Copley Scientific has announced the availability of 2 new breath simulators, the BRS 2100 and BRS 3100, that can generate patient-derived breathing profiles for inhaler and nebulizer testing in addition to the pharmacopeoeial standard breathing profiles. Compared to previous generations, the new breath simulators are faster an more flexible, the company said.
The BRS 2100, with a maximum volume of 900 mL, is designed for tidal breathing applications such as testing of nebulizers per US Pharmacopeia Chapter <1601> and testing of MDIs with spacers or valved holding chambers per USP Chapter <1602>.
The BRS 3100, which has a volume range of 500-5000 mL and a maximum flow rate of 240 L/min, is capable of generating typical profiles for patients using MDIs and DPIs for in vitro-in vivo correlations.
Both breath simulators generate standard neonate, infant, child, and adult profiles which can be edited for use in development studies, and users can also build their own profiles based on recordings of real world breathing patterns or techniques. Both can be used for delivered dose uniformity testing or in conjunction with a cascade impactor for aerodynamic particle size distribution.
Copley Scientific Sales Director Mark Copley commented, “In recent years, breath simulators have become a core piece of OIP testing equipment. This is partly because of the need to achieve better in vitro-in vivo relationships to enhance product development, and also in response to changing regulatory guidance, which has been updated for greater clinical relevance. Significant progress was made when the previous generation of breath simulators were introduced and now, with our upgraded series of instruments, we are very pleased to be putting state-of-the-art tools once again into the hands of our users.”
Read the Copley Scientific press release.