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The aim of this paper was to examine the impact of mechanical tablet splitting on in vitro dissolution of naproxen sodium. Naproxen (250 and 500 mg) was used in the experiment. The in vitro tests were conducted using the USP paddle apparatus. The release of the drug from the 500-mg (whole 500-mg tablets or two 250-mg tablets), 250 mg (whole 250-mg tablets or fragments obtained by halving a 500-mg tablet), and 125 mg (fragments obtained by halving a 250-mg tablet or quartering a 500-mg tablet) formulations of naproxen in phosphate buffer solution (pH = 6.8) were monitored spectrophotometrically at 271 nm. The difference factor (f1) and the similarity factor (f2) for the obtained profiles were derived. The dissolution profiles were also analyzed using first-order, second-order, and Korsmeyer-Peppas model equations. The release rate constants, half release times, and correlation coefficients for these models were also calculated. Statistical methods including Student’s t-test were employed for comparison of the dissolution profiles. Kinetic studies and statistical analysis suggested that splitting naproxen tablets did not alter the dissolution profile or pharmacokinetics, although the values obtained for f1 and f2 may indicate differences between the release from intact tablets and fragments containing the same amount of the drug.

Influence of Tablet Splitting on Dissolution of Tablets with Naproxen Sodium