Controlled Release Oral Dosage Form

• US 20100278926A1
• Filed: 07/14/2010
• Published: 11/04/2010
• Est. Priority Date: 02/26/1999
• Status: Active Grant

• Current Assignee: Avinash Nangia, Boyong Li, Chih Ming Chen, Xiu Xiu Cheng
• Original Assignee: Avinash Nangia, Boyong Li, Chih Ming Chen, Xiu Xiu Cheng
• Inventors: Nangia, Avinash, Chen, Chih Ming, Cheng, Xiu Xiu, Li, Boyong
• Granted Patent: US 8,747,898 B2
• Time in Patent Office: Days
• US Class Current: 424/495
• 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 salt formulation is disclosed.

Claims

1-37. -37. (canceled)

38. A sustained release oral formulation comprising:

a) a core comprising 75-450 mg of buproprion or a pharmaceutically acceptable salt thereof and 2-10% of a water soluble binder; and

b) a coating surrounding the core comprising 1-20% of ethylcellulose based upon the total weight of the dosage form and a plasticizer

wherein the sustained release dosage form is administered once a day and provides a Tmax of about 5 or more hours.

39. The sustained release oral formulation as defined in claim 38 wherein the Tmax is about 8 hours.

40. The sustained release dosage formulation as defined in claim 38 wherein the Tmax is about 5.1 hours.

41. A method for treating depression comprising orally administering to a patient, once a day, the sustained release formulation as defined in claim 38.

42. A method for treating tobacco dependence withdrawal comprising orally administering to a patient, once a day, the sustained release formulation as defined in claim 38.