Table 5.
Derived parameters for glycopyrronium
| Parameter | Abbreviation | Units | Model-based analysis* | Noncompartmental analysis† |
|---|---|---|---|---|
| Systemic clearance | CL | l h−1 | 44.9 | 42.5 |
| Volume of distribution at steady state‡ | Vss | l | 102 | 82.7 |
| Ratio Vss/CL | – | h | 2.3 | 1.95 |
| Absolute bioavailability inhaled without charcoal vs. i.v. | FTOT | – | 56.5% | 40% |
| Fraction of dose absorbed through GI tract | FGI | – | 3.9% | – |
| Fraction of absorbed drug going through lung | FRLUNG | – | 93.1% | 90% |
| Fraction of absorbed drug going through GI tract | FRGI | – | 6.9% | 10% |
| Fraction of lung absorption via fast rate | Ffast | – | 12% | – |
| Fraction of lung absorption via intermediate rate | Fmed | – | 9% | – |
| Fraction of lung absorption via slow rate | Fslow | – | 79% | – |
| Fast lung absorption half-life | t1/2fast | h | <∼0.03 (estimate) | – |
| Intermediate lung absorption half-life | t1/2med | h | 0.45 | – |
| Slow lung absorption half-life | t1/2slow | h | 80 | 52 or 57§ |
| Inferred absolute oral bioavailability | FORAL | – | 8.2% | 5% |
| GI tract absorption half-life | t1/2GI | h | 2 | – |
Parameters of the population PK model (Table 2), or calculated from the population PK model parameters, with rate constants, K, expressed as half-lives, t1/2 = ln(2)/K.
From Novartis, data on file (CL, Vss) or Sechaud et al. [12].
V1 + V2 + V3.
Terminal half-lives estimated for the inhaled treatments. GI, gastrointestinal; i.v., intravenous; PK, pharmacokinetic.