15a
Table 2. Comparison of the Seizures Produced in Mice by Oral Doses of a 2 hr
Controlled Release Formulation of Bupropion to Those
Produced by Oral Doses of Bupropion HCl in Water
|
|
Seizure |
|
Avg. Time to |
Lethality |
|
|
mg/kg |
#Conv |
|
Seizure |
#dead |
|
Treatment |
po |
#dosed |
% |
(min) + SE |
#dosed |
% |
Bupropion |
|
|
|
|
|
|
Controlled |
|
|
|
|
|
|
Release* |
170.9 |
0/18 |
0 |
----- |
1/20 |
5 |
|
366.0 |
4/20b |
20 |
13.7±0.9c |
|
|
|
|
|
|
|
|
|
Bupropion
HCl |
152 |
0/12 |
0 |
----- |
|
0 |
in
water |
304 |
0/12 |
75 |
10.6±2 |
1/12 |
8.5 |
|
366 |
12/12b |
100 |
6±1c |
8/12 |
66 |
|
|
|
|
|
|
|
*Calculations
of dosage were based on each bead weighing 0.38 mg and containing 0.69 mg
bupropion HCl per mg of bead material. |
||||||
bp<0.01
– Comparing frequency of mice showing seizures after bupropion HCl in eater
to frequency of mice showing seizures after the same dose formulated in
controlled release beads X2 Statistic |
||||||
cp<0.002
– Bupropion controlled release vs bupropion HCl in water, students t-test |
TPZZ/88/0029/01
6
ITEM 5 1.5