STABILITY OF DANTROLENE ORAL SUSPENSION PREPARED FROM CAPSULES

Citation
Jp. Fawcett et al., STABILITY OF DANTROLENE ORAL SUSPENSION PREPARED FROM CAPSULES, Journal of clinical pharmacy and therapeutics, 19(6), 1994, pp. 349-353
Citations number
9
Categorie Soggetti
Pharmacology & Pharmacy
ISSN journal
02694727
Volume
19
Issue
6
Year of publication
1994
Pages
349 - 353
Database
ISI
SICI code
0269-4727(1994)19:6<349:SODOSP>2.0.ZU;2-M
Abstract
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.