Method of obtaining a pharmaceutic for prevention of sexual diseases

The present invention relates to a method for the prevention of sexually transmitted diseases such as AIDS and the following abbreviated MST.

MST diseases (diseases transmitted through sexual contact) are most often caused by viruses, bacteria, parasitic organisms and fungi. Against the development of these diseases, so far there is no preventive measure, sufficiently effective and suitable to be offered as an alternative to the use of condoms, which are however known to be imperfect and inconvenient.

In fact, it is known that various chemicals have some effectiveness against the germs that cause MST. Among the agents most commonly used, dimethylalkyl benzalkonium chloride or benzalkonium chloride and nonylphenol polyoxyethylene or nonoxynol 9 may be mentioned. However, these products only show relative efficacy in the sense that on the one hand their scope of action is narrow, since they only cover a few germs that cause MST, and on the other hand, the period of time required for their action is long and therefore not. acceptable as it is about preventing MST.

It is known, for example, that infection with the AIDS virus can occur from the first minutes of its contact with healthy mucous membranes. On the other hand, inactivation of this virus by benzalkonium chloride at a concentration of 1% occurs after at least 10 minutes of contact, making the possibility of infection extremely high and unacceptable in practice. Consequently, the use of known products does not allow effective prevention of MST, even when they have virucidal properties.

It is known from European Patent No. 113,998 that the deoxycholic and principal dehydrocholic acid derivatives of cholic acid can be used in the treatment of viral infections caused by the Herpes Simplex I or Π virus.

However, in that case it is a curative and not a preventive action, and the object of the present invention is to provide a method of prevention. The line between treatment and prevention is not always very clear, but an understanding of the difference between the two modes of action is justified here, since it is the choice of one or the other that determines the pharmaceutical agent to be used, the method of treatment, the form of the drug, the route of administration, as well as its scope. use.

Contrary to the preventive action which concerns healthy individuals, the therapeutic treatment described in European Patent No. 113,998 produces effects on already infected individuals. In this case, the infection is visible or at least detectable and consequently too well developed for the disease to be remedied by the drug. It is therefore possible to define in great detail the sites infected with the Herpes Simplex I or II virus to which treatment should be applied, if local treatment is carried out.

As a result, two modes of administration are envisaged: parenterally or by local action in the sense of a highly localized action at a specific site at which the infection occurs.

In the present invention, topical administration means the application of a pharmaceutical agent not only to a zone delimited by possible infection, but on the contrary to a large area, often complex and always indefinite, since the infection to be prevented is consequently not localized. Thus, the term local action, used in the case of therapy and also in EP 113,998 (treatment of a well-defined area already affected), should not be equated with the same expression as used here for prevention, the meaning of which, as indicated above, is completely different.

Moreover, in the prevention of MST, the topical route is valued more than the parenteral route because of the presence of certain compounds that are necessary to produce true efficacy but which should not be introduced into the body. Indeed, they can become toxic when absorbed in high doses and then metabolized by the body.

Finally, it should be noted that in EP 113,998, only the action against Herpes Simplex I and II is described, while the present invention relates to the prevention of a broad spectrum of viruses that cause MST, the main strains of which are for example:

- genital herpes viruses (Herpes genital I and Π).

- AIDS HIV I and HIV Π viruses,

- hepatitis B virus,

- papillomasvirus (HPV), (multiple papilloma).

To achieve the aim, the present invention implies the protection of large complex zones. Well, the indications in European Patent No. 113,998 do not impose on the skilled person the use of one of the cholic acid derivatives:

- on the one hand, for an effective preventive action during several hours, which requires the application of a pharmaceutical, uniformly and sufficiently to an area with undefined limits, either healthy, but susceptible to infection, or affected, and therefore capable of infecting the partner,

- on the other hand, for a broad spectrum of the virus which corresponds to various symptoms such as that of Herpes Simplex, and therefore of a much more general extent.

GB 1,161,484 describes disinfectants and deodorants for women. These agents are in the form of aerosol foams and contain bactericides and softeners. Certain silicone products are mentioned among the softeners, however, these are oily products which cannot act as dispersants. In contrast, the present invention uses silicone substances having film-forming and dispersing properties, which is a necessary condition for producing a barrier effect, which is the most important feature of the present invention. Conversely, the agents described in GB 1,161,484 create a particularly effective contact between the skin or mucosa and the bactericidal substance, as stated on page 1, 41-45 of the above description. The above description of GB1 161 484 does not suggest a barrier effect, nor does it concern agents intended for the prevention of sexually transmitted diseases.

