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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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.
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Spray drying of amorphous dispersions improves solubility and bioavailability, enabling supersaturation in the intestine and driving higher absorption rates when compared to crystalline drug forms.
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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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The solution to the carbon footprint of respiratory disease is complicated. The prevailing “myths” must be examined and addressed to achieve the shared industry vision of a decarbonized inhaler market.
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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.
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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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Combination products provide significant avenues for increasing patient adherence and overall efficacy. This collection outlines the opportunity and identifies strategies for gaining regulatory approval.
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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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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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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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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Developing an optimized formulation tailored to your API nanoparticles is critical to unlocking their full potential.
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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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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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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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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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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.