Deposition of Dry Powder Generated by Solovent in Sophia Anatomical Infant Nose-Throat (SAINT) Model

Abstract

Purpose: To quantify deposition of 99m technetium-labeled powder in the Sophia Anatomical Infant Nose-Throat (SAINT) model of a 9-month old. Methods: Powder was generated by the Solovent (BD Technologies), an active dry powder inhaler with spacer, during 30 seconds of tidal volume (TV) breathing. Activity that passed through the model was captured on a filter and represented powder that was available for deposition in the lungs. Deposition in the nasal cavity, on the filter, and in the spacer was expressed as a percentage of the injected dose into the spacer. Results: Mean (± SD) injected dose averaged 89.5 ± 0.09%, 90.3 ± 0.11%, and 91.3 ± 0.05% at 50, 100, and 200 mL TV, respectively. Mean nasal deposition increased significantly from 50 mL to 100 mL and 200 mL TV with 0.60 ± 0.002%, 1.72 ± 0.007%, and 6.75 ± 07.21%, respectively (all p ≤ 0.05). Similarly, mean filter deposition increased significantly from 50 mL to 100 mL to 200 mL with 0.28 ± 0.00%, 1.14 ± 0.00%, and 3.87 ± 0.01%, respectively (all p < 0.05). Mean retention in the spacer was similar at 50 mL (93.38 ± 0.02%) and at 100 mL TV (89.97 ± 0.04%), but decreased significantly to 71.47 ± 0.05% at 200 mL TV (all p < 0.05). Conclusions: These data suggest for the first time the feasibility of delivering a dry powder formulation to infants and toddlers by actively introducing the powder into a spacer. Lung deposition and nasal deposition, as a percent of injected dose, were dependent on tidal volume with deposition increasing with increasing TV. Nevertheless, deposition, as

Development of high efficiency ventilation bag actuated dry powder inhalers

“…However, there are a number of advantages to this approach including stable formulations, inexpensive devices, and the potential to deliver large doses of medication to the lungs. The nose to lung aerosol administration case study of Laube et al (2012) achieved an ED of approximately 90% from the insufflator; however, a majority of the dose was lost in the device with 0.3–4% reaching the lungs of an in vitro infant model. In the current study, one of the best performing devices (3.1–565-ECG with PTFE coating) achieved an ED of 78.2% from the cannula with a FPF <5μm/ED = 78.9% and an MMAD of 1.47 μm.…”

“…Passive devices depend on patient inspiratory effort, and in contrast, active devices reduce the dependence on the patient inspiratory effort by providing energy input from an external source to aerosolize and deliver the powder (Concessio et al, 1997; Crowder and Hickey, 2006). Because active devices are not dependent on patient inhalation rate they are useful in a number of situations such as mechanical ventilation (Tang et al, 2011), pediatric and geriatric patients with low inhalation flow rates (Laube et al, 2012), nose-to-lung aerosol delivery (Golshahi et al, 2013; Longest et al, 2011), and aerosol delivery to test animals (Grainger et al, 2004). …”

“…The emitted fine particle fractions (<5 μm based on loaded dose) ranged from 20–30% and the emitted doses were in the range of 50–60%. Considering aerosol delivery to infants, Laube et al (2012) administered radiolabeled powder through a facemask into the Sophia anatomical infant nose-throat model (SAINT) using the Solovent ® active DPI. The authors reported 90% emitted dose from the Solovent device with a majority of the powder retained in the spacer, resulting in a range of approximately 0.3–4% deposition on a filter positioned distal to the SAINT model.…”

Aerosol Drug Delivery During Noninvasive Positive Pressure Ventilation: Effects of Intersubject Variability and Excipient Enhanced Growth

“…However, recent studies have demonstrated research devices that make this approach possible. (28,29,51,54,55) Simulating one of these in-line DPI devices and a conventional aerosol size with mask seal leak (Table 5), the relative difference in lung PF between Subjects A and B is 134.3%. EEG delivery reduces this relative difference to 17.4%, again providing an approximate order of magnitude decrease in intersubject aerosol delivery variability.…”

“…Such in-line devices have recently been described by Tang et al, (51) Pornputtapitak et al, (55) Behara et al, (28) and Longest et al (29) The VCU in-line DPI (28,29) incorporates a new 3D rod array to efficiently deaggregate the EEG powder and was shown to be capable of producing aerodynamically small (*1.5 lm) aerosols using low air volumes. Laube et al (54) recently reported on the connection of an active DPI to a mask interface for aerosol delivery to infants and found 0.3%-4% lung delivery efficiency with an in vitro system. Longest et al (29) recently reported high lung delivery efficiency (up to 63%) with an EEG powder and 3D rod array in-line DPI during HFNC therapy.…”