Biomedical Engineering Reference
In-Depth Information
TABL E 9.3. Example of Stability Risk Assessment
Modification/Degradation
Activity Impact
Grow on Stability
Risk Assessment
Variable region
Yes
Yes
High
Yes
No
Medium
Constant region
No
Yes
Medium
No
No
Low
Aggregation
Yes
Yes
High
diagram (Fig. 9.4) [4]. The criticality of each of these identified factors can be determined
based on forced degradation and preformulation study results to help set up the
multivariate formulation optimization study.
9.8 FORMULATION OPTIMIZATION AND DESIGN SPACE
The next step is to optimize the critical formulation variables with respect to those
degradations of high risk that are identified via risk assessment based on preformulation
and forced degradation studies. Amultivariate statistical DOE study is set up to optimize
the key formulation parameters with respect to chemical and physical stabilities.
Figure
9.4.
Example of the Ishikawa (Fishbone) diagram for stable solution formulation.
