Stability of Dispersible Aspirin Tablets Repacked into Dosette Boxes

Abstract

ABSTRACT Background Although guidelines indicate that dispersible aspirin tablets should not be repacked into dose administration aids, it is common practice especially among older people. Aim To determine the stability of acetylsalicylic acid (ASA) in aspirin tablets repacked into Dosette boxes. Method Dispersible aspirin 300 mg tablets were removed from their primary (foil) packaging, and repacked as whole and split (halved) tablets into Dosette boxes under 4 storage conditions: refrigeration (2–8 °C), controlled room temperature (25 °C; 60% relative humidity [RH]), accelerated (40 °C; 75% RH), and ‘in‐use’ with natural variations in daylight exposure and internal temperature fluctuations (23–26 °C; 45–60% RH) for 1 week. The high performance liquid chromatography method developed was validated for accuracy, precision, linearity and range, sensitivity, robustness and specificity, and the suitability of extraction media evaluated. Results Linearity (r 2 > 0.999), precision (relative standard deviation < 2%) accuracy (recovery: 95–102%) and selectivity for the high performance liquid chromatography method were confirmed. The ASA content remained within specifications (95–105% of labelled amount) for all except the accelerated storage condition, with 93% of the ASA remaining. The split tablets did not display any additional ASA degradation when compared to the whole tablets under the same conditions. Conclusion While the ASA content of the dispersible aspirin tablets remained within specifications at room temperature, there were changes in the physical appearance under accelerated storage conditions.