Stability of levamisole oral solutions prepared from tablets and powder.
OBJECTIVE
To study the stability of levamisole oral solutions (25 mg/mL) prepared from powder and tablets stored at 4 +/- 3 degrees C and 23 +/- 2 degrees C in amber glass prescription bottles.


METHODS
Levamisole 25 mg/mL solutions were prepared from commercially available 50-mg tablets or from pure powder in sterile water. Levamisole concentrations were determined in duplicate by a stability-indicating HPLC method at 0, 1, 2, 3, 4, 7, 14, 30, 60 and 90 days. The initial and final pHs of solutions were measured.


RESULTS
The recovery of levamisole from tablets was 100 +/- 2.1%. No color or odour changes were observed during the study period. The oral solutions prepared from powder were stable at least 90 days stored at 4 and 23 degrees C. The oral solutions prepared from tablets were stable at least 90 days at 4 degrees C and 15 days when stored at 23 degrees C. The initial pH of solutions prepared from powder and tablets were 5.30 and 4.55, respectively. Initial and final pH values were significantly different (p<0.001) for the two solutions.


CONCLUSIONS
Levamisole 25 mg/mL oral solutions can be prepared from tablets or powder with sterile water for irrigation and stored for 90 days under refrigeration, taking account of the lack of microbiological contamination.
Chiadmi
Fouad
F
Department of Pharmacy and Toxicology, University Hospital of Jean Verdier, Avenue du 14 Juillet, 95140 Bondy, France.
Lyer
Abdel
A
Cisternino
Salvatore
S
Toledano
Audrey
A
Schlatter
Joël
J
Ratiney
Robert
R
Fontan
Jean-Eudes
JE
D000284:Administration, Oral; D004355:Drug Stability; D007978:Levamisole / Q000008:administration & dosage / Q000032:analysis* / Q000138:chemical synthesis*; D019999:Pharmaceutical Solutions / Q000008:administration & dosage / Q000032:analysis / Q000138:chemical synthesis; D011208:Powders; D013607:Tablets
D019999:Pharmaceutical Solutions; D011208:Powders; D013607:Tablets; D007978:Levamisole