Controlled Release Compositions Comprising an Antipsychotic Agent
The invention relates to a formulation for the treatment of acute manic episodes associated with Bipolar I Disorder comprising an antipsychotic agent selected from the group consisting of: a dibenzothiazepine derivative; lithium; and divalproex. The formulation comprises a first component which comprises a first population the antipsychotic agent and at least one subsequent component which comprises a subsequent population of the antipsychotic agent and which allows for the modified release of the agent. The combination of the first and the subsequent components in operation deliver the antipsychotic agent in a pulsed or controlled manner over a period of up to twenty-four hours.
1 . A formulation comprising: (A) a first component which comprises a first population of an antipsychotic agent selected from the group consisting of: a dibenzothiazepine derivative; lithium; and divalproex; and (B) at least one subsequent component which is a modified release component and which comprises a subsequent population of an antipsychotic agent selected from the group consisting of: a dibenzothiazepine derivative; lithium; and divalproex.
2 . A formulation according to claim 1 wherein said formulation comprises only one subsequent component.
3 . A formulation according to claim 1 wherein said modified release component comprises a modified release means.
4 . A formulation according to claim 3 wherein said modified release means is a modified release coating or a modified release matrix material.
5 . A formulation according to claim 1 wherein said antipsychotic agent is a dibenzothiazepine derivative.
6 . A formulation according to claim 1 wherein said antipsychotic agent is quetiapine or a salt thereof.
7 . A formulation according to claim 1 wherein said antipsychotic agent is quetiapine fumarate.
8 . A formulation according to claim 1 wherein said subsequent component releases said subsequent population over a period of up to twenty-four hours.
9 . A formulation according to claim 1 wherein said subsequent component comprises an erodable formulation.
10 . A formulation according to claim 1 wherein said subsequent component comprises a diffusion controlled formulation.
11 . A formulation according to claim 1 wherein said subsequent component comprises an osmotic controlled formulation.
12 . A formulation according to claim 7 wherein quetiapine fumarate is present in each component in an amount of from about 0.1 mg to about 1 g.
13 . A formulation according to claim 1 wherein said first population is substantially released prior to the release of a subsequent population.
14 . A formulation according to claim 3 wherein said modified release means is a modified release coating.
15 . A formulation according to claim 14 wherein the integrity of said coating is pH-dependent.
16 . A formulation according to claim 14 wherein said coating comprises methacrylate copolymers.
17 . A formulation according to claim 14 wherein said coating comprises a mixture of methacrylate and ammonio methacrylate copolymers in a ratio sufficient to achieve a pulse of the active ingredient following a time delay.
18 . A formulation according to claim 17 wherein said ratio of methacrylate to ammonio methacrylate copolymers is 1:1.
19 . A dosage form comprising the formulation of claim 1 wherein said dosage form comprises: (A) particles which comprise said first component; and (B) particles which comprise said subsequent component.
20 . A dosage form according to claim 14 wherein said particles are contained in a capsule.
21 . A dosage form comprising the formulation of claim 1 wherein said dosage form comprises: (A) mini-tablets which comprise said first component; and (B) mini-tablets which comprise said subsequent component.
22 . A method for the treatment of acute manic episodes associated with Bipolar I Disorder in a patient, comprising administering to said patient a therapeutically effective amount of a formulation according to claim 1 .