Circadin 2 mg prolonged-release tablet is the only licensed melatonin product available in\nthe UK. Circadin is indicated for patients with primary insomnia aged 55 and over, but is more widely\nused ââ?¬Å?off-labelââ?¬Â to treat sleep disorders especially in the paediatric population. Children and older\npeople often have difficulty swallowing tablets and dividing the tablet is sometimes required to ease\nadministration. The aim of this study was to measure the release profile of melatonin from Circadin\ntablets when divided or crushed, and compare this with release from intact tablets. Dissolution\ntesting was also performed for unlicensed melatonin products for comparison. Dissolution tests were\nperformed using the pharmacopoeial paddle apparatus, with melatonin release analyzed by high\nperformance liquid chromatography. Melatonin content, hardness, friability, and disintegration of\nthe products were also evaluated. The prolonged release of melatonin from Circadin tablets was\nunlike that of any other product tested. When divided into halves, Circadin preserved most of\nthe prolonged-release characteristic (f2 = 58), whereas quarter-cut and crushed tablet had a more\nimmediate melatonin release profile. Circadin is significantly less expensive and should be preferred\nto unlicensed medicines which are not pharmaceutically equivalent and offer less quality assurance.
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