Table I.
A Sample of Drug Incompatibility with Excipient Impurities
| Drug | Impurity | Excipient | Drug loading (w/w) |
|---|---|---|---|
| BMS-203452 (18) | Formaldehyde | PEG 300 or Tween 80 | 1% |
| Fluoxetine HCl (6) | Reducing sugars | Lactose | 10% |
| Org-30659 (94) | Lactose phosphate | Lactose | 0.10% |
| Compound A (39) | Peroxides | Povidone/Copovidone | 2–3% |
| Compound B (39) | Peroxides | Povidone/Copovidone | 2–3% |
| Raloxifene (37) | Peroxides | Povidone/Copovidone | 12.50% |
| CP448187 (82) | Free radicals/peroxides | Microcrystalline Cellulose | 0.50% |
| BMS-A (9) | Free radicals/peroxide/reducing sugars | Microcrystalline Cellulose | 0.83% |
| Vigabatrin (8) | Reducing sugars, aldehydes | Microcrystalline cellulose | – |
| Irbesartan (19) | Formaldehyde | PEG in film coating | Low strength |
| Haloperidol (27) | Furfuraldehyde | Lactose | 0.575% |
| Varenicline (16) | Formic acid/formaldehyde | PEG | 0.68% |
| Hydralizine (28) | Aldose | Starch | 10% |