Table 3.
Evaluation parameters of prepared metronidazole microcapsule-containing bioadhesive vaginal gels
| Formulation code | F1 | F2 | F3 | F4 | |||||
|---|---|---|---|---|---|---|---|---|---|
| Drug content (%) (X±S.D) |
78.72 ± 0.030 | 73.33 ± 0.055 | 94.52 ± 0.043 | 72.98 ± 0.029 | |||||
| Drug content uniformity | ** | ** | *** | ** | |||||
| pH (X±S.D) |
7.5 ± 0.011 | 7.3 ± 0.016 | 6.8 ± 0.027 | 7.2 ± 0.025 | |||||
| Extrudability | * | ** | *** | *** | |||||
| Spreadability (g.cm/sec) (X±S.D) |
46.87 ± 0.098 | 75.02 ± 0.134 | 150.1 ± 0.324 | 187.5 ± 0.315 | |||||
| Viscosity (cps) (X × 104) |
2.015 | 1.742 | 1.802 | 1.555 | |||||
| Vaginal irritation test | - | - | - | - | |||||
| In vitro drug diffusion (%)(18 h study) (X±S.D) | 46.946±1.12 | 72.958±0.989 | 55.234±1.09 | 76.907±1.05 | |||||
| Bioadhesive strength (Kg) (X±S.D) |
1.25 ± 0.56 | 3.50 ± 0.15 | 8.50 ± 0.46 | 4.65 ± 0.38 | |||||
| Bioadhesion time (h) | 8-9 | 18-19 | >36 | 22-23 | |||||
| Zero order (r) | 0.562 | 0.751 | 0.581 | 0.676 | |||||
| First order (r) | 0.716 | 0.746 | 0.797 | 0.658 | |||||
| Higuchi square root (r) | 0.858 | 0.889 | 0.945 | 0.871 | |||||
| Korsmeyer and Peppas (r) | 0.883 | 0.848 | 0.925 | 0.818 | |||||
| (n) | 0.403 | 0.624 | 0.456 | 0.444 | |||||
| ANOVA | |||||||||
| Source of variation | SS | df | MS | F | P-value | F crit | |||
| Between groups | 1782.4644 | 3 | 594.15481 | 0.3064569 | 0.020553 | 2.838745 | |||
| Within groups | 77551.489 | 40 | 1938.78724 | ||||||
| Total | 79333.954 | 43 | |||||||
n- Diffusion exponent related to mechanism of drug release, according to equation, mt / m¥ = ktn.
All the values are expressed in mean ± Standard deviation (n=3). Standard error mean < 0.844.
F1: Carbopol 934, F2: Carbopol 940, F3: Carbopol 974 and F4: Carbopol 980.
* (good), ** (very good), *** (excellent) and - (no irritation).