Generic developers looking to apply the recently proposed draft US Pharmacopoeia (USP) monograph for Albuterol Inhalation Aerosols will find relevant new testing equipment at the Copley Scientific stand at Respiratory Drug Delivery 2018 (April 22nd to 26th, Tucson, Arizona). The new TPK™ 2100 Critical Flow Controller, a highly automated unit for reproducible, cost-efficient dry powder inhaler (DPI) testing, will also make its US debut. Copley Scientific is proud to be sponsoring this key event in the inhalation calendar, and experts from the company will be in attendance throughout to discuss any aspect of inhaler testing.
Albuterol, a popular generic target also known as salbutamol, is a β2 agonist (bronchodilator) used globally for the treatment of asthma and chronic obstructive pulmonary disease. Product specific FDA guidance and USP monographs directly 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, which was released in January 2018, 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 Scientific will use the conference to launch new equipment to directly 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 TPK™ 2100 breaks new ground in terms of ease of use, improved reproducibility, and enhanced data output and recording. It exemplifies a suite of innovative designs that Copley has introduced over the last year to minimize the potential impact of user variability in inhaler testing and boost analytical productivity.
Receive the latest drug manufacturing news straight to your inbox. Become a free member today.