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Tried and Tested

 

Extractables and leachables are a very important part of OINDP development because of two factors. Firstly, the regulatory concerns associated with it (see Table 1), but also the analytical challenges associated with their testing.

Why are pressurised metered dose inhalers (pMDIs) the most challenging in terms of extractable and leachable testing? A pMDI is a pressurised canister containing liquefied volatile propellant with suspended active drugs, and may contain additional excipients to optimise drug delivery (see Figure 1). The major area for concern is the valve assembly.

In a pMDI, contact with polar propellant (HFa 134a or HFa 227) can result in extraction of chemical species from both polymeric and elastomeric materials. Consequently, extractables and leachables require extensive study. In addition to the valve and the can, other potential sources of extractables and leachables include secondary packaging and labels. For other orally inhaled and nasal drug products (OINDP) dosage forms, such as dry powder inhalers (DPIs) and aqueous nasal sprays that do not have the prolonged exposure to a polar solvent, leachable levels are typically lower. However, the same extractable testing of the critical components is required.


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Dr Andrew Feilden is a Senior Scientist within the Analytical Development of AstraZeneca. He has over 10 years of experience in the pharmaceutical industry, mainly in the use of hyphenated techniques and trace level analysis. He is responsible for the extractable and leachable testing, primarily of pMDIs. Andrew gained a degree and DPhil from York University. He is a member of both the IPAC-RS container closure group and the ELSIE group.
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Andrew Feilden
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