IT201900000388A1 - COMPOSITION FOR USE IN THE TREATMENT OF VAGINAL, GLAND AND ANAL INJURIES - Google Patents

Description

Description of the invention entitled:

"COMPOSITION FOR USE IN THE TREATMENT OF VAGINAL, GLAND AND ANAL INJURIES"

Description

Field of technique

The present invention relates to the medical sector and in particular to the dermatological one. Specifically, the said invention relates to a particular composition for medical use formulated in gel which can be used for the treatment of inflammations, dryness, localized in the external tract of the vaginal, glans and anal mucous membranes.

Known art

To date, the interest in the treatment of both gynecological and proctological pathologies and their clinical relevance are widely recognized. Vaginitis in fact represent one of the most common gynecological problems: infectious pathologies of the female genital system involve, in addition to the physical and psychological discomfort for the patient, a high health expense and represent the most frequent reason that leads the woman to a consultation gynecological. It is therefore a pathology that deserves attention both for the frequency of relapsing forms, sometimes a source of chronic discomfort and a poor relationship life, and for the possible complications, some of which (such as pelvic inflammatory disease, salpingitis, recurrent abortion, premature rupture of membranes and premature birth) of particular relevance for the implications in the reproductive field. Proctological pathologies, that is, those affecting the rectum such as anal fissures and hemorrhoids, are also frequent and of considerable importance in terms of social cost, because they affect young and active patients. The resulting disorders are generally more annoying than dangerous and cause chronic discomfort due to the reduction of work activity. Specifically, vaginitis is one of the most frequent infections of the female genital tract and, in the United States, is the main reason for gynecological consultation. Candida albicans, Trichomonas vaginalis and Gardnerella vaginalis are responsible for 90% of cases of vaginal inflammation. From the literature it emerges that a variable percentage between 5% and 40% of the female population suffers, at least once in their life, from an episode of vaginal candidiasis.

The research carried out in recent years has improved the understanding of the process that leads to inflammation and consequently the methods of diagnosis and treatment have improved. The most common causes of vaginal infections are yeast infections, bacterial vaginosis, and Trichomonas infections.

To understand the causes and be able to formulate diagnoses and treatments, it is necessary to describe what vaginitis is, but specifically what happens to the vaginal environment and what are the changes in vaginal discharge compared to physiological situations. In the vaginal environment, similar to what occurs in the oral cavity and in the intestine, numerous microorganisms coexist which constitute the so-called "vaginal flora" consisting of both aerobic and anaerobic bacteria such as Candida Albicans or Gardnerella, which are part of the normal bacterial flora but they have a pathogenic potential that can manifest itself in some circumstances. The composition of the vaginal flora undergoes qualitative and quantitative changes, often the cause of inflammation, which are related to the age, hormonal status, sexual activity and general health conditions of the woman which in turn causes a change in the vaginal discharge. However, the amount and fluidity of vaginal discharge can vary during the menstrual cycle, regardless of the presence of inflammation. Cervical mucus becomes more fluid during the ovulation period and women often confuse this change in consistency for an abnormal situation. Stress states can increase the rate of vaginal peeling and therefore the amount of discharge, which patients may also mistake for pathological. The increase in secretions was also observed during pregnancy or due to the use of oral contraceptives. Women typically have no other symptoms if such losses are physiological. Clinically, physiological vaginal discharge is light or opaque white, non-homogeneous, very viscous and is not associated with itching or odor. Conversely, a pathological leak adheres to the vaginal walls and is often accompanied by irritation, itching, odor, or urinary symptoms such as dysuria. Causes of pathological vaginal discharge include infectious causes of vaginitis such as yeast infection, bacterial vaginosis and Trichomonas infection, as well as cervicitis and sexually transmitted diseases such as gonorrhea and chlamydial infection.

