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https://www.ncbi.nlm.nih.gov/pmc/articles/PMC474646/
The dose delivered when actuating the MDI at 30 second intervals was no different from that when intervals was no different from that when intervals of five seconds were used. Two actuations separated by one second had no effect on the total dose but reduced the "respirable" dose by 15.8%, while four rapid actuations reduced the total and "respirable" doses by 8.2% and 18.2%, respectively.Author: M L Everard, S G Devadason, Q A Summers, P N Le Souëf
https://forum.wordreference.com/threads/re-suspendibility-caking-dose-delivery-per-actuation.1535270/
Dec 09, 2009 · "Failure to meet the acceptance criteria for appearence, physical attributes, and functionality test (e.g., color, phase separation, resuspendibility, caking, hardness, dose delivery per actuation)" My proposal:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022309s020lbl.pdf
minimum of 20.25 mg of testosterone (1 pump actuation or a single 20.25 mg packet) and a maximum of 81 mg of testosterone (4 pump actuations or two 40.5 mg packets).
http://ftp.uspbpep.com/v29240/usp29nf24s0_c601s42.html
If 3–6 doses of the 20 doses collected are outside of 80% to 120% of the label claim, but none are outside of 75% to 125% of label claim, and the means for each of the beginning and end doses fall within 85% to 115% of label claim, select 20 additional containers for second-tier testing.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3747606/
Aug 05, 2013 · Although many pMDIs contain more than the labelled number of doses, drug delivery per actuation may be very inconsistent and unpredictable after the labelled number of actuations. Beyond the labelled number of actuations, propellants can release an aerosol plume that contains little or no drug, a phenomenon called tail-off [ 30 ].Author: Federico Lavorini
https://pharma.aptar.com/en-us/dispensing-solutions/bds.html
BDS The DUAL SHOT NASAL bidose system for disposable use . BDS was designed to enable the systemic delivery of drugs without the need for injection or administration by a healthcare professional. Primeless, with one handed actuation and 360° functionality, this device is approved by the FDA.
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