Formulation and Optimization of Sodium Alginate Polymer Film as a Buccal Mucoadhesive Drug Delivery System Containing Cetirizine Dihydrochloride
Abstract
:1. Introduction
2. Materials and Methods
2.1. Materials
2.2. Preparation of Films
2.3. Thickness of Films
2.4. Tensile Strength (Hardness) of Films
2.5. In Vitro Mucoadhesion Test
2.6. Contact Angle and Surface Free Energy (SFE) Measurement
2.7. FTIR Spectroscopy Measurement
2.8. Raman Spectroscopy Measurement
2.9. Dissolution Test
2.10. Statistical Analysis
3. Results
3.1. Thickness and Tensile Strength of the Films
R2 = 0.9218
R2 = 0.9784
R2 = 0.9461
R2 = 0.9972
(2% polymer films containing CTZ)
y2 = 25.32 + 1.72∙x1 − 5.93∙x2 + 1.32∙x22
(3% polymer films containing CTZ)
R2 = 0.9784
(2% polymer films without CTZ)
R2 = 0.9955
(3% polymer films without CTZ)
R2 = 0.9979
3.2. In Vitro Mucoadhesion Test
(2% polymer films containing CTZ)
R2 = 0.6133
(3% polymer films containing CTZ)
y3 = 18.96 − 1.21∙x1 − 4.47∙x2 + 0.44∙x1∙x2
(2% polymer films without CTZ)
R2 = 0.8408
(3% polymer films without CTZ)
R2 = 0.9120
3.3. Contact Angle and Surface Free Energy (SFE) Measurement
(2% polymer films containing CTZ)
R2 = 0.9638
R2 = 0.9054
y4 = 57.81 + 3.19∙x1 + 5.67∙x2 + 0.84∙x22
(2% polymer films without CTZ)
R2 = 0.7854
(3% polymer films without CTZ)
R2 = 0.7237
3.4. FTIR Measurement
3.5. Raman Spectroscopy Measurement
3.6. Dissolution Test
(2% polymer films containing CTZ)
R2 = 0.9671
(3% polymer films containing CTZ)
R2 = 0.9996
4. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
Abbreviations
References
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Total Polymer (%) | Samples | SA (w/w %) | HPMC (w/w %) | GLY (w/w %) | CTZ (10 mg) |
---|---|---|---|---|---|
2 | 1 | 1 | 1 | 1 | − |
2 | 1 | 1 | 1 | + | |
3 | 1 | 1 | 3 | − | |
4 | 1 | 1 | 3 | + | |
5 | 1 | 1 | 5 | − | |
6 | 1 | 1 | 5 | + | |
7 | 1.33 | 0.66 | 1 | − | |
8 | 1.33 | 0.66 | 1 | + | |
9 | 1.33 | 0.66 | 3 | − | |
10 | 1.33 | 0.66 | 3 | + | |
11 | 1.33 | 0.66 | 5 | − | |
12 | 1.33 | 0.66 | 5 | + | |
3 | 13 | 1.5 | 1.5 | 1 | − |
14 | 1.5 | 1.5 | 1 | + | |
15 | 1.5 | 1.5 | 3 | − | |
16 | 1.5 | 1.5 | 3 | + | |
17 | 1.5 | 1.5 | 5 | − | |
18 | 1.5 | 1.5 | 5 | + | |
19 | 2 | 1 | 1 | − | |
20 | 2 | 1 | 1 | + | |
21 | 2 | 1 | 3 | − | |
22 | 2 | 1 | 3 | + | |
23 | 2 | 1 | 5 | − | |
24 | 2 | 1 | 5 | + |
Total Polymer Concentration (%) | Factors | Low Level | Zero Level | High Level |
---|---|---|---|---|
2% | Concentration of SA (x1) | 1 | - | 1.33 |
Concentration of GLY (x2) | 1 | 3 | 5 | |
3% | Concentration of SA (x1) | 1.5 | - | 2 |
Concentration of GLY (x2) | 1 | 3 | 5 |
Samples | Thickness (µm) | Tensile Strength (N) | Mucoadhesion (N) |
---|---|---|---|
1 | 56.25 ± 8.54 | 5.61 ± 0.01 | 16.94 ± 1.20 |
2 | 104.75 ± 7.27 | 13.89 ± 0.92 | 8.56 ± 1.52 |
3 | 128.00 + 7.7 | 6.07 ± 1.07 | 15.70 ± 1.32 |
4 | 142.32 ± 8.52 | 9.90 ± 1.19 | 11.94 ± 1.31 |