Another important characteristic of the vaginal environment is the pH: it is equal to 3.5-4.5 in women of childbearing age and represents a factor of primary importance in maintaining the ecosystem within the normal limits as it inhibits growth. of anaerobic bacteria and promotes the adhesion of lactobacilli (bacillus of Doderlein) to the vaginal epithelium. In prepubertal age the vaginal pH is more alkaline than in adulthood, the epithelium of the mucosa is of the columnar type and the glands are absent: in this phase of life the normal vaginal bacterial flora is mainly constituted by Gram-positive bacteria and by Gram-negative anaerobes. On the contrary, in adulthood the vaginal pH is more acidic, the epithelium of the mucosa is of a stratified squamous type and some glands are present: in this case lactobacilli prevail in the vaginal environment. The latter are destined to progressively reduce in menopause when, due to estrogen deficiency, the mucosa undergoes a process of atrophy with a decrease in the glycogen necessary for their metabolism.

The therapeutic approach for the patient with pathological vaginal discharge can be obtained if the exact etiology has been determined. Although the causes of vaginitis are different and numerous, and not always of an infectious nature, it is now evident that about 95% of these disorders derive from some main conditions: fungal vulvovaginitis, bacterial vaginosis, Trichomonas vaginitis, Chlamydia trachomatis genital infections, Herpes virus, Human Papilloma Virus and Neisseria Gonorrhoeae. Among these, the three most frequently diagnosed infections are Candida vulvovaginitis, Trichonomas vaginitis and bacterial vaginosis.

Candida vulvovaginitis, often simply called Candida, affects up to 75% of women at least once during the childbearing age and is caused in most cases by a fungus, Candida Albicans. The latter is a fungus that is normally found on the surfaces of the vaginal mucosa. It is overproduced, causing vaginitis, due to factors that alter the vaginal environment such as: the reduction of the normal bacterial population resulting from the use of broad-spectrum antibiotics, an increased presence of vaginal epithelial glycogen during pregnancy or in diabetic states, or due to excessive perineal heat associated with the use of tight and insulating pants. A concomitant factor may be HIV: for women who have recurrent and difficult to cure vaginitis, the HIV test must be considered. The normal intestinal flora is able to inhibit the proliferation of fungi such as Candida. In vitro studies have shown that some strains of lactobacilli can prevent the colonization of vaginal cells by fungi thanks to the production of a protein that anchors lactobacilli to the vaginal mucosa, decreasing the probability of infection.

The symptoms of a Candida are: itching that affects both the vagina and the vulvar area, whitish and cheesy-looking discharge. Upon physical examination, the vagina appears erythematous and inflamed, with leaks adhering to the wall; when the infection also affects the vulvar area this may also have cracks and in that case it is necessary to consider a possible herpes virus which must be ascertained through a viral culture. Inflammatory involvement of the vulvar area and the presence of fissures are highly indicative of vaginal fungal disease.

For an accurate diagnosis it is necessary to collect information on the patient's clinical history: use of broad-spectrum antibiotics, systemic steroids or oral contraceptives. Although the most recent oral contraceptives have a lower dosage of estrogen reducing the risk of infections, however, adverse effects have also occurred with an increased possibility of Candida and fungal infection in general, in these cases it may be useful to stop therapy oral contraceptive. The presence of hyphae, or filaments of the vegetative body of the fungus, on a histological preparation treated with potassium hydroxide is strongly predictive of a Candida infection. Other clues that may indicate a candidiasis diagnosis are a pH below 4.5. The diagnosis of candidiasis is most frequently made through a purely clinical analysis. The microscopic examination of vaginal discharge is also very useful, as it has been seen to highlight the presence of the fungus in 50% to 80% of cases. A fungal culture is advisable to confirm the diagnosis. When no fungal elements are identified under the microscope and there are no typical signs, the patient may not have Candida vaginitis. For women with frequent fungal vaginitis, topical azole antifungal treatments such as miconazole and clotrimazole for 7 days are recommended as first-line therapy. In pregnancy, miconazole nitrate is recommended due to its limited absorption from mucous membranes. However, the prolonged use of antifungal drugs causes greater resistance resulting in treatment failure. Other recommended treatments are vaginal suppositories with boric acid which are effective when used twice a day for 2 weeks and can be considered if there is a contraindication to other treatments. Common alternative treatments include: povidone iodine, boric acid, tea tree oil, lactobacilli recolonization, and garlic.

