Issue link: https://www.e-digitaleditions.com/i/1515319
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 February 2024 Inhalation release stated the Ventolin inhaler is currently prescribed to approx- imately 35 million patients and its current propellant accounts for 49% of GSK's carbon footprint. The next-generation propellant technology has the potential to reduce Ventolin greenhouse gas emissions by approximately 90%. Kindeva, Orbia to collaborate for propellant conversion WOODBURY, MINNESOTA, ST. LOUIS, MISSOURI AND B O S T O N , M A S S A C H U - SETTS—Kindeva Drug Deliv- e r y a nd Or bi a F luor i n a t e d Solutions (Koura) announced a co- development collaboration for the conversion from existing marketed pressurized metered dose inhaler (pMDI) products to Kou- ra's propellant more sustainable and environmentally-conscious medi- cal propellant HFA 152a, named Zephex ® 152a. A joint news release explained the partnership aims to facilitate conversion of pMDI prod- ucts to the lower GWP propellent 152a and progress them through clinical development. e con- verted pMDI products will be available for licensing with antic- ipated launches occurring in-line with the expected commencement of a phase-down of existing pMDI systems containing HFC-134a and HFC-227ea within the European Union. "We are proud to partner with Koura to help achieve the dual objectives of significantly reduc- ing the environmental impact of pMDI inhalers and ensuring patient access to inhaler options is not compromised," said David Stevens, Global Chief Commercial Officer of Kindeva. Recipharm, Oz-UK to collaborate for low GWP pMDIs STOCKHOLM, SWEDEN AND C H I PPE N H A M, U N I T E D K INGDOM— Recipharm has announced a collaboration with Oz-UK to accelerate the develop- ment and manufacture of "green" INDUSTRY NEWS Intertek becomes IPAC-RS associate member MELBOURN, CAMBRIDGE, UNITED KINGDOM— Intertek announced it has become an Asso- ciate Member of the International Pharmaceutical Aerosol Consor- tium on Regulation & Science (IPAC-RS). Chris Vernall, Intertek Commercial Director, commented, "IPAC-RS plays an essential role in building the OINDP community and contributing to the advance- ment of regulatory science for orally inhaled and nasal drug prod- ucts. Joining IPAC-RS is a fantastic opportunity to share cross-industry understanding on a range of scien- tific and regulatory topics, and to contribute to the evolving area of inhaled biologics and DNA medi- cine development, with a common objective of better patient out- comes." Mike Needham, IPAC-RS Chair, noted, "IPAC-RS has greatly benefitted from the contributions and commitment of its Associate Members and warmly welcomes Intertek as an Associate Member. We look forward to Intertek 's active engagement and collabora- tion in the consortium's scientific and regulatory initiatives." GSK to begin Phase III trials of low carbon Ventolin BRENTFORD, UNITED KING- DOM—GSK announced it will begin Phase III trials of a low car- bon version of its metered dose inhaler (MDI), Ventolin ® (salbu- tamol), using a next generation propellant. Recent data from early clinical trials has supported the company's decision. Dosing of ini- tial patients is planned in the first half of 2024. If successful, regu- latory submissions will begin in 2025. "We recently confirmed our plan to invest in our Evreux, France site to manufacture the inhaler, so that we are ready to start supply quickly, should clinical trials and regulatory processes be successful, said Emma Walmsley, GSK Chief Executive Officer. A company news • Centrally manage all projects, product testing confi gurations, and apparatuses. • Create re-usable workfl ow templates for all testing, analytics, and reporting. • Supports all USP / Ph. Eur. apparatuses and confi gurations. Fully supports 21 CFR 11 compliance. • Full bi-directional CDS automation for ChemStation, Chromeleon ™ , and Empower ™ . • Companion module for formulation and device design R&D. For faster and better in vitro inhaler testing results, contact S-Matrix Sales: sales@smatrix.com Fusion Inhaler Testing Software ™ The only fully automated off -the-shelf solution! continued on page 32