NDLI: Stability Implications of Repackaging Paracetamol Tablets into Dose Administration Aids

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Stability Implications of Repackaging Paracetamol Tablets into Dose Administration Aids

Content Provider	Semantic Scholar
Author	Haywood, Alison Mangan, Martina Glass, Beverley D.
Copyright Year	2006
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.
Starting Page	25
Ending Page	28
Page Count	4
File Format	PDF HTM / HTML
DOI	10.1002/j.2055-2335.2006.tb00881.x
Volume Number	36
Alternate Webpage(s)	https://research-repository.griffith.edu.au/bitstream/handle/10072/14259/33428_1.pdf
Alternate Webpage(s)	https://research-repository.griffith.edu.au/bitstream/handle/10072/14259/33428_1.pdf;jsessionid=09A9C7CA3CA9E633804D7299CC85E84E?sequence=1
Language	English
Access Restriction	Open
Content Type	Text
Resource Type	Article

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