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A new draft guidance document from ICH, issued jointly with the EMA, adopts the position that the assessment of leachables and extractables requires a holistic framework for risk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 VIDEOS
In this segment of the Drug Delivery Leader Live online event, Eying The Drug Delivery Regulatory Landscape: The 'Must See' Watch List For 2026, Chief Editor Tom von Gunden invites panelists Fran DeGrazio, Barr Weiner, and Rumi Young to identify and comment on their most important takeaways from their panel conversation. They point to platform thinking, post-market manufacturing, and the representation of combination products in regulatory guidances.
How do Essential Drug Delivery Outputs (EDDOs) differ from Primary Functions – for example, as described in ISO 11608 regarding needle-based injection systems? In this segment of the Drug Delivery Leader Live event The FDA Guidance on EDDO: What to Know, What to Do, Alan Stevens, regulatory head of complex devices and drug delivery systems at AbbVie and formerly at FDA, describes the differences between the two concepts, including how they differently relate to considerations of risk.
Among the characteristics of a device design feature that helps identify it as an Essential Drug Delivery Output (EDDO) is “device dependent.” In this segment of the Drug Delivery Leader Live event The FDA Guidance on EDDO: What to Know, What to Do, consultant Susan Neadle of Combination Products Consulting Services, LLC explains the differences between the concepts of device-dependent versus device-independent and illustrates why only the former is applicable to an EDDO.
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, underscores the importance of cascading business and regulatory strategies for advanced therapies and delivery products throughout the organization’s quality management systems.
INHALATION DRUG DELIVERY RESOURCES
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![GettyImages-1346675635-lab-tablet-research-team]( "Simultaneous Spray Drying For Innovative Dry Powder Inhaler Combination Formulations")
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.
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![Signing contract-GettyImages-1405364155]( "Contract Design And Development Vs. In-House: How To Find The Best Fit")
Explore the rationale behind opting for a contract development organization (CDO) to fulfill organizational requirements and underscore vital considerations for evaluating CDOs to ensure alignment with your project objectives.
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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.
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![Kindeva]( "Promising Early Results For New High-Performance DPI")
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.
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![GettyImages-1371705046-lab-scientist-team]( "Spray Drying For Improved Solubility")
Gain expert insights into how to develop a spray dried powder formulation and scale it from early feasibility studies to commercial manufacturing.
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![GettyImages-528041162-lab-testing]( "Simultaneous Spray Drying For Large/Small Mol Combinations")
Gain insights into a “simul-spray” process pioneering for combining small and large molecules into a single, atomized drug product for inhalation administration.
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![GettyImages-1206035004-spectroscopy-lab]( "Application Of Nano-Emulsion Technology To Address Unmet Medical Needs: A Case Study Of Clopidogrel IV By 505(b)(2) Pathway")
Review a process where the insoluble and unstable free-base form of clopidogrel is converted to a form with acceptable drug loading and is protected from chemical degradation.
INHALATION DRUG DELIVERY SOLUTIONS
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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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![iStock-493302504-scientist-lab-development]( "Pre-Formulation And Material Sciences")
Our formulation development and material sciences experts have over 30 years’ experience in pre-formulation and solid state characterization.
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![ulab thumb]( "Battelle uLAB")
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.
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![OFM]( "Pharmaceutical Filling System For Non-Injectable Products: Ophthalmic, Nasal Sprays, Syrups: OFM")
OFM automatic filling and closing machines are designed for pharmaceutical formulations, such as syrups, ophthalmic products, and nasal sprays either in glass or plastic containers.
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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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![GettyImages-1268574717-food-inspect-ship-package]( "A/L/P Assembly, Label And Packaging")
Integrated device assembly, labeling, and packaging solutions streamline pharma delivery, ensuring compliance, scalability, and patient-centric design from clinical trials to commercial production.
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![GettyImages-1600719545 lab]( "Innovative Formulations And Higher Drug Loads Across The Life-Cycle")
Advanced particle engineering enhances the performance and life-cycle of therapeutics. Superior bioavailability, higher drug load, and improved stability are enabled for small and large molecules.
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![pulmonary-GettyImages-2148494976]( "Pulmonary")
See key inhalation platforms and their advantages, showing how targeted delivery, formulation flexibility, and patient-friendly design support efficient development and stronger therapeutic outcomes.
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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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![Getty Images-823447656-vector-viral-lab-AAV-cell-development]( "Global Experts In Nanotechnology And Drug Particle Engineering")
Discover the nanoparticle engineering, formulation and GMP manufacturing services that can drive forward your market success and unlock the power of “small."
