DDU of Soft Mist Inhalers (SMIs)
Both MDIs and DPIs suffer from the same two inherent problems: low lung deposits (typically 5-20%) and dose variability (often due to patient difficulties in coordination or inspiration).SMIs (often known as “Inhalation Metered Sprays’’ or “Aqueous Droplet Inhalers”) actively aerosolise the liquid, forming a ‘soft mist’ to overcome these problems. These inhalers generally deliver a higher fine particle fraction than MDIs or DPIs. However, as with any multi-dose liquid system, microbial contamination can be a problem. Since they are active, aqueous-based devices, the DDU testing of ADIs is similar to that of MDIs, with testing carried out at a constant flow rate of 28.3 L/min.
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DDU Over the Entire Contents
In the case of multiple dose devices, tests might need to be carried out throughout the life of the inhaler i.e. dose uniformity over the entire contents.
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We also offer a range of equipment for additional MDI testing application support:
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Two factors have been identified as being critical to improving the clinical relevance of DDU testing and APSD measurement: realistic breathing profiles and realistic throat and nasal models.
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Semi-Automation Tools
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All of the tests involved in Delivered Dose Uniformity require the collection and drug recovery of individual doses into the collection tube of a Dosage Unit Sampling Apparatus (DUSA) appropriate to its type (MDI or DPI) prior to assay.
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