BILLERICA, Mass. — Pion Inc., a leader in analytical technologies for pharmaceutical development, has announced the release of DissoSpec™, a fully integrated dissolution monitoring system that promises to streamline and modernize dissolution testing—a critical step in drug formulation and quality control.
Dissolution testing is used to evaluate how quickly and efficiently a drug dissolves in its dosage form. Traditionally, this process involves extracting samples from a dissolution bath and analyzing them separately, often requiring multiple instruments and steps that can lead to delays and variability in data. Pion’s new DissoSpec system aims to eliminate these inefficiencies by enabling direct, in-vessel analysis through its integration of the Rainbow® R6 UV-VIS spectrometer and fiber optic probes with the company’s DissoPRO™ software.
Dan Klevisha, CEO of Pion Inc., said the new system offers a significant advancement in the field. “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,” he explained. “The DissoSpec system represents a major step forward, enabling scientists to characterize complete dissolution profiles to develop a validated method for transfer to QC.”
By allowing direct measurement within the dissolution vessel, DissoSpec removes the risks associated with manual sample collection, media replacement, and sample degradation. It also supports automated data capture, which reduces variability between users and across shifts. The semi-automated system is designed for walk-away operation, allowing analysts to initiate the test and return later to a complete report. Its simplified workflow and minimal maintenance requirements are aimed at saving both time and operational costs.
DissoSpec is particularly suited for analyzing long-acting injectable (LAI) formulations. To support this capability, Pion has licensed specialized USP2 and USP4 adapters developed by Dr. Diane J. Burgess, a distinguished professor and the Pfizer Distinguished Chair in Pharmaceutical Technology at the University of Connecticut. The system is compatible with standard USP 1/2/5/6 apparatuses and the LAI-specific sample holders from the Burgess Research Lab.
With the launch of DissoSpec, Pion Inc. is positioning itself at the forefront of pharmaceutical testing innovation, offering a solution that enhances efficiency, consistency, and regulatory compliance in dissolution analysis.
