|
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 36 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.
For comprehensive product details, specifications and part numbers, please request a copy of our brochure “Quality Solutions for Inhaler Testing”.
|