Breathing Simulators, instruments that generate an inhalation and/or exhalation profile that mimics that of a human subject, have become a routine feature of orally inhaled product testing to replace existing constant flow conditions with breathing profiles more representative of conditions in vivo.
Their use is two-fold:
1) To measure the delivered dose uniformity (DDU) from:
(a) Nebulisers as per the relevant Pharmacopoeia and
(b) MDIs when used in conjunction with Spacers and VHCs and
2) To replace the fixed flow rate vacuum pump employed for regulatory testing with a unit capable of producing breath profiles more representative of conditions in vivo.
Copley Scientific offer a choice of three Breathing Simulators (Models BRS 1100, BRS 2000 and BRS 3000) covering a range of breathing patterns from neonate through to infant, child and adult. The simplest, microproessor controlled version covers the volume range 0 - 800 mL, whilst the largest unit is an embedded computer controlled 5 Litre system capable of testing MDIs, DPIs, Nebulisers, Spacers and Holding Chambers. The latter can be used for improved IVIVC applications, with real breath profiles generated in clinic.
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