Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Ketone doai
Patent
1993-03-08
1995-06-06
Henley, III, Raymond
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Ketone doai
514675, 514678, A61K 3112
Patent
active
054223741
DESCRIPTION:
BRIEF SUMMARY
This application is a 371 of PCT/JP90/00947 filed July 25, 1990.
TECHNICAL FIELD
This invention relates to pharmaceutical compositions for the treatment of sleep apnea.
BACKGROUND ART
Sleep apnea is a disease in which apnea occurs during sleep without subjective symptom. It is more prevailing in male middle- and old-aged persons in their forties and fifties and approximately one per 100 persons is reported to suffer from the disease. In the disease there is repeated many times in sleep a sequence of 20-40 second's apnea, about 10 second's pneusis and 20-40 second's apnea. For example, approximately 400. occurrences of apnea during a 6.5-hour sleep, corresponding to a total apneic time of approximately 4 hours are observed. As a result, there occur phenomena such as daytime sleepiness to cause a trouble in driving or working, and when conditions are severer, loss of energy or appetite, swelling in the lower part of body and shortness of breath. Increase in leucocyte number, development of polycythemia and even cardiomegaly are then associated. Furthermore, decrease in oxygen concentration in blood is induced, which can be a cause of sudden death. The disease are observed not only in adults of middle or advanced age but also in infants, and may be an indirect cause of hypertension, cardiac insufficiency and arrhythmia.
Therapy currently adopted for the disease include bodyweight reduction (the frequency in obese people is as high as 83%), pressure application through the nose (CPAP), surgical operation (tonsillectomy or adenoidectomy) and use of a drug such as acetazolamide. Although drug administration is the simplest treatment among them, there have been found no effective drugs currently in use.
DISCLOSURE OF THE INVENTION
As a result of extensive studies on drugs for the treatment of sleep apnea, we have discovered pharmaceutical compositions which are capable of producing excellent results.
Thus the invention relates to a therapeutic agent for sleep apnea which comprises a pharmaceutical composition containing an effective amount of ubidecarenone and pharmaceutical carriers.
The active ingredient for the present invention, ubidecarenone, which is also called coenzyme Q.sub.10, is a constituent of the mitochondrial lipids in cells and is reported to participate in oxidation-reduction reactions as a constituent in the ATP production-conjugating electron transport system. Because of less adverse reactions, it is now in wide use as a myocardial activator for the improvement of symptoms associated with slight or moderate congestive heart failure and is under basic therapy (edema, pulmonary congestion, hepatic swelling and angina pectoris).
The pharmaceutical compositions of the invention are prepared by combining ubidecarenone with appropriate pharmaceutical carriers (including conventional pharmaceutical adjuvants such as diluent, binder, filler, disintegrating agent, flavor, colorant, lubricant or preservative).
The compositions are preferably formulated to a unit dosage form and made an adequate form for medical use.
A dosage of ubidecarenone depends upon conditions of the patient. It also depends particularly upon patient's capacity in absorbability of the drug, as well as frequency and route of administration.
Ubidecarenone is formulated so as to be administered by any route. For example, it is in the form for oral or rectal administration. If desired, it may be designed for a formulation sustained-releasing ubidecarenone.
The composition may be, for example, in the form of tablets, capsules, packs, powders, granules, troches or suppositories.
For example, the composition preferable for oral administration may contain conventional additives such as binder (e.g., syrup, gum arabic, gelatin, sorbitol, tragacanth or polyvinylpyrrolidone); filler (e.g. lactose, sucrose, corn starch, calcium phosphate, sorbitol or glycerin); disintegrating agent (e.g. starch, polyvinylpyrrolidone, sodium starch glycolate or microcrystalline cellulose); lubricant for tableting (e.g. magnesium stearate) or pharmaceuti
REFERENCES:
patent: 4599232 (1986-07-01), Bertelli
patent: 4684520 (1987-08-01), Bertelli
patent: 4751241 (1988-06-01), Motoyama et al.
patent: 4778798 (1988-10-01), Brasey
Chemical abstracts 88(25): 183027y, 1977, (Pichugin et al.).
"The Merck Index" (11th Ed.), Budavari et al. (Eds.), Merck and Co., Inc., Rahway, N.J., 1989, p. 1549.
European Neurology, 28(2), 1988, Tatsumi, C. et al: "Mitochondrial Encephalomyopathy with Sleep Apnea", pp. 64-69.
Patent Abstracts of Japan, No. 14459 (C-0767), Oct. 4, 1990, JP-A-21 88 523, Jul. 24, 1990.
Miyao Kouhei
Miyao Setsuko
Nishimura Tateo
Henley III Raymond
Moezie M.
Nisshin Flour Milling Co. Ltd.
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