Copley Scientific has introduced the new TPKTM 2100 Critical Flow Controller, a highly automated unit for reproducible dry powder inhaler (DPI) testing.  

Albuterol, a β2 agonist (bronchodilator), is used globally for the treatment of asthma and chronic obstructive pulmonary disease. Product specific USP monographs and FDA guidance support the development of important generic drugs but frequently call for the application of unique test equipment, associated with the original product development.
The proposed USP monograph for Albuterol Inhalation Aerosols, specifies a non-standard sampling apparatus for delivered dose uniformity (DDU) testing, and an alternative to the standard USP induction port for aerodynamic particle size distribution (APSD) measurement using an Andersen Cascade Impactor (ACI).

Copley has launched new equipment to meet these requirements along with an accessory that allows the use of existing mouthpiece adapters, to simplify interfacing the inhaler with the induction port.

Copley Critical Flow Controllers are an internationally recognized standard for DPI testing that enable the set-up, control and documentation of all the parameters associated with both DDU and APSD measurement. The third generation TPKTM 2100 provides ease of use, improved reproducibility, and enhanced data output and recording, according to the company. It’s part of a suite of recently introduced designs to help minimize the potential impact of user variability in inhaler testing and boost analytical productivity.