Research Article
Quality by Design (QbD) Assisted Fabrication of Fast Dissolving Buccal Film for Clonidine Hydrochloride: Exploring the Quality Attributes
Table 3
Characterization of fast dissolving buccal film formulations (FDBFs) of CLH.
| Sr. No. | Evaluation Parameters | Formulation Batches | F1 | F2 | F3 | F4 | F5 | F6 | F7 | F8 | F9 |
| 1. | Thickness (mm) | 0.113 ± 0.014 | 0.125 ± 0.012 | 0.132 ± 0.017 | 0.127 ± 0.015 | 0.153 ± 0.021 | 0.164 ± 0.015 | 0.142 ± 0.012 | 0.173 ± 0.014 | 0.198 ± 0.016 | 2. | Disintegration Time (s) | 21 ± 2.3 | 25 ± 3 | 27 ± 3.6 | 21 ± 2.6 | 26 ± 3.3 | 28 ± 2.9 | 22 ± 2 | 26 ± 2.3 | 28 ± 3 | 3. | Folding Endurance | 271 ± 4.65 | 288 ± 3.48 | 291 ± 3.91 | 279 ± 4.59 | 284 ± 4.35 | 295 ± 2.28 | 269 ± 5.72 | 274 ± 4.62 | 278 ± 3.23 | 4. | Tensile Strength (kg) | 0.289 ± 0.009 | 0.312 ± 0.013 | 0.337 ± 0.007 | 0.293 ± 0.008 | 0.336 ± 0.015 | 0.352 ± 0.011 | 0.304 ± 0.019 | 0.357 ± 0.015 | 0.392 ± 0.023 | 5. | Moisture Content (%) | 10.59 ± 0.92 | 11.25 ± 1.34 | 3.90 ± 0.67 | 11.02 ± 1.47 | 12.64 ± 1.26 | 4.94 ± 0.89 | 7.76 ± 1.09 | 5.87 ± 0.76 | 1.95 ± 0.59 | 6. | Surface pH | 6.63 ± 0.05 | 6.51 ± 0.03 | 6.86 ± 0.07 | 6.62 ± 0.04 | 6.76 ± 0.06 | 6.83 ± 0.08 | 6.79 ± 0.07 | 6.54 ± 0.02 | 6.72 ± 0.05 | 7. | Drug Content (%) | 90.21 ± 2.31 | 89.46 ± 3.60 | 92.20 ± 3.73 | 91.19 ± 2.81 | 95.96 ± 3.41 | 98.97 ± 3.27 | 91.24 ± 2.16 | 89.72 ± 3.83 | 88.65 ± 3.46 | 8. | In Vitro Drug Dissolution (%) | 96.27 ± 1.37 | 97.09 ± 2.46 | 97.81 ± 1.79 | 95.98 ± 1.52 | 96.9 ± 1.84 | 99.7 ± 1.03 | 94.72 ± 2.65 | 96.02 ± 1.91 | 95.05 ± 1.64 |
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Data is represented as mean ± SD, n = 3.
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