Abstract
Tablets are often used in splitting process when the appropriated, registered dose is not available on the market or patients exhibit swallowing difficulties caused by the size of the tablet. The aim of the work was to assess the impact of physical division of tablets on the kinetics of in vitro gliclazide release from the intact and divided tablets. Gliclazide was released from prolonged release tablets containing 30 or 60 mg of the drug into a phosphate buffer, pH 7.4 and the amount of the drug in acceptor fluid was determined by UV–Vis spectrophotometry. The dissolution profiles were fit to zero- and first-order kinetics as well as to the Korsmeyer-Peppas equation. The largest discrepancy in the values of rate constants was obtained in the case of the release of gliclazide from intact and from splitting tablets using zero- and first-order kinetics. The values of the rate constants k0 obtained from the release of the drug from the intact tablets and from fragments with a dose of the drug of 30 mg were (4.2 ± 0.1) × 10−5 g min−1 and (5.8 ± 0.1) × 10−5 g min−1, respectively, and k1 were (2.3 ± 0.1) × 10−3 min−1 and (4.7 ± 0.6) × 10−3 min−1, respectively. These discrepancies were confirmed by the value of f2 coefficient that was 45.9. The results suggest that physical division of tablets accelerate the release of gliclazide from its prolonged form.Graphical abstract
Highlights
The oral dosage form, such as tablets is a very convenient method used in pharmacotherapy
The results suggest that physical division of tablets accelerate the release of gliclazide from its prolonged form
The in vitro release study revealed that physical division of tablets results in fragments not always containing the amount of the drug that is necessary in pharmacotherapy
Summary
The oral dosage form, such as tablets is a very convenient method used in pharmacotherapy. Facilitate the administration of formulations that cause swallowing problems, what is often associated with discomfort and can discourage patients from taking the medicine [3] Another advantage of physical division of tablets is the economic aspect. Splitting of tablets can result in loss of modified release properties These medications are formulated to release drug in a defined dosing period. The greatest weight loss was observed during manual division of tablets, especially in the case of older patients [8,9,10,11]. The weight variability, content nonuniformity and chemical degradation were found, especially in the case of digoxin formulations Based on this observation it was stated that tablets should not be split ahead of time, but only immediately before administration
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