Stability Implications of Repackaging Paracetamol Tablets into Dose Administration Aids.

Loading...
Thumbnail Image
File version
Author(s)
Haywood, A
Mangan, M
Glass, B
Griffith University Author(s)
Primary Supervisor
Other Supervisors
Editor(s)

Professor Jo-anne E Brien

Date
2006
Size

571856 bytes

20586 bytes

File type(s)

application/pdf

text/plain

Location
License
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 heat-sealing in a DAA frequently employed in practice, then at ambient (25ꃻ 60% relative humidity) and accelerated (40 ꃻ 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 heatsealing, 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.

Journal Title

Journal of Pharmacy Practice and Research

Conference Title
Book Title
Edition
Volume

36

Issue

1

Thesis Type
Degree Program
School
Publisher link
Patent number
Funder(s)
Grant identifier(s)
Rights Statement
Rights Statement

© 2006 Journal of Pharmacy Practice and Research. The attached file is reproduced here in accordance with the copyright policy of the publisher.

Item Access Status
Note
Access the data
Related item(s)
Subject

Pharmacology and pharmaceutical sciences

Persistent link to this record
Citation
Collections