05 December 2024

Overcoming Coning Challenges in Dissolution Testing

Coning – a buildup of undissolved material below the paddle – can pose significant challenges in dissolution testing, leading to inconsistent results and regulatory scrutiny.

At SOTAX, we provide tailored solutions to address these issues head-on, offering both advanced automation with the ATF Xtend™ and expert support through our specialized Pharma Services.
 

Automate for Consistency and Efficiency

The ATF Xtend™ isn’t just about throughput and cycle time reduction; it’s also a powerful tool for addressing coning. By automating key parameters, the ATF Xtend™ helps improve the accuracy and reliability of your dissolution testing:
 

• Paddle Speed DOE: Fine-tune dissolution rates by adjusting paddle speed according to the Noyes-Whitney equation.
   

• Diverse Sinker Options: Ensure light or floating dosage forms are consistently exposed for accurate results.
   

• Apex Vessels: The ATF Xtend™ can integrate apex vessels (peak vessel) to reduce coning by enhancing shear distribution, without altering the test method.

Pharma Services: Expertise and Full cGMP Support

SOTAX Pharma Services is the only CRO specialized in dissolution method development. Our team of experts can help you investigate and resolve coning challenges, implement automated solutions, and support labs moving toward full automation. Additionally, our Pharma Services lab is a fully equipped, GMP-compliant facility with inspected labs and stability chambers, making it an ideal partner for release testing and stability programs.

Whether you’re seeking a reliable GMP lab for product release or looking to automate your testing workflow, SOTAX has the tools and expertise to streamline your dissolution testing. Contact us to learn more about our innovative solutions for consistent, compliant results.