Stability implications of repackaging paracetamol tablets into dose administration aids

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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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.

Item ID: 4160
Item Type: Article (Research - C1)
ISSN: 1445-937X
Keywords: DAA; HPLC; stability
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Date Deposited: 03 Nov 2009 00:51
FoR Codes: 11 MEDICAL AND HEALTH SCIENCES > 1115 Pharmacology and Pharmaceutical Sciences > 111599 Pharmacology and Pharmaceutical Sciences not elsewhere classified @ 100%
SEO Codes: 92 HEALTH > 9299 Other Health > 929999 Health not elsewhere classified @ 100%
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