The most important advantage and advantage of the method according to the invention is the possibility of producing an agent that allows the production of a barrier film that prevents the penetration of both active substances (which allows time for their action on viruses) and pathogenic viruses to pass through the mucosa. This is also very important when the composition contains ingredients known to be toxic, such as, for example, nonoxynol-9 or benzalkonium chloride. The barrier (isolating) effect also allows the use of smaller amounts of these components, since the presence of the barrier film reduces their migration. Thus, the present invention relates to a method for obtaining a pharmaceutical composition containing one or more active substances effective for the prevention of MST.

The invention also relates to a method of producing a pharmaceutical which allows the protection by topical application of high-risk zones such as that of a woman's vagina. The vagina is a mucosa which by its nature facilitates the passage of a substance also well by emitting it to the outside of itself as well as by absorption into the body. Well, for effective prevention of MST, one or more active substances should not be absorbed by the organism, especially through the vaginal mucosa.

In fact, until now, certain substances could not be used for effective prevention because these substances rapidly diffuse into the body.

This problem is solved by the present invention. The present invention relates to a method for the preparation of a pharmaceutical for the prevention of sexually transmitted diseases (MSTs) for application to the vaginal mucosa, wherein at least one salt of cholic acid active against the viruses or bacteria causing said MSTs is treated with compounds from the group of silicones, having film-forming and dispersing properties, whereby the compound from the group of silicones is used in the form of an emulsion and in an amount effective to inhibit said active substance through the mucosa, and then the obtained product is combined with a pharmaceutically acceptable base, after which the obtained product in the form of a gel is disintegrated, and then a tampon is placed thereon vaginal, which is allowed to allow the gel to penetrate into the tampon by capillary action.

The compound from the group of silicones is preferably dimethyl polysiloxane, in particular in an amount of about 3.5% by weight. Preferably a salt of cholic acid such as sodium cholate is used as the active ingredient.

Cholic acid is known to be a natural component of bile and is currently used in therapy, as well as its pharmaceutically acceptable salts, as a bile yield agent.

It is known from European Patent Application No. 285,285 to use a dispersant, presented in this document as the only agent capable of lowering the interfacial tension in an aqueous medium, in combination with a cholic acid derivative, for the treatment of viral infections.

Knowing that the virus consumes the proteins of the cell on which it parasites the formation of an envelope around the nucleic acid chain (DNA or RNA), the anti-viral effect of the dispersant postulated in European Patent Application No. 285,285 is the rupture of the viral envelope, which cannot overcome other cells is thus destroyed.

It is important to specify here that the dispersing agent, the action of which is described above, is part of a pharmaceutical to be administered parenterally. The pharmaceutical containing the dispersant in question is injected directly into the bloodstream.

The action of the dispersing agent in combination with one or more of the active ingredients of the agent of the invention is quite different. This factor has no direct effect on viruses, contrary to what is described in the above patent application.

The agent obtained in the process of the invention is intended for topical application, contrary to the methods of administration (parenteral and oral route) described in European Patent Application No. 285,285.

It should be noted that in the process of the invention, the amount of the film former is very important compared to the amounts of the active ingredient. This is due to the fact that the aim is to create a film not only of the entire extent of the surface to be protected (which is large in the case of the vaginal mucosa), but also of an appropriate compactness so as to obtain a passive isolating effect as effective as possible to achieve two goals. :

- reducing (but it is desirable to completely prevent) the risk of transmission of pathogens both originating from the mucosa and targeting the mucosa,

- avoiding absorption by the mucosa of the active ingredients attached to the membrane, thus keeping the active ingredients in place where their local action is necessary.

This amount may advantageously be increased rather than decreased because the film-forming effect tends to increase with concentration.

An acceptable pharmaceutical medium that meets the objectives of the invention is a classic vehicle that is adapted to the topical administration of the resulting agent. For the protection of the vaginal mucosa, the carrier must be suitable for internal use and prolonged action. Most preferably, one skilled in the art will select an aqueous base that provides adhesion and dilution with natural fluids.

To advantageously carry out the process of the invention, a buffering agent such as hydrochloric acid may be added to adjust the pH to 4.7. This value saves the vaginal flora and the Doederlein bacilli ^ It is very important not to destroy the Doederlein bacilli as it has a protective effect against infections of the reproductive organs. Therefore, it is necessary to protect it.

