Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...
Patent
1997-09-19
1999-05-25
Goldberg, Jerome D.
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Having -c-, wherein x is chalcogen, bonded directly to...
A61K 31335
Patent
active
059069937
DESCRIPTION:
BRIEF SUMMARY
furane-2(1H)-one is a natural bicyclic terpenoid which is found for example in tobacco. II. Kaneko, Agr. Biol. Chem. 35(9): 1461 (1971). (+) Sclareolide has the following structure: ##STR1##
(+) Sclareolide is known for increasing or developing the organoleptic properties of food products. See for example U.S. Pat. Nos. 4,917,913; 4,960,603; 4,966,783; 4,988,527; and 4,999,207. This compound was used as a perfume for cigarettes (Japanese Patent No. 60,123,483) and as an additive to eliminate the bitter taste of coffee (U.S. Pat. No. 4,988,532).
However, to the filer's knowledge, (+) sclareolide has never been used or presented as a pharmacologically active compound.
The present invention relates to a method for inhibiting a disease characterized by excessive proliferation of cells in a patient (for example, a mammal such as man) including the administration to the patient of a therapeutically effective quantity of (+) sclareolide.
In one configuration, the patient is suffering from a disease associated with excessive proliferation of benign cells (i.e. non-malignant). Examples of such diseases are fibrosis, benign prostate hyperplasia, atherosclerosis, restenosis, glomulerosclerosis, cheloid, psoriasis, and other diseases of the skin and non-malignant neoplastic diseases.
In another configuration, the patient is suffering from a disease associated with an excessive proliferation of malignant cells (for example, cancer). Examples of such diseases are adenomas, carcinomas, cancers found in the prostate, the lungs, the liver, the pancreas, the brain, the breast, and the skin, as well as leukemia.
The therapeutically effective quantity depends upon the condition treated and the route of administration chosen, as well as the specific activity of the compound used and will be decided finally by the attending physician or veterinarian. (.vertline.) Sclareolide is administered in quantities of 0.1 to 500 mg/kg of body weight (for example, 1 to 100 mg/kg of body weight).
While it is possible to administer (+) sclareolide in the form of a pure or substantially pure compound, this product may also be presented in the form of a formula, a preparation, or a pharmaceutical composition. The formulas to be used in the present invention, both for human beings and animals, include the (+) sclareolide associated with one or more acceptable pharmaceutical vehicles of the latter and optionally other therapeutic agents. The vehicle must be "acceptable," i.e. compatible with the active ingredient(s) of the formula and not noxious to the subject to be treated.
Formulas may be conveniently presented in the form of a single dosage and may be prepared by any of the well known methods in the art of pharmacy. All methods include the phase comprising of bringing (+) sclareolide into an association with a vehicle which may contain one or more auxiliary agents. In general, compositions intended for the manufacture of tablets (for example for oral administration) or of powders are prepared by thorough and uniform mixing of (+) sclareolide with the finely divided solid vehicles, followed if necessary, as in the case of tablets, by placing the product into a mold to give it the desired size and shape.
Compositions suitable for parenteral administration (for example, subcutaneous, intravenous, or intramuscular) moreover include conveniently sterile aqueous solutions in which the (+) sclareolide is soluble. Preferably the solutions are isotonic with the blood of the subject to be treated. These compositions may be conveniently prepared by dissolving the (+) sclareolide in an aqueous solution of this type, said solution subsequently being rendered sterile. The composition may be presented in single or multiple dose containers, for example sealed vials.
Consequently the invention likewise relates to pharmaceutical compositions including as an active substance (+) sclareolide in association with one or more acceptable pharmaceutical vehicles.
Another subject matter of the invention comprises claiming the use of (+) sclareolide for the preparatio
REFERENCES:
Okamoto et al, "Inhibition of . . . Related Compounds", Cancer Letters, vol. 21, No. 1, 1983, pp. 29-35.
Bigg Denis
Braquet Pierre
Goldberg Jerome D.
Societe de Conseils de Recherches et d'Applications Scientifique
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