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Beskrivning
| Land | Sverige |
|---|---|
| Lista | Spotlight |
| Sektor | Hälsovård |
| Industri | Medicinteknik |
Inhalation Sciences AB (ISAB) has been awarded a new order from a returning customer for an Inhalation Research Services (IRS) project. The client has once again chosen DissolvIt, ISAB's in vitro dissolution testing module, known for its precise prediction and comparison of how test generic formulations and originator products perform in the lung. DissolvIt provides a unique advantage for developers of complex generic inhaled therapies. DissolvIt testing is being adopted by a growing number of generic and novel biopharma companies.
The returning client is amongst the world's top five generic pharma' manufacturers and has commissioned the project as a follow-up to a previous study, this time comparing a range of inhaled formulations.
DissolvIt a critical enabler of inhaled pharmaceuticals
The scale and value of the project underscores DissolvIt's growing reputation and leading capabilities in preclinical in vitro dissolution testing. For developers of inhaled pharmaceuticals, DissolvIt's ability to generate reliable comparative data on substances in the preclinical phase and how they will behave in the clinical phase delivers valuable benefits, reducing risk, costs and, potentially, regulatory hurdles.
Particularly in the US, DissolvIt could prove to be an enabler for increasing the number of inhaled generic pharmaceutical treatments available on the market, a sought-after goal for both the industry and healthcare sector. The cost of clinical tests required in the US has contributed to few commercially available inhaled generics. Only 15% of the 62 inhalers for asthma and COPD approved by the FDA between 1986 and 2020 were generics (1).
DissolvIt's capabilities are currently being evaluated in an FDA BAA (Broad Agency Announcement) contract research project at Inhalation Sciences' facilities in Huddinge, Sweden.
CEO Manoush Masarrat: "We're seeing preclinical in vitro testing gaining traction industry-wide, in particular amongst innovative and generic drug developers. DissolvIt stands at the forefront of this exciting field. We're pleased to welcome this esteemed client back to Inhalation Sciences and our services".
Discover DissolvIt[® ]
Read ISAB's publications on DissolvIt[®]here. (https://www.inhalation.se/publications/)
Discover DissolvIt's in vitro capabilities here. (https://www.inhalation.se/inhalation-research-services/dissolvit-in-vitro-dissolution/)
Explore Inhalation Research Services here (https://www.inhalation.se/inhalation-research-services/).
1. Patents and regulatory exclusivities on inhalers for asthma and COPD, 1986-2020 William B. Feldman, Doni Bloomfield, Reed Beall, Aaron S. Kesselheim