Formulation and In Vitro Characterization of Mouth Dissolving Film of Clopidogrel Hydrogen Sulphate †
Abstract
:1. Introduction
2. Materials
3. Method
3.1. Method of Preparation of Mouth Dissolving Film
3.2. Steps for Preparation of MDF of Clopidogrel Hydrogen Sulphate [4]
4. Determination of λmax
5. Preparation of Calibration Curve [5]
6. Drug–Polymer Compatibility Study [6]
7. Result and Discussion
7.1. Thickness
7.2. Weight Variation
7.3. Folding Endurance
7.4. Percentage Drug Content
7.5. Surface pH Determination
7.6. Disintegration Time
7.7. In Vitro Dissolution Study
8. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Ingredients | A1 | A2 | A3 | A4 | A5 |
---|---|---|---|---|---|
Clopidogrel Hydrogen Sulphate | 125 | 125 | 125 | 125 | 125 |
HPMC E5 | 300 | 350 | 400 | 450 | 500 |
PVP | 50 | 50 | 50 | 50 | 50 |
Sucralose | 20 | 20 | 20 | 20 | 20 |
Citric Acid | 20 | 20 | 20 | 20 | 10 |
Flavor | 5 | 5 | 5 | 5 | 5 |
Water (mL) | 10 | 10 | 10 | 10 | 10 |
Methanol (mL) | 5 | 5 | 5 | 5 | 5 |
Sr. No. | Concentration (μg/mL) | Absorbance |
---|---|---|
1 | 0.0 | 0.0 |
2 | 20 | 0.116 |
3 | 40 | 0.221 |
4 | 60 | 0.345 |
5 | 80 | 0.455 |
6 | 100 | 0.585 |
Sample | Wavenumber (cm−1) | Functional Group |
---|---|---|
Clopidogrel Hydrogen Sulphate with HPMC E5 and PVP | 1750.81, 1644.80, 1185.42, 1296.22, 1152.63, 1067.25, 944.31 | C-O, C=O, C-O, C-N, C-O, C-O, O-H, C-C |
Batch | Thickness | Weight Variation | Folding Endurance | Surface pH Determination | Disintegration Time | Drug Content |
---|---|---|---|---|---|---|
A1 | 0.03 ± 0.003 | 111.33 ± 0.577 | 54.66 ± 0.577 | 2.66 ± 0.577 | 64.66 ± 0.577 | 61 ± 1 |
A2 | 0.05 ± 0.005 | 72 ± 1 | 75.66 ± 0.577 | 3.66 ± 0.57 | 59.65 ± 0.573 | 83.5 ± 4.784 |
A3 | 0.08 ± 0.005 | 100.66 ± 0.577 | 95.66 ± 4.932 | 4.033 ± 0.95 | 54.66 ± 0.577 | 92.7 ± 3.223 |
A4 | 0.09 ± 0.005 | 61.33 ± 0.57 | 173.6 ± 0.22 | 6.13 ± 0.057 | 22.33 ± 2.081 | 96.33 ± 1.15 |
A5 | 0.04 ± 0.004 | 98 ± 1 | 120.33 ± 0.57 | 3.76 ± 1.594 | 48.33 ± 0.577 | 81.36 ± 1.06 |
Time (min) | % Drug Release | ||||
---|---|---|---|---|---|
A1 | A2 | A3 | A4 | A5 | |
10 s | 24.01 | 30.25 | 22.68 | 38.20 | 38.59 |
1 min | 33.46 | 40.25 | 30.85 | 50.49 | 55.21 |
2 min | 48.25 | 59.26 | 37.10 | 56.18 | 62.01 |
3 min | 58.45 | 75.15 | 47.01 | 75.14 | 78.63 |
4 min | 60.20 | 81.21 | 64.72 | 87.12 | 80.20 |
5 min | 79.21 | 85.20 | 79.60 | 96.00 | 90.15 |
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Chaudhari, A.; Tadavi, S.; Patil, B.; Pawar, S. Formulation and In Vitro Characterization of Mouth Dissolving Film of Clopidogrel Hydrogen Sulphate. Eng. Proc. 2023, 56, 268. https://doi.org/10.3390/ASEC2023-16286
Chaudhari A, Tadavi S, Patil B, Pawar S. Formulation and In Vitro Characterization of Mouth Dissolving Film of Clopidogrel Hydrogen Sulphate. Engineering Proceedings. 2023; 56(1):268. https://doi.org/10.3390/ASEC2023-16286
Chicago/Turabian StyleChaudhari, Ankita, Sandip Tadavi, Bhagyashri Patil, and Sunil Pawar. 2023. "Formulation and In Vitro Characterization of Mouth Dissolving Film of Clopidogrel Hydrogen Sulphate" Engineering Proceedings 56, no. 1: 268. https://doi.org/10.3390/ASEC2023-16286