Dissolution testing is a key part of drug development and quality control, as dissolution has a profound impact on the way a medicine behaves in the body.
The US Pharmacopoeia has developed various standards for apparatus use, and one of these - USP 4 - covers the flow-through method, which is becoming more commonly used as it can handle a broad range of dosage forms, including not only tablets and capsules but also implants, stents, suppositories and powders or granules.
Sotax already markets a complete system for flow-through dissolution - the CE 7 smart, and the new CP 7 ceramic poiston pump is designed to be used as part of this system.
"In a flow-through dissolution method, the pump is responsible for ensuring the most important parameter: the flow rate of the media," said Sotax. "This flow rate must stay constant throughout the duration of the test, even in cases of back pressure created by filter resistance."
In answer to this stringent requirement, Sotax has designed the CP 7 with seven valveless ceramic pump heads, which it says ensure a high level of reproducibility and consistency for the flow rate. Meanwhile, it also fulfils another requirement of USP 4, which is to use only inert material.
Other features of the pump include an automatic calibration/validation function, and the ability to run completely different flow rates channel by channel. This means, for example, that a test can be carried out using all three recommended flow rates - (4, 8 and 16 ml/min) during a single run.