Haywood, Alison, Mangan, Martina, and Glass, Beverley (2006) Stability implications of repackaging paracetamol tablets into dose administration aids. Journal of Pharmacy Practice and Research, 36 (1). pp. 25-28.

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Abstract

Background: Despite 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.

Aim: To investigate the physicochemical stability of paracetamol tablets repackaged in DAAs.

Method: Physicochemical stability studies were performed on a commonly used paracetamol tablet directly after heal-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.

Results: All 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.

Conclusion: This 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.

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