Table 1.
Group[g] | |||||
---|---|---|---|---|---|
1 | 2 | 3 | 4 | 5 | |
Administered dose (μg)[a] | 169 ± 10 | 148 ± 5 | 162[h] | 164 ± 14 | 167 ± 15 |
Cmax (ng/ml)[b] | 60 ± 12 | 12 ± 5* | 31 ± 15* | 49 ± 12 | 68 ± 7 |
tmax (h)[c] | 0.7 ± 0.3 | 0.7 ± 0.3 | 0.8 ± 0.3 | 0.6 ± 0.2 | 0.7 ± 0.3 |
t1/2 (h)[d] | 1.2 ± 0.2 | 0.9 ± 0.3 | 1.4 ± 0.1 | 1.1 ± 0.2 | 1.1 ± 0.3 |
AUC (h·ng/ml)[e] | 174 ± 35 | 20 ± 13* | 101 ± 49* | 120 ± 28* | 181 ± 26 |
BA (%)[f] | 100 ± 20 | 13 ± 8* | 61 ± 29* | 71 ± 17* | 106 ± 15 |
The applied dose was measured with ELISA (n=4).
Cmax is the maximum hGH concentration.
tmax is the time recorded as the peak concentration of hGH, Cmax
t1/2 is half-life of hGH concentration relative to Cmax.
Area under the curve (AUC) was calculated from Fig. 3 using the trapezoid method.
Bioavailability (BA) was calculated as (AUCgroup/Dosegroup)/(AUCgroup 1./Dosegroup 1)
The group numbers are the same as in Figure 3: (1) SC injection, (2) CMC microneedle patch, (3) SC injection of reconstituted CMC patch (after 15 months storage), (4) CMC/trehalose microneedle patch, (5) SC injection of reconstituted CMC/trehalose patch.
The Group 3 dose is the original amount of hGH encapsulated in the microneedles on dry basis, not the amount of active hGH after storage.
Significantly different from Group 1 (Student's t-test, p < 0.05)