A comparative study of the antimycotic activity of a miconazole HP-beta cyclodextrin solution and a surfactant solution.
The antimycotic activity of a new parenteral solution containing miconazole was compared to that of a marketed solution (Daktarin IV solution). This solution has been withdrawn from the belgian market probably because of the toxic effects related to the presence of polyoxyl 35 castor oil. We propose a new formulation containing 10 mg of miconazole per ml (as the marketed solution), in combination with HP-beta cyclodextrin and lactic acid. The MIC of these two solutions were determined by broth microdilution method (following the NCCLS guidelines) against 15 yeasts and 16 filamentous fungi isolates. This study showed that MIC obtained with these two solutions are not significantly different. In vitro, the cyclodextrin solution has the same antimycotic activity as the Daktarin IV solution and can be proposed as a safe and effective parenteral solution to replace the previous surfactant solution.
Piel
G
G
Laboratoire de Technologie Pharmaceutique, Université de Liège, Belgium.
Hayette
M P
MP
Evrard
B
B
Van Hees
T
T
De Mol
P
P
Delattre
L
L
D000935:Antifungal Agents / Q000008:administration & dosage / Q000494:pharmacology*; D003505:Cyclodextrins; D005079:Excipients; D005658:Fungi / Q000187:drug effects; D008825:Miconazole / Q000008:administration & dosage / Q000494:pharmacology*; D008826:Microbial Sensitivity Tests; D019999:Pharmaceutical Solutions; D013501:Surface-Active Agents; D047392:beta-Cyclodextrins
D000935:Antifungal Agents; D003505:Cyclodextrins; D005079:Excipients; D019999:Pharmaceutical Solutions; D013501:Surface-Active Agents; D047392:beta-Cyclodextrins; D008825:Miconazole; C031215:betadex