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Beskrivning
| Land | Sverige |
|---|---|
| Lista | Spotlight |
| Sektor | Hälsovård |
| Industri | Medicinteknik |
(Stockholm, Sweden, 9 January 2025) Inhalation Sciences Sweden AB (ISAB) is proud to announce the submission of the project report and summary data to the U.S. Food and Drug Administration (FDA) for final review and approval. This marks a key milestone in ISAB's ongoing FDA BAA (Broad Agency Agreement) Contract 75F40122C00197 for a collaborative research project which evaluates the discriminative dissolution potential of its innovative DissolvIt® system for assessing drug formulations designed for inhalation therapy.
The DissolvIt® system is designed to address a critical need in pharmaceutical development: early-stage insights into drug dissolution and absorption in the lungs. These insights can help optimize the development of both new and generic inhalation therapies.
Unlike traditional dissolution methods that generate cumulative curves, DissolvIt® provides single-pass dissolution data which more closely mimics how the lungs dissolve and absorb drug substances into the bloodstream. This novel capability may support pharmaceutical developers to gain early insights into drug candidates' performance already in pre-clinical stage as well as eliminate non-viable options efficiently.
As previously communicated on October 16, 2024, the study evaluated 16 compounds with different formulations, particle sizes, and manufacturing methods, comparing their dissolution and absorption profiles. The results generated indicate that DissolvIt®:
- Can detect similarities and differences in dissolution/absorption profiles with promising accuracy
- Has the potential to predict drug concentration levels in clinical plasma profiles
- Provides high-resolution data sets valuable for advanced particle-engineered formulations approaching clinical trials
CSO Per Gerde comments: "Early findings indicate that DissolvIt® not only reproduces existing cumulative dissolution data but also generates a unique, high-resolution dataset. This added level of detail will be of value for characterizing the rapidly increasing number of formulations moving toward clinical trials that are based on advanced particle engineering."
CEO Manoush Masarrat says: "We are very pleased with the results of this important study done in collaboration with the FDA. DissolvIt® continues to demonstrate its potential as a valuable tool in pharmaceutical development. We look forward to sharing the final report and findings with the market following the FDA's review."
The project - Contract 75F40122C00197 - was initially communicated by ISAB on September 15th, 2022. Its completion will represent an important step in demonstrating the value of DissolvIt® for advancing inhalation therapy development.
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.