Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...
Patent
1997-11-17
1999-05-11
Krass, Frederick
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Having -c-, wherein x is chalcogen, bonded directly to...
514455, 514810, 514811, 514812, A61K31/35;35/78
Patent
active
059028238
DESCRIPTION:
BRIEF SUMMARY
BACKGROUND OF THE INVENTION
The present invention relates to pharmaceutical compositions for the treatment of alcohol addiction, characterized in that they contain--as the active principle--forskolin or extracts containing it.
Alcohol abuse and alcohol addiction, phenomena which can be collectively referred to by the term alcoholism, represent a serious problem for the whole of modern society (Gessa G. L., Bisogno compulsivo di bere e II, 5 (1994)). In Italy, for example, more than 9% of the population (about 5 million people) are heavy drinkers and more than 1 million people are alcohol-addict (Calamo-Specchia F. P.--Epidemiologia dell'alcolismo in S.I.A.! Mediserve, Rome, 295-301, (1991)). These figures become much higher if we consider countries such as the United States of America where there are more than 13 million alcohol-addicts. Alcohol abuse and actual alcohol addiction result in an enormous outlay of public money (recently, since 1991, in the United States about 200 thousand million dollars a year have been spent) and are the cause of enormous social and psychological damage for the individuals involved.
The existing approaches for the treatment of alcoholism, in addition to those of a psychological nature (group therapy, etc.), consist in the use of drugs such as disulfiram and calcium carbamide which act on the metabolism of alcohol, inhibiting hepatic aldehyde-dehydrogenase and therefore raising the hematic levels of acetaldehyde, with all the undesiderable phenomena which occur each time ethanol is taken.
According to the present state of the art, the sole plant whose derivatives have been used for the treatment of alcoholism is the Pueraria lobata (Radix puerarie), which is widely used in traditional Chinese medicine and forms the subject of Patent Application WO 93/00896.
SUMMARY OF THE INVENTION
It has now been surprisingly found that forskolin can be used with success for reducing the voluntary consumption of alcohol and other drugs which induce addiction.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1(a) and 1(b) is a graph showing the effect of treatment on alcohol and water consumption.
DETAILED DESCRIPTION OF THE INVENTION
Forskolin, i.e. 17-.beta.-acetoxy-8,13-epoxy-1.alpha., 6.beta., 9.alpha.-trihydroxylabd-14-en-11-one, of formula: ##STR1## is a diterpenoid isolated from the plant Coleus forskohlii, native to India, which is capable of activating adenylate cyclase.
Its pharmacological activity is described by De Souza and Shah in Economic and Medicinal Plant Research vol. 2, H. Wagner, H. Hihino and N. Farusuworth ed., Academic Press. 1988.
The uses of forskolin in the treatment of cardiocirculatory and respiratory diseases and of glaucoma are known; for a review see, for example, the above cited reference; Seamon and Daly, Adv. Cyclic Nucleotide Res. 20, 1.
Determination of the inhibiting action on alcohol consumption was performed using alcohol-consuming rats of the strain called "Sardinian alcohol-preferring" (Sp) (Fadda P., Mosca E., Colombo G., Gessa G. L., Alcohol--preferrinq rats: Genetic sensitivity to alcohol--induced stimulation of dopamine metabolism, in Physiol. Behav. 47, 727 (1990)).
These animals, which given a free choice between alcohol and water consume daily 6 to 7 g of alcohol per kg of body weight (with a water-to-alcohol ratio higher than 2:1), during the last few years have been used with success to determine the effect of various substances on the voluntary consumption of alcohol; see, for example, Balakleevsky A., Colombo G., Fadda F., Gessa G. L., Ro 19-4603, a benzodiazepine receptor inverse agonist, attenuates voluntary ethanol consumption in rats selectively bred for hiah ethanol preference, in Alcohol Alcohol. 25, 449-452 (1990); Fadda F., Garau B., Colombo G., Gessa G. L., Isradipine and other calcium channel antagonists attenuate ethanol consumption in ethanol--preferring rats, in Alcoholism: Clinical and Experimental Research 16(3), 449-452 (1992).
The animals, which were kept under normal housing conditions, were given a free choice between wa
REFERENCES:
patent: 4120975 (1978-10-01), Orr et al.
patent: 4782082 (1988-11-01), Kreutner et al.
patent: 5366990 (1994-11-01), Reid
patent: 5371104 (1994-12-01), Feigenbaum
Szabo et al., Forskolin Promotes the Development of Ethanol Tolerance in 6-Hydroxydopamine-Treated Mice, Life Science, vol. 42, pp. 615-621 (1988).
Bombardelli Ezio
Morazzoni Paolo
Indena S.p.A.
Krass Frederick
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