INHALATION DRUG DELIVERY ARTICLES
Delivery Device Functional Scrutiny: Can You Pass Without The Test?
In this article, Chief Editor Tom von Gunden considers the relationship between regulatory testing and the biopharma industry’s interest in leveraging drug delivery platform technologies to reduce regulatory burden in product development. Tom includes a conversation with guest columnist Doug Mead about waivers on testing in the context of FDA’s guidance on Essential Drug Delivery Outputs (EDDOs).
INHALATION DRUG DELIVERY RESOURCES
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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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Combination products provide significant avenues for increasing patient adherence and overall efficacy. This collection outlines the opportunity and identifies strategies for gaining regulatory approval.
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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.
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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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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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Discover how patient-centric design principles can improve the development of medical devices. By focusing on user needs and behaviors, manufacturers can ensure that products align with expectations.
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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.
INHALATION DRUG DELIVERY SOLUTIONS
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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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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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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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Our formulation development and material sciences experts have over 30 years’ experience in pre-formulation and solid state characterization.
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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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Human‑relevant models deliver greatest value with clear questions, rigorous execution, and confident interpretation — turning innovation into trusted evidence for development and regulatory decisions.
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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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Explore new approach methodologies, integrating in vitro and computational models to improve toxicology testing, and drug development, enhancing accuracy, efficiency, and human relevance.
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Our integrated capabilities and vast knowledge encompasses pre-formulation sciences, formulation development, device evaluation, clinical trial manufacturing and the clinical assessment of a variety of inhaled formats for nasal and pulmonary delivery.
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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.