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A new draft guidance document from ICH, issued jointly with the EMA, adopts the position that the assessment of leachables and extractables requires a holistic framework for risk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
-
The support of an experienced CDMO is critical to overcoming complexity when working with highly potent APIs and when solving solubility challenges.
-
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?”
-
By embracing new approach methods, regulatory agencies can revolutionize toxicology testing. These methods can be adapted for various medications, including inhalers and nasal-administered drugs.
-
Explore an integrated service package designed to simplify and accelerate the development pathway, even for APIs with challenging properties such as low aqueous solubility and poor bioavailability.
-
Review the challenges and intricacies of effectively delivering drugs to the lung and the advantages of using nanoparticles and gentle particle processing techniques to enable delivery of sensitive drugs.
-
To mitigate inherent risks like inconsistent dosing, user error, and low adoption due to complex usage procedures, technological innovation in delivery devices is best guided by lessons from the past, including user feedback and follow-on learnings from market data.
-
Gain expert insights into how to develop a spray dried powder formulation and scale it from early feasibility studies to commercial manufacturing.
INHALATION DRUG DELIVERY SOLUTIONS
-
Developing an optimized formulation tailored to your API nanoparticles is critical to unlocking their full potential.
-
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.
-
How integrated analytics, formulation, and manufacturing enable fast‑acting, noninvasive nasal therapies while helping teams align delivery needs, regulations, and performance goals.
-
Unlock superior performance for peptides and proteins using nanotechnology. Achieve high drug loads for subcutaneous delivery and stable, aerodynamic dry powders for deep-lung inhalation.
-
This comprehensive suite of services encompasses the entire spectrum of user research, starting from the conceptualization of study designs to meticulous data analysis and comprehensive reporting.
-
An overview of analytical capabilities to boost product quality, meet regulatory expectations, and drive development through phase‑appropriate methods and specialized testing for complex drug programs.
-
By partnering with Battelle, your organization can reduce risks and save on investment costs, leading to more successful and sustainable outcomes.
-
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.
-
See key inhalation platforms and their advantages, showing how targeted delivery, formulation flexibility, and patient-friendly design support efficient development and stronger therapeutic outcomes.
-
Modern inhalation platforms, improved formulations, and greener propellants speed development and strengthen respiratory performance, with key factors guiding device choice and clinical readiness.