Trichomonas is a single-celled protozoan that commonly inhabits the lower genitourinary tract. It is an anaerobic bacterium and represents the third cause of infectious vaginitis. Although this bacterium can be transmitted sexually, however, this is not the only way of transmission because the bacterium is able to survive in tap water, soapy water, tubs, swimming pools with chlorine, and hot baths; it can also be present on wet wipes or swimwear, toilet seats or hygienic wipes.

It has been found that the presence of the Trichomonas bacterium can coexist with other infections such as gonococcal infection and bacterial vaginosis. In fact, Trichomonas generates hydrogen, which combines with oxygen, eliminating oxygen from the vaginal environment, facilitating the growth of other anaerobic bacteria and thus predisposing the person to bacterial vaginosis.

Women with Trichomonas vaginitis generally have foul-smelling yellowish discharge, vaginal itching, irritation of the vaginal mucosa with widespread erythema, redness of the vulva, and a burning sensation when urinating. It is highly recommended that the sexual partner be treated as well, as Trichomonas vaginitis is one of the sexually transmitted diseases.

In the case of Trichomonas vaginitis the vaginal pH is very alkaline, usually 6 to 7, and there are many white blood cells. Although a Pap smear may suggest Trichomonas infection, the test produces a significant number of false positives and false negatives, the result must therefore be confirmed by a culture. The latter is the most sensitive diagnostic modality to the Trichomonas bacterium and is also relatively cheap.

For nearly four decades, metronidazole (MTZ) has been the treatment of choice for Trichomonas vaginitis. MTZ had a 95% success rate along with its related compounds such as tinidazole (TNZ) and seconidazole. The World Health Organization (WHO) has issued guidelines for the treatment of Trichomonas vaginitis which include: MTZ or TNZ single dose and MTZ 400-500 mg for 7 days.

Bacterial vaginosis is a pathological complex that is poorly understood from the pathophysiological point of view even if it represents a frequent cause of vaginitis. A bacterial vaginosis results from the proliferation of some bacterial species in conjunction with a decrease in the normal bacterial flora and lactobacilli. Normally the vagina contains several bacteria, including one, Doderlein's lactobacillus, which has the function of maintaining the acidity necessary to prevent the multiplication of unwanted organisms. In the case of bacterial vaginosis, lactobacilli decrease and harmful bacteria proliferate abnormally with bacterial concentrations increasing by about 100 times. One of the bacteria most frequently responsible for bacterial vaginosis is Gardnerella vaginalis, whose infection occurs through sexual intercourse. Symptoms of infection are manifested by significant vaginal discharge with a characteristic unpleasant odor, generally stronger after sexual intercourse, of a homogeneous type and grayish in color. Almost half of women suffering from bacterial vaginosis will not perceive any symptoms and the infection will be discovered by chance during a routine examination; unlike other types of vaginitis, vaginosis does not usually involve vaginal discomfort or irritation.

The traditional diagnosis of bacterial vaginosis is the study of the clinical status, which requires three of the following four criteria in the evaluation of vaginal discharge: 1. a pH of 4.5 or higher;

2. an annoying smell;

3. homogeneous losses;

4. the presence of cells.

One clue is the presence of a squamous epithelial cell whose boundary is obscured by adhering bacteria. The presence of such a situation indicates a greater number of organisms, including Gardnerella, which is indicative of infection. Treatment of bacterial vaginosis is carried out with antibiotics. Metronidazole is an antimicrobial agent that has been approved by the Food and Drug Administration (FDA) since 1992 for the treatment of bacterial vaginosis. Two formulations of metronidazole are available, both intravaginal and oral, and although both have similar efficacy, producing success rates from 70% to 80%, it has been seen that intravaginal use is associated with lower efficacy.

The treatment regimens recommended by the Centers of Disease and Control and Prevention (CDC) are:

● Oral metronidazole 500mg twice a day for 7 days

or

● Metronidazole gel 0.75%, one application (5g) in the vagina for 5 days.

Clindamycin 2% cream, one application (5g) in the vagina for 7 days, is not the first choice drug because it is less effective and more expensive.

