Development of Novel Tamsulosin Pellet-Loaded Oral Disintegrating Tablet Bioequivalent to Commercial Capsule in Beagle Dogs Using Microcrystalline Cellulose and Mannitol
Abstract
:1. Introduction
2. Results and Discussion
2.1. Tamsulosin Pellets
2.2. Tamsulosin Pellet-Loaded ODTs
2.3. Pharmacokinetics
3. Materials and Methods
3.1. Materials
3.2. Preparation of Tamsulosin Pellets
3.2.1. Drug Layer
3.2.2. Subsequent SR Layer
3.2.3. Tamsulosin Pellets
3.3. Preparation of Tamsulosin Pellet-Loaded ODTs
3.4. Flow Properties
3.5. Morphology, Differential Scanning Calorimetry (DSC), Powder X-ray Diffraction (PXRD), Fourier Transform Infrared Spectroscopy (FT-IR)
3.6. Dissolution
3.7. Uniformity of Content
3.8. Disintegration and Friability
3.9. Stability
3.10. Pharmacokinetics
3.10.1. Administration in Beagle Dogs
3.10.2. Plasma Sample Preparation and Analysis
4. Conclusions
Author Contributions
Funding
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Ingredients | I | II | III | IV | V | VI |
---|---|---|---|---|---|---|
Tamsulosin pellet | 32.16 * | 32.16 | 32.16 | 32.16 | 32.16 | 32.16 |
Mannitol·MCC mixture | 165.84 | - | - | 163.84 | 161.84 | 159.84 |
Mannitol·croscarmellose sodium mixture | - | 165.84 | - | - | - | - |
Mannitol·povidone mixture | - | - | 165.84 | - | - | - |
Silicon dioxide | - | - | - | 2.0 | 4.0 | 6.0 |
Magnesium stearate | 2.0 | 2.0 | 2.0 | 2.0 | 2.0 | 2.0 |
Total weight (mg) | 200.0 | 200.0 | 200.0 | 200.0 | 200.0 | 200.0 |
Parameter | Tamsulosin Pellet-Loaded ODT | Commercial Capsule |
---|---|---|
Tmax (h) | 2.833 ± 0.718 | 2.917 ± 0.515 |
Cmax (ng/mL) | 7.237 ± 2.324 | 7.625 ± 2.634 |
AUC (h·ng/mL) | 45.988 ± 15.345 | 46.251 ± 14.245 |
t1/2 (h) | 4.311 ± 0.537 | 3.832 ± 0.520 |
Kel (h−1) | 0.161 ± 0.020 | 0.181 ± 0.025 |
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Cho, H.J.; Kim, J.S.; Jin, S.G.; Choi, H.-G. Development of Novel Tamsulosin Pellet-Loaded Oral Disintegrating Tablet Bioequivalent to Commercial Capsule in Beagle Dogs Using Microcrystalline Cellulose and Mannitol. Int. J. Mol. Sci. 2023, 24, 15393. https://doi.org/10.3390/ijms242015393
Cho HJ, Kim JS, Jin SG, Choi H-G. Development of Novel Tamsulosin Pellet-Loaded Oral Disintegrating Tablet Bioequivalent to Commercial Capsule in Beagle Dogs Using Microcrystalline Cellulose and Mannitol. International Journal of Molecular Sciences. 2023; 24(20):15393. https://doi.org/10.3390/ijms242015393
Chicago/Turabian StyleCho, Hyuk Jun, Jung Suk Kim, Sung Giu Jin, and Han-Gon Choi. 2023. "Development of Novel Tamsulosin Pellet-Loaded Oral Disintegrating Tablet Bioequivalent to Commercial Capsule in Beagle Dogs Using Microcrystalline Cellulose and Mannitol" International Journal of Molecular Sciences 24, no. 20: 15393. https://doi.org/10.3390/ijms242015393