Stability Implications of Repackaging Paracetamol Tablets into Dose Administration Aids

Abstract

ABSTRACTBackgroundDespite the widespread use of dose administration aids (DAAs) there is little available data on the stability of drugs during repackaging or storage in these devices.AimTo investigate the physicochemical stability of paracetamol tablets repackaged in DAAs.MethodPhysicochemical stability studies were performed on a commonly used paracetamol tablet directly after heat‐sealing in a DAA frequently employed in practice, then at ambient (25 °C; 60% relative humidity) and accelerated (40 °C; 75% relative humidity) conditions, over a 3‐month period. Physical characteristics of the tablets (weight uniformity, physical appearance, thickness, hardness, friability, disintegration, dissolution rates) were evaluated at time = 0, directly after heat‐sealing, 1 month and 3 months. Chemical stability was confirmed by high performance liquid chromatography (HPLC). The results were compared to control samples stored in the original packaging at the various environmental conditions studied.ResultsAll compendial requirements for physicochemical stability were met for both ambient and accelerated conditions over the 3‐month period. Chemical stability of paracetamol content fell within the required range of 95–105% of the labelled amount, for all environmental conditions.ConclusionThis study provides evidence on the stability of paracetamol tablets in a DAA, to support pharmacists in making sound clinical and operational decisions regarding the repackaging of paracetamol in these devices.