Generated: April 23, 2017
|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|
|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.
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.