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News about companies that support development of orally inhaled and nasal drug products (OINDPs), including regulatory approvals, new partnerships, new products and services and results of clinical studies. 8 OctOber 2023 Inhalation controlled and realistic delivery of warm, humid air into a DPI prior to routine tests to evaluate drug de- livery performance. Using the PES, developers can detect how inhaler misuse impacts critical quality attri- butes of the DPI and work towards improved device robustness. Insmed announces positive topline results from Phase III ARISE study BRIDGEWATER, NEW JER- SEY—Insmed announced positive topline results from its Phase III ARISE study of Arikayce in patients with newly diagnosed or recur- rent nontuberculous mycobacte- rial (NTM) lung infection caused by Mycobacterium avium complex (MAC), who had not started anti- biotics. PR Newswire reported the study met its primary objective of demonstrating that the Quality of Life—Bronchiectasis (QOL-B) respiratory domain works effec- tively as a patient- reported out- come (PRO) instrument in patients with MAC lung disease. Based on these results, Insmed plans to pro- pose to the United States Food and Drug Administration (FDA) that the QOL-B respiratory domain PRO be the primary endpoint for its ENCORE study without any modifications. Insmed also plans to explore, with global regulators, accelerating the filing for approval of Arikayce in newly infected patients with MAC lung disease. In parallel, the company continues to enroll patients in its ENCORE study and anticipates reporting topline data in 2025. Renaissance Lakewood announces new laboratory facilities LAKEWOOD, NEW JERSEY— Renaissance Lakewood announced a significant expansion of their quality control spray/particulate laboratory as well as both of their analytical and formulation research and development laboratories in Ocean County, New Jersey, US. e facilities upgrade began in warming potential than hydro- fluoroalkane (HFA) propellants. In addition, it is non- flammable, non-ozone- depleting and volatile organic compound (VOC)-exempt under federal and state guidelines. e joint news release stated Reci- pharm is the first CDMO to part- ner with Honeywell for use of Solstice Air. e partnership follows Recipharm's announcement that it is expanding its pMDI product development and manufacturing capabilities. Research will be con- ducted at the company's dedicated inhalation development facility in Research Triangle Park, North Carolina, US. e collaboration is supported by Recipharm's invest- ment in manufacturing with HFO- 1234ze(E) cGMP at its Holmes Chapel, United Kingdom site and the further development of its Bespak ® valve range to ensure required product performance. Copley Scientific introduces Patient Exhalation Simulator NOTTINGHAM, UNITED KINGDOM—Copley Scien- tific announced its introduction of a Patient Exhalation Simulator (PES) to assist developers of dry powder inhaler (DPI) devices in understanding the impact of poor patient technique and ways to op- timize product designs for more ro- bust drug delivery. A company news release noted that poor technique is a widely recognized issue associated with use of inhalers that can lead to inadequately controlled respi- ratory disease and an over-reliance on emergency remedies. Further, reports suggest that up to 22% of patients routinely exhale into their DPI prior to dose inhalation. Such misuse can increase powder reten- tion in the device, reducing the quantity of the drug the patient receives. Associated outcomes may include a lack of improvement and prescription of higher doses, increas- ing the risk of adverse reactions, side-effects and treatment costs. e Copley PES allows investiga- tors to simulate this misuse with INDUSTRY NEWS MKON files for patent for novel pMDI ferrule ROUND ROCK, TEXAS— MKON, LLC, a package engineer- ing consulting firm, announced it has filed for patent protection for its novel ferrule for pressurized metered dose inhalers (pMDIs). A ferrule is a small aluminum cap that securely holds a pMDI valve to an inhaler canister. A company news release noted that industry regula- tions, along with country import/ export laws, require each inhaler to be tested by submersion in a two- minute 55º C (131ºF) water bath to verify container closure integrity against component defects and man- ufacturing issues. Currently, inhalers are tightly crimped and leave little or no pathway for leaking propel- lant gas to escape. is can result in defective canisters falsely passing the leak test. MKON's ferrule design utilizes an open lattice wall, allow- ing the leaking gas from a defective seal to escape, thereby making posi- tive gas bubble detection easier and faster, and minimizing false negative results. In addition, the lattice design results in a 9-14% material weight reduction, depending upon ferrule size. e removed material can be claimed as pre-production scrap and used to meet sustainability goals. e company is also preparing data for regulatory approval. Recipharm and Honeywell partner for inhalers with near- zero GWP propellant STOCKHOLM, SWEDEN AND MORRIS PLAINS, NEW JER- SEY—Recipharm and Honey- well announced a partnership to speed development of pressurized metered dose inhalers (pMDIs) that use Honeywell's near-zero global warming potential (GWP) propellant. Honeywell Solstice ® Air (HFO-1234ze(E) cGMP) is a hydrofluoroolefin (HFO) pro- pellant in clinical development for pMDIs and has 99.9% less global continued on page 37

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