Pharmacy & Therapeutics - October 2008 - (Page PP13)

PRODUCT PROFILER: Granisetron Transdermal Delivery System Patch 52 cm2 6 5 4 3 2 1 0 0 24 48 72 96 120 Hours 144 168 192 216 240 Mean concentration patch 52 cm2: 2.2 ng/ml Patch 33 cm2 Mean concentration patch 33 cm2: 1.2 ng/ml Patch 15 cm2 Mean concentration patch 15 cm2: 0.7 ng/ml Patch removal Figure 4 Pharmacokinetic parameters of granisetron after application of the transdermal patch for six days. (From Study 392MD/11/C, p 34.20) reached for treatment B was 1, and the maximal score reached for treatments C and D was 2.20 In general, skin irritation was low and there was no clear difference among treatment groups. A total of 27 treatment-emergent AEs were reported during the study in 10 subjects. Of the 27 AEs, 20 were considered to be drug-related, consisting primarily of dizziness, headache, and constipation. There were no major differences between the four treatments. All AEs were of mild or moderate intensity except for a headache that was reported as severe with treatment D. No other serious AEs were reported for this study. All AEs related to the study medication resolved spontaneously and did not result in the need for a change in the study drug.20 Safety measurements (laboratory tests, vital signs, physical findings, and ECGs) did not show any clinically relevant changes during the study.20 Overall, the three doses of GTDS were well tolerated both locally and systemically.20 In summary, the 52-cm2 granisetron patch resulted in Cavg concentrations similar to those with once-daily oral dosing of 2-mg granisetron; the in vivo delivery rate for the patch was 3.30 mg/day. Granisetron’s pharmacokinetic parameters were proportional to the size of the patch. Within-subject variability of granisetron pharmacokinetics was moderate, with values ranging from 31% to 42% for Cavg and AUC concentrations. Between-subject variability was high, with values ranging from 70% to 110% (CV on Cavg and AUC), but they were comparable to between-subject variability observed with oral granisetron dosing (CV range, 42%–68% for Cmax and 80%–120% for AUC).20 Table 4 Numerical Scoring System for Irritation after Treatment Irritation Score 0 1 2 3 4 5 6 7 Definition No evidence of irritation Minimal erythema, barely perceptible Definite erythema, readily visible; minimal edema or minimal papular response Erythema and papules Definite edema Erythema, edema, and papules Vesicular eruption Strong reaction spreading beyond test site From Study 392MD/11/C, p 13.20 13

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Pharmacy & Therapeutics - October 2008 Contents Editorial Medication Errors Prescription: Washington New Drugs/Drug News/ New Medical Devices Drug Forecast Medical Management of Parkinson’s Disease Why Is Health Care Regulation So Complex? The Next President’s Prescription for Action on Drugs Trends in Managing Multiple Sclerosis Product Profiler: Sancuso®

Pharmacy & Therapeutics - October 2008

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