The method according to the invention makes it possible to obtain a pharmaceutical agent that can be in the form of solutions (vaginal irrigations, creams or gels). One skilled in the art will select a pharmaceutically acceptable vehicle suited to the formulation. The choice of form under which the agent of the invention appears is related to the method of use.

The agent should also have a specific viscosity, adapted to the way in which it is used.

To complete the process according to the invention, a thickening agent is added in order to obtain a suitable rheological behavior. Among the classic thickeners, a preferred compound for the purposes of the invention is hydroxypropyl methylcellulose, manufactured under the trade name Metholose 60 SH 4000 by ŚEPPIC. This thickener makes it possible to adjust the density to a degree more suited to the form of the agent (solution, cream, gel, etc.). The viscosity thus obtained does not change much as the pH of the composition changes during its preparation.

The significance of this factor will be explained below.

Thus, the dosages applied to the compounds used in the process according to the invention are shown in Table I:

TABLE I

- 0.25 to 1% by weight of sodium cholate

- 10% by weight solution containing 35% by weight of dimethyl polysiloxane

- 4% by weight of hydroxypropyl methylcellulose

- hydrochloric acid: quantity needed to obtain a pH = 4.7

- water: make-up quantity up to 100%.

According to the method of the invention, several active ingredients are combined to enhance the action of sodium cholate, especially against certain bacteria.

Furthermore, one or more virucidal and bactericidal agents which additionally have spermicidal properties, in addition to sodium cholate and a dispersing film former, can be incorporated into the method of the invention. Among these virucidal, bactericidal and spermicidal agents, benzalkonium chloride and nonoxynol 9 are most preferably selected.

It should be noted here that nonoxynol-9 may show some toxicity when it penetrates the body in high doses due to significant accumulation in the kidneys. Moreover, its ability to pass through the vaginal mucosa increases by approximately 80%. Well, the use of nonoxyl-9 in the process according to the invention is completely possible and without risk due to the presence of an insulating membrane formed by the film-forming agent introduced into this process, which is an inhibitor that opposes the penetration of this active ingredient into the body.

The amounts of the benzalkonium chloride of nonoxynol 9 used are preferably from 0.5 to 1% by weight, based on the total weight of the compounds used.

Preferred proportions which meet the particular purposes of the invention are indicated in the following table II:

TABLE Π

0.25 to 1% by weight of sodium cholate

- 0.50 to 1% by weight of benzalkonium chloride

- 0.25 to 1% by weight of nonoxynol 9

- 10% by weight solution containing 35% by weight of dimethyl polysiloxane

- 4% by weight of hydroxypropyl methylcellulose

- hydrochloric acid: amount required to adjust the pH to 4.7

- water: make-up quantity up to 100%.

The method according to the invention, carried out in accordance with the proportions of ingredients given in table 1, makes it possible to prepare a pharmaceutical agent especially suited to the prevention of MST due to the specific value of this agent. It allows for very effective protection.

Indeed, its action is virucidal, spermicidal and bactericidal at the same time. It thus effectively inactivates viruses that cause MST, among which the following may be mentioned:

- Staphylococus Aureus

- Candida Albicanus

- Streptococus Agalactiae

- Neisseria Gonorrhoeae

- Gamella Vaginalis

- Trichomonas Yaginalis

The three active ingredients, used together in the process of the invention, are shown in Table II, they act in a complementary manner and have a very broad spectrum of activity. One can cite as an example the effective action of nonoxylone 9 on Chlamidia Trachomatis, which causes a very significant increase in the number of infections caused by Candida Albicans.

The method according to the invention consists in forming a pharmaceutical as described previously, in turn preparing a vaginal tampon, and then impregnating the tampon with a pharmaceutical agent.

The vaginal tampon is manufactured in the manner described in French Patent Specification No. 2,614,525. The tampon overcomes the disadvantages inherent in classic tampons used against conception: difficulty in extraction, irritation, lack of discretion. This is due to the presence of at least one groove on its surface, which serves as a means for sticking and pulling out.

For a preferred use according to the invention, the tampon must furthermore have characteristic properties related to the method of its manufacture. Thus, in the method of the invention, the tampon used as a carrier for a pharmaceutical agent for the prevention of MST is made of an open-cell foam material such as, for example, polyurethane ether. The polyether polyurethane foam from which the pad is made has a density of preferably 15-28, a breaking strength of preferably 70 to 150 KPa. In contrast, the average cell size of the polyurethane ether sponge is preferably 0.67-0.53 mm.

