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Table 3 Initial risk assessments for formulation development based on prior knowledge, experience, and published literature

From: Optimized chronomodulated dual release bilayer tablets of fexofenadine and montelukast: quality by design, development, and in vitro evaluation

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

  1. Low: the risk is broadly acceptable and requires no further investigation
  2. Medium: acceptable risk. Further investigation may be required for risk reduction
  3. High: unacceptable risk. Further investigation required for risk reduction