INHALATION DRUG DELIVERY ARTICLES

How-To-GettyImages-1315383657 Conducting A Medical Device Stability Study: A Practical Guide

Stability studies measure how medical devices respond to environmental stresses such as temperature, humidity, light, and time. Let's take a closer look at designing and conducting a stability study.

INHALATION DRUG DELIVERY VIDEOS

Explore the latest in nanotechnology advancements including recent clinical data, formulation applications, and API optimization to NanoImprove formulations.

In this episode of Sit and Deliver, host Tom von Gunden talks with Merck VP of Pharmaceutical Sciences and Clinical Supply Allen Templeton about formulation and device considerations for combination products and other delivery systems deployed across a range of molecule types and sizes. The conversation takes them from small molecules, through peptides and mAbs, to large molecule biologics, across various routes of administration including oral, injectable, and inhalation.

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 segment of the Drug Delivery Leader Live online event, Eying The Drug Delivery Regulatory Landscape: The 'Must See' Watch List For 2026, Chief Editor Tom von Gunden asks the panel to comment on regulatory movements of note. From his combination products and global operations leadership roles at FDA and now as regulatory consultant, panelist Barr Weiner points to global harmonization of regulatory definitions and requirements. Panelists Rumi Young and Fran DeGrazio weigh in on stability testing and specific ICH, ISO, and AAMI standards.

INHALATION DRUG DELIVERY RESOURCES

INHALATION DRUG DELIVERY SOLUTIONS

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

  • Integrated device assembly, labeling, and packaging solutions streamline pharma delivery, ensuring compliance, scalability, and patient-centric design from clinical trials to commercial production.

  • 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.

  • 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.

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

  • 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.

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

  • Explore new approach methodologies, integrating in vitro and computational models to improve toxicology testing, and drug development, enhancing accuracy, efficiency, and human relevance.

  • 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).

  • Our newly expanded in-house capabilities span clinical and commercial scale manufacturing for DPIs, unit-dose, bi-dose and preserved multi-dose nasal sprays.