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Dissolution testing is a key pharmaceutical QC test required for release of oral dosage forms. It is also commonly used to predict in vivo behavior of the formulation. Filtration is a key sample preparation step that follows the drug dissolution test before sample analysis. Because of the simplicity of the filtration process, the choice of filtration devices is often ignored, leading to inaccurate and irreproducible results. This paper discusses the effects of drug binding and extractable impurities from syringe filters on dissolution data. The data presented here demonstrate that various basic and acidic drugs bind strongly to nylon membrane filters, thereby reducing drug recovery and giving an incorrect dissolution profile. On the other hand, various drugs with different physicochemical properties do not bind to hydrophilic polytetrafluoroethylene (PTFE) syringe filters, thereby leading to quantitative drug recovery. In combination with its very low extractable profile, hydrophilic PTFE is an ideal filtration choice for dissolution testing.

Impact of Sample Preparation on Dissolution Testing: Drug Binding and Extractable Impurities and Their Effect on Dissolution Data