Hemorrhoids (from the Greek haîma, “blood” and rhéó, “flow”) represent a pathology of great clinical and economic importance in consideration of their wide diffusion. The prevalence of the disease is 4.4% with no significant sex-related differences, while the distribution by age reveals a peak incidence between 45 and 65 years.

Hemorrhoids are vascular structures of the anal canal that play an important role in maintaining fecal continence and therefore normally present in the anal canal from birth (internal hemorrhoidal plexus in the submucosa and external hemorrhoidal plexus in the subcutaneous tissue) which can become pathological structures when they are swollen or inflamed, giving rise to a symptomatology: we then speak of haemorrhoidal disease.

The most common symptom of hemorrhoidal disease is rectal bleeding associated with bowel movement. Abnormal dilation and distortion of the vascular canal, together with the destructive changes in the supporting connective tissue within the anal cushion are the consequences of this pathology. Hemorrhoids are distinguished, by the location, in internal and external. The first are located below the rectal mucosa, just above the internal sphincter, the others, subcutaneous, are located on the anal contour. The symptoms are different in both cases:

● External hemorrhoids appear as nodules of various sizes, purplish-red, soft, arranged in various numbers around the anus and, sometimes, are the site of itching or burning. When inflammation of the hemorrhoids occurs, thrombosis of the nodules (hemorrhoidal fluxion) can occur, which increase in volume and consistency and become intensely painful. Sometimes they become infected, resulting in the formation of an abscess. In most cases, they are treated conservatively, recommending a lifestyle change, the use of fiber supplements or anti-inflammatory drugs

● Internal hemorrhoids can only be recognized with digital exploration and endoscopic examinations (anus and rectoscopy), which allow to ascertain the presence of typical sessile, purplish, soft, small, multiple nodules. Relative disorders consist of an unpleasant feeling of weight in the sitting position, bleeding that can even lead to anemia in the patient; sometimes they protrude outside only during defecation (and internal procurants); later, however, they prolapse. In this case, due to sphincter contractions, they can be strangled, leading to thrombosis and necrosis. If the hemorrhoids are internal but not serious, they can be effectively treated with drugs or non-invasive measures such as elastic ligation or sclerotherapy (injection of a sclerosing fluid into the submucosa around the vascular pedicle of the hemorrhoid at the level of the anorectal ring ). Surgical treatment is instead indicated for more severe internal hemorrhoids or when other non-surgical approaches have failed, or complications have occurred. Although the gold standard for complicated and / or advanced stage hemorrhoids remains hemorrhoidectomy, recently minimally invasive operations such as doppler-guided hemorrhoidal arteries ligation, introduced in order to avoid post-hemorrhoidectomy pain have been introduced. Another non-invasive approach is the IRC technique, Infrared Coagulation, for the thermal ablation of hemorrhoids: it is an easy, non-invasive, painless treatment, giving results comparable to surgical treatment but without the consequences of the latter.

There are several risk factors that are found to be at the basis of the development of haemorrhoidal disease: age, obesity, abdominal obesity, depression and pregnancy, some conditions related to an increase in intra-abdominal pressure, due to to constipation and prolonged exertion. Certain types of foods and lifestyles, including a low-fiber diet, spicy foods and alcohol intake, have been linked with the development of hemorrhoids or the aggravation of a pre-existing hemorrhoidal disease.

The choice of treatment, as already mentioned, depends mainly on the type and severity of the hemorrhoids but also on the patient's preference. The proposed treatments can be of a medical-conservative or surgical type. The latter is often and improperly used. Surgical treatment does not reduce the risk of complications, relapse and anal incontinence. It is therefore necessary to intervene promptly and preferably with a medical therapy, less invasive and less traumatic.

It is therefore necessary to introduce a further classification of hemorrhoids, according to which it is possible to base the choice of the right therapy:

Table 1.

