Steady State Plasma Levels of Bupropion After Administration of 3x150 Mg Extended Release Reference Tablets and Switching to 1x450 Mg Extended Release 450ER Tablets

In order to provide patients who take 450 mg/day bupropion hydrochloride for the treatment of severe depressive disorder with a safe and convenient alternative to currently existing dose regimens, a high-dose bupropion ER tablet formulation containing 450 mg of bupropion hydrochloride was developed. The results of the single dose pharmacokinetic study demonstrated bioequivalence of the 450 mg ER tablet with three tablets of the 150 mg strength taken at once, thus confirming that the 450 mg tablet is safe and effective. In addition, the simulation of steady state bupropion plasma levels after administration of 3x150 mg bupropion ER fasting and subsequent switch to 1x450 mg bupropion ER fed confirm that even under “worst case conditions” patients who switch from 3x150 mg to 1x450 mg bupropion ER won’t experience an elevated average Cmax and hence are not exposed to an increased risk of seizures.