Patch application presumably decreases variance as rub-off, wash and exfoliation steps are diminished.
Longer patch application times may be required for persistent disease where biofilms are implicated.
Plasma nicotine concentrations were measured 15 times during the first 24-h period and at 48, 48.5, 49.5, and 51 h following initial patch application.
Using multiple regression analysis, two equations based on drugs physicochemical characteristics are suggested for partial prediction of peak plasma concentration (Cmax) after patch application.
There is an approximate 2-week rest period followed by a Challenge phase of a single 24-h patch application of test article applied to a naïve site on the back.
We also expect that possible skin irritation at the site of patch application will be minimal, but these expectations need to be verified in clinical trials".
Systemic exposure was proportional to dose, and the effectiveness was observed between the first observation at 2 h after patch application and 12 h after patch application.
Likewise, as indicator of feasibility was used the times for patch application: "time to determine and mark the painful area", "time of patch application" and "time to monitor".
The steady-state plasma concentration was reached between 24 and 30 hours after patch application.
Biopsy specimens were collected before and at 6 hr and 24 hr after patch application.
The median (range) total time of patch application was 60 (58–65) minutes.
