Inhalation drug delivery involves four principal device technologies:
  • Nebulizers
  • Pressurized metered dose inhalers (MDIs)
  • Breath-activated inhalers (including dry powder inhalers)
  • Liquid inhalers.
These specialized drug-device combination products deliver drugs directly to lung - helping millions of people control chronic conditions such as asthma or COPD, as well as treat acute respiratory attacks and infectious diseases.

Controlling extractables and leachables for inhalation drug delivery devices

As with other combination products, a key challenge for developers of inhalation therapies is the formulation-device interaction, including the extractables and leachables which originate from the device materials and the selection of those materials. According to FDA guidance for industry on container closure systems for packaging human drugs and biologics, inhalation aerosols and solutions pose the highest level of risk and concern for packaging component-dosage from interaction.

With our unrivaled expertise in extractable and leachable studies and understanding of the rubber and plastic materials used in inhalation device components, Smithers can design and conduct controlled extraction studies to establish extractables / leachables profiles and achieve control of leachables.

How Smithers can help

Smithers can support you throughout the development process for your inhalation device.
 
  • Materials: Expert support with selection, characterization and compatibility
  • Compliance: Testing to help you demonstrate regulatory with FDA, MHRA, EMA, USP and ISO as well as BPOG and PQRI guidelines.
  • Extractables and Leachables: extensive expertize in controlled extraction studies, identification of extractables and leachable profile assessments.
  • Device Testing: From testing container closure to connection compatibility, we test devices to ensure they perform as designed and meet relevant regulations.
  • Transit studies: Simulated distribution testing to recreate supply chain condition faced by your device.
  • Product simulation studies: Combination of testing studies to simuate real life usage of your device and the impact this might have on patient safety through its lifetime.
 

  Contact us today for expert support and analysis

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