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Abstract
The Mexican Pharmacopeia (MP) dissolution general test was carried out on one and two lots of suspensions from each one of three commercial drug products, containing benzoyl metronidazole, and using water or 0.1 N hydrochloric acid as dissolution medium. When we used paddles at 100 rpm, and water as dissolution medium, 72 to 99% of the active substance was dissolved after 60 minutes, showing differences between the dissolution profiles from these drug products. When testing conditions were changed to 0.1 N hydrochloric acid at 75 r.p.m., the amount dissolved of active substance varied from 25 to 100%, showing different dissolution rate profiles for all 6 drug products.
The ANOVA for the statistical model with repeated measurements was applied to the observed dissolution rate data, showing no parallel behaviour between each dissolution profile. Using the ANOVA for nested models, and the hydrochloric acid data to investigate the dissolution efficiency, we found intraclass difference but no interclass difference. In contrast, by using the per cent dissolved with the same dissolution medium data, we found significant differences between drug products, but not between lots.
Significant difference was observed between drug products, when using water as dissolution medium, either when using the dissolution efficiency data or the per cent dissolved in 60 minutes.
The data suggests that pharmaceutical suspensions have the same problems with the deaggregation rate such as tablets and capsules do, therefore, it is important to extend the dissolution testing for suspensions with a poor water solubility.