GRADE DESCRIPTION

1 Internal not prolapsed but bleeding

2 Prolapse during defecation but return spontaneously

3 Prolapse during defecation but return with manual maneuver 4 Prolapse permanently with swelling of the anal mucosa

In 1st degree hemorrhoids, treatments with mass-forming laxatives (fibers, agar, psyllium), aimed at counteracting constipation and making the stool soft, reduce symptoms. A meta-analysis of 7 clinical trials including 378 patients with hemorrhoids showed that fiber, as a nutritional supplement, has a substantial advantage in relieving the symptoms of hemorrhoidal disease and reducing the risk of bleeding by approximately 50% (24). . Although there is little information on the efficacy of an adequate diet and lifestyle in treating hemorrhoids, many doctors include advice in this regard as part of conservative hemorrhoid treatment and as a preventive measure. Nutritional advice usually includes an increase in the intake of dietary fiber and oral fluids, regular exercise, minimizing effort and avoiding the use of drugs that cause constipation or diarrhea.

The numerous drugs on the market (flavonoids, ointments based on local anesthetics and cortisones) can in varying degrees reduce symptoms in the initial stages (grade I and II) without definitively treating the hemorrhoidal pathology. In fact, the main goal of medical treatment is to control the symptoms of hemorrhoids rather than cure the true pathology. There are several modern drugs used that are available in a variety of formats including cortisone-based topical pills, suppositories, creams, ointments and ointments, such as hydrocortisone with soothing, anti-inflammatory and mildly anesthetic action. Other topical anesthetics that help heal hemorrhoids are benzocaine, lidocaine, or dibucaine. All these preparations must be applied after careful hygiene of the anal area carried out with warm water and soap or a little sodium bicarbonate. Even washes with natural infusions, such as mallow or chamomile based, can be effective for mild hemorrhoids.

An oral preparation based on flavonoids, which represent the most common phlebotonic agents, can be effectively used for the treatment of hemorrhoids. It has been widely established that flavonoids can increase vascular tone, decrease capillary permeability, facilitate lymphatic drainage and have anti-inflammatory effects. A large meta-analysis on the use of phlebotonics for hemorrhoids in 2012 showed significant beneficial effects on bleeding, itching and a general improvement in symptoms.

Non-serious internal hemorrhoids, therefore of I and II degree, are also effectively treated with outpatient procedures such as elastic ligation and sclerotherapy. For grade III and IV hemorrhoids and grade I and II hemorrhoids refractory to medical-conservative therapy, the most effective therapy is surgical. Various procedures have been proposed but the most used are two: hemorrhoidectomy and hemorrhoidopexy. Hemorrhoidectomy consists in the removal of prolapsed haemorrhoidal gavoccioli. The presence of an open (Milligan-Morgan technique) or closed (Fergusson technique) surgical wound in the anal canal makes this operation painful and therefore feared by patients. Hemorrhoidopexy, proposed by the Italian surgeon Antonio Longo, consists in reducing the haemorrhoidal prolapse in order to reposition the haemorrhoidal cushions in their physiological position. The absence of surgical wounds in the anal canal, richly innervated by sensitive fibers, makes this surgery less painful than traditional hemorrhoid excision techniques.

The anal fissure is a linear lesion of the epithelium lining the anal canal that tends to become chronic. In most cases, it involves the posterior wall of the anus, where vascular perfusion is reduced.

The increase in the tone of the anal sphincter contributes to the onset of this pathology, both because it hinders blood circulation and because it increases the trauma resulting from the passage of stool. The characteristic symptom is pain on defecation, often of strong intensity that can cause bleeding and / or itching. The patient tends to delay defecation precisely to prevent the onset of pain, thus aggravating the clinical picture due to the onset of constipation with the emission of hard stools that intensify the pain itself.

The fissure can be acute or chronic:

● Acute fissure presents as a red, easily bleeding wound often located in the back of the anal canal. In this case, the therapy is conservative and provides for the contrast of constipation with the use of dietary and laxative measures and the reduction of sphincter tone with muscle relaxant drugs.

● The chronic fissure is a wound whose margins are hard and rigid, the bottom is whitish and deep, until the bundles of the internal sphincter muscle are discovered, in this case it is necessary to resort to surgery. Surgical treatment consists in reducing the tone of the anal sphincter through the surgical section of a portion of the sphincter muscle or by injecting chemicals into the anal sphincter itself. The most fearful complication is anal incontinence, which can be both temporary and definitive.

