Stabilized pharmaceutical compositions containing bupropion hydrochloride
AssigneeImpax Laboratories, LLC
InventorsChien-Hsuan Han, Gary Liaw
Life of this patent
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Abstract
This invention is directed to stabilized pharmaceutical preparations containing bupropion hydrochloride. The preferred stabilizers comprise salts of organic bases including those selected from the group consisting of creatinine hydrochloride, pyridoxine hydrochloride, and thiamine hydrochloride. Another stabilizer utilized includes a salt of an inorganic acid such as potassium phosphate monobasic. The compositions retain at least 80% of the initial potency of bupropion hydrochloride after one week at 60° and 75% relative humidity (RH), as well as four or twelve weeks at 40° C. and 75% RH.
Claims55
A pharmaceutical composition comprising bupropion hydrochloride and a pharmaceutically acceptable stabilizer in an effective stabilizing amount, in which at least about 80% of an initial potency of said bupropion hydrochloride in the composition is maintained after storage for one week at 60° C. and 75% relative humidity.
A pharmaceutical composition comprising bupropion hydrochloride and a pharmaceutically acceptable stabilizer in an effective stabilizing amount, in which at least about 80% of an initial potency of said bupropion hydrochloride in the composition is maintained after storage for one week at 60° C. and 75% relative humidity, and, wherein said stabilizer is selected from the group consisting of a salt of an organic base and a salt of an inorganic acid.
A method of stabilizing bupropion hydrochloride in a pharmaceutical composition so that at least about 80% of the potency of bupropion hydrochloride is maintained after storage for one week at 60° C. and 75% relative humidity, wherein said method comprises the step of mixing bupropion hydrochloride with a pharmaceutically acceptable stabilizer in an effective stabilizing amount.
A method of stabilizing bupropion hydrochloride in a pharmaceutical composition so that at least about 80% of the potency of the bupropion hydrochloride is maintained after storage for one week at 60° C. and 75% relative humidity, wherein said method comprises the step of mixing bupropion hydrochloride with a pharmaceutically acceptable stabilizer in an effective stabilizing amount and, where the step of mixing utilizes a dry blend of said bupropion hydrochloride, said pharmaceutically acceptable stabilizer, and other pharmaceutically acceptable excipients.
A pharmaceutical composition comprising bupropion hydrochloride and a pharmaceutically acceptable stabilizer in an effective stabilizing amount, in which at least 80% of an initial potency of said bupropion hydrochloride in the composition is maintained after storage for 4 or 12 weeks at 60° C. and 75% relative humidity.
A pharmaceutical composition comprising bupropion hydrochloride and a pharmaceutically acceptable stabilizer in an effective stabiling amount, in which at least about 80% of an initial potency of said bupropion hydrochloride in the composition is maintained after storage for 4 or 12 weeks at 40° C. and 75% relative humidity, and, wherein said stabilizer is a salt of an organic base or a salt of an inorganic acid.
A method of stabilizing bupropion hydrochloride in a pharmaceutical composition so that at least 80% of the potency of bupropion hydrochloride is maintained after storage for 4 or 12 weeks at 60° C. and 75% relative humidity, wherein said method comprises the step of mixing a dry blend of bupropion hydrochloride with a pharmaceutically acceptable stabilizer in an effective stabilizing amount.
A method of stabilizing bupropion hydrochloride in a pharmaceutical composition so that at least 80% of the potency of the bupropion hydrochloride is maintained after storage for 4 or 12 weeks at 40° C. and 75% relative humidity, wherein said method comprises the step of mixing a dry blend of bupropion hydrochloride with a pharmaceutically acceptable stabilizer in an effective stabilizing amount, and, wherein said stabilizer is a salt of an organic base or a salt of an inorganic acid.
A pharmaceutical composition comprising bupropion hydrochloride and a pharmaceutically acceptable stabilizer in an effective stabilizing amount, in which the stabilizer is selected from the group consisting of an organic base and a salt of an inorganic acid.
A pharmaceutical composition comprising bupropion hydrochloride and a pharmaceutically acceptable stabilizer in an effective stabilizing amount, in which the stabilizer is selected from the group consisting of an organic base and a salt of an inorganic acid, and in which at least about 80% of an initial potency of said bupropion hydrochloride in the composition is maintained after storage for one week at 60° C. and 75% relative humidity.
Dependencies are inferred from the claim text.