Comparison of ISO standards for device performance; 20072 and 27427: a critical appraisal.

Two separate international standards, ISO 20072:2009 and ISO 27427:2010, have recently been published that relate to the development and performance testing of oral inhaled products (OIPs). The scope of ISO 20072 encompasses all OIP forms except nebulizing systems, whereas ISO 27427 was developed specifically for this class of OIP. Compliance with these standards will likely be necessary for manufacturers seeking approval to market inhaler devices in the European Union (EU).

Laser diffractometry as a technique for the rapid assessment of aerosol particle size from inhalers.

The rapid assessment of aerosols produced by medicinal inhalers is highly desirable from several standpoints, including the assurance of product quality, the development of new delivery systems, and the need to meet an increasing requirement by regulatory bodies for reliable in vitro performance data. Particle size analysis has traditionally been undertaken by cascade impactor on account of the direct assessment of active pharmaceutical ingredient(s) (APIs) that is possible by this method. However, laser diffractometry is less labor-intensive, more rapid, and can be a less invasive procedure.