INHALATION DRUG DELIVERY ARTICLES
Human Factors: A Key Factor In Regulatory Approvals
In this article, combination product consultant Doug Mead demonstrates the practice and results of using GenAI search tools to conduct precedent research on Human Factors (HF) regulatory considerations. He illuminates query responses related to Complete Response Letters (CRLs), HF study waivers, use errors, critical tasks, and other aspects of FDA approvals for combination products and other delivery devices.
INHALATION DRUG DELIVERY RESOURCES
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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.
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This paper presents three approaches to address poor solubility in organic solvents for spray drying as well as case studies outlining their successful application during development.
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In a recent webinar, Lonza discussed the process it uses to develop a spray dried powder formulation and scale from early feasibility studies to manufacturing.
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The support of an experienced CDMO is critical to overcoming complexity when working with highly potent APIs and when solving solubility challenges.
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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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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.
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Everything from glass or plastic bottles to the ink used in labels can leach unwanted contaminants. The first challenge chemists address is to narrow the focus on the most likely suspects.
INHALATION DRUG DELIVERY SOLUTIONS
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Discover the nanoparticle engineering, formulation and GMP manufacturing services that can drive forward your market success and unlock the power of “small."
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Developing an optimized formulation tailored to your API nanoparticles is critical to unlocking their full potential.
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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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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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Modern inhalation platforms, improved formulations, and greener propellants speed development and strengthen respiratory performance, with key factors guiding device choice and clinical readiness.
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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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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.
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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.
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Our formulation development and material sciences experts have over 30 years’ experience in pre-formulation and solid state characterization.
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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.