INHALATION DRUG DELIVERY ARTICLES

patient talking to doctor-GettyImages-1667822839 Patient-Centric Drug Delivery: Do Possible And Preferable Always Align?

In this article, Chief Editor Tom von Gunden discusses the alignment of drug delivery method with patient preference and need. He reflects on recent conversations in which he heard from experts in drug and delivery product development, as well as patients themselves, about patient-centric considerations such as safety, efficacy, usability, and convenience. The primary use case is the transition from clinically administered IV to subcutaneous injection, including self-administration.

INHALATION DRUG DELIVERY VIDEOS

In this unique episode of In Combination, series host Tom von Gunden, Chief Editor at Drug Delivery Leader, puts himself in combination with DDL Executive Editor Fran DeGrazio as the two share perspectives on drug delivery trends.

In this episode of The Combination Products Handbook: The Series, host Tom von Gunden discusses Chapter 10 of The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems (CRC Press) with the book’s editor, Susan Neadle, and chapter co-author Fran DeGrazio. On the topic of supplier quality and controls, Susan and Fran discuss key considerations for using third-party suppliers of raw materials, constituent parts, and services in combination product development.

Why does the FDA’s new guidance on drug-led or biologic-led device design include a change in terminology from Essential Performance Requirements (EPRs) to Essential Drug Delivery Outputs (EDDOs)?  In this segment of the Drug Delivery Leader Live event The FDA Guidance on EDDO: What to Know, What to Do, Alan Stevens,  regulatory head of complex devices and drug delivery systems at AbbVie and formerly at FDA, offers his perspective on how the change in terminology clarifies key concepts related to design controls.

After Essential Drug Delivery Outputs (EDDOs) have been identified, each will need to be controlled during the development of a drug delivery device.  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 provides the rationale for a risk-based approach to EDDO control strategies.

INHALATION DRUG DELIVERY RESOURCES

INHALATION DRUG DELIVERY SOLUTIONS

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

  • 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.

  • 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.

  • 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.

  • How integrated analytics, formulation, and manufacturing enable fast‑acting, noninvasive nasal therapies while helping teams align delivery needs, regulations, and performance goals.

  • 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.

  • 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.

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

  • Discover the nanoparticle engineering, formulation and GMP manufacturing services that can drive forward your market success and unlock the power of “small."

  • 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).