Controlled release oral dosage form

• US 6,905,708 B2
• Filed: 05/09/2003
• Issued: 06/14/2005
• Est. Priority Date: 02/26/1999
• Status: Expired due to Term

• Current Assignee: Andrx Pharmaceuticals LLC (Teva Pharmaceutical Industries Limited)
• Original Assignee: Andrx Pharmaceuticals (NC), Inc. (Abbvie Incorporated)
• Inventors: Nangia, Avinash, Chen, Chih Ming, Cheng, Xiu Xiu, Li, Boyong
• Primary Examiner(s): Spear, James M.
• Application Number:
  US10/435,012
• Publication Number:
  US 20030198683A1
• Time in Patent Office: 767 Days
• Field of Search: 424/497, 424/489, 424/490, 424/457, 424/458
• US Class Current: 424/489
• CPC Class Codes: A61K 31/137 Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
• CPC Class Codes: A61K 9/1676 having a drug-free core with discrete complete coating layer containing drug adsorbates of liquid drug formulations on inert powders without simultaneous granulation step A61K9/141; with further drug-free outer coating A61K9/5078; drug conjugated to non-active particles A61K47/6921
• CPC Class Codes: A61K 9/2081 with microcapsules or coated microparticles according to A61K9/50
• CPC Class Codes: A61K 9/5078 with drug-free core
• CPC Class Codes: A61K 9/5084 Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs tablets containing such a mixture A61K9/2077
• CPC Class Codes: A61P 25/34 Tobacco-abuse

Abstract

A once a day bupropion hydrochloride formulation is disclosed

Claims

1. A once daily dosage form comprising 150 mg of an bupropion or salt of bupropion, said dosage form providing an in vivo plasma profile selected from:

(a) Mean T_max of about 5 or more hours

(b) Mean C_max of less than about 90 ng/ml, and

(c) Mean AUC_0-120h of more than about 350 (ng-h)ml.

2. The once daily dosage form of claim 1 wherein said mean C_max is less than about 80 ng/ml.

3. The once daily dosage form of claim 1 wherein said mean C_max is less than about 70 ng/ml.

4. The once daily dosage form of claim 1 wherein said mean C_max is less than about 60 ng/ml.

5. The once daily dosage form of claim 1 wherein said mean C_max is less than about 50 ng/ml.

6. The once daily dosage form of claim 1 wherein said mean C_max is less than about 40 ng/ml.