The anal fissure mainly affects young adults, with a maximum incidence between 20 and 40 years. In this age group it prefers the male sex, while between 0 and 19 years old women have a 2.5 times higher incidence.

The causes of the onset of the anal fissure are many: hypertonia of the internal anal sphincter muscle is a favorable condition to which are added triggers such as constipation, inflammatory states of the anorectal region and diarrhea. Anal fissures usually appear at the posterior midline of the anal canal while lateral fissures can arise from other causes, such as Crohn's disease, ulcerative colitis, tuberculosis, HIV, or syphilis.

Most anal fissure patients recover without any therapy. Medical therapy (local creams and ointments, treatment of constipation with fiber supplements) and accurate food hygiene rules are often recommended in acute pathology. If the fissure does not heal after medical treatment, it is necessary to intervene in order to reduce anal hypertonus (when present) and treat the triggering factors. The reduction of anal tone can be achieved through the use of a nitroglycerin ointment, or through the injection of botulinum toxin.

Another non-invasive and non-bloody solution comes from the local application of a cream containing nifedipine and lidocaine. Nifedipine, a well-known antihypertensive drug, is proposed as an etiological drug, that is, aimed at eradicating sphincter hypertonia, the cause of the aforementioned morbid conditions; lidocaine, a common local anesthetic, completes the combination by providing it with an intense pain-relieving action. In controlled studies, the preparation has been shown to cure anal fissure. This local treatment almost always allows the symptoms to disappear, avoiding surgery. The patient applies the ointment twice a day for three weeks; already after the first few days of application, the patient feels relief because bleeding and disorders upon evacuation are reduced and disappear. Experimental studies have also recognized the active ingredient nifedipine as an anti-inflammatory, modulating action on the microcirculation and the ability to act locally. This helps to resolve the inflammatory component that supports the vicious circle, responsible for the pathogenetic mechanism of proctological pathologies sustained by hypertonicity of the internal anal sphincter (anal fissure, hemorrhoids in the initial phase and in thrombosis, pain after hemorrhoid surgery and tenesmus anal, very annoying irritation typical of chronic colitis).

The use of cryotherapy anal dilators offers excellent results (daily endoanal applications for about 30 days). These treatments act on the triggering cause of the anal fissure, namely sphincter hypertonia and poor vascularization.

When these methods fail, surgery becomes the therapy of choice. In an acute fissure, the internal sphincterotomy is carried out, which consists in modulating the lower part of the fibers of the internal anal sphincter muscle. A radial sphincterotomy can also be used using a balloon which gradually and under sedation is inflated in the anal canal. In chronic fissure, in addition to sphincterotomy, it is preferred to associate fissurectomy, that is, the cleaning of the fissure with the removal of the wound margins and surgical cleaning of the bottom of the sore. These types of treatments can be performed in the day hospital, do not involve post-operative pain and complete recovery is achieved in 4, 6 weeks.

Anal and / or vulvar scars are usually the result of surgical operations such as hemorrhoidectomy or episiotomy following a natural birth.

Episiotomy is a surgical incision in the perineum, the area between the bottom of the vaginal opening and the anus, in order to increase the size of the vaginal opening during childbirth.

Repair of an episiotomy is usually straightforward. Errors can be caused by a hasty repair, or, more commonly, if you don't have a good view of the area to be repaired. If the area is not properly stitched up, the edges of the wound may not heal properly. However, some women have post-episiotomy pain that can almost always be resolved. If it is a fistula, surgical repair will solve the problem either with ice packs or anesthetizing cream.

Another disease causing vaginal scars is lichen sclerosus: a chronic dermatological disorder that particularly affects the genital and anal area, although in some cases it can also appear on the trunk, chest and upper forearms. In the early stages of the disease, white spots appear on the skin, they are usually shiny and flat, but later become larger. The skin of the pustules thins and wrinkles, tears easily, and reddish or purplish bruises usually form. In some cases, scars can form. In mild forms, the disorder can also remain asymptomatic.

