INHALATION DRUG DELIVERY ARTICLES
Minding The Gap: Submission Strategies For Combined Use Combination Products
For combination product regulatory submissions, there is no one-size-fits-all approach. Regulatory pathways and application types vary across global health authorities.
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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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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IVIVR modeling leverages in-vitro testing knowledge toward predicting in-vivo testing results, often reducing long-term development costs by facilitating more informed decision-making during drug development.
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Review the challenges and intricacies of effectively delivering drugs to the lung and the advantages of using nanoparticles and gentle particle processing techniques to enable delivery of sensitive drugs.
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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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This report discusses the benefits of the αeolus technology, a passive, high-performance, high-consistency dry powder inhaler platform concept, and the preliminary performance data from early-stage development.
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In recent years, the quantity of approvals for products and 505(b)(2) applications has risen, causing developers to map out their regulatory strategy as early as possible.
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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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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See key inhalation platforms and their advantages, showing how targeted delivery, formulation flexibility, and patient-friendly design support efficient development and stronger therapeutic outcomes.
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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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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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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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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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Our formulation development and material sciences experts have over 30 years’ experience in pre-formulation and solid state characterization.