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Details for Patent: 5,541,231

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Details for Patent: 5,541,231

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 E. (Greenville, NC)
Assignee: Glaxo Wellcome Inc. (Research Triangle Park, NC)
Filing Date:Aug 25, 1994
Application Number:08/296,252
Claims:1. A pharmaceutical composition in solid form comprising bupropion hydrochloride and absorbic acid or isoascorbic acid 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.

2. A pharmaceutical composition according to claim 1, wherein the aqueous solution of the stabiliser has a pH of about 0.9 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 tablet of capsule according to claims 1, 2, or 3, wherein the amount of bupropion hydrochloride is 25 to 300 mg.

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

6. A method of stabilising 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 ascorbic or isoascorbic acid of which an aqueous solution in a concentration of about 6% w/w has a pH of about 0.9 to about 4.
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