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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. News on R&D and progress in the treatment of respiratory diseases, such as asthma and COPD. 8 April 2024 Inhalation and combination drug products. In addition, the collaboration enables Resyca to provide all aspects of turnkey solutions for both oral and nasal inhalation, leveraging soft mist technology. It is anticipated that the enhanced collaboration will result in breakthroughs in the nasal delivery of fragile biological formu- lations, such as mRNA vaccines for pandemic applications. RESPIRATORY MEDICINE NEWS Inhaled statins being studied as asthma treatment SACR A MENTO, CALIFOR- NIA—e University of Califor- nia Davis Health announced that a team of researchers is conducting a study, funded by the US National Institutes of Health, to determine whether statins can be delivered by inhalation to treat obstructive air- way diseases such as asthma. While statins can decrease cholesterol lev- els in patients at high risk of car- diovascular disease, they also have anti-inflammatory effects. Preclinical studies have shown statins decrease airway epithelial cell dysfunction, airway smooth muscle (ASM) cell proliferation, immune cell activa- tion and the release of various pro- inflammatory mediators. In animal models, statins have been efficacious with acute and chronic allergen- mediated asthma. However, in clini- cal trials oral statins have had mixed to largely negative results in treating asthma. Consequently, the research- ers are examining the mechanisms and pharmacology by which statins affect ASM function in asthma. "To our surprise, we have discovered that statins also work as a bronchodilator, in which they directly relax ASM tissue, leading to the opening of airways," explained principal inves- tigator Amir Zeki, MD, Founder and Director, VA COPD Clinic and Associate Professor, Department of Internal Medicine. "Instead of work- ing through the cell surface recep- tors, the statins target the signaling INDUSTRY NEWS Catalent adds potent capsule filling capabilities SOMERSET, NEW JERSEY— Catalent announced it has com- pleted upgrades to handle potent drugs in its capsule filling of dry powders for inhalation and capsule blistering suites in Boston, Massa- chusetts, US. e upgrades include isolators for potent compound pro- cessing and cleanroom upgrades for safe handling and containment of powders through the installation of misting showers and airlocks. e capsule-filling lines use drum dosing technology with in-line AMV (advanced mass verification) sensor technology and flexibility for custom powder feeding based on complex powder characteristics. e changes will increase the site's annual capacity to 300 million capsules, one-third of which can be employed for potent drugs. Capac- ity for development and commer- cial spray drying has also been increased. e Boston facility is Catalent's Global Center of Excel- lence for large-scale spray drying and dry powder inhaler (DPI) cap- sule manufacture and packaging. e company's inhalation formu- lation and analytical development services are based at its Morrisville, North Carolina, US facility. Recipharm, Medspray, Resyca ® extend collaboration STOCKHOLM, SWEDEN— Recipharm has announced an exclusive license and collaboration agreement with Medspray and Resyca ® to develop soft mist nasal delivery devices for single and com- bination drug products. e col- laboration extends the partnership between Recipharm and Medspray that resulted in the Resyca joint venture. Resyca is developing soft mist inhalers utilizing Medspray's nozzle technology to achieve high lung doses and less degradation of biologically active pharmaceutical ingredients. Under the agreement, Resyca will gain exclusive rights to Medspray's proprietary spray nozzle technology for use in nasal devices • 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 36