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Pharma Newsletters >> Eurofins BioPharma Services Newsletter 21 - October 2018 >> Inhalation testing

Inhalation testing enhances Eurofins BPT service portfolio for all drug delivery systems

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By Wayland Rushing, Scientific Affairs Director, Eurofins BioPharma Product Testing

Inhalation drug products represent a significant and expanding portion of the overall pharmaceutical, biopharmaceutical, and generic markets. The Asthma and Chronic Obstructive Pulmonary Disease (COPD) markets alone are expected to exceed $50 billion annually by the year 2022. Beyond these respiratory diseases, inhalation delivery is also used for a variety of additional treatments: neurological disorders, poorly soluble drugs, nanoparticle delivery, etc., making it one of the fastest expanding delivery technologies.

Specialised drug-device combination products are used to deliver drugs directly to lungs: pressurised metered dose inhalers (pMDI), dry powder inhalers (DPI), and nebulisers. While the chemical testing (assay, related substances, etc.) of these products is very similar to those of the other delivery routes (parenteral, ophthalmic, oral, etc.), the inhalation performance testing of the devices is very specialised and technically challenging. The performance testing measures the ability to deliver the correct amount of the drug to the correct location in the lungs. Several specialised tests are used to properly monitor the performance: spray pattern, leak rate, dose content uniformity, through-life, shot weight, and most importantly aerodynamic particle size, which measures how deeply into the lung the drug is being delivered.

With the recent acquisition of the Eurofins BPT Columbia facility (previously EAG labs) located in Columbia, MO, Eurofins is now able to offer this testing to its customers. The Columbia facility has been performing inhalation testing for over 15 years on both developmental and commercial products. The expert technical team has decades of experience working on all types of inhalation devices. The facility includes two temperature and humidity controlled inhalation testing rooms along with all specialised instrumentation. This addition now means that Eurofins can provide analytical testing services for all drug delivery systems, which are utilised in the pharmaceutical market. Combined with the existing testing, synthesis, and manufacturing services, this further establishes Eurofins as the premier contract laboratory in the industry.

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