INHALATION DRUG DELIVERY ARTICLES

Nitric oxide-GettyImages-1458025913 Turning A Historically Limited Modality Into A Respiratory Drug Opportunity

How can sponsors revive a promising modality with known safety limits? Vast Therapeutics CEO Nate Stasko, Ph.D., explains how ALX1 is reshaping nitric oxide delivery.

INHALATION DRUG DELIVERY VIDEOS

In what ways are Essential Drug Delivery Outputs (EDDOs) different from design inputs for combination products? In this segment of the Drug Delivery Leader Live event The FDA Guidance on EDDO: What to Know, What to Do, consultant Susan Neadle of Combination Products Consulting Services, LLC explains the difference.

In this segment of the Drug Delivery Leader Live online event, Just Breathe: Increasing Efficacy And Expanding Targets With Inhalation Delivery, Chief Editor Tom von Gunden asks panelist Stephen Stein to comment on sustainability considerations for inhalation delivery. Stein notes propellants and plastics as two key focus areas for climate-attentive innovations in inhaler design. 

In this episode of The Combination Products Handbook: The Series, host Tom von Gunden discusses Chapter 2 of The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems (CRC Press) with the book’s editor and Chapter 2 author, Susan Neadle. Considering both product development and the global regulatory landscape, the discussion focuses on answers to the question posed by the chapter title, “What Is a Combination Product?”

The discussion highlights key aspects of a biopharma organization’s business and operations that must be effectively integrated when developing drugs and devices in tandem. These include imperatives such as establishing common terminology, applying QbD (Quaility by Design) principles, and managing supplier controls for providers of constituent parts.

INHALATION DRUG DELIVERY RESOURCES

INHALATION DRUG DELIVERY SOLUTIONS

  • Our formulation development and material sciences experts have over 30 years’ experience in pre-formulation and solid state characterization.

  • Large volume humidifiers and nebulizers – typically in sizes from 250 – 1000mL – can be specifically designed to fit existing delivery devices. Custom designs to facilitate the control of humidification in oxygen delivery can be developed.

  • 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.

  • 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.

  • Developing an optimized formulation tailored to your API nanoparticles is critical to unlocking their full potential.

  • 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.

  • 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.

  • 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.

  • Modern inhalation platforms, improved formulations, and greener propellants speed development and strengthen respiratory performance, with key factors guiding device choice and clinical readiness.

  • 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).