Table 2.
Prevalence of Excipient Categories by Molecule Type of Active Pharmaceutical Ingredients
| Excipient category | Antibody conjugate (n = 8) | Cytokine and growth factor (n = 83) | Enzyme (n = 48) | Monoclonal antibody (n = 118) | Polypeptide hormone (n = 109) | Pulmonary surfactant (n = 3) | Recombinant fusion protein (n = 18) | Toxin (n = 10) | Total (n = 397) |
|---|---|---|---|---|---|---|---|---|---|
| Buffering agent | 87.50% | 96.39% | 77.08% | 96.61% | 72.48% | 0.00% | 100.00% | 10.00% | 84.63% |
| Surfactant | 62.50% | 67.47% | 33.33% | 93.22% | 22.94% | 33.33% | 55.56% | 0.00% | 56.17% |
| Lyoprotectant | 62.50% | 44.58% | 29.17% | 65.25% | 50.46% | 0.00% | 83.33% | 50.00% | 52.39% |
| Tonicity agent | 50.00% | 43.37% | 52.08% | 25.42% | 16.51% | 100.00% | 44.44% | 50.00% | 32.49% |
| pH-adjusting agent | 12.50% | 4.82% | 25.00% | 8.47% | 60.55% | 33.33% | 5.56% | 0.00% | 23.93% |
| Antimicrobial preservative | 0.00% | 19.28% | 10.42% | 0.00% | 53.21% | 0.00% | 0.00% | 0.00% | 19.90% |
| Stabilizer | 0.00% | 26.51% | 8.33% | 0.00% | 36.70% | 0.00% | 0.00% | 100.00% | 19.14% |
| Solubilizing agent | 0.00% | 14.46% | 4.17% | 10.17% | 36.70% | 0.00% | 11.11% | 0.00% | 17.13% |
| Antioxidant | 0.00% | 12.05% | 2.08% | 7.63% | 6.42% | 0.00% | 0.00% | 0.00% | 6.80% |
| Complexing agent | 0.00% | 3.61% | 6.25% | 11.02% | 0.00% | 0.00% | 5.56% | 0.00% | 5.04% |
| Other | 0.00% | 15.66% | 10.42% | 0.00% | 0.00% | 0.00% | 0.00% | 0.00% | 4.53% |
| Diluent for solid dosage form | 0.00% | 0.00% | 10.42% | 0.00% | 5.50% | 0.00% | 0.00% | 0.00% | 2.77% |
| Dispersing agent | 0.00% | 2.41% | 0.00% | 3.39% | 0.00% | 0.00% | 0.00% | 0.00% | 1.51% |
| Antiadhesive agent | 0.00% | 6.02% | 0.00% | 0.00% | 0.00% | 0.00% | 0.00% | 0.00% | 1.26% |
*Subcategories for diluent for solid dosage forms include drug powder inhaler carrier, coating agent, plasticizing agent, glidant, disintegrant, lubricant, binder and water-repelling agent