Issue link: https://www.e-digitaleditions.com/i/1481142
Recent news about companies that support development of orally inhaled and nasal drug products, including regulatory approvals, new indications for OINDPs and results of clinical studies. 8 OctOber 2022 Inhalation INDUSTRY NEWS Copley Scientific introduces benchtop environmental chamber NOT TINGH A M, U NITED KINGDOM—Copley Scientific has announced their introduction of the EnviroMate™, a benchtop environmental chamber for use by analysts who are struggling to achieve stable environmental con- ditions for delivered dose unifor- mity (DDU) and aerodynamic particle size distribution (APSD) testing. Developed specifically for testing of orally inhaled and nasal drug products (OINDPs) and to accommodate all types of dose uni- formity sampling apparatus and cascade impactors, the EnviroMate is designed to maintain uniform temperature and humidity distri- bution throughout the chamber, while a built-in anti-static system minimizes the effects of electro- static charge. By providing analysts with consistent environmental con- trol in the immediate test area, the system can enhance OINDP test data accuracy and repeatability. FDA approves and will co-finance Inhalation Sciences research proposal STOCKHOLM, SWEDEN— Inhalation Sciences, AB (ISAB) has announced that the United States Food and Drug Administration's (FDA's) National Center for Tox- icological Research has approved ISAB's research proposal for a study aiming to validate the company's in vitro lung simulation model and dissolution testing tool, DissolvIt ® , as an FDA-recommended stan- dard research method for inhaled drug development in the US. e study will evaluate DissolvIt's abil- ity to demonstrate in vitro/in vivo correlation (IVIVC), as well as bio- equivalence, and detect even small formulation differences in a wide range of active pharmaceutical ingre- dients. An ISAB news release noted that the National Center for Toxico- logical Research funds research proj- ects and prioritizes those that "spur the development of new regulatory approaches that can help improve predictability" and "replace, reduce and/or refine animal testing." e FDA will support and co-finance the study with up to $250,000 annually for up to two years. Recipharm to assist Transpire in developing two inhaled treatments MIAMI, FLORIDA—Transpire Bio has asked Recipharm to assist in development of two of its inhaled drug candidates for treatment of asthma and chronic obstructive pul- monary disease (COPD), according to Fierce Pharma. ey indicated "Transpire's pipeline features a range of dry powder, multi-dose and soft mist inhaler treatments for asthma and COPD." All the candidates are at the formulation and device development stages, with in vitro bioequivalence stud- ies to be conducted before Transpire continued on page 35