Controlled release oral dosage form
AssigneeAndrx Pharmaceuticals, Inc.
InventorsBoyong Li, Avinash Nangia, Chih Ming Chen, Xiu Xiu Cheng
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Abstract
A once a day bupropion hydrochloride formulation is disclosed
Claims37
A pelletized or extruded composition comprising:
- a core which comprises
- (a) a carrier, and
- (b) at least one aminoketone antidepressant.
The dosage form of claim II further comprising at least one polymer for controlled release delivery.
A once daily dosage form comprising 150 mg of an aminoketone antidepressant, said dosage form providing an in vivo plasma profile selected from:
- (a) Mean Tmax of about 5 or more hours
- (b) Mean Cmax of less than about 90 ng/ml, and
- (c) Mean AUC0-120h of more than about 350 (ng-h)ml.
A pellet comprising:
- (a) a core comprising (1) an inert carrier;
- (2) bupropion, its salts or isomers, or a pharmaceutically acceptable aminoketone antidepressant agent, and (3) a binder;
- and
- (b) a coating comprising a pH dependent coating agent selected from the group consisting of hydroxypropyl methylcellulose phthalate and a methacrylic acid copolymer.
A pellet comprising:
- (a) a core comprising (1) an inert carrier;
- (2) bupropion, its salts or isomers, or a pharmaceutically acceptable aminoketone antidepressant agent;
- and (3) a binder;
- and
- (b) a coating comprising a methacrylic acid copolymer and a water insoluble polymer.
A dosage form comprising 150 mg of an aminoketone antidepressant wherein the aminoketone antidepressant has a dissolution profile as measured in pH 7.5 buffer at 1 hour between about 20% and 35%, at 4 hours between about 50 and 80% and at 8 hours between about 75 and 95%.
A dosage form comprising 150 mg of an aminoketone antidepressant wherein the aminoketone antidepressant has a dissolution profile of the active as measured in SGF 1.5 pH of less than 25% at 8 hours, of between about 25 and 45% at 10 hours and between about 50 and 80% at 18 hours.
Dependencies are inferred from the claim text.