Controlled release oral dosage form
First Claim
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1. A pelletized or extruded composition comprising:
- a core which comprises (a) a carrier, and (b) at least one aminoketone antidepressant.
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Abstract
A once a day bupropion hydrochloride formulation is disclosed.
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Citations
37 Claims
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1. A pelletized or extruded composition comprising:
a core which comprises (a) a carrier, and (b) at least one aminoketone antidepressant. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 31, 32, 33)
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23. A once daily dosage form comprising 150 mg of an aminoketone antidepressant, said dosage form providing an in vivo plasma profile selected from:
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(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. - View Dependent Claims (24, 25, 26, 27, 28)
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29. A pellet comprising:
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(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.
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30. A pellet comprising:
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(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.
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- 34. 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%.
- 35. 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.
Specification