Jp. Fawcett et al., STABILITY OF DANTROLENE ORAL SUSPENSION PREPARED FROM CAPSULES, Journal of clinical pharmacy and therapeutics, 19(6), 1994, pp. 349-353
The chemical stability of an extemporaneously compounded dantrolene or
al suspension (5 mg/ml dantrolene sodium) in Syrup BP containing citri
c acid with and without methyl hydroxybenzoate preservative was studie
d on storage at 5, 25 and 40 degrees C for 150 days in high density po
lyethylene dispensing bottles. The amount of dantrolene free acid in s
uspension was monitored by a stability indicating HPLC assay. There wa
s no significant decomposition of dantrolene under all storage conditi
ons irrespective of the presence of preservative. The results show tha
t the formulation of dantrolene oral suspension provides a convenient
and stable dosage form for use in pediatric patients and in those unab
le to swallow capsules. It is recommended that the formulation be stor
ed at room temperature and in the absence of microbiological testing a
shelf-life of 30 days is proposed for the product prepared with prese
rved syrup.