Table 3.
Composition of lipid nanoparticles.
| Active ingredient (Company) | Patisiran (Alnylam) | Tozinameran (Pfizer/BioNTech) | Elasomeran (Moderna) |
|---|---|---|---|
| Single dosage | 0.3 mg/kg siRNA | 0.030 mg mRNA | 0.10 mg mRNA |
| Unit | 5 mL | 0.45 mL | 0.5 mL |
| Drug substance | 10 mga | 0.225 mg | 0.10 mg |
| Ionizable lipid | 65.0 mg | 3.23 mg | 1.075 mg |
| Phospholipid | 16.5 mg | 0.7 mg | 0.275 mg |
| Cholesterol | 31.0 mg | 1.4 mg | 0.47 mg |
| PEG-lipid | 8.0 mg | 0.4 mg | 0.115 mg |
| Total lipid | 120.5 mg | 5.7 mg | 1.94 mg |
| Total lipid/RNA (wt/wt) | 12.1 | 25.5 | 19.4 |
| Drug concentration | 2.0 mg/mL | 0.5 mg/mL | 0.2 mg/mL |
| Sucrose in formulation | NA | 46 mg | 43.5 mg |
| Sucrose concentration | NA | 102 g/L | 87 g/L |
| pH | 6.4–7.5 | 6.9–7.9 | 7.0–8.0 |
| State of drug product | liquid | frozen suspension | frozen suspension |
| Shelf life of drug product (unopened vials)b | 27 months (2–8 °C, avoid freeze) | 6 months (−90 to −60 °C) | 6 months (−25 to −15 °C) |
The information is derived from the interview form archived in PMDA as of May 2021(21–23).
a
As Patisiran, without sodium salt.
b
Shelf life of each drug is updated by ongoing storage stability tests.