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
-
A compound with poor biopharmaceutical properties or improper formulation design could lead to a delay in the project or even program termination.
-
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.
-
David Lyon, Ph.D., and Molly Adam answer attendee questions from a recent webinar about three enabling technologies designed to improve drug solubility in organic solvents for spray drying.
-
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.
-
Explore the material and performance properties of spray-dried and jet-milled mannitol for respiratory delivery of crystalline mannitol.
-
Combination products provide significant avenues for increasing patient adherence and overall efficacy. This collection outlines the opportunity and identifies strategies for gaining regulatory approval.
-
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.
INHALATION DRUG DELIVERY SOLUTIONS
-
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.
-
Developing an optimized formulation tailored to your API nanoparticles is critical to unlocking their full potential.
-
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.
-
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.
-
Integrated device assembly, labeling, and packaging solutions streamline pharma delivery, ensuring compliance, scalability, and patient-centric design from clinical trials to commercial production.
-
Our formulation development and material sciences experts have over 30 years’ experience in pre-formulation and solid state characterization.
-
Explore new approach methodologies, integrating in vitro and computational models to improve toxicology testing, and drug development, enhancing accuracy, efficiency, and human relevance.
-
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.
-
Advanced nanotechnology improves biologics with higher drug loads, better stability, new delivery routes, and enhanced performance in injectables, inhalation, and long‑acting therapies.