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 was dependent on the nebuliser/drug combination and not just on the nebuliser alone.
As a result of the EMA initiative and recognising the lack of suitable test methods for nebulisers, the Pharmacopoeias have in turn introduced a new Chapter on “Preparations for Nebulisation: Characterisation” (see Ph.Eur. Chapter 2.9.44 and USP Chapter <1601>).
The method concerned is based on the Next Generation Impactor (NGI) described on Page 50 of our Inhaler Testing Brochure (see right). The recommended flow rate of 15 L/min employed in the APSD testing of nebulisers is lower than that of other OINDPs in order to better simulate the normal tidal breathing conditions employed in their in vivo use.
For this reason, the archival calibration of the Next Generation Impactor was extended from 30 L/min down to 15 L/min in 2004.
A special NGI Cooler is available to prevent the solvent evaporation losses commonly experienced during Nebuliser testing. If allowed, these losses produce artificially low particle size measurements and thus compromise the integrity of the resulting data.
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