Effects of deaeration methods on dissolution testing in aqueous media: a study using a total dissolved gas pressure meter.
Dissolution testing is a critical method for the determination of pharmaceutical product quality and bioequivalence. For some products, dissolved gases in the dissolution medium affect dissolution results thus requiring degassing of the medium prior to use. In this study, we use a total dissolved gas and oxygen meter to measure both oxygen and total gases in dissolution media before and after application of a variety of deaeration methods. Dissolution testing results using a 10 mg Prednisone tablet (NCDA #2) are compared with the percent saturation of oxygen and total gases found in the medium. Reaeration of the medium during different stirring rates was also measured. This study confirms that measurement of total gases and not just oxygen in the medium is necessary to assess adequacy for dissolution testing. For those deaeration techniques that are performed at room temperature, the percent saturation of the total dissolved gases must be well below 100% to prevent outgassing once medium is brought to dissolution test method temperature, typically 37 degrees C.
Gao
Zongming
Z
Food and Drug Administration, Center for Drug Evaluation and Research, Division of Pharmaceutical Analysis, St. Louis, Missouri 63101, USA. gaoz@cder.fda.gov
Moore
Terry W
TW
Doub
William H
WH
Westenberger
B J
BJ
Buhse
Lucinda F
LF
D002626:Chemistry, Pharmaceutical / Q000295:instrumentation / Q000379:methods*; D004784:Environmental Monitoring / Q000295:instrumentation / Q000379:methods; D005740:Gases / Q000032:analysis*; D010100:Oxygen / Q000032:analysis*; D011241:Prednisone / Q000737:chemistry*; D012995:Solubility; D013696:Temperature; D014867:Water / Q000737:chemistry
D005740:Gases; D014867:Water; D010100:Oxygen; D011241:Prednisone