Drug product CQAs | Formulation variables | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Fexofenadine HCl layer | Montelukast sodium layer | |||||||||
Sodium bicarbonate | Lactose level | Starch level | Sodium starch glycolate level | MCC level | Magnesium stearate level | HPMC E 5 LV level | PVP K30 level | Lactose level | Magnesium stearate level | |
Friability | Low | Medium | High | Medium | High | Medium | High | High | Medium | Medium |
Assay | Low | Low | Low | Low | Low | Low | Low | Low | Low | Low |
Hardness | Low | Medium | High | Medium | High | Low | High | High | Medium | Low |
Weight variation | Low | Low | Low | Low | Low | Low | Low | Low | Low | Low |
Dissolution | High | Medium | High | High | High | Medium | High | High | Medium | Medium |