Table 3.
Freeze/thaw stability of NLG207 NDCs in plasma, including measurements of total camptothecin concentrations (A), free camptothecin concentrations (B), and the calculated ratio of free to total camptothecin concentrations (C).
| A | Total Camptothecin | |||||||
|---|---|---|---|---|---|---|---|---|
| 30 ng/mL | 300 ng/mL | 3000 ng/mL | 9000 ng/mL | |||||
| Free/Thaw Cycle | GM (ng/mL) | DEV (%) | GM (ng/mL) | DEV (%) | GM (ng/mL) | DEV (%) | GM (ng/mL) | DEV (%) |
| 0 (fresh) | 33.08 | - | 332.0 | - | 3503 | - | 9898 | - |
| 1 | 32.88 | −0.6 | 315.1 | −5.1 | 3231 | −7.8 | 9470 | −4.3 |
| 2 | 35.02 | 5.9 | 317.6 | −4.3 | 3296 | −5.9 | 9746 | −1.5 |
| 3 | 35.34 | 6.8 | 335.1 | 1.0 | 3359 | −4.1 | 9696 | −2.0 |
| 4 | 33.22 | 0.4 | 312.5 | −5.8 | 3272 | −6.6 | 9656 | −2.4 |
| B | Free Camptothecin | |||||||
|---|---|---|---|---|---|---|---|---|
| 30 ng/mL | 300 ng/mL | 3000 ng/mL | 9000 ng/mL | |||||
| Free/Thaw Cycle | GM (ng/mL) | DEV (%) | GM (ng/mL) | DEV (%) | GM (ng/mL) | DEV (%) | GM (ng/mL) | DEV (%) |
| 0 (fresh) | 1.02 | - | 10.83 | - | 110.1 | - | 305.6 | - |
| 1 | 1.08 | 5.6 | 10.68 | −1.4 | 104.7 | −4.9 | 321.9 | 5.3 |
| 2 | 1.08 | 6.2 | 9.98 | −7.8 | 97.13 | −11.8 | 337.6 | 10.5 |
| 3 | 1.09 | 7.2 | 10.12 | −6.6 | 97.05 | −11.9 | 300.5 | −1.7 |
| 4 | 0.99 | −2.6 | 9.91 | −8.5 | 95.93 | −12.9 | 317.0 | 3.7 |
| C | Ratio of Free: Total Camptothecin | |||||||
|---|---|---|---|---|---|---|---|---|
| 30 ng/mL | 300 ng/mL | 3000 ng/mL | 9000 ng/mL | |||||
| Free/Thaw Cycle | % Free CPT | DEV (%) | % Free CPT | DEV (%) | % Free CPT | DEV (%) | % Free CPT | DEV (%) |
| 0 (fresh) | 3.18 | - | 3.37 | - | 3.24 | - | 3.19 | - |
| 1 | 3.27 | 2.9 | 3.39 | 6.5 | 3.24 | 1.9 | 3.40 | 6.8 |
| 2 | 3.09 | −2.8 | 3.14 | −1.2 | 2.95 | −7.4 | 3.46 | 8.9 |
| 3 | 3.09 | −2.8 | 3.02 | −5.1 | 2.89 | −9.2 | 3.10 | −2.6 |
| 4 | 2.99 | −6.0 | 3.17 | −0.3 | 2.93 | −7.9 | 3.28 | 3.1 |
Abbreviations: GM, grand mean; DEV (%), relative deviation from fresh.