Design of Mucoadhesive Strips for Buccal Fast Release of Tramadol
Abstract
:1. Introduction
2. Materials and Methods
2.1. Materials
2.2. Design and Preparation of Systems
2.3. Analysis of Thickness and Density
2.4. Determination of the Swelling Index
2.5. Mechanical Evaluation
2.5.1. Folding Endurance
2.5.2. Tensile Analysis
2.6. Ex Vivo Evaluation of Mucoadhesive Properties
2.7. Water Vapor Permeability
2.8. In Vitro Evaluation of Tramadol Release Profile
2.9. Statistical Analysis
3. Results and Discussion
3.1. Film Preparation
3.2. Thickness and Density
3.3. Swelling Index (SI)
3.4. Mechanical Evaluation
3.5. Mucoadhesive Properties
3.6. Water Vapor Permeability (WVP)
3.7. In Vitro Evaluation of Tramadol Release Profile
4. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Acknowledgments
Conflicts of Interest
References
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Independent Variables/Factors (%, w/w) ** | Levels | ||
---|---|---|---|
Low | Central | High | |
(−1) | (0) | (+1) | |
X1 = PVA | 50 | 60 | 70 |
X2 = PVP | 10 | 20 | 30 |
X3 = EC | 12.5 | 15 | 17.5 |
Standard run (formulations) | X1 | X2 | X3 |
F1 | - | - | - |
F2 | - | - | + |
F3 | + | - | - |
F4 | + | - | + |
F5 | - | + | - |
F6 | - | + | + |
F7 | + | + | - |
F8 | + | + | + |
F9 (C) | 0 | 0 | 0 |
F10 (C) | 0 | 0 | 0 |
Formulations | Thickness (mm) | Mass (g) | Density (g/mL) * | SI (%) *,** |
---|---|---|---|---|
F1 | 0.11500 ± 0.05263 a | 0.01435 ± 0.00690 a | 0.00014 ± 0.00007 | 156.88 ± 73.63 |
F2 | 0.18275 ± 0.08176 b | 0.01610 ± 0.00748 a | 0.00016 ± 0.00007 | 92.52 ± 17.05 |
F3 | 0.11750 ± 0.05857 a | 0.01550 ± 0.00706 a | 0.00016 ± 0.00007 | 130.82 ± 64.96 |
F4 | 0.15250 ± 0.06870 c | 0.01658 ± 0.00748 b | 0.00017 ± 0.00007 | 147.50 ± 53.98 |
F5 | 0.13500 ± 0.06301 c | 0.01658 ± 0.00743 b | 0.00017 ± 0.00007 | 148.75 ± 39.16 |
F6 | 0.15000 ± 0.07141 c | 0.01818 ± 0.00831 c | 0.00018 ± 0.00008 | 100.68 ± 49.04 |
F7 | 0.16750 ± 0.07701 b | 0.02005 ± 0.00898 c | 0.00020 ± 0.00009 | 147.50 ± 10.85 |
F8 | 0.17250 ± 0.07950 b | 0.02148 ± 0.00962 c | 0.00021 ± 0.00010 | 131.99 ± 63.82 |
F9 (C) | 0.10750 ± 0.04827 a | 0.01440 ± 0.00648 a | 0.00014 ± 0.00006 | 89.91 ± 10.28 |
F10 (C) | 0.11500 ± 0.05167 a | 0.01478 ± 0.00663 a | 0.00015 ± 0.00007 | 80.11 ± 11.24 |
Formulation | Young’s Modulus (MPa) | Fmax (N) | F (N) | Folding Endurance (Times) * | Mucoadhesive Force (N) |
---|---|---|---|---|---|
F1 | 1.39 ± 0.25 | 20.19 ± 2.27 | 16.97 ± 2.28 | >300 | 0.0760 ± 0.0120 |
F2 | 2.13 ± 0.38 | 18.20 ± 1.87 | 34.59 ± 2.07 | >300 | 0.1350 ± 0.0270 |
F3 | 0.39 ± 0.02 | 15.43 ± 0.32 | 13.57 ± 1.72 | >300 | 0.080 ± 0.0050 |
F4 | 2.52 ± 0.31 | 35.51 ± 4.60 | 26.32 ± 5.83 | >300 | 0.0610 ± 0.0120 |
F5 | 4.28 ± 1.37 | 14.20 ± 4.76 | 11.79 ± 5.72 | >300 | 0.0790 ± 0.0200 |
F6 | 1.73 ± 0.22 | 13.52 ± 5.35 | 8.31 ± 1.42 | >300 | 0.1330 ± 0.0150 |
F7 | 0.61 ± 0.41 | 10.95 ± 3.11 | 5.94 ± 1.09 | >300 | 0.0930 ± 0.0260 |
F8 | 3.31 ± 0.73 | 28.80 ± 11.66 | 17.90 ± 13.55 | >300 | 0.0680 ± 0.0090 |
F9 (C) | 4.33 ± 0.86 | 15.22 ± 8.60 | 7.03 ± 1.87 | >300 | 0.0750 ± 0.0070 |
F10 (C) | 1.69 ± 0.28 | 20.97 ± 1.59 | 7.40 ± 5.61 | >300 | 0.1000 ± 0.0050 |
Formulations | WVP (× 10−5 g/h.mm2) | ||||
---|---|---|---|---|---|
24 h * | 48 h * | 72 h * | 96 h * | 120 h * | |
F3 | 1.5624 ± 0.0389 | 1.4982 ± 0.0387 | 1.4390 ± 0.0398 | 1.3919 ± 0.0349 | 1.4490 ± 0.0432 |
F5 | 1.5481 ± 0.0435 | 1.5169 ± 0.0496 | 1.4920 ± 0.0398 | 1.4209 ± 0.0263 | 1.4710 ± 0.0489 |
F7 | 1.7823 ± 0.0590 | 1.6190 ± 0.0280 | 1.52610 ± 0.0476 | 1.4972 ± 0.0354 | 1.6200 ± 0.0374 |
F9 (C) | 1.6723 ± 0.0489 | 1.5163 ± 0.0387 | 1.4910 ± 0.0452 | 1.4961± 0.0411 | 1.5900 ± 0.0399 |
F10 (C) | 1.6340 ± 0.0378 | 1.5129± 0.0412 | 1.4730 ± 0.0431 | 1.501± 0.0398 | 1.5410 ± 0.0452 |
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Pastório, N.F.G.; Vecchi, C.F.; Said dos Santos, R.; Bruschi, M.L. Design of Mucoadhesive Strips for Buccal Fast Release of Tramadol. Pharmaceutics 2021, 13, 1187. https://doi.org/10.3390/pharmaceutics13081187
Pastório NFG, Vecchi CF, Said dos Santos R, Bruschi ML. Design of Mucoadhesive Strips for Buccal Fast Release of Tramadol. Pharmaceutics. 2021; 13(8):1187. https://doi.org/10.3390/pharmaceutics13081187
Chicago/Turabian StylePastório, Nayla Francine Garcia, Camila Felix Vecchi, Rafaela Said dos Santos, and Marcos Luciano Bruschi. 2021. "Design of Mucoadhesive Strips for Buccal Fast Release of Tramadol" Pharmaceutics 13, no. 8: 1187. https://doi.org/10.3390/pharmaceutics13081187
APA StylePastório, N. F. G., Vecchi, C. F., Said dos Santos, R., & Bruschi, M. L. (2021). Design of Mucoadhesive Strips for Buccal Fast Release of Tramadol. Pharmaceutics, 13(8), 1187. https://doi.org/10.3390/pharmaceutics13081187