Table II.
Simulated Pharmacokinetic Parameters for a Single Dose of 30 mg Using Particle Size Distributions with Two Different D50 Values. For Each D50, a Range of D90 Values is Explored
| PSD1 | PSD2 | PSD3 | PSD4 | PSD5 | |
|---|---|---|---|---|---|
| D50 of 3.6 μm | |||||
| D10a (μm) | 0.8 | 0.4 | 0.2 | 0.16 | 0.1 |
| D50b (μm) | 3.6 | 3.6 | 3.6 | 3.6 | 3.6 |
| D90c (μm) | 12 | 24.8 | 47.6 | 79.2 | 131.2 |
| Simulated Cmax (ng/mL) | 206 | 194 | 185 | 179.4 | 175 |
| Simulated AUCinf (ng h/mL) | 6,685 | 6,670 | 6,582 | 6,478 | 6,381 |
| D50 of 8 μm | |||||
| D10a (μm) | 2.5 | 1.2 | 0.6 | 0.38 | 0.22 |
| D50b (μm) | 8 | 8 | 8 | 8 | 8 |
| D90c (μm) | 27.6 | 56 | 108.4 | 179.2 | 301.2 |
| Simulated Cmax (ng/mL) | 184 | 171 | 162 | 157 | 153 |
| Simulated AUCinf (ng h/mL) | 6,635 | 6,450 | 6,214 | 6,046 | 5,884 |
a10%,of the volume of drug material was measured as below the given diameter
b50% of the volume of drug material was measured as below the given diameter
c90% of the volume of drug material was measured as below the given diameter