INHALATION DRUG DELIVERY ARTICLES
FDA Modernizes Container Closure Guidance: What Is Changing And Why It Matters
The proposed revision reflects changes in packaging technology, drug delivery systems, quality risk management, and more that have occurred since 1999's guidance.
INHALATION DRUG DELIVERY VIDEOS
Both a URRA (Use-Related Risk Analysis) and IFU (Instructions for Use) can help to mitigate the risk of user misuse of a combination product. In this segment of the Drug Delivery Leader Live event Human Factors Risk Analysis: Leveraging URRA And UFMEA Tools, Shannon Hoste, chief scientific officer at Pathway for Patient Health, offers rationale for starting and conducting the URRA ahead of developing or finalizing IFU.
In this segment of the Drug Delivery Leader Live online event, Next-Gen Drug Delivery: Rethinking Routes For New Therapies, James Wabby, head of global regulatory affairs for emerging device technologies and combination products at AbbVie, provides a landscape overview of emerging and advancing therapeutic methodologies. These include antibody-drug conjugates, CRISPR-edited gene therapies, companion diagnostics, complex generics, and AI-enabled biomarker identification.
In this segment of the Drug Delivery Leader Live online event, Next-Gen Drug Delivery: Rethinking Routes For New Therapies, James Wabby, head of global regulatory affairs for emerging device technologies and combination products at AbbVie, traces key conditions driving and impacting the development of advanced therapies and combination products. These include the demand for precision medicines, the complexity of regulatory frameworks, and pressures on healthcare systems.
In this segment of the Drug Delivery Leader Live online event, Just Breathe: Increasing Efficacy And Expanding Targets With Inhalation Delivery, panelists David Morton, Geraldine Venthoye, Stephen Stein, and Nani Kadrichu comment on the current state of innovation, platform technologies, supplier consolidation, and the role of CDMOs in the inhalation drug delivery industry.
INHALATION DRUG DELIVERY RESOURCES
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![GettyImages-1279969622-self-injector-injection]( "Streamlining The Path To Market For Generic Drug-Device Combinations")
Developing g-DDCPs is a complex and time-consuming process. By using a risk-based approach, manufacturers can streamline the development process and bring g-DDCPs to market more quickly.
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![Delivered _by _DeGrazio_Logo_Color_2]( "Procuring Packaging And Delivery Systems: Single Versus Dual Sourcing")
In this article, Fran DeGrazio examines the trend toward dual sourcing of products, components, and materials for drug delivery packaging and systems. She outlines the key differences between single and dual sourcing and makes recommendations about using one versus the other while mitigating supply chain and product quality risk.
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![science drug development data iStock-1209661917]( "Is Your Combination Product Drug-Led Or Device-Led?")
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?”
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![combination]( "Combination Products: Market Trends And Regulatory Considerations")
Combination products provide significant avenues for increasing patient adherence and overall efficacy. This collection outlines the opportunity and identifies strategies for gaining regulatory approval.
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![GettyImages-995087800-lab]( "Drug Formulation Development: Quick Reference Guide")
This guide shares the steps involved in formulation development, considerations during formulation, and how partnering with an experienced CDMO can lead to a successful commercial product.
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![GettyImages-1264101698-lab-research-scientist]( "Formulation Development From Preclinical To First-In-Human")
A compound with poor biopharmaceutical properties or improper formulation design could lead to a delay in the project or even program termination.
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![Lonza 1]( "Engineering Approaches To Respiratory Drug Delivery")
Explore the material and performance properties of spray-dried and jet-milled mannitol for respiratory delivery of crystalline mannitol.
INHALATION DRUG DELIVERY SOLUTIONS
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![Nasal spray, allerfies, common cold-GettyImages-2147519597]( "Nasal Drug Delivery")
How integrated analytics, formulation, and manufacturing enable fast‑acting, noninvasive nasal therapies while helping teams align delivery needs, regulations, and performance goals.
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![Biological drug products]( "Blow/Fill/Seal Packaging Systems")
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.
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![iStock-474771466-inhaler-inhale]( "Inhaled Product Development")
Our integrated capabilities and vast knowledge encompasses pre-formulation sciences, formulation development, device evaluation, clinical trial manufacturing and the clinical assessment of a variety of inhaled formats for nasal and pulmonary delivery.
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![GettyImages-1426756188-scientists-in-lab-with-computer-analyzing]( "Improve The Performance Of Your Biologic Formulations")
Advanced nanotechnology improves biologics with higher drug loads, better stability, new delivery routes, and enhanced performance in injectables, inhalation, and long‑acting therapies.
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![analytical-timelines-GettyImages-2247278213]( "A Comprehensive Approach That's Exceptional By Design")
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.
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![Syringes-injectables=tablets-GettyImages-1353657651]( "Combination Products")
Kymanox provides turnkey services to bring your product from concept to commercialization — and helps keep your product on the market. Kymanox has expertise in injectables (e.g., syringes, mechanical and electromechanical autoinjectors, wearable injectors, dual chamber systems, reconstitution systems), respiratory combination products (e.g., metered dose inhalers, dry powder inhalers, nasal sprays), and in ocular products (e.g., multi-dose containers, single-use injectables).
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![GettyImages-1435081495-Self-Injector_Auto-Injector]( "Transforming Drug Delivery")
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.
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![GettyImages-1392016982 business meeting]( "Medical Device Technical Due Diligence")
By partnering with Battelle, your organization can reduce risks and save on investment costs, leading to more successful and sustainable outcomes.
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![Working on testing machine]( "Organ On A Chip: Advancing New Approach Methodologies")
Explore new approach methodologies, integrating in vitro and computational models to improve toxicology testing, and drug development, enhancing accuracy, efficiency, and human relevance.
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![lung-health-GettyImages-1360866086]( "Fast-Tracking Healthier Tomorrows For Patients And Our Planet")
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.