For a preferred use in the method according to the invention, the tampon is manufactured so as to have no skin, that is to say it has no more or less continuous outer surface and is practically devoid of open cells. To achieve this, the tampon is cut into flakes of the appropriate width, each of which is cut from the side of the foam, previously stripped of the outer skin by a shearing operation.

It is up to one skilled in the art to choose a tampon suited to the anatomy of the wearer, taking into account the stated criteria, the form and dimensions of the tampon.

According to the process of the invention, the pharmaceutical is preferably prepared in the form of a hydrated gel; hydrated due to the place where the tampon is used. Indeed, it is internal use, in a very sensitive area: on the vaginal mucosa that must not be irritated or damaged. On the other hand, this form of gel is perfectly suited to be retained in a tampon. Of course, the agent should not, for example, escape too abundantly from the tampon by pressure exerted on it by the wearer to introduce it into the vagina. Moreover, the tampon should be secured and, above all, remain effective for quite a long time, for at least a few hours, therefore the pharmaceutical form with which the tampon is impregnated must be such that there is no excess secretion in the first minutes of use. The use of a gel is important to prevent this inconvenience. Due to its particular viscosity, the gel form also allows good contact with the mucous membranes as well as a homogeneous distribution.

The above proves the significant role of the thickener in obtaining the necessary viscosity of the gel with which the tampon is impregnated.

The amount of hydrated gel that is put into the tampon depends on the size and composition of the tampon. However, experience has shown that it is preferable that the tampon is not completely saturated as, on the one hand, too much gel would be released when the user presses the tampon into the vagina and, on the other hand, natural fluids should be allowed to be absorbed. (by substitution) and neutralized. The amount of gel needed to impregnate the tampon should meet the above conditions, and is in the order of 25% of the total absorbent volume of the tampon.

Each tampon is packed individually in a waterproof capsule. For a tampon with a diameter of 45 mm and a thickness of 20 mm, a capsule with an internal diameter of 46 mm and a height of 24 mm is selected, the set thus obtained corresponds to the impregnation method according to the invention. The capsule has a 5 mm wide circumferential rim to enable the capsule to be covered by welding a lid on the rim in question. Covering is facilitated by the presence of a small headspace above the tampon resulting from the difference in the dimensions of the capsule (24 mm) and the tampon (20 mm).

The capsule may be made of a material of the polyvinyl chloride type. The lid is formed from an aluminum complex compound typically used to cover plastic containers. According to the invention, impregnation is carried out as follows. The required amount of gel is distributed inside the capsule. For a 45 x 20 mm tampon, approximately 5 g of gel will be needed. This gel is spread in a thin layer over the entire surface of the tray. The tampon is then placed over the gel and covers the cartridge. The gel penetrates the tampon due to the capillary phenomenon.

The impregnation time is on the order of 30 seconds, while closing preferably takes a few seconds immediately after insertion of the tampon, that is, before the end of impregnation of the tampon. Consequently, the impregnation ends during further storage.

The reverse approach of placing the gel on the tampon rather than inside the capsule is discouraged if the inner volume of the capsule is close to the outer volume of the tampon. In this case, there is indeed a high probability that the gel will be accidentally introduced onto the rim of the capsule during its closure. Since the lid has to be fixed at this edge, generally by welding, the presence of the gel would create an obstacle to this welding, all the more so as the gel contains silicone. A slight amount of gel would be enough to cause an inaccurate closure, i.e. a leak. However, it is unnecessary to sterilize the tampon due to the high content of virucidal and bactericidal agents. Thus, the use of a tampon impregnated with the combined active ingredients offers, due to their additional activity, new benefits that are tailored specifically to the prevention of MST.

As a result, having open cells all over the tampon allows the aqueous gel it is impregnated with to be present and active upon application of the tampon, i.e. from its insertion into the vaginal opening, and to gradually cover the entire vaginal mucosa as this occurs. which are the necessary conditions for real and immediate protection.

The hydrated gel fraction drawn from the tampon is gradually replaced at the edges of the tampon by a gel initially contained in the cells of the central zone due to communication between the open cells. Moreover, due to internal transmission, the amount of gel that is released is greater during sexual intercourse due to the movements that occur, which is especially beneficial for destroying germs entrained in the vaginal environment as well as in semen and sperm.

