MXPA00000067A - Medicine containing yohimbine and arginine for treating erectile dysfunction - Google Patents

Medicine containing yohimbine and arginine for treating erectile dysfunction

Info

Publication number
MXPA00000067A
MXPA00000067A MXPA/A/2000/000067A MXPA00000067A MXPA00000067A MX PA00000067 A MXPA00000067 A MX PA00000067A MX PA00000067 A MXPA00000067 A MX PA00000067A MX PA00000067 A MXPA00000067 A MX PA00000067A
Authority
MX
Mexico
Prior art keywords
arginine
yohimbine
dose
drug
administration
Prior art date
Application number
MXPA/A/2000/000067A
Other languages
Spanish (es)
Inventor
Gorny Philippe
Original Assignee
Gorny Philippe
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Gorny Philippe filed Critical Gorny Philippe
Publication of MXPA00000067A publication Critical patent/MXPA00000067A/en

Links

Abstract

The invention concerns the use in combination of yohimbine and arginine as active ingredients for preparing a medicine for treating erectile dysfunction. The combination has a marked synergistic effect.

Description

DRUG FOR THE TREATMENT OF ERECTILE DYSFUNCTIONS DESCRIPTION OF THE INVENTION The invention relates to the use of yohimbine and arginine, in combination, in the preparation of a drug that is intended for the treatment of erectile dysfunction. The erection process is known as outlined schematically below. The erectile tissue of the penis, known as the corpus cavernosum, is a spongy tissue capable of being filled with blood. When at rest, the arteries of the penis are subject to adrenergic tone, which keeps them contracted, so that there is no blood flow to fill the corpus cavernosum. With a stimulus, the erectile nerves inhibit the adrenergic tone, the arteries of the penis dilate, and the corpus cavernosum is filled with blood, it grows, and the increased internal pressure causes it to become rigid. As it grows, it compresses the veins of the penis to prevent drainage of the blood it contains, which ensures that stiffness is maintained. After ejaculation, adrenaline is released locally again, and the blood flow of blood is immediately reduced, the pressure inside the cavernous body decreases, and the accumulated blood can be drained through the veins that are not already compressed, which it results in the loss of rigidity and returns to the resting state. It is known that a very significant proportion of men suffer from permanent or temporary erectile dysfunctions. These disorders may have an organic origin, in which case specific treatments adapted to each cause are required. However, a majority of non-organic erectile dysfunctions are observed, often of psychogenic origin. For these latter cases, several treatments are available. The cavernous intrabody injection of vasoactive substances is apt to give good results, but is not easily accepted by a significant proportion of patients. Oral treatments are generally better accepted. For this purpose, different products have been proposed which are often derived from plants: ginseng, ginger, yohimbine, cola nut, spirulina, ilang-ilang, chirivia, cinnamon, etc. Yohimbine is a substance extracted from the bark of Corynan the yohimbe. It has antagonistic properties with respect to the presynaptic alpha-2-adrenergic receptors. In other words, they inhibit the effects of adrenaline, and thus promote the supply of the corpus cavernosum with arterial blood. It has been proposed as a treatment for impotence of psychogenic origin. Certain studies published on this subject cite improvements in approximately 35 to 45% of cases treated with yohimbine, but these results have been disputed. In addition, several side effects have been observed, such as dizziness, anxiety, nervousness, migraines, insomnia, and elevated blood pressure, although for relatively high doses; see, for example, The Medical Letter, French Edition, Vol. 17, No. 2, 5-6 (ML USA No. 938), 1995. It is also proposed to administer L-arginine. The administration of arginine would have the effect of relaxing the arterial muscles of the cavernous body, relaxation which is necessary to obtain an erection. The administration of 2800 mg per day of L-arginine would have a positive effect on erectile dysfunction in approximately 40% of cases; see A. W. Zorgniotti and E. F. Lizza, Int. J. Impotence Res., 6, 33-36 (1994). It has now been discovered that in this domain, the combination of yohimbine and arginine has interesting properties. Indeed, tests have shown that the combination of arginine and yohimbine, due to a synergistic effect, provides positive results in the treatment of non-organic erectile dysfunctions, mainly using weaker doses of yohimbine than those previously used. The combination of yohimbine and arginine also allows a reduction in the dose of arginine used. In many cases, this combination seems to act quickly, and in this way, it can be used for the treatment of temporary erectile dysfunctions. Thus, the object of the invention is to use yohimbine and arginine in combination as the active ingredients in the preparation of a drug that is intended for the treatment of non-organic erectile dysfunctions. Yohimbine and arginine can be used in the form of a free base or in the form of pharmacologically acceptable salts. The active ingredients in the drug according to the invention can be presented separately, each in an appropriate pharmaceutical form, or combined in the same package. To facilitate the simultaneous administration of the active ingredients, however, it is generally preferred to prepare the drug according to the invention in a pharmaceutical form comprising both yohimbine and arginine.
The drug according to the invention can be prepared in a pharmaceutical form that allows the administration of a sufficient dose of yohimbine, notably a dose of 2 to 8 mg, particularly 2 to 6 mg per day, administered in one or two doses. This dose is calculated by the weight of yohimbine in free base form. The drug according to the invention is prepared in a pharmaceutical form that allows the administration of a sufficient dose of arginine, for example, a dose of 1 to 4 g per day, particularly 1 to 2 g per day, administered one or two times, so the dose is calculated by the weight of arginine as a free base. The drug according to the invention can be administered orally, sublingually, nasally, rectally, or cutaneously. For this purpose, it can be presented in any form that allows administration by mouth (particularly in the form of capsules, drinkable solutions, granules or tablets), by the nose (solutions to be administered in the form of drops or sprays), or by the rectum (suppositories) or through the skin (ointments or patches). These pharmaceutical forms are prepared in the customary manner and can comprise suitable excipients and conventional vehicles.
Yohimbine can be used in the form of a free base or in the form of a salt such as a hydrochloride. Arginine can be used in the form of a free base or in the form of an acceptable salt in pharmacology, such as a hydrochloride, glutamate, aspartate or citrate. The duration of treatment may vary, for example, from 2 to 4 weeks or more. It can also be considered episodic use. The following examples illustrate the invention.
EXAMPLE 1 A capsule was prepared consisting of a gelatin capsule comprising: - Arginine: 0.5 g. Yohimbine: 1 mg.
EXAMPLE 2 Double blind randomized trials were conducted with 42 adults, married men, aged 28 to 64, suffering from erectile dysfunction with no detectable organic cause. The treatment consisted of administering any of (21 cases) 4 capsules as described in Example 1 above (2 in the morning and 2 at night), or analogously (21 cases) a placebo (4 capsules of identical appearance but containing only 0.5 g of lactose). The people participating in the trial as well as the people who supplied the test compounds did not know which of them received or supplied the combination of yohimbine + arginine or placebo. 2 weeks later, participants in the trial were questioned to see if they had noticed an improvement in erectile function. An evaluation of the results allows to draw the following conclusions: -between the subjects suffering from temporary erectile dysfunction (22 cases), 12 received the placebo, 7 cases reported improvements with the combination being tested and 4 cases with the placebo; -between subjects suffering from chronic erectile dysfunction (20 cases), 9 received placebo, 4 cases reported improvements with the combination being tested and 1 case with placebo.
It is noted that in relation to this date, the best method known to the applicant to carry out the aforementioned invention, is that which is clear from the present description of the invention.

