Table 1.
Key physical and chemical properties of RDX7675 and SPS
| Parameter | RDX7675 | SPS: Kayexalate® | SPS: Resonium A® |
|---|---|---|---|
| Calcium content (%, w/w)a | 8.5–11.5 | 0.001 | 0.011 |
| Sodium content (%, w/w)a | ≤0.1 | 11.6 | 10.9 |
| Water content (%) | ≤10.0 | 6.6 | 8.7 |
| Particle sizeb (µm) | |||
| D10 | 14.4±1.2 | 8.2 | 11.3 |
| D50 | 31.0±1.3 | 45.9 | 55.3 |
| D90 | 52.2±1.7 | 119.7 | 124.2 |
| Swelling ratio (water) | 5.2 | 2.9 | 2.9 |
Notes: Dx represents distribution(x%).
a
Calculated on an anhydrous basis.
b
Measured using a wet dispersion technique. RDX7675 data are mean ± SD values obtained from eight different batches of drug substance; data for Kayexalate® and Resonium A® are from a single batch of each drug.
Abbreviations: SPS, sodium polystyrene sulfonate; SD, standard deviation; w/w, weight per weight.