| UPDATE | 07.00 |
| PATENT NUMBER | This data is not available for free |
| PATENT GRANT DATE | 11.07.00 |
| PATENT TITLE |
Composition for treating impotence in men containing dried roe and yohimbine |
| PATENT ABSTRACT |
A composition for treating impotence in human males contains a synergistic mixture of dried sturgeon roe and yohimbine hydrochloride wherein the weight percent ratio of said dried sturgeon roe:yohimbine hydrochloride is from about 25:1 to 1000:1, with an optimum ratio of about 132:1. The roe can be dried via either lyophilization or air drying under ambient temperature and pressure with reduced environmental humidity. A method of treating impotence in human males includes administration of such compositions containing the synergistic mixture of roe and yohimbine. Also, a method of treating impotence in human males by administration of dried roe in doses of from 300 to 900 mg. The roe is prepared either via lyophilization or air drying under ambient temperature and pressure with reduced environmental humidity. |
| PATENT INVENTORS | This data is not available for free |
| PATENT FILE DATE | 07.02.98 |
| PATENT REFERENCES CITED | This data is not available for free |
| PATENT PARENT CASE TEXT | This data is not available for free |
| PATENT CLAIMS |
What is claimed and desired to be protected by Letters Patent is set forth in the appended claims: 1. A composition for treating impotence in human males comprising a mixture of dried Sturgeon roe and yohimbine wherein the weight percent ratio of said dried roe:yohimbine is from about 25:1 to 1000:1. 2. The composition for treating impotence in human males as defined in claim 1, wherein the weight percent ratio of dried Sturgeon roe:yohimbine is from about 50:1 to 500:1. 3. The composition for treating impotence in human males as defined in claim 1, wherein the weight percent ratio of dried Sturgeon roe:yohimbine is from about 100:1 to 200:1. 4. The composition for treating impotence in human males as defined in claim 2, wherein the weight percent ratio of dried Sturgeon roe:yohimbine is about 132:1. 5. The composition for treating impotence in human males as defined in claim 1, wherein said yohimbine is yohimbine hydrochloride. 6. The composition for treating impotence in human males as defined in claim 4, wherein said yohimbine is yohimbine hydrochloride. 7. The composition for treating impotence in human males as defined in claim 1, wherein said mixture of dried Sturgeon roe and yohimbine is encased in a capsule for oral administration. 8. The composition for treating impotence in human males as defined in claim 7, wherein said capsule contains from about 300 to about 900 mg of said mixture of dried Sturgeon roe and yohimbine. 9. The composition for treating impotence in human males as defined in claim 4, wherein said mixture of dried Sturgeon roe and yohimbine is encased in a capsule for oral administration. 10. The composition for treating impotence in human males as defined in claim 9, wherein said capsule contains from about 300 to about 900 mg of said mixture of dried Sturgeon roe and yohimbine. 11. The composition for treating impotence in human males as defined in claim 10, wherein said capsule contains about 600 mg of said mixture of dried Sturgeon roe and yohimbine. 12. The composition for treating impotence in human males as defined in claim 1, wherein said dried Sturgeon roe is lyophilized roe. 13. The composition for treating impotence in human males as defined in claim 3, wherein said dried Sturgeon roe is lyophilized roe. 14. The composition for treating impotence in human males as defined in claim 10, wherein said dried Sturgeon roe is lyophilized roe. 15. The composition for treating impotence in human males as defined in claim 1, wherein said dried Sturgeon roe is ambient temperature and pressure-dried roe. 16. The composition for treating impotence in human males as defined in claim 3, wherein said dried Sturgeon roe is ambient temperature and pressure-dried roe. 17. The composition for treating impotence in human males as defined in claim 10, wherein said dried Sturgeon roe is ambient temperature and pressure-dried roe. 18. The composition for treating impotence in human males as defined in claim 10, further including a pharmaceutically acceptable preservative. 19. The composition for treating impotence in human males as defined in claim 1, further including one or more supplemental components selected from vitamins, minerals, plant extracts, flavoring agents and coloring agents. 20. A method of treating impotence in human males comprising administration to a male in need of such treatment an effective amount of the composition defined in claim 1. 21. A composition for treating impotence in human males comprising a mixture of dried lyophilized Sturgeon roe and yohimbine, wherein the weight percent ration of said dried roe:yohimbine is from about 25:1 to 1000:1, said roe having a moisture content of at least 30 weight percent, for inclusion in the composition, and prepared by: a) lyophilizing said roe by exposure to conditions including a temperature of -20.degree. C. or less and a pressure of 300 millitorr or less until the total moisture content of said roe is less than 5 weight percent; b) grinding said lyophilized roe to a powder; and c) adding to said lyophilized roe powder one or more preservatives selected from methyl paraben, propyl paraben, BHA and BHT. 22. A composition for treating impotence in human males comprising a mixture of dried Sturgeon roe and yohimbine, wherein the weight percent ration of said dried roe:yohimbine is from about 