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

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.

Can a diligent focus on patient safety during combination product development inadvertently lead to missed opportunities for device use enhancements? In this segment of the Drug Delivery Leader Live event Human Factors Risk Analysis: Leveraging URRA And UFMEA Tools, Natalie, Abts, head of human factors engineering at Genentech, discusses ways to keep the organization focused on developing quality products that enhance user adoptability while also mitigating user-related harm.

In this segment of the Drug Delivery Leader Live event New FDA QMSR: Its Role in Part 4 Compliance for Combination Products, DDL Executive Editor Fran DeGrazio enlists consultants Laurie Auerbach of Compliance Prodigies and Ed Bills of Edwin Bills Consultant to summarize where Part 4 is documented in the new guidance.

INHALATION DRUG DELIVERY RESOURCES

INHALATION DRUG DELIVERY SOLUTIONS

  • 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.

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

  • This comprehensive suite of services encompasses the entire spectrum of user research, starting from the conceptualization of study designs to meticulous data analysis and comprehensive reporting.

  • 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.

  • 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).

  • By partnering with Battelle, your organization can reduce risks and save on investment costs, leading to more successful and sustainable outcomes.

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

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

  • 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.