Full
Outline
To evaluate the biowaiver of domestic bisoprolol fumarate tablets using computer simulations and parallel artificial membrane permeability assay (PAMPA).
First, DDDplusTM software was used to evaluated the effects of physical parameters of API and excipients on dissolution behavior of bisoprolol fumarate tablets. Second, population simulation using GastroplusTM software was used to predict the absorption behavior of the drug with different release rates (t85%=15~120 min) and obtain the release rate range which had no effect on bioequivalence. Third, the membrane permeation curves of domestic bisoprolol fumarate tablets, bisoprolol fumarate raw material and reference preparation were determined to evaluate the influence of excipients on permeation rate and predict their bioequivalence.
The results of DDDplusTM simulation indicated that the in vitro dissolution behavior of bisoprolol fumarate tablets did not change when the particle size of API and excipients, or the amount of excipients, or the particle size of excipients changed. The results of population simulation revealed that the drug preparation could be bioequivalent to the reference preparation as long as it was completely dissolved in 90 minutes. In the jejunum model solution, the membrane permeation rate curve showed that excipients did not affect the membrane permeation behavior of the drug, and the test preparation is bioequivalent with the reference preparation. There was no significant difference in ρmax and AUC0→t.
The application of computer simulations and PAMPA can provide evidence for the biowaiver study of bisoprolol fumarate tablets.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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