INHALATION DRUG DELIVERY ARTICLES
Patient-Centric Drug Delivery: Do Possible And Preferable Always Align?
In this article, Chief Editor Tom von Gunden discusses the alignment of drug delivery method with patient preference and need. He reflects on recent conversations in which he heard from experts in drug and delivery product development, as well as patients themselves, about patient-centric considerations such as safety, efficacy, usability, and convenience. The primary use case is the transition from clinically administered IV to subcutaneous injection, including self-administration.
INHALATION DRUG DELIVERY VIDEOS
What does the FDA’s guidance on Essential Drug Delivery Outputs (EDDOs) mean for activities involved in preconditioning the device delivery components of combination products? 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, discusses the likely intent and impact of EDDOs on preconditioning for both manufacturers and sponsor companies.
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.
In this segment of the Drug Delivery Leader Live event New FDA QMSR: Its Role in Part 4 Compliance for Combination Products, DDL Executive Editor Fran DeGrazio enlists consultants Laurie Auerbach of Compliance Prodigies and Ed Bills of Edwin Bills Consultant to summarize where Part 4 is documented in the new guidance.
In this videocast episode, host Tom von Gunden discusses Chapter 14 of The Combination Products Handbook (CRC Press) with the book’s editor Susan Neadle, along with chapter coauthors Stephanie Goebel, Cherry Malonzo Marty, and Viky Verna. The group provides overviews of the commonalities and variances in regulatory definitions and guidances for combination products across global jurisdictions and agencies.
INHALATION DRUG DELIVERY RESOURCES
-
![GettyImages-1148337130 product pathway]( "Using 505(B)(2) To Streamline Approval Of Combination Products")
In recent years, the quantity of approvals for products and 505(b)(2) applications has risen, causing developers to map out their regulatory strategy as early as possible.
-
![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.
-
![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.
-
![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.
-
![iStock-474771466-inhaler-inhale]( "Understanding The In-Vitro/In-Vivo Relationship (IVIVR): Inhaled Medicinal Products")
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.
-
![GettyImages-1219894348-lab-cleanroom-PPE]( "Driving Sustainability In Spray Drying Through Enabling Technologies")
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.
-
![GettyImages-946264472-test-tube-lab]( "Improving Toxicology Testing For Inhalation Products")
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.
INHALATION DRUG DELIVERY SOLUTIONS
-
![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.
-
![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.
-
![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.
-
![scientist in lab microscope-GettyImages-1867575565]( "NanoImprove The Performance Of Your Biologic Formulation")
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.
-
![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.
-
![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.
-
![GettyImages-884796056-solubility-test-pill]( "Pharmaceutical Development")
Developing an optimized formulation tailored to your API nanoparticles is critical to unlocking their full potential.
-
![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.
-
![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.
-
![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.
