Table 1. Salivary pharmacokinetic parameters for miconazole.
| 50 mg bioadhesive tablet | 100 mg bioadhesive tablet | Oral gel | |
|---|---|---|---|
| Cmax(µg ml−1) | |||
| Mean | 15.1 | 39.1 | 1.6* |
| SD | 16.2 | 49.3 | 1.6 |
| Range | 0.5–64.7 | 1.7–179.5 | 0–6.6 |
| CV (%) | 107.5 | 126.2 | 100.9 |
| P values vs gel | P < 0.0001 | P < 0.0001 | |
| P value vs 100 mg | P = 0.001 | ||
| tmax(h) | |||
| Median | 7 | 6 | 4# |
| Range | 2–24 | 3–12 | 0.5–9 |
| AUC(0,12 h) (µg ml−1h) | |||
| Mean | 43.0 | 78.6 | 3.4 |
| SD | 32.0 | 78.4 | 4.1 |
| Range | 0–117.3 | 2.0–244.0 | 0–13.9 |
| CV (%) | 74.4 | 99.7 | 120.9 |
| P values vs gel | P < 0.0001 | P < 0.0001 | |
| P value vs 100 mg | NS (P = 0.06) | ||
| AUC (0,24 h) (µg ml−1h) | |||
| Mean | 55.2 | 136.1 | 4.2 |
| SD | 35.1 | 149.5 | 6.4 |
| Range | 0.5–128.3 | 2.0–607.0 | 0–24.2 |
| CV (%) | 63.5 | 109.8 | 152.1 |
| P values vs gel | P < 0.0001 | P < 0.0001 | |
| P value vs 100 mg | P = 0.001 | ||
| Mean duration of exposure above 0.4 µg ml−1(h) | |||
| Mean | 13.6 | 10.2 | 1.5 |
| SD | 8.0 | 6.1 | 2.2 |
| Global difference | < 0.001 | ||
| Differences location | NS vs 50 mg | S vs tablets | |
| Mean duration of exposure above 1 µg ml−1(h) | |||
| Mean | 7.1 | 7.2 | 0.6 |
| SD | 5.3 | 3.4 | 1.7 |
| Global difference | < 0.001 | ||
| Differences location | NS vs 50 mg | S vs tablets | |
CV, coefficient of variation, NS, not statistically significant difference, S statistically significant difference (α= 0.05).
#
corresponding to 0.5 h after the second application.
*
corresponding to the mean of the highest concentrations observed over 24 h, means after each administrations were of 0.9 ± 1.0, 0.8 ± 0.8 and 1.1 ± 1.7 µg ml−1. Global difference: P value obtained after anova comparing the three treatments.