INHALATION DRUG DELIVERY ARTICLES
Organic Impurities: New Draft ICH Q3E Guidance For Leachables And Extractables
A new draft guidance document from ICH, issued jointly with the EMA, adopts the position that the assessment of leachables and extractables requires a holistic framework for risk evaluation.
INHALATION DRUG DELIVERY RESOURCES
-
The $118 billion combination-product market is projected to increase at a CAGR of 8.8%. This article answers the question: “Is this actually a combination product? What do we need to do if it is?”
-
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.
-
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.
-
Precision powder microdosing makes it possible to quickly get formulations to the clinic, saving time, money, and use of limited APIs.
-
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.
-
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.
-
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.
INHALATION DRUG DELIVERY SOLUTIONS
-
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.
-
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.
-
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.
-
Discover the nanoparticle engineering, formulation and GMP manufacturing services that can drive forward your market success and unlock the power of “small."
-
Developing an optimized formulation tailored to your API nanoparticles is critical to unlocking their full potential.
-
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.
-
Modern inhalation platforms, improved formulations, and greener propellants speed development and strengthen respiratory performance, with key factors guiding device choice and clinical readiness.
-
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.
-
How integrated analytics, formulation, and manufacturing enable fast‑acting, noninvasive nasal therapies while helping teams align delivery needs, regulations, and performance goals.
-
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).