25:1 to 1000:1, said roe having a moisture content under 5 weight percent, for inclusion in the composition, and prepared by: a) spreading said roe in a thin layer in a tray; b) placing said tray into a closed environment with temperatures and humidity controls; c) maintaining said closed environment at about room temperature; d) periodically mixing and respreading said roe in layers in said tray; e) circulating air within said closed environment over said roe layers; f) gradually decreasing the humidity of said closed environment by removing moisture from the air in said environment, until the moisture content of said roe falls below 5 weight percent; g) removing said roe from said closed environment; h) grinding said roe to a powder; and i) adding to said roe powder one or more preservatives selected from methyl paraben, propyl paraben, BHA and BHT. -------------------------------------------------------------------------------- |
| PATENT DESCRIPTION |
BACKGROUND OF THE INVENTION 1. Field of the Invention The instant invention relates generally to a composition for treating impotence in men that relieves erectile dysfunction and enhances sexual desire, and specifically to a composition for treating impotence by using fish roe either alone or in combination with yohimbine. The invention relates also to methods of preparing fish roe for use as a pharmaceutical product to treat impotence and for incorporation into the compositions of the present invention. 2. Description of the Prior Art Therapies for treating impotence are known in the art. These include the compositions and treatment methods described below. Hormonal Treatments (Androgens) Testosterone and its derivatives are obtained only by prescription. They are administered orally or via injection, buccal tablets or other pharmaceutical dosage forms. The main use is for hypogonadism, male climactric and impotence. Testosterone also has other applications in medicine. As with other hormonal treatments, during administration of exogenous testosterone, endogenous testosterone release is inhibited through the negative feedback mechanism of pituitary lutenizing hormone (LH, or lutropin). Large doses of exogenous androgens may suppress spermatogenesis through a negative feedback response by inhibition of pituitary follicle stimulating hormone (FSH, or follitropin). This characteristically results in inadequate endogenous testosterone production once exogenous testosterone administration is discontinued. Testosterone and its derivatives have been used successfully to develop or to maintain sexual characteristics and other physiologic functions in androgen deficient males. However it is of no benefit to patients that are not androgen deficient as can be demonstrated by plasma testosterone levels. Yohimbine Yohimbine is an indolalkylamine alkaloid having the chemical formula C.sub.21 H.sub.26 O.sub.3 N.sub.2 and a molecular weight of 354.5. It is the principal alkaloid of the bark (yohimbehe) of the west African Corynanthe johimbe (Rubiaceae) tree. Other, informal names for yohimbine include quebrachine, methyl yohimbate and corynine. Yohimbine is primarily an a.sub.2 adrenergic blocker, i.e., it blocks presynaptic a.sub.2 adrenoreceptors causing release of norepinephrine. Its peripheral autonomic nervous system effect is to increase parasympathetic (cholinergic) activity and to decrease sympathetic (adrenergic) activity. In male sexual performance, erection is linked to cholinergic activity which theoretically results in increased penile blood inflow, decreased penile blood outflow, or both, causing erectile stimulation without increasing sexual desire (Drug Facts and Comparison, p. 731h, April 1995). Yohimbine has been successfully used to treat impotence in some patients, particularly those with conditions of vascular or diabetic origin. A typical effective dosage of yohimbine in such treatments is 18 mg/day. At such dosages, yohimbine is known to produce various side effects, for example, increased blood pressure and heart rate, paresthesias and others. These side effects make such dosages unsuitable for patients with renal disease, cardio-renal disorders, gastric or duodenal ulcerations, and for psychiatric and geriatric patients. Papaverine Papaverine injection is only available by prescription; generally it is not the treatment of choice for impotence patients. Papaverine has been used as an injection administered into the penis directly. Erection usually occurs within 5-15 minutes after injection. Papaverine injection causes pain and bruising at the site of injection. Persistent painful erection that occurs independently of sexual desire (priapism) is a side effect which often lasts from 5-7 hours causing embarrassment and discomfort to the patient. Fibrous growth in the penis tissue has also been reported. Caverject Caverject is a brand name marketed and available only by prescription. It is the synthetic version of alprostadil (prostaglandin E) which the body uses to help produce an erection. The medication is injected directly into the penis shortly before intercourse. It relaxes smooth muscle tissue in the penis which in turn enhances blood flow to the penis and causes erection. Caverject is often effective for men whose impotence is due to diabetic complications, anxiety or radical prostatectomy. One of the major drawbacks of caverject is that the subject, after injection, may have long lasting painful erection (priapism), which may last more than 6 hours and cause serious and permanent damage to the delicate spongy structure of the penis which may never again function