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Generated: September 23, 2017

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Title: Stabilized pharmaceutical
Abstract:This application discloses a method of inhibiting degradation of the antidepressant bupropion hydrochloride in a solid pharmaceutical formulation, so that the pharmaceutical formulation will maintain at least 80% of its initial bupropion potency after one year.
Inventor(s): Ruff; Michael D. (Greenville, NC), Kalidindi; Sanvasi R. (Edison, NJ), Sutton, Jr.; Joel Elmore (Greenville, NC)
Assignee: Glaxo Wellcome Inc. (Research Triangle Park, NC)
Application Number:08/667,239
Patent Claims: 1. A pharmaceutical composition in solid form comprising bupropion hydrochloride and a pharmaceutically acceptable stabiliser in an effective stabilising amount, in which the composition contains at least about 80% w/w of undegraded bupropion hydrochloride after storage for 6 weeks at about 40.degree. C. and 75% relative humidity and in which an aqueous solution of the stabiliser in a concentration of about 6% w/w has a pH of about 0.9 to about 4, the stabiliser being selected from the group consisting of L-cysteine hydrochloride, glycine hydrochloride, malic acid, sodium metabisulfite, citric acid, tartaric acid and L-cystine dihydrochloride.

2. A pharmaceutical composition according to claim 1, wherein the aqueous solution of the stabiliser has a pH of about 09. to 2.

3. A pharmaceutical composition according to claim 1, wherein the aqueous solution of the stabiliser has a pH of around 1.

4. A pharmaceutical composition according to claim 1, 2 or 3 which contains at least about 90% w/w of undegraded bupropion hydrochloride after storage for 6 weeks.

5. A pharmaceutical composition according to claims 1, 2 or 3 which contains at least 95% w/w of undegraded bupropion hydrochloride.

6. A pharmaceutical composition according to claims 1, 2 or 3 which contains at least 98% w/w of undegraded bupropion hydrochloride.

7. A pharmaceutical composition according to claims 1, 2 or 3, wherein the amount of stabiliser is 2.7% to 27% of the weight of bupropion hydrochloride in the composition.

8. A pharmaceutical composition according to claims 1, 2 or 3, wherein the amount of stabiliser is 5% to 16.2% of the weight of bupropion hydrochloride in the composition.

9. A tablet or capsule containing a composition according to claims 1, 2, or 3, wherein the amount of bupropion hydrochloride is 25 to 500 mg.

10. A tablet or capsule containing a composition according to claims 1, 2, or 3, wherein the amount of bupropion hydrochloride is 25 to 300 mg.

11. A tablet or capsule containing a composition according to claim 1, 2, or 3, wherein the amount of bupropion hydrochloride is 50, 75, 100 or 150 mg.

12. A method of stabilizing bupropion hydrochloride in a solid pharmaceutical composition so that at least about 80% w/w of bupropion hydrochloride is present in the undegraded form after storage for 6 weeks at about 40.degree. C. and 75% relative humidity, wherein said method comprises mixing bupropion hydrochloride with a stabiliser of which an aqueous solution in a concentration of about 6% w/w has a pH of about 0.9 to about 4, the stabiliser being selected from the group consisting of L-cysteine hydrochloride, glycine hydrochloride, malic acid, sodium metabisulfite, citric acid, tartaric acid and L-cystine dihydrochloride.
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Covington
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Cipla
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US Army
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Argus Health
Cantor Fitzgerald
Chubb

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