Leachables And Extractables Handbook Pdf

leachables and extractables handbook pdf

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Published: 16.06.2021

By Wiley. A practical and science-based approach for addressing toxicological concerns related to leachables and extractables associated with inhalation drug products.

Extractables and Leachables Testing for Inhaled Medicines

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Leachables and Extractables Handbook (eBook)

Orally inhaled and nasal drug product OINDP formulations, which are primarily a propellant including an organic solvent, have a high potential for the leaching of substances from the delivery device components. In this context, a device such as a dry powder inhaler DPI or pressurized metered dose inhaler pMDI is considered a primary packaging material or a container closure system CCS. Extractables are compounds that are released from a CCS into an extraction solution, which is typically a simulation solvent that mimics the drug formulation, during forced extraction experiments. Leachables are compounds that leach from a CCS into the drug formulation under normal storage conditions, such as those applied during a formal stability study. Extractables are common, but not always the worst-case leachables; new reaction products formed from extractables and drug formulation components can also be considered as extractables. Leachables are drug product impurities that have the potential to affect patient safety. For example, in a pMDI, precipitates were identified that were found to be polyaromatic hydrocarbons PAHs , mercapto-benzothiazol, and N-nitrosamines originating from the rubber materials used for construction of the inhaler devices 1, 2.

Add the following:. This section addresses specific considerations for leachables in orally inhaled and nasal drug products OINDP , including metered dose inhalers MDIs ; nasal sprays; inhalation solutions, suspensions, and sprays; and dry powder inhalers DPIs. Although OINDP can be a combination of products that are comprised of drug and device constituent parts, the primary mode of action is typically through the drug. Note that the following discussion is primarily devoted to organic leachables. For consideration of inorganic i. In addition to the key terms listed in , some additional key terms more specific to OINDP are the following:.

Leachables and Extractables Handbook (eBook, PDF)

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