porcine and human skin. J. Control Release. 77(1–2): 17-25.
Andersen LP, Werner MU, Rosenkilde MM, Harpsoe NG, Fuglsang H, Rosenberg J, Gogenur I. 2016. Pharmacokinetics of oral and intravenous melatonin in healthy volunteers. BMC Pharmacol. Toxicol. 17(1): 8.
Barrenetxe J, Delagrange P, Martinez JA. 2004. Physiological and metabolic functions of melatonin. J. Physiol. Biochem. 60(1): 61-72.
Bénès L, Claustrat B, Horrière F, Geoffriau M, Konsil J, Parrott KA, DeGrande G, McQuinn RL, Ayres JW. 1997. Transmucosal, oral controlled-release, and transdermal drug administration in human subjects: a crossover study with melatonin. J. Pharm. Sci. 86(10): 1115-1119.
Doi Y. 2009. Epidemiologic research on insomnia in the general Japanese populations. Nihon Rinsho. 67(8): 1463-1467.
Dragicevic-Curic N, Maibach HI. 2013. Percutaneous Penetration Enhancers-Chemical Methods in Penetration Enhancement: Drug Manipulation Strategies and Vehicle Effects. Berlin: Springer.
Dubey V, Mishra D, Asthana A, Jain NK. 2006. Transdermal delivery of a pineal hormone: Melatonin via elastic liposomes. Biomaterials. 27(18): 3491-3496.
Dubey V, Mishra D, Jain NK. 2007. Melatonin loaded ethanolic liposomes: Physicochemical characterization and enhanced transdermal delivery. Eur. J. Pharm. Biopharm. 67(2): 398-405.
Dziegiel P, Podhorska-Okolow M, Zabel M. 2008. Melatonin: adjuvant therapy of malignant tumors. Med. Sci. Monit. 14(5): RA64-70.
Hadgraft J, Guy RH. 2003. Feasibility Assessment in Topical and Transdermal Delivery: Mathematical Models and In Vitro Studies. In R. H. Guy & J. Hadgraft (Eds.), Transdermal Drug Delivery: Second Edition, Revised and Expanded. New York: Marcel Dekker, Inc.
Hafner A, Lovric J, Pepic I, Filipovic-Grcic J. 2011. Lecithin/chitosan nanoparticles for transdermal delivery of melatonin. J. Microencapsul. 28(8): 807-815.
Hoffmeister CR, Durli TL, Schaffazick SR, Raffin RP, Bender EA, Beck RC, Pohlmann AR, Guterres SS. 2012. Hydrogels containing redispersible spray-dried melatonin-loaded nanocapsules: a formulation for transdermal-controlled delivery. Nanoscale Res. Lett. 7(1): 251.
Kandimalla KK, Babu RJ, Singh M. 2010. Biphasic flux profiles of melatonin: The Yin-Yang of transdermal permeation enhancement mediated by fatty alcohol enhancers. J. Pharm. Sci. 99(1): 209-218.
Kaneita Y, Ohida T, Osaki Y, Tanihata T, Minowa M, Suzuki K, Wada K, Kanda H, Hayashi K. 2006. Insomnia among Japanese adolescents: a nationwide representative survey. Sleep. 29(12): 1543-1550.
Kanikkannan N, Andega S, Burton S, Babu RJ, Singh M. 2004. Formulation and in vitro evaluation of transdermal patches of melatonin. Drug Dev. Ind. Pharm. 30(2): 205-212.
Kikwai L, Kanikkannan N, Babu RJ, Singh M. 2002. Effect of vehicles on the transdermal delivery of melatonin across porcine skin in vitro. J. Control Release. 83(2): 307-311.
Komada Y, Nomura T, Kusumi M, Nakashima K, Okajima I, Sasai T, Inoue Y. 2012. A two-year follow-up study on the symptoms of sleep disturbances/insomnia and their effects on daytime functioning. Sleep Med. 13(9): 1115-1121.
Lane EA, Moss HB. 1985. Pharmacokinetics of melatonin in man: first pass hepatic metabolism. J. Clin. Endocrinol. Metab. 61(6): 1214-1216.
Leger D, Bayon V, Ohayon MM, Philip P, Ement P, Metlaine A, Chennaoui M, Faraut B. 2014. Insomnia and accidents: cross-sectional study (EQUINOX) on sleep-related home, work and car accidents in 5293 subjects with insomnia from 10 countries. J. Sleep Res. 23(2): 143-152.
Morphy H, Dunn KM, Lewis M, Boardman HF, Croft PR. 2007. Epidemiology of insomnia: a longitudinal study in a UK population. Sleep. 30(3): 274-280.
Oh H-J, Oh Y-K, Kim C-K. 2001. Effects of vehicles and enhancers on transdermal delivery of melatonin. Int. J. Pharm. 212(1): 63-71.
Prausnitz MR, Langer R. 2008. Transdermal drug delivery. Nature Biotechnol. 26(11): 1261-1268.
Priano L, Esposti D, Esposti R, Castagna G, De Medici C, Fraschini F, Gasco MR, Mauro A. 2007. Solid lipid nanoparticles incorporating melatonin as new model for sustained oral and transdermal delivery systems. J. Nanosci. Nanotechnol. 7(10): 3596-3601.
Ranade VV, Cannon JB. 2011. Drug Delivery Systems. 3rd ed. Florida: CRC Press.
Roberts MS, Cross SE, Pellett MA. 2007. Skin Transport. In K. A. Walters (Ed.), Dermatological and Transdermal Formulations. New York: Informa Healthcare USA, Inc.
Rougier A, Lotte C, Maibach HI. 2001. In Vivo Relationship Between Percutaneous Absorption and Transepidermal Water Loss. In R. L. Bronaugh & H. I. Maibach (Eds.), Topical Absorption of Dermatological Products. New York: Marcel Dekker, Inc.
Ruby PK, Pathak SM, Aggarwal D. 2014. Critical attributes of transdermal drug delivery system (TDDS) – a generic product development review. Drug Dev. Ind. Pharm. 40(11): 1421-1428.
Schomerus C, Korf HW. 2005. Mechanisms regulating melatonin synthesis in the mammalian pineal organ. Ann. N. Y. Acad. Sci. 1057(1): 372-383.
Sukying C, Bhokakul V, Udomsubpayakul U. 2003. An epidemiological study on insomnia in an elderly Thai population. J. Med. Assoc. Thailand. 86(4): 316-324.
Walsh JK. 2004. Clinical and socioeconomic correlates of insomnia. J. Clin. Psychiatry. 65(Suppl 8): 13-19.
Westerlund A, Bellocco R, Sundström J, Adami HO, Åkerstedt T, Trolle Lagerros Y. 2013. Sleep characteristics and cardiovascular events in a large Swedish cohort. Eur. J. Epidemiol. 28(6): 463-473.
Wiedersberg S, Guy RH. 2014. Transdermal drug delivery: 30+ years of war and still fighting! J. Control Release. 190: 150-156.
Williams AC, Barry BW. 2004. Penetration enhancers. Adv. Drug Deliv. Rev. 56(5): 603-618.
Wokovich AM, Prodduturi S, Doub WH, Hussain AS, Buhse LF. 2006. Transdermal drug delivery system (TDDS) adhesion as a critical safety, efficacy and quality attribute. Eur. J. Pharm. Biopharm. 64(1): 1-8.
Zailinawati A, Ariff K, Nurjahan M, Teng C. 2008. Epidemiology of insomnia in Malaysian adults: a community-based survey in 4 urban areas. Asia Pac. J. Public Health. 20(3): 224-233.