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. Author manuscript; available in PMC: 2021 Dec 1.
Published in final edited form as: J Pharm Sci. 2020 Sep 8;109(12):3598–3607. doi: 10.1016/j.xphs.2020.09.007

Table 3.

Design space and actual variation in the manufacturing process for the optimized formulation

Variable Unit Design space
 Actual variation
Targeted value Lower limit Upper limit Lowest value Highest value
SA content % 4.5 4.28 4.73 N/A N/A
Drug load % 49 46.5 51.5 48.9 50.4
Pellet size mm 1.0 0.8 1.2 0.94 1.15