INHALATION DRUG DELIVERY ARTICLES

Vintage door keys-GettyImages-2225311044 Risk Is the Spine: What The First 100 QMSR Inspections Reveal

The FDA has now completed just over 100 inspections under its new Quality Management System Regulation, and the agency has begun sharing preliminary observations from those inspections.

INHALATION DRUG DELIVERY VIDEOS

In this segment of the Drug Delivery Leader Live online event, Innovations In Drug Delivery: Opportunities For Enhancing Familiar, Mature Approaches, host Fran DeGrazio asks panelists James Wabby of biopharmaceutical company AbbVie and Carolyn Dorgan and Courtney Evans of device consultancy Suttons Creek to comment on trends and advances they anticipate in the next phase of delivery development. Those include combination therapies, nanotechnology, reconstitution, and microfluidics.

In this episode of The Combination Products Handbook: The Series, host Tom von Gunden discusses Chapter 1 of The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems (CRC Press, 2023) with the book’s editor, Susan Neadle. Given that the initial chapter was penned by the FDA’s John “Barr” Weiner, the discussion focuses on reasons for establishing the historical and regulatory context for combination products early in the handbook’s topic coverage.

Learn about new data on nanotechnology formulations for multiple dose forms and routes of delivery, including oral, long-acting injectables, inhalation, and ophthalmic.

What technical issues need to be addressed if an API is to be successfully micronized? Explore a robust process development strategy that ensures all attributes critical for quality are maintained.

INHALATION DRUG DELIVERY RESOURCES

INHALATION DRUG DELIVERY SOLUTIONS

  • Modern inhalation platforms, improved formulations, and greener propellants speed development and strengthen respiratory performance, with key factors guiding device choice and clinical readiness.

  • 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.

  • By partnering with Battelle, your organization can reduce risks and save on investment costs, leading to more successful and sustainable outcomes.

  • 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.

  • 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.

  • Developing an optimized formulation tailored to your API nanoparticles is critical to unlocking their full potential.

  • Our formulation development and material sciences experts have over 30 years’ experience in pre-formulation and solid state characterization.

  • How integrated analytics, formulation, and manufacturing enable fast‑acting, noninvasive nasal therapies while helping teams align delivery needs, regulations, and performance goals.

  • 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.

  • Human‑relevant models deliver greatest value with clear questions, rigorous execution, and confident interpretation — turning innovation into trusted evidence for development and regulatory decisions.