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The drug agency recommends using a calibrated dropper or a metered dose spray for children from 2 to 6.
Topical film-forming metered dose spray formulations were designed for management of pain.
The additional small sample experiment with the high dose spray sessions (i.e., 4 sprays to each nostril, each administration) produced considerably higher nicotine levels; mean nicotine level post-spray was 22.4 ng/ml and mean increase was 18.6 ng/ml.
Although it is possible that this additional study was under-powered to detect significant effects on negative symptoms, the high dose spray did produce an effect on a cognitive measure, spatial processing.
Metered dose spray containers, organic solvents, film forming polymers and permeation enhancers were utilized to fabricate the Metered Dose topical spray.
There was also a trend (p <.10) for both diastolic and systolic pressure to be increased more by the active than placebo nasal spray, with the high dose spray producing a small but significant (p =.01) increase in systolic blood pressure.
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Vivus now is in middle-stage trials of a metered-dose spray of testosterone, the "male" hormone.
In this study, twenty-five patients with second-division trigeminal neuralgia were randomized to receive two sprays (0.2 ml) of either lidocaine 8% or saline placebo in the affected nostril using a metered-dose spray.
After priming, the spray delivers 1 mg of nicotine per metered-dose spray.
To look at whether the issues of low nicotine levels and side-effects could be countered, we ran a third preliminary study, with 10 subjects, of high dose nasal spray (four spray administrations to each nostril 2 sprays twice within 5 min).
In the subjects tested in the higher dose nasal spray sub-study there were stronger drug effects on improved performance in the two-choice reaction time (p =.008) and in spatial rotation accuracy (p =.025), which were significant at traditional significance levels (Table 4, Figure 1).
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