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

Both a URRA (Use-Related Risk Analysis) and IFU (Instructions for Use) can help to mitigate the risk of user misuse of a combination product. In this segment of the Drug Delivery Leader Live event Human Factors Risk Analysis: Leveraging URRA And UFMEA Tools, Shannon Hoste, chief scientific officer at Pathway for Patient Health, offers rationale for starting and conducting the URRA ahead of developing or finalizing IFU.

What constitutes an EDDO (Essential Drug Delivery Output)? In this segment of the Drug Delivery Leader Live event EDDOs Revisited: Putting Essential Drug Delivery Outputs Into Practice, consultant Susan Neadle of Combination Products Consulting Services, LLC illustrates how to identify system-level drug delivery outputs that are device-dependent and, therefore, essential. 

Dry powder capsules offer a compact, portable means for patients to receive treatment. Examine the challenges of dry powder formulation and unlock the potential of high-dose inhaled medications.

In this episode of The Combination Products Handbook: The Series, host Tom von Gunden discusses Chapter 3 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. The conversation focuses on building into product development a regulatory strategy that incorporates key enablers of market success from early clinical studies, through the marketing application, to post-market changes.

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."

  • 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).

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

  • 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.

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

  • 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.

  • 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.

  • August Bioservices is a US-based, quality-driven CDMO that offers end-to-end drug development, analytical testing, and fill/finish manufacturing services to clients of all sizes and stages, from pre-clinical to commercial.

  • 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.