Abstract
A modified release bi-layered tablet of melatonin incorporating a fast release fraction consisting of melatonin-beta-cyclodextrin inclusion complex and a slow release fraction containing melatonin in HPMC K15M and Carbopol 971 P matrices was prepared. The formulation developed showed an initial burst followed by a near zero order release pattern for a period of 8 h. The drug content, physical characteristics and the release profile were unaffected after 3 months of an accelerated stability study at 40 degrees C and 75% relative humidity.
Publication types
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Research Support, Non-U.S. Gov't
MeSH terms
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Acrylic Resins
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Antioxidants / administration & dosage*
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Antioxidants / chemistry
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Calorimetry, Differential Scanning
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Chemistry, Pharmaceutical
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Cyclodextrins / chemistry*
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Delayed-Action Preparations
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Drug Stability
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Excipients
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Kinetics
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Lactose / analogs & derivatives*
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Melatonin / administration & dosage*
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Melatonin / chemistry
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Methylcellulose / analogs & derivatives*
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Microscopy, Electron, Scanning
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Oxazines
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Polyvinyls
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Solubility
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Spectroscopy, Fourier Transform Infrared
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Tablets
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beta-Cyclodextrins*
Substances
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Acrylic Resins
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Antioxidants
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Cyclodextrins
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Delayed-Action Preparations
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Excipients
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Oxazines
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Polyvinyls
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Tablets
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beta-Cyclodextrins
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carboxypolymethylene
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Methylcellulose
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MK 458
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Lactose
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Melatonin
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betadex