The random vibration effects on dissolution testing with USP apparatus 2.
Dissolution testing is of primary importance for optimization of drug formulation and quality control, but test results typically show large variability. Vibration is one of the factors that can increase variability of dissolution testing. In this study, a Distek USP Apparatus 2 was used to perform dissolution testing using disintegrating 10 mg prednisone tablets at 50 rpm in 500 mL of 37 degrees C degassed water medium. A controllable vertical random vibration was applied to the dissolution apparatus during the dissolution testing. Real-time vibration waveforms were recorded using accelerometers placed at various locations on the vessel plate and on the dissolution vessels. Preliminary results showed a strong correlation between induced vibration and dissolution results. The vibration measured on the vessel plate correlates well with that measured within nearby vessels. The observed dissolution profiles suggest that vibration affects the disintegration and dissolving processes by different mechanisms, leading to high or low results depending upon during which phase of the dissolution process the vibration occurs. This study also presents a method capable of measuring vibration in a meaningful manner and how to determine where best to measure it.
Gao
Zongming
Z
Food and Drug Administration, Center for Drug Evaluation and Research, Division of Pharmaceutical Analysis, St. Louis, Missouri 63101, USA. zongming.gao@fda.hhs.gov
Moore
Terry W
TW
Buhse
Lucinda F
LF
Doub
William H
WH
D004364:Pharmaceutical Preparations / Q000032:analysis / Q000737:chemistry*; D012995:Solubility; D013678:Technology, Pharmaceutical / Q000295:instrumentation* / Q000379:methods*; D014732:Vibration
D004364:Pharmaceutical Preparations