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Claims for Patent: 7,645,802

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Claims for Patent: 7,645,802

Title:Bupropion hydrobromide and therapeutic applications
Abstract:Bupropion hydrobromide formulations as well as their use for the treatment of conditions is described.
Inventor(s): Oberegger; Werner (Burlington, CA), Maes; Paul (Chatillon, FR), Saleh; Mohammad Ashty (Oakville, CA), Jackson; Graham (Co. Kildare, IE)
Assignee: Biovail Laboratories International SRL. (St. Michael, BB)
Application Number:11/930,644
Patent Claims: 1. A modified release bupropion hydrobromide composition comprising: a core comprising a therapeutically effective amount of bupropion hydrobromide; and a controlled release polymeric coat comprising from about 1% to about 12% by weight of tablet dry weight of a water-insoluble polymer and from about 1.5% to about 10% by weight of tablet dry weight of a water-soluble polymer; wherein said coat at least partially surrounds said core; and wherein said composition releases bupropion hydrobromide in a first dissolution medium consisting of 0.1 N HCl and 5%-40% v/v ethanol at a rate that is less than or equal to about 1.1 times the rate of release of bupropion hydrobromide from an identical modified release pharmaceutical composition in a second dissolution medium consisting of 0.1 N HCl, measured over a time period of at least from 0 to 2 hours measured using a USP Apparatus I at 75 rpm and at 37.+-.0.5.degree. C.

2. The modified release composition according to claim 1 wherein said composition releases bupropion hydrobromide in a first dissolution medium consisting of 0.1 N HCl and 5%-40% v/v ethanol at a rate that is less than or equal to the rate of release of bupropion hydrobromide from the identical modified release composition in a second dissolution medium consisting of 0.1 N HCl.

3. The modified release composition according to claim 2 wherein the first dissolution medium consists of 0.1 N HCl and 5% v/v ethanol.

4. The modified release composition according to claim 2 wherein the first dissolution medium consists of 0.1 N HCl and 40% v/v ethanol.

5. The modified release composition according to claim 1 wherein the time period is from 0 to 16 hours.

6. The modified release composition according to claim 1 wherein the composition is a tablet comprising 174 mg, 348 mg or 522 mg of bupropion hydrobromide.

7. The modified release bupropion hydrobromide composition according to claim 1 wherein said composition releases bupropion hydrobromide in a dissolution medium consisting of 0.1 N HCl and 40% v/v ethanol at a rate that is less than the rate of release of bupropion hydrochloride from a modified release bupropion hydrochloride composition, in the identical dissolution medium consisting of 0.1 N HCl and 40% v/v ethanol, measured over a time period of at least from 0 to 2 hours measured using a USP Apparatus I at 75 rpm and at 37.+-.0.5.degree. C.; wherein the modified release bupropion hydrochloride composition comprises: a core comprising bupropion hydrochloride, in an amount equimolar to the amount of bupropion hydrobromide in the modified release bupropion hydrobromide composition; and the identical controlled release polymeric coat comprising a water-insoluble polymer and a water-soluble polymer, used in the bupropion hydrobromide composition; and wherein the coat at least partially surrounds the core of the modified release bupropion hydrochloride composition.

8. A method of reducing alcohol-induced dose dumping of bupropion hydrobromide in a patient comprising administering to a patient the modified release pharmaceutical composition of claim 1.

9. The method of claim 8 wherein the composition is a tablet comprising 174 mg, 348 mg or 522 mg of bupropion hydrobromide.

10. The modified release composition according to claim 1, wherein said water insoluble polymer is selected from the group consisting of cellulose ethers, cellulose esters, polyvinyl alcohol, and mixtures thereof.

11. The modified release composition according to claim 1, wherein said water soluble polymer is selected from the group consisting of polyvinylpyrrolidone, hydroxypropyl methylcellulose, hydroxypropyl cellulose, and mixtures thereof.

12. The modified release composition according to claim 1 wherein said water insoluble polymer is ethyl cellulose.

13. The modified release composition according to claim 1 wherein said water soluble polymer is polyvinylpyrrolidone.

14. The modified release composition according to claim 1 wherein said water insoluble polymer is ethyl cellulose and said water soluble polymer is polyvinylpyrrolidone.

15. A modified release bupropion hydrobromide composition comprising: a core comprising a therapeutically effective amount of bupropion hydrobromide; and a controlled release polymeric coat comprising from about 0.5% to about 10% by weight of tablet dry weight of a water-insoluble polymer and from about 1.5% to about 10% by weight of tablet dry weight of a water-soluble polymer; wherein said coat at least partially surrounds said core; and wherein said composition releases bupropion hydrobromide in a first dissolution medium consisting of 0.1 N HCl and 5%-40% v/v ethanol at a rate that is less than or equal to about 1.1 times the rate of release of bupropion hydrobromide from an identical modified release pharmaceutical composition in a second dissolution medium consisting of 0.1 N HCl, measured over a time period of at least from 0 to 2 hours measured using a USP Apparatus I at 75 rpm and at 37.+-.0.5.degree. C.
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