Pion Inc., a leading provider of innovative analytical solutions for drug development, announced the launch of its latest product, DissoSpec™ QC Dissolution Monitoring System, a groundbreaking instrument set to transform dissolution analysis in the pharmaceutical industry.
Dissolution testing is a critical process in drug development and quality control, used to evaluate the rate and extent a drug substance dissolves from its dosage form. Traditional methods involve taking a sample from a dissolution bath and transferring it to a separate instrument for analysis. This process can be time-consuming, labor-intensive, and requires multi-step data capture and reporting. The DissoSpec system addresses these challenges with its fully integrated design, incorporating the Rainbow® R6 UV-VIS instrument where in situ fiber optic probes sit directly in the dissolution vessels, simplifying data collection and interpretation.
“Combining the Rainbow fiber optic probes with the dissolution bath and our DissoPRO™ software, we can now provide in situ analysis, ensuring stable, reliable data collection’” said Dan Klevisha, CEO at Pion Inc. “The DissoSpec system represents a major step forward, enabling scientists to characterize complete dissolution profiles to develop a validated method for transfer to QC.”
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Key features and benefits of DissoSpec include:
No Sampling: Direct in-vessel measurement eliminates accuracy risks associated with differences between collected samples, media replacement errors, filter sample retention and offline sample degradation.
Reduced Analyst Variability: Automated in situ data analysis accommodates multi-shift or multi-user scenarios, reducing variability and ensuring consistent results.
Minimal Maintenance: Avoid complex sampling systems and frequent component replacements, saving time and costs.
Semi-automated System: Press “start” and let it go with walk-away automation.
Simplified Workflow: At the end of your dissolution experiment, come back to a complete and integrated report.
In situ measurements make the DissoSpec system particularly suitable for long-acting formulations. To enable testing of long-acting injectables (LAI), Pion has licensed USP2 and USP4 adapters developed by Dr. Diane J. Burgess, Distinguished Professor, Pfizer Distinguished Chair in Pharmaceutical Technology at the University of Connecticut. The DissoSpec system is a compendial USP 1/2/5/6 apparatus and can be used with the LAI USP 2 sample holders developed by the Burgess Research lab at the University of Connecticut.
Source: Businesswire