The physical distribution of the gel has the advantage of being consistent and regular, which cannot be achieved with a normal tampon. This enhances the effect of dimethyl polysiloxane, which allows the formation of a protective film on the mucous membranes and on the skin at the same time. The insulating and hydrophobic effect is related to the very nature of dimethyl polysiloxane, which belongs to the group of silicones.

Considering that the gel has a low content of active ingredients and that the film former has an inhibitory effect on the penetration of these ingredients into the body, the gel used in the method according to the invention is suitable for repeated use and prolonged use. In this way, the wearer can renew the impregnated tampon as often as desired. The same tampon can be left in place for several hours without the risk of irritating the vaginal mucosa, even if forgotten. However, it is recommended that he be kept for at least 6 hours after the last sexual intercourse to ensure the best possible protection.

The presence of Alkonium chloride in the kit according to Table II enhances the effect of sodium cholate and avoids the risk of Toxic Shock Syndrome.

Toxic shock syndrome results from the rapid multiplication of Staphylococus Aureus cells when other pathogens are destroyed. Staphylococus Aureus produces malignant toxins that become fatal very quickly. Well, both benzalkonium chloride and sodium cholate have a significant effect on this very dangerous germ.

An impregnated tampon as previously described provides a double protection. When it comes to AIDS, for example, several cases are notable:

-Sexual intercourse between a healthy woman and a partner with a declared disease or with a positive serological test result: the woman's body is isolated and protected by a membrane covering the vaginal mucosa. The active ingredients destroy the infectious agents contained in the sperm or brought by the partner.

-Sexual intercourse between a woman with a declared disease or a positive serological test result and a healthy partner: covering the vaginal cavity with a gel membrane, isolates the mucosa and possible transition points for viruses (erosions, ruptures). Therefore, viruses cannot leave the body of an affected woman. The gel that comes out of the tampon is also deposited on the partner's male member. In this way, the membrane protects it by direct contact and induction on the skin.

-Sexual relationship between a woman and a partner in whom the disease was declared or serologically tested: the action of the gel prevents recurrence of serious infection with sera-positive results, by mutual isolation and destruction of infectious agents of two origins, causing infection of both carriers.

The impregnated tampon is therefore particularly suited to the prevention of AIDS. An impregnated tampon as described previously can be used to prevent MST, in addition to the conventional anti-fertilization agents (pills, sterilants, etc.). The use of a tampon also ensures discretion. Unlike a condom, it is not noticed by partners. This aspect, in the case of a condom, greatly restricts the development of its use. Regarding the present invention, this obstacle is removed. Moreover, the impregnated tampon is delivered in a single package, which allows it to be protected and stored properly, and is very easy to use.

The method of the invention is of particular importance especially, but not exclusively, for combating AIDS. The invention will now be illustrated in more detail by means of the following examples. Products used:

- Sodium cholate produced by CIPEC, France.

- Benzalkonium chloride produced under the trade name REWOQUAT B 50 by SCHERING, France.

- Nonoxynol 9 produced under the trade name SIMULSOL 930 NP by SEPPIC, France,

- Dimethyl polysiloxane produced under the trade name 365 MEDICAL GRADE EMULSION by the company dOw CORNING CORPORATION, USA, being an emulsion containing 35% dimethyl polysiloxane.

- Hydroxypropyl methylcellulose produced under the trade name METHOLOSE 60 SH 4000 by the company SEPPIC, France.

Example I. Manufacture of a vaginal tampon impregnated with a hydrated gel according to the formula given in Table I.

Pad: It is made of foam polyether polyurethane which has the following characteristics:

- density: approx. 22

- breaking strength: approx. 130 KPa

- average cell size: 0.6 mm

Two depressions are made on its surface as described in French patent Fr-A-2 614 525

- it is cut from a board without skin on an area of ​​the following dimensions: 45 mm in diameter and 20 mm in width

Gel: To impregnate a pad, 5 g of a gel having the above-mentioned characteristics is needed (the total absorption volume of such a pad is 20 g) .

• Ο

The proportion of ingredients used to make the gel are as follows:

- Sodium cholate 0.025 g (0.5%)

- Dimethyl polysiloxane (35% solution) 0.50 g (10%)

- Hydroxypropyl methylcellulose 0.20g (4%)

- Hydrochloric acid (IN) quantum satis for pH = 4,7

- Purified water quanrnm satis up to 5 g

Gel preparation: (This procedure applies irrespective of the amount entered). In the stainless steel tank (tank B), sodium cholate is dissolved at ambient temperature in half the amount of purified water. Then, dimethyl polysiloxane is added. The solution is then mixed by shaking until a homogeneous solution is obtained. : • The roducts are surface-active, so the solution should form at a low stirring speed.

