Pharmaceutical composition containing bupropion hydrochloride and a stabilizer
AssigneeBurroughs Wellcome Co.
InventorsMichael D. Ruff, Sanyasi R. Kalidindi, Joel E. Sutton, Jr.
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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.
Claims17
A pharmaceutical composition in solid form comprising bupropion hydrochloride and a pharmaceutically acceptable stabilizer in an effective stabilizing amount and which is solid or liquid at 30.degree. C. wherein said stabilizer has a aqueous solution pH of about 0.9 to about 4 at an aqueous solution concentration of about 6% w/w, and said composition, when stored for 6 weeks at about 50 degrees C. and at about 27% relative humidity contains at least about 80% of the labelled amount of bupropion hydrochloride in the composition, said stabilizer selected from the group consisting of L-cysteine hydrochloride, glycine hydrochloride, malic acid, sodium metabisulfate, citric acid, tartaric acid and L-cysteine dehydrochloride.
A method of inhibiting degradation of bupropion hydrochloride in a tablet or capsule which comprises mixing bupropion hydrochloride with a stabilizer, having an aqueous solution pH between about 0.9 to 4 at an aqueous solution concentration of 6% w/w, in an amount of about 2.7% to about 27% of the weight of bupropion hydrochloride to form a solid form of the mixture in the form of a tablet or capsule, said tablet or capsule maintaining at least 80% of its initial potency after storage for six weeks at about 50.degree. C. at about 27% humidity.
Dependencies are inferred from the claim text.