INHALATION DRUG DELIVERY ARTICLES
Organic Impurities: New Draft ICH Q3E Guidance For Leachables And Extractables
A new draft guidance document from ICH, issued jointly with the EMA, adopts the position that the assessment of leachables and extractables requires a holistic framework for risk evaluation.
INHALATION DRUG DELIVERY RESOURCES
-
Dr. Kimberly Shepard, a principal R&D engineer at Lonza, offered insights on recent innovations pioneered in spray drying. Shepard also discussed spray drying technologies capable of combining small-molecule APIs with biotherapeutic molecules.
-
By transitioning to alternative solvents or leveraging process aids, the challenges associated with the use of these chemicals can be addressed, helping create a sustainable, greener footprint.
-
The $118 billion combination-product market is projected to increase at a CAGR of 8.8%. This article answers the question: “Is this actually a combination product? What do we need to do if it is?”
-
IVIVR modeling leverages in-vitro testing knowledge toward predicting in-vivo testing results, often reducing long-term development costs by facilitating more informed decision-making during drug development.
-
The support of an experienced CDMO is critical to overcoming complexity when working with highly potent APIs and when solving solubility challenges.
-
This report discusses the benefits of the αeolus technology, a passive, high-performance, high-consistency dry powder inhaler platform concept, and the preliminary performance data from early-stage development.
-
The solution to the carbon footprint of respiratory disease is complicated. The prevailing “myths” must be examined and addressed to achieve the shared industry vision of a decarbonized inhaler market.
INHALATION DRUG DELIVERY SOLUTIONS
-
Discover the nanoparticle engineering, formulation and GMP manufacturing services that can drive forward your market success and unlock the power of “small."
-
Our formulation development and material sciences experts have over 30 years’ experience in pre-formulation and solid state characterization.
-
A focused look at how low‑GWP propellant technologies support sustainability goals while preserving inhaler performance, offering guidance for planning regulatory readiness, device compatibility, and long‑term respiratory portfolio strategy.
-
Explore new approach methodologies, integrating in vitro and computational models to improve toxicology testing, and drug development, enhancing accuracy, efficiency, and human relevance.
-
Modern inhalation platforms, improved formulations, and greener propellants speed development and strengthen respiratory performance, with key factors guiding device choice and clinical readiness.
-
Large volume humidifiers and nebulizers – typically in sizes from 250 – 1000mL – can be specifically designed to fit existing delivery devices. Custom designs to facilitate the control of humidification in oxygen delivery can be developed.
-
Learn how our team of scientists, engineers, and human-centered designers, as well as our world-class facilities, empower us to confidently guide your product toward a successful market launch.
-
See key inhalation platforms and their advantages, showing how targeted delivery, formulation flexibility, and patient-friendly design support efficient development and stronger therapeutic outcomes.
-
Developing an optimized formulation tailored to your API nanoparticles is critical to unlocking their full potential.
-
Weiler Engineering’s ASEP-TECH® Blow/Fill/Seal machines are ideal for processing temperature sensitive products such as biological and protein-based materials – providing a level of enhanced sterility assurance.