Method of promoting smoking cessation

Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...

Reexamination Certificate

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C514S813000, C514S958000, C548S486000, C548S493000, C206S569000

Reexamination Certificate

active

06218421

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to a method for smoking cessation treatment, and especially to the use of ropinirole in such treatment.
BACKGROUND OF THE INVENTION
Pharmaceutical products with antihypertensive and anti-anginal properties are described in U.S. Pat. No. 4,452,808 and U.S. Pat. No. 4,588,740. An especially important compound among those disclosed is 4-[2-(di-n-propylamino)ethyl]-1,3-dihydro-2H-indolin-2-one hydlochlorid (ropinirole). This compound has also been found to be a potent CNS active non-ergot dopamine receptor agonist (see U.S. Pat. No. 4,824,860 and U.S. Pat. No. 4,912,126). The hydrochloride salt of ropinirole is approved for human use in therapy to treat Parkinson's disease.
Processes for the production of ropinirole hydrochloride are disclosed in U.S. Pat. No. 4,997,954 and U.S. Pat. No. 5,336,781.
Bromocriptine, another anti-Parkinson's drug, has been proposed for use in controlling tobacco use (see U.S. Pat. No. 4,800,204). Bromocriptine, however is an ergot alkaloid and has a number of well known side effects.
OBJECTS OF THE INVENTION
An object of the present invention is to provide an improved method of treating smoking addiction.
Another object of the present invention is to provide a method of smoking cessation treatment which avoids the administration of an ergot alkaloid.
It has been surprisingly discovered that ropinirole has potential therapeutic utility as a medicament for smoking cessation treatment.
SUMMARY OF THE INVENTION
Accordingly, the present invention provides a method for promoting smoking cessation, which method comprises administering an effective, non-toxic amount of ropinirole or a pharmaceutically acceptable salt or solvate thereof, to an human in need thereof.
The present invention also provides the use of ropinirole or a pharmaceutically acceptable salt or solvate thereof in the manufacture of a medicament for use in smoking cessation treatment.
Ropinirole used in the present invention is suitably in the form of the free base or a pharmaceutically acceptable salt thereof. A preferred pharmaceutically acceptable salt of ropinirole is crystalline hydrochloride. Suitable procedures for preparing ropinirole hydrochloride include those mentioned in U.S. Pat. No. 4,997,954, and preferably those mentioned in U.S. Pat. No. 5,336,781.
A medicament for use in smoking cessation treatment may be prepared by a mixture of ropinirole or a pharmaceutically acceptable salt or solvate thereof with an appropriate carrier, which may contain a diluent, binder, filler, disintegrant, flavouring agent, colouring agent, lubricant or preservative in conventional manner.
Preferably, the medicament is in unit dosage form. For example, such preparations may be in a pack form accompanied by written or printed instructions for use as a smoking cessation treatment.
The suitable dosage range for ropinirole or a pharmaceutically acceptable salt or solvate depends on the severity of the smoking disorders and on the condition of the patient. It will also depend, inter alia, upon the relation of potency to absorbability and the frequency and route of administration.
Typically the human in need of treatment in accordance with this invention will not be suffering from Parkinson's disease and/or will not be receiving treatment for Parkinson's disease using ropinirole.


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patent: 4452808 (1984-06-01), Gallagher
patent: 4575510 (1986-03-01), Sjoerdsma
patent: 4588740 (1986-05-01), Gallagher
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patent: 4824860 (1989-04-01), Owen
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patent: 4997954 (1991-03-01), Fortunak
patent: 5039680 (1991-08-01), Imperato et al.
patent: 5204340 (1993-04-01), Flaugh et al.
patent: 5336781 (1994-08-01), Giles et al.
patent: 5747512 (1998-05-01), Keenan et al.

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