Non-Sink Conditions in Dissolution Testing

Non-sink conditions refer to situations where the concentration of the drug substance in the dissolution medium is not significantly lower than its solubility.

 

While sink conditions are commonly preferred in dissolution testing to ensure rapid and complete drug dissolution, there are certain instances where non-sink conditions can be useful. Here are a few examples:

 

Poorly Soluble Drugs

Some drugs have low solubility, and achieving sink conditions may be difficult or impractical. In such cases, non-sink conditions can provide valuable information about the dissolution behavior and kinetics of these drugs, even if complete dissolution is not achieved. This data can be useful in formulation development or in assessing the impact of different dissolution media on drug release. Employing non-sink conditions can offer insights into the dissolution behavior and may aid in establishing correlations with in vivo drug absorption.

 

Modified-release Formulations

Non-sink conditions can be beneficial when evaluating modified-release formulations designed to release drugs gradually over an extended period. These formulations often result in drug concentrations that approach or exceed the solubility limit during dissolution testing. By using non-sink conditions, it becomes possible to assess the dissolution profile under more realistic conditions, closer to what may occur in vivo.

 

Supersaturating Formulations

Supersaturating formulations are designed to generate and maintain drug concentrations above the thermodynamic solubility in the gastrointestinal tract. In dissolution testing, non-sink conditions can simulate the supersaturated state and provide information on the dissolution kinetics, precipitation tendencies, and potential drug recrystallization.

 

Identification of Functional Formulation Excipients

Study by Maria T. Cruañes et. al demonstrates how purposefully selected media for non-sink in vitro work can support the identification of a critical formulation component consistent with the Quality-by-Design approach.

 

It’s important to note that the use of non-sink conditions in dissolution testing should be justified and well-documented, with careful consideration of the specific drug properties, formulation characteristics, and intended purpose of the testing.

• Guide to Determine Sink Conditions in Dissolution Testing
• Pooled Sampling in Dissolution
• Measurement of Discriminatory Power of Dissolution Method