properly. Penile Implants Penile implants, primarily made from silicone rubber, are surgically inserted in the shaft of the penis to make it sufficiently rigid for vaginal intercourse. Penile implant operations were first preformed in the 1960's and now some 30,000 men have the surgery each year. Penile implants come in different styles and sizes; semirigid, flexible rods or cylinders that are surgically inserted into both sides of the penis but do not get as hard as a natural erection. Men with this kind of implant have permanent enlargement (erection). Inflatable Implants Inflatable implants are another type of penile implant. They consist of twin cylinders connected to a pump and a fluid-filled reservoir. The cylinders are inserted in the penis, the pump concealed in the scrotum and the reservoir in the abdominal cavity. When the pump is squeezed, the fluid is forced out of the reservoir into the cylinders, causing an erection. When the pump is squeezed again, the fluid is released back into the reservoir, lowering the erection. Implants have their own drawbacks; they are uncomfortable, require surgery which may have serious complications, are very expensive, and not every man is a candidate for penile implantation. Most men look for less invasive remedies. In addition to the treatments described above, the following substances are often misconceived as sex stimulants. Marijuana Some people think marijuana use will cause sexual stimulation, however marijuana is more likely to be a sexual depressant and is also illegal to possess or use in many states. Alcohol Alcohol is also perceived as a sexual stimulant but is actually a sexual depressant and results in liver damage when consumed in quantity. Amyl Nitrate Amyl nitrate has been used (as an inhalant) because of its peripheral vasodilation effect which is perceived as a sexual stimulant, but actually is not. Its side effects are of serious concern, particularly in men and women with hypertension or over the age of 40. BRIEF SUMMARY OF THE INVENTION It is, therefore, an object of the present invention to provide a composition for treating impotence which will achieve positive effects on both the libido and the penile erectile function, both of which are necessary for optimal sexual performance. An additional object is to reinstate self-confidence in the patient by successfully treating his impotence. It is also an object of the present invention to provide a composition to treat impotence that is safe, effective, and easy to administer with minimal or no side effects. It is still a further object of the present invention to provide a composition for treating impotence that will overcome the shortcomings of the prior art through a more holistic approach that emphasizes the synergistic action of the two ingredients, lyophilized roe and yohimbine. It is yet a further object of the invention to provide a product that has a synergistic effect that will dramatically improve the sexual activity of the man. Another object is to provide a method for drying fresh roe for use in a composition for treating impotence by drying the roe either through lyophilization (freeze-drying) or by drying under ambient temperatures and pressures with reduced humidity; the dried roe can then be put into hard gelatin capsules for oral use to treat impotence or reduced sexuality in human male subjects, or the dried roe can be blended with yohimbine hydrochloride and that mixture packed in capsules for oral use. Yet another object is to provide a composition for treating impotence which contains a synergistic combination of about 99 weight percent dried fish roe and about 1 weight percent yohimbine HCl. A further object of the present invention is to provide a product composed of natural constituents that will serve the purpose of solving the dilemma of impotence without using harsh devices or causing any damage or serious side effects to the body. A final object is to provide a composition for treating impotence that is economical in cost both to the manufacturer and to the patient. The foregoing and other objects, advantages and characterizing features will become apparent from the following description of certain illustrative embodiments of the invention. The novel features which are considered characteristic for the invention are set forth in the appended claims. The invention itself, however, both as to its construction and its method of operation, together with additional objects and advantages thereof, will be best understood from the following description of the specific embodiments when read and understood in connection with the accompanying drawings. Attention is called to the fact, however, that the drawings are illustrative only, and that changes may be made in the specific construction illustrated and described within the scope of the appended claims. BRIEF DESCRIPTION OF THE DRAWING FIGURES Various other objects, features and attendant advantages of the present invention will become more fully appreciated as the same becomes better understood when considered in conjunction with the accompanying drawings, in which like reference characters designate the same or similar parts throughout the several views. FIG. 1 is a graphic representation of the lyophilization process of the present invention. FIG. 2 is representative example of a self-assessment form for use by the patient to monitor his sexual activity before and during the treatment process. |
| PATENT EXAMPLES | This data is not available for free |
| PATENT PHOTOCOPY | Available on request |
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