Stability of Dispersible Aspirin Tablets Repacked into Dosette Boxes

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 ꃩ, controlled room temperature (25 ꃻ 60% relative humidity [RH]), accelerated (40 ꃻ 75% RH), and 'in-use' with natural variations in daylight exposure and internal temperature fluctuations (23-26 ꃻ 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 (r2 > 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.