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Beskrivning
| Land | Sverige |
|---|---|
| Lista | Spotlight |
| Sektor | Hälsovård |
| Industri | Medicinteknik |
Stockholm, Sweden - March 3, 2025 - Inhalation Sciences AB (ISAB), a leader in inhalation research and drug development, welcomes the U.S. Food and Drug Administration's (FDA) latest guidelines[1], which establish dissolution testing as a key method for evaluating inhaled drug products. The updated recommendations reinforce the relevance of ISAB's proprietary DissolvIt® system, which has already been the focus of an FDA-financed study aimed at improving regulatory science in inhalation drug development.
The new FDA guidelines highlight dissolution testing as a recommended approach for evaluating inhaled drugs at the B life stage of product development. The guidelines stress that dissolution methods must be sensitive, reproducible, and able to detect variations in drug formulation or manufacturing.
ISAB's DissolvIt® system is uniquely positioned to meet these regulatory requirements. It enables in vitro testing that mimics the dissolution and absorption of aerosolized drug particles in the lungs, providing crucial insights into drug behavior at the air-blood barrier. Using the PreciseInhale® platform, DissolvIt® deposits dry powder particles onto a controlled glass surface, allowing researchers to track dissolution, absorption, and permeability in real time. This method closely mirrors clinical absorption profiles, making it an essential tool for evaluating both innovative and generic inhaled therapies.
As part of its commitment to advancing inhalation science, ISAB has, as previously communicated on September 15th, 2022, collaborated with the FDA in a co-financed study - FDA BAA (Broad Agency Agreement) Contract 75F40122C00197 - which evaluates the discriminative dissolution potential of its innovative DissolvIt® system for assessing drug formulations designed for inhalation therapy. This partnership demonstrates the growing regulatory acceptance of advanced in vitro methodologies and highlights ISAB's role in shaping the future of inhalation drug development.
"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." says Manoush Masarrat, CEO of Inhalation Sciences AB.
For more information about Inhalation Sciences AB and the DissolvIt® system, please visit www.inhalation.se.
For more information about Inhalation Sciences, please contact:
Manoush Masarrat, CEO
E-mail: Manoush.masarrat@inhalation.se
Mobile: +46 (0)73 628 9153
About Inhalation Sciences Sweden AB (publ)
Inhalation Sciences Sweden AB (publ) develops and commercializes world-leading instruments and services for research into inhalation. The company's patented lab instruments PreciseInhale® and DissolvIt® enable researchers in the pharma industry to make drug pipeline decisions at an early stage, saving time and resources for R&D departments, and enables researchers in academic institutions to define how aerosols and small particles impact our lungs, and so our health, when being inhaled.