Possible symptoms include:

● itching (very frequent),

● discomfort or pain,

● bleeding,

● blistering.

The therapy involves the use of strong cortisone-based topical creams or ointments, it is necessary to apply them on the lesions every day, for several weeks, in order to eliminate the itching. Subsequently, the application is reduced to twice a week for a long time, to prevent the disorder from reappearing. This therapy does not eliminate the lesions and scars that have already formed.

If creams and ointments are not effective they can be used:

● retinoids (drugs with a composition similar to that of vitamin A),

● Tacrolimus-based creams (FK-506),

● ultraviolet ray therapies (not suitable for genital skin).

The purpose of the present patent application for industrial invention is to propose a new composition of particular efficacy in the treatment of inflammations localized in the external tract of the vaginal and anal mucous membranes.

Description of the invention

The present description refers to a particular composition for medical use formulated in gel which can be used for the treatment of inflammations localized in the external tract of the vaginal and anal mucous membranes.

In more detail, the goal of this composition is the creation of a restructuring, natural and transpiring film-forming barrier on the mucous membranes, protecting them from external agents. The natural substances included in the formulation contribute to restoring the physiological mechanisms involved in the healing processes of the mucous membranes.

In particular for vaginal inflammations the therapeutic strategy of the composition formulated in gel object of the present invention tends to two objectives:

- the reconstitution of the normal conditions of the altered cervicovaginal environment;

- the elimination of causative agents.

Even more in detail, it is a pourable gel obtained from the hydroxyethylcellulose polymer and water. The product is cloudy white in color, has a characteristic odor and is preferably, but not limited to, contained in a 50 ml Airless Dispenser. As aforesaid, the gel according to the present invention is capable of creating a restructuring, natural and transpiring film-forming barrier which allows to protect the mucous membranes from external agents. Specifically, said medical composition, described in detail hereinafter, comprises: water, hydroxyethylcellulose of medium viscosity, allantoin, tea tree oil, chlorhexidine digluconate in 20% solution, 18-β glycyrrhetic acid. It is also of interest to underline that the said composition is biocompatible both in its individual components and in its entirety.

Detailed description of the invention

The medical composition according to the present invention comprises substances such as: hydroxyethylcellulose of medium viscosity, water, tea tree oil, chlorhexidine digluconate in 20% solution and 18-β glycyrrhetic acid.

According to what is reported in the following table, said composition preferably comprises hydroxyethylcellulose of medium viscosity at 2% by weight, Water at 94.3% by weight, allantoin at 0.1% by weight, Tea tree oil at 0.5% by weight. weight, Chlorhexidine digluconate, in solution at 20%, at 3% by weight and 18-β glycyrrhetic acid at 0.1% by weight.

Table 2.

Of the aforementioned components, Allantoin is a natural substance, present in both the natural and plant world and is also found naturally in the human body where it essentially performs antioxidant functions. It has been shown that the action of allantoin is to actively participate in the healing process of inflammation, wounds and bruises, thanks to the ability to promote cell proliferation, even in a rapid manner. In particular, the healing mechanism takes place through the regulation of the inflammatory response, also guaranteeing stimulation of fibroblastic proliferation and the synthesis of the extracellular matrix, fundamental components for tissue regeneration of open wounds. Allantoin also participates in the formation of epithelial tissue, avoiding the formation of disfiguring scars, so it can also be used for the treatment of burn scars, as well as in the topical treatment of post-operative scars. For this purpose, it is able to constitute a real plaster on the wound, carrying out an action not only antibacterial and protective from contamination of external agents, but also allows the transpiration of the tissue. It therefore performs an important skin-repairing action but also has moisturizing properties, making it suitable for the treatment of dry, dull, chapped skin.

In high concentrations it has a certain keratolytic activity, that is, it loosens the junctions between cells in the stratum corneum, so that the superficial necrotic elements can be removed, with the advantage of softening and regenerating the skin.

It is one of the main constituents of snail slime extract and its antioxidant, soothing, moisturizing and repairing capabilities make it one of the perfect molecules for promoting physiological cell regeneration.

In addition, tests and safety assessments were conducted on the use of Allantoin with concentrations up to 2% with positive results.

