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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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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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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Combination therapies delivered directly to the lung by dry powder inhalants are an effective means of reducing patient burden. Read about case studies that illustrate the potential for improving care.
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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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Nose‑to‑brain delivery enables targeted neurological treatment by using direct neural pathways to boost precision and limit systemic exposure, with new formulations and devices driving rapid progress.
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Early stage formulation studies, which should support the emerging target product profile, will often yield important experimental results to aid subsequent development of clinically relevant dosage forms.
INHALATION DRUG DELIVERY SOLUTIONS
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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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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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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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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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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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Developing an optimized formulation tailored to your API nanoparticles is critical to unlocking their full potential.
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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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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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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.