5 | 159.14 ± 6.32 | 5.50 ± 1.95 | 7.13 ± 2.04 |
6 | 174.43 ± 6.02 | 6.33 ± 0.75 | 6.38 ± 1.59 |
7 | 81.50 ± 6.66 | 18.15 ± 1.45 | 16.02 ± 2.20 |
8 | 86.74 ± 6.34 | 27.37 ± 0.28 | 11.57 ± 1.45 |
9 | 105.31 ± 8.18 | 12.85 ± 2.37 | 8.54 ± 1.10 |
10 | 146.00 ± 6.06 | 14.56 ± 2.18 | 6.63 ± 1.25 |
11 | 166.52 ± 3.87 | 9.10 ± 1.91 | 7.97 ± 2.23 |
12 | 179.19 ± 4.99 | 16.92 ± 1.46 | 5.37 ± 1.64 |
13 | 93.53 ± 6.35 | 8.53 ± 0.57 | 22.12 ± 2.11 |
14 | 125.29 ± 5.56 | 28.06 ± 3.76 | 9.66 ± 0.70 |
15 | 146.22 ± 5.91 | 11.39 ± 0.91 | 17.59 ± 0.63 |
16 | 164.79 ± 5.88 | 26.47 ± 1.42 | 9.07 ± 1.95 |
17 | 188.03 ± 2.71 | 4.58 ± 0.37 | 15.64 ± 1.41 |
18 | 200.22 ± 8.14 | 16.28 ± 2.92 | 5.83 ± 2.11 |
19 | 87.23 ± 1.26 | 17.96 ± 1.52 | 17.32 ± 2.74 |
20 | 102.00 ± 2.71 | 32.68 ± 3.03 | 10.82 ± 1.99 |
21 | 145.12 ± 3.46 | 23.47 ± 2.49 | 16.87 ± 1.51 |
22 | 169.20 ± 2.49 | 27.68 ± 3.65 | 10,7 ± 2.33 |
23 | 212.55 ± 9.98 | 16.96 ± 1.95 | 11.95 ± 0.30 |
24 | 246.65 ± 5.51 | 20.75 ± 0.22 | 8.56 ± 1.87 |
Samples | γtot (mN/m) | γd (mN/m) | γp (mN/m) | Polarity (%) |
---|---|---|---|---|
1 | 49.59 | 32.54 | 17.05 | 34.38 |
2 | 74.88 | 38.85 | 36.03 | 48.12 |
3 | 51.65 | 36.34 | 15.31 | 29.64 |
4 | 76.33 | 37.44 | 38.89 | 50.95 |
5 | 62.60 | 36.35 | 26.25 | 41.93 |
6 | 75.72 | 35.60 | 40.12 | 52.98 |
7 | 53.56 | 32.28 | 21.29 | 39.75 |
8 | 76.86 | 39.17 | 37.69 | 49.04 |
9 | 66.21 | 31.85 | 34.36 | 51.90 |
10 | 76.89 | 40.57 | 36.32 | 47.24 |
11 | 63.23 | 28.15 | 35.08 | 55.48 |
12 | 75.98 | 38.26 | 37.73 | 49.66 |
13 | 54.32 | 33.12 | 21.20 | 39.03 |
14 | 68.61 | 38.80 | 29.87 | 43.54 |
15 | 57.36 | 36.21 | 21.15 | 36.87 |
16 | 73.78 | 35.14 | 38.65 | 52.39 |
17 | 50.84 | 33.59 | 17.25 | 33.93 |
18 | 73.72 | 36.07 | 37.65 | 51.07 |
19 | 47.99 | 33.56 | 14.43 | 30.07 |
20 | 61.05 | 35.11 | 25.93 | 42.47 |
21 | 48.72 | 31.61 | 17.11 | 35.12 |
22 | 71.73 | 37.12 | 34.61 | 48.25 |
23 | 52.68 | 36.01 | 16.67 | 31.64 |
24 | 65.12 | 38.40 | 26.72 | 41.03 |
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Pamlényi, K.; Kristó, K.; Jójárt-Laczkovich, O.; Regdon, G., Jr. Formulation and Optimization of Sodium Alginate Polymer Film as a Buccal Mucoadhesive Drug Delivery System Containing Cetirizine Dihydrochloride. Pharmaceutics 2021, 13, 619. https://doi.org/10.3390/pharmaceutics13050619
Pamlényi K, Kristó K, Jójárt-Laczkovich O, Regdon G Jr. Formulation and Optimization of Sodium Alginate Polymer Film as a Buccal Mucoadhesive Drug Delivery System Containing Cetirizine Dihydrochloride. Pharmaceutics. 2021; 13(5):619. https://doi.org/10.3390/pharmaceutics13050619
Chicago/Turabian StylePamlényi, Krisztián, Katalin Kristó, Orsolya Jójárt-Laczkovich, and Géza Regdon, Jr. 2021. "Formulation and Optimization of Sodium Alginate Polymer Film as a Buccal Mucoadhesive Drug Delivery System Containing Cetirizine Dihydrochloride" Pharmaceutics 13, no. 5: 619. https://doi.org/10.3390/pharmaceutics13050619