Chlorhexidine is a disinfectant substance with bactericidal antiseptic action for topical use, of synthetic origin and bis-guanide structure. Mostly used in the prevention of inflammatory and infectious diseases of the oral cavity and as an adjuvant in the prevention of gingivitis and periodontitis.

It is able to alter the integrity of the normal structure of the bacterial membrane by increasing its permeability and inducing cell death by osmotic lysis. Varieties of formulations are available and the most used in healthcare is chlorhexidine gluconate. The spectrum of action is broad as it is active against Gram-positive, Gram-negative bacteria, yeasts and lipid enveloped viruses. Numerous empirical studies have also shown activity against Candida Albicans. Potent sporicidal activity can be induced by temperature increases, pH alteration and addition of ethanol. Thanks to its wide spectrum of action and its excellent safety profile, it has been used for many decades for hand hygiene and for the disinfection of the patient's skin before a surgical procedure or before the insertion of a catheter. Chlorhexidine has been shown to significantly reduce the microbial load present on the skin, showing persistent activity for many hours even after application. Chlorhexidine is occasionally associated with contact dermatitis and rarely associated with anaphylaxis and hypersensitivity reactions. A study conducted to reduce the risk of surgical site infections due to skin bacterial load, which compares the activity of an innovative polyester cloth impregnated with 2% chlorhexidine gluconate with the application of a standard procedure of a topical antiseptic of 4% chlorhexidine in skin preparation before surgery. The bacterial flora of the skin often includes numerous species of Staphylococcus and in particular Staphylococcus epidermidis.

It has been shown that hand washing with chlorhexidine reduces the bacterial flora present by 86-92%. In addition, chlorhexidine has residual activity on the skin that helps prevent the rapid re-growth of bacterial organisms by improving the skin's antiseptic action.

In particular, the presence of Chlorhexidine in the medical composition in question makes the medical device highly effective not only to cure but also to prevent infections that can often occur on open wounds, burns and sores of all kinds. In particular, clinical studies have shown a significant reduction in infections occurring in the wounds of patients treated with Chlorhexidine in a preventive manner. However, even on already infected wounds, Chlorhexidine was effective in their treatment.

Tea Tree Oil, also called Melaleuca, is extracted from an Australian plant and has always been used for herbal purposes, but in recent decades, demonstrations of its medicinal capabilities have emerged in the scientific literature as an adjunct treatment for wounds. Its properties are portentous and effective from the first use: antiviral, antibacterial, anti-parasitic, calming and balsamic. In particular it is used as an antiseptic and disinfectant of wounds.

In particular, the antibacterial action of tea tree oil has been demonstrated against Staphylococcal infections and no side effects of topical use have been reported. Finally, 18-β glycyrrhetic acid is extracted from licorice roots and its fundamental anti-inflammatory but also soothing and adjuvant properties in skin repair processes have been demonstrated pharmacologically.

The anti-inflammatory effects of 18-β glycyrrhetic acid are attributable to its ability to enhance the effects of glucorticoids on the one hand and to inhibit the generation of neutrophils, potential mediators of inflammation.

Claims (7)

Claims 1. Composition comprising hydroxyethylcellulose of medium viscosity, water, allantoin, tea tree oil, chlorhexidine digluconate, in solution at 20%, and 18-β glycyrrhetic acid. 2. Composition according to the preceding claim in which the hydroxyethylcellulose of medium viscosity is present in a quantity of 2% by weight, the water of 94.3% by weight, the Allantoin of 0.1% by weight, the oil of tea tree of 0.5% by weight, Chlorhexidine digluconate, in solution at 20%, of 3% by weight and 18-β glycyrrhetic acid of 0.1% by weight, all components completing 100% by weight of the said composition. Composition according to any one of the preceding claims in the form of a gel. 4. Composition according to any one of the preceding claims for medical use. 5. Composition for use according to the previous claim in a method of treating inflammations localized in the external tract of the vaginal and anal mucous membranes. 6. Composition for use according to the previous claim to be administered topically. 7. 50 ml dispenser containing the composition according to any one of claims 1 to 3.