Stability of sodium valproate tablets repackaged into dose administration aids

Llewelyn, Victoria K., Mangan, Martina F., and Glass, Beverley D. (2010) Stability of sodium valproate tablets repackaged into dose administration aids. Journal of Pharmacy and Pharmacology, 62 (7). pp. 838-843.

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Objectives: Since sodium valproate, a commonly used antiepileptic drug, has been reported to be unstable in the presence of moisture, our objective was to investigate the effect of repackaging into dose administration aids.

Methods: Sodium valproate 100 mg immediate-release tablets were repackaged and stored for 56 days at accelerated conditions (40°C/75% relative humidity), room temperature (25°C) and under refrigeration (2–8°C). Samples were analysed at 3, 7, 10, 14, 21, 35, 49 and 56 days to determine chemical stability using high-performance liquid chromatography, while physical testing included assessment of weight changes and dissolution behaviour.

Key findings: The results revealed that the sodium valproate content in the tablets remained within the acceptable range of 90–110% under all storage conditions for 56 days. Physical stability, however, was not maintained, with a total weight gain of 12.36% under accelerated conditions over the 56 days. Samples stored under all conditions showed variable dissolution compared to the controls, with the amount of sodium valproate in solution following 45 min of dissolution testing below 75% for half of all the intervals determined.

Conclusions: Repackaging sodium valproate tablets into dose administration aids results in unacceptable weight variation and changes in the dissolution profiles.

Item ID: 11643
Item Type: Article (Research - C1)
ISSN: 0022-3573
Keywords: dose administration aids; physiochemical stability; repackaging; sodium valproate
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Date Deposited: 09 Aug 2010 03:53
FoR Codes: 11 MEDICAL AND HEALTH SCIENCES > 1115 Pharmacology and Pharmaceutical Sciences > 111503 Clinical Pharmacy and Pharmacy Practice @ 100%
SEO Codes: 92 HEALTH > 9299 Other Health > 929999 Health not elsewhere classified @ 100%
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