ISAB's DissolvIt® Aligns with New FDA Guidelines

Inhalation Sciences AB (ISAB) is making significant strides in the pharmaceutical industry with its innovative DissolvIt® system. The recent FDA guidelines, which emphasize the importance of dissolution testing for inhaled drugs at the B life stage of product development, have placed ISAB's technology in the spotlight.

The FDA's focus on sensitive, reproducible methods to detect variations in drug formulation or manufacturing aligns perfectly with the capabilities of the DissolvIt® system. This advanced in vitro testing system replicates the dissolution and absorption of aerosolized drug particles in the lungs, providing critical insights into drug behavior at the air-blood barrier. By utilizing the PreciseInhale® platform, DissolvIt® allows for real-time tracking of dissolution, absorption, and permeability, closely mirroring clinical absorption profiles.

ISAB's collaboration with the FDA, under the Broad Agency Agreement Contract 75F40122C00197, further underscores the regulatory acceptance of their technology. This partnership not only validates the DissolvIt® system but also strengthens ISAB's position in the rapidly evolving inhalation drug development market.

Manoush Masarrat, CEO of ISAB, stated, 'The FDA’s new guidance reinforces what we at ISAB have long believed - that dissolution testing is essential for understanding inhaled drug performance. Our collaboration with the FDA further validates our technology and strengthens our position in this evolving market.'

Given these developments, ISAB appears to be well-positioned for future growth. Investors should consider holding their positions as the company continues to align with regulatory advancements and expand its influence in the pharmaceutical sector.