Claims (11)

i CLAIMS Having described the invention as above, the content of the following claims is claimed as property:
1. The use, in combination, of yohimbine and arginine as active ingredients in the preparation of a drug that is intended for the treatment of erectile dysfunction.
2. The use according to claim 1, wherein yohimbine and / or arginine are used in the form of a free base or in the form of a salt.
3. The use according to claim 1, wherein the drug is prepared in a pharmaceutical form that allows simultaneous administration of the active ingredients.
4. The use according to any of the preceding claims characterized in that the drug is prepared in a pharmaceutical form that allows the administration of a dose of 2 to 8 mg of yohimbine, administered in one or two doses, so the dose is calculated by the weight of yohimbine in free base form.
5. The use according to any of the preceding claims characterized in that the Me. The drug is prepared in a pharmaceutical form that allows the administration of a dose of 1 to 4 g, particularly 1 to 2 g, of arginine, administered in one or two doses, whereby the dose is calculated by the weight of the arginine. in the form of a free base.
6. The drug is intended to treat erectile dysfunctions, characterized in that it contains arginine in free form or salt and yohimbine in free or salt form as active ingredients.
7. The drug according to the preceding claim, characterized in that it contains the active ingredients separately, in one and the same package.
8. The drug according to claim 6, characterized in that it is presented in a single pharmaceutical form containing the two active ingredients.
The drug according to any of claims 6 to 8, characterized in that it is presented in a pharmaceutical form that allows the administration of a dose of 2 to 8 mg, particularly 2 to 6 mg of yohimbine administered in one or two doses , so the dose is calculated by the weight of yohimbine in free base form.
10. The drug according to any of claims 6 to 9, characterized in that it is presented in a pharmaceutical form that allows the administration of a dose of 1 to 4 g, particularly 1 to 2 g, of arginine, administered in one or two doses , so the dose is calculated by the weight of arginine in free base form.
11. The drug according to any of claims 6 to 10, characterized in that it is presented in the form of capsules, drinkable solutions, granules, tablets, ointments, patches, suppositories or nasal solutions to be administered in the form of drops or sprays.
MXPA/A/2000/000067A 1997-07-04 2000-01-03 Medicine containing yohimbine and arginine for treating erectile dysfunction MXPA00000067A (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
FR97/08504 1997-07-04

Publications (1)

Publication Number Publication Date
MXPA00000067A true MXPA00000067A (en) 2001-11-21

Family

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