Organic compounds -- part of the class 532-570 series – Organic compounds – Amino nitrogen containing
Reexamination Certificate
2001-06-14
2002-10-08
Barts, Samuel (Department: 1621)
Organic compounds -- part of the class 532-570 series
Organic compounds
Amino nitrogen containing
C564S343000, C424S488000
Reexamination Certificate
active
06462237
ABSTRACT:
BACKGROUND OF INVENTION
1. Field of Invention
The present invention relates to a stabilized sustained-release pharmaceutical composition of bupropion hydrochloride containing an inclusion complex of bupropion hydrochloride with beta cyclodextrin. The invention also relates to the preparation of a stabilized sustained release pharmaceutical compositions of bupropion hydrochloride containing the inclusion complex of bupropion hydrochloride with beta cyclodextrin.
The invention further relates to a method for preventing the degradation of bupropion hydrochloride by making an inclusion complex with beta cyclodextrin, thus allowing the preparation of acceptable pharmaceutical compositions for sustained release tablets and capsules.
2. Description of Related Art
Bupropion hydrochloride is an antidepressant of the aminoketone class. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propane hydrochloride. Bupropion hydrochloride has been shown to decompose in variety of pharmaceutical compositions formulated without the use of stabilizer.
In the present application the term stabilizer means a composition which prevents the decomposition of bupropion hydrochloride.
It has been found that by making an inclusion complex of bupropion hydrochloride with beta cyclodextrin, improved stability of the bupropion hydrochloride results. Accordingly, pharmaceutical compositions of bupropion hydrochloride that contain an inclusion complex of bupropion hydrochloride with beta cyclodextrin will decompose more slowly and maintain their effectiveness for longer periods of time.
It is thus desirable to provide an inclusion complex of bupropion hydrochloride with beta cyclodextrin that improves the stability of the bupropion hydrochloride. It is also desirable to provide a method for preparing an inclusion complex of bupropion hydrochloride with beta cyclodextrin that improves the stability of the bupropion hydrochloride. It is further desirable to provide a stabilized sustained-release pharmaceutical composition of bupropion hydrochloride that contains an inclusion complex of bupropion hydrochloride with beta cyclodextrin. It is still further desirable to provide a method of preparing a stabilized sustained-release pharmaceutical composition of bupropion hydrochloride that contains an inclusion complex of bupropion hydrochloride with beta cyclodextrin.
BRIEF SUMMARY OF THE INVENTION
One aspect of the invention is to provide a method for preparing a composition of an inclusion complex of bupropion hydrochloride with beta cyclodextrin that stabilizes bupropion hydrochloride against degradation, is safe for use as a pharmaceutical composition, is efficient, economical and simple, and which is suitable for manufacture on a commercial scale.
Another aspect of the invention is to provide a method for preparing a stabilized sustained release pharmaceutical composition containing an inclusion complex of bupropion hydrochloride with beta cyclodextrin, which is safe for use as a pharmaceutical composition and stabilizes bupropion hydrochloride against degradation.
REFERENCES:
patent: 6383471 (2002-05-01), Chen et al.
Gidwani Suresh Kumar
Singnurkar Purushottam
Tewari Prashant Kumar
Barts Samuel
Gibbons Del Deo Dolan Griffinger & Vecchione
USV Limited
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