- In the second double wall stainless steel tank (tank A), half of the amount of purified water is heated to 70 ° C by means of steam circulation in l double wall. The hydroxypropyl methylcellulose is then introduced and dispersed by filtration until a homogeneous gel is obtained. Thereafter, the gel is cooled to temperature and rolled by circulating cold water in the double wall of the tank.

- The solution obtained in tank B is gradually added to the room temperature at ambient temperature

i. the gel formed in zbironuk A with shaking until a homogeneous gel is obtained.

- The pH is adjusted by adding sufficient 1N hydrochloric acid to bring the pH to 4.7.

- The total weight of the gel is adjusted to 5 g by adding purified water.

Impregnation of the tampon: the gel obtained above is placed in a capsule with an internal diameter of 46 mm, a height of 24 mm and a circumferential rim width of 5 mm.

- The tampon is placed on top of a gel which penetrates the tampon through the capillary phenomenon.

- The capsule is closed by welding the lid tightly.

Example Π. Manufacture of a vaginal tampon impregnated with hydrated -: ohm according to the formula given in table Π. It is prepared according to the same characteristics as in Example 1.

Gel: - 5 g of gel is needed to impregnate a tampon.

The proportions of the ingredients needed to make the gel are as follows:

Sodium cholate

Benzalkonium chloride Nonoxynol 9

Dimethyl polysiloxane (35% solution) Hydroxypropyl methylcellulose Hydrochloric acid (IN)

Purified Water

0.025 g (0.5%)

0.050 g (1%)

0.025 g (0.5%)

0.50g (10%)

0.20 g (4%) quantum satis for pH = 4.7 quantum satis up to 5 g (4 a 4.2 g)

Gel preparation - It is prepared as in Example 1. Alkonium chloride and nonoxynol 9 are added at the same time as dimethyl polysiloxane.

Impregnating the Tampon - This is identical to Example 1.

PHARMACOLOGICAL PROPERTIES A - Virucidal properties

In the solution, infected with AIDS HIV I, inhibition of the virus enzyme factor was found by dosing the Transcriptase Inverse activity:

a - with sodium cholate under the following conditions:

<td>% Sodium cholate concentration</td><td>% Inhibition of Transcriptase Inverse</td><td>Treatment time</td>

<td> 0,04</td><td> 70</td><td>15 minutes</td>

<td> 0,25</td><td> 90</td><td>5 minutes</td>

<td> 0,50</td><td> 99</td><td>1 minute</td>

b - with the gel, the composition of which corresponds to that given in example Π

<td>Gel concentration vol. : vol.</td><td>% Inhibition of Transcriptase Inverse</td><td>Treatment time</td>

<td> 10'⁶</td><td> 5</td><td></td>

<td> 10'⁵</td><td> 7</td><td></td>

<td> 10'⁴</td><td> 99</td><td></td>

<td> 10'³</td><td> 100</td><td>less than 2 min</td>

<td> 10'²</td><td> 1(00</td><td>less than 2 min</td>

B - bactericidal properties

The gel, the composition of which corresponds to that given in Example 2, shows the following bactericidal activity at 32 ° C:

<td>Strains</td><td>Antiseptic Concentration (Vol: Vol)</td><td>Contact time required</td>

<td>Staphylococus Aureus CIP 53 127</td><td> 0,5%</td><td>5 min</td>

<td>Candida Albicans CIP 1180.79</td><td> 5%</td><td>5 min</td>

<td>Streptococus Agalaciae CIP 55 118</td><td> 0,5%</td><td>5 min</td>

<td>Neisseria Gonorrhoeae CIP 79 18</td><td> 0,1%</td><td>5 min</td>

<td>Gamella Yaginalis CIP 7074</td><td> 0,5%</td><td>5 min</td>

The bacterial strains listed in this table represent the types of bacteria responsible for sexually transmitted vaginal infections.

The minimum antiseptic concentration according to the French Pharmacopoeia is 5% (g: milliliter) within 15 minutes.

C - Antiparasitic properties

At a concentration of 0.5% (g: milliliter) in water, with a contact time of 5 minutes at 37 ° C, the gel (the composition of which corresponds to that given in Example 2) shows an immediate antiparasitic effect which destroys the Trichomonas Vaginalis population with a factor of at least 1000.