When developing methods for dissolution testing of solid dosage forms, identifying the optimum set of parameters can be difficult and time-consuming. Variables such as bath temperature and paddle speed have a significant impact on API release rates and on the ability to create a consistently repeatable method that will pass the scrutiny of regulatory agencies responsible for approving the drug’s quality control and batch approval specifications.
To overcome this challenge, Teledyne Hanson’s testers have been developed with event programming capabilities that allow parameters such as bath temperature and drive speed to be changed automatically during a test. This provides method developers with the opportunity to assess the impact of key parameters at various stages during a single test. Now, rather than running a time-consuming series of individual tests with fixed method parameters, a single scouting run with pre-programmed changes to key variables can produce critical insights into API release rates in a fraction of the time.
Dissolution bath temperatures and stirring speeds on Teledyne Hanson testers can be independently programmed to increase or decrease during a test. There are many applications for this capability. A commonly encountered example is for accelerated dissolution testing. With automated documentation of changes in parameters built into the system, analysts can easily correlate changes in the release profile of the drug to these events. The programmable temperature range is 25 °C to 55 °C, with an accuracy of ± 0.5 °C. The programmable drive speed includes zero (for off) and 25 rpm to 250 rpm.
For further information on our complete line of six-vessel, eight-vessel, and 14-vessel testers, visit our dissolution testing page.
For inquires, quotations, and other assistance contact your local Teledyne Hanson representative or click on the Request Information button at lower right.