.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Claims for Patent: 5,358,970

« Back to Dashboard

Claims for Patent: 5,358,970

Title: Pharmaceutical composition containing bupropion hydrochloride and a stabilizer
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; Sanyasi R. (Edison, NJ), Sutton, Jr.; Joel E. (Greenville, NC)
Assignee: Burroughs Wellcome Co. (Research Triangle Park, NC)
Application Number:08/105,437
Patent Claims: 1. 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.

2. The composition of claim 1 in the form of a tablet or a capsule comprising bupropion hydrochloride and inactive ingredients wherein the weight of bupropion hydrochloride in the tablet or capsule is Y and the amount of inactive ingredients is greater than about 50% of Y and less than about 400% of Y.

3. The tablet of claim 2 in which the amount of bupropion hydrochloride in the tablet or capsule is 25 to 500 mg.

4. The tablet or capsule of claim 2 in which the amount of bupropion hydrochloride in the tablet is 50, 75, 100 or 150 mg.

5. The composition of claim 1 in the form of a tablet containing 25 to 300 mg of bupropion hydrochloride.

6. The composition of claims 1, 2, 3, 4, or 8 in which the amount of the stabilizer is 2.7% to 27% of the weight of bupropion hydrochloride in the composition.

7. The composition of claims 1, 2, 3, 4, or 8 in which the amount of stabilizer is 5% to 16.2% of the weight of bupropion hydrochloride in the composition.

8. 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.

9. The method of claim 8 in which said amount of stabilizer is about 5% to about 16.2%.

10. The method of claim 7 or 8 in which the stabilizer is cysteine hydrochloride in the L form.

11. The method of claim 7 or 8 in which the stabilizer is glycine hydrochloride.

12. The composition of claim 1 in which the stabilizer is L-cystsine hydrochloride.

13. The composition of claim 2 in which the stabilizer is L-cystsine hydrochloride.

14. The composition of claim 3 in which the stabilizer is L-cystsine hydrochloride.

15. The composition of claim 4 in which the stabilizer is L-cystsine hydrochloride.

16. The composition of claim 14 in which the amount of stabilizer is 2.7% to 27% of the weight of bupropion hydrochloride in the composition.

17. The composition of claim 16 in which the amount of stabilizer is 5% to 16.2 of the weight of bupropion hydrochloride in the composition.
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

`abc