Table 3.
Formulation Analysis of Effera™ and Bovine LF.
| Test Product | Dose Level (mg/kg/day) | Nominal Concentration (mg/mL) | Average Calculated Concentration (mg/mL) c | Average % Recovery a | %Relative Standard Deviation |
|---|---|---|---|---|---|
| Vehicle Control | 0 | 0.000 | BLQ | NA | NA |
| Effera™ | 200 b | 20.000 | 19.007 – 20.077 | 95.0 – 100.4 | 1.965 – 2.206 |
| Effera™ | 600 | 60.000 | 59.300 – 59.475 | 98.8 – 99.1 | .075 – .970 |
| Effera™ | 2000 b | 200.000 | 195.749 – 200.252 | 97.9 – 100.1 | .637 – 1.482 |
| Bovine LF | 2000 b | 200.000 | 198.121 – 212.644 | 99.1 – 106.3 | 1.546 – 4.747 |
Abbreviations: BLQ, below the limit of quantitation (<4.0000 mg/mL); LF, lactoferrin.
aAverage % recovery was calculated from the nominal concentration.
bThe averaged result from homogeneity analysis served as concentration verification.
cConcentration refers to active LF (rhLF or bLF) in formulation.