APSD for Nebulisers

Nebulisers convert liquids into a cloud of droplets suitable for respiration. Conventional nebulisers are widely used in both hospital and home. Their main advantage is that unlike other devices, they require little or no coordination on the part of the patient in order to use them.

In 2006, the European Medicines Agency (EMA) issued a new “Guideline on the Pharmaceutical Quality of Inhalation and Nasal Products” in which they included regulatory guidance on the drug aspects of nebulisers on the grounds that the safety and efficacy of nebulisers are dependent on the nebuliser/drug combination and not just on the nebuliser alone.

As results published in 2004 indicated, the NGI could be used to meet the requirements of the future standard using a system as indicated below.

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