Case Study 4 Small Volume Dissolution Testing

5 CASE STUDY 4 SMALL VOLUME DISSOLUTION TESTING 

1 Small Volume Dissolution Apparatus Calibration and Method Development 

During development of Compound B, several low-dose tablet formulations were investigated in clinical studies, including 0.05, 0.1, 0.25, and 0.4 mg tablet strengths. With these low-dose tablets, dissolution testing in 500 mL yielded low sample 

TABLE 10.5 Dissolution Method for Tablets of Compound B Using Small Volume Vessels and Minipaddles 

Apparatus USP apparatus 2 with 100 mL small volume vessels and Teflon-coated minipaddles 

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