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 segment of the Drug Delivery Leader Live online event, Next-Gen Drug Delivery: Rethinking Routes For New Therapies, Carolyn Dorgan, director of technical services at device design consultancy Suttons Creek, outlines key management considerations for biopharma companies developing combination therapies. These include suppliers, partnerships, quality, container closure, and regulatory. 

In this segment of the Drug Delivery Leader Live online event, Innovations In Drug Delivery: Opportunities For Enhancing Familiar, Mature Approaches, Courtney Evans, principal consultant at delivery device consultancy Suttons Creek and formerly at FDA, discusses regulatory implications of the integration or compatibility of digital applications with autoinjectors, combination products, and other drug delivery devices.

In this episode of The Combination Products Handbook: The Series, host Tom von Gunden discusses Chapter 1 of The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems (CRC Press, 2023) with the book’s editor, Susan Neadle. Given that the initial chapter was penned by the FDA’s John “Barr” Weiner, the discussion focuses on reasons for establishing the historical and regulatory context for combination products early in the handbook’s topic coverage.

In this episode of Sit and Deliver, Matt D’Onofrio, CEO of Evoke Pharma, talks with host Tom von Gunden about using nasal delivery to alleviate the discomfort of gastroparesis while smoothing the path for oral drug delivery to patients suffering from it.

INHALATION DRUG DELIVERY RESOURCES

INHALATION DRUG DELIVERY SOLUTIONS

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

  • 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).

  • 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.

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

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.