ITMI20111228A1 - COMBINATION OF MELAGRANE AND D-MANNOSE EXTRACT AND ITS USE IN THE TREATMENT AND / OR PREVENTION OF URINARY TRACK INFECTIONS - Google Patents
COMBINATION OF MELAGRANE AND D-MANNOSE EXTRACT AND ITS USE IN THE TREATMENT AND / OR PREVENTION OF URINARY TRACK INFECTIONS Download PDFInfo
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- ITMI20111228A1 ITMI20111228A1 IT001228A ITMI20111228A ITMI20111228A1 IT MI20111228 A1 ITMI20111228 A1 IT MI20111228A1 IT 001228 A IT001228 A IT 001228A IT MI20111228 A ITMI20111228 A IT MI20111228A IT MI20111228 A1 ITMI20111228 A1 IT MI20111228A1
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- combination
- cystitis
- mannose
- treatment
- urinary tract
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7004—Monosaccharides having only carbon, hydrogen and oxygen atoms
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
Description
"Combinazione di estratto di melagrana e D-mannosio e suo uso nel trattamento e/o prevenzione delle infezioni delle vie urinarie" "Combination of pomegranate extract and D-mannose and its use in the treatment and / or prevention of urinary tract infections"
La presente invenzione à ̈ diretta ad una combinazione di estratto di melagrana e D-mannosio, ed alla medesima per uso nella prevenzione e/o trattamento delle infezioni delle vie urinarie. The present invention is directed to a combination of pomegranate extract and D-mannose, and to the same for use in the prevention and / or treatment of urinary tract infections.
Un altro aspetto dell’invenzione à ̈ diretto ad una composizione farmaceutica, dietetica e/o alimentare, preferibilmente un integratore alimentare, contenente detta combinazione unitamente ad almeno un eccipiente fisiologicamente accettabile ed alla medesima composizione per uso nella prevenzione e/o trattamento delle infezioni delle vie urinarie. STATO DELL’ARTE Another aspect of the invention is directed to a pharmaceutical, dietary and / or food composition, preferably a food supplement, containing said combination together with at least one physiologically acceptable excipient and the same composition for use in the prevention and / or treatment of infections. of the urinary tract. STATE OF THE ART
Le alterazioni della funzionalità dell’apparato uro-vescicale, soprattutto alle basse vie urinarie, sono particolarmente comuni nelle giovani donne, durante la gravidanza e nel periodo peri e post menopausa. In molti casi queste sono causate da batteri normalmente non patogeni presenti nella microflora intestinale o nella vagina, che trovano condizioni che ne consentono l’adesione all’urotelio e lo sviluppo nel tratto sterile urovescicale. Anche l’uomo à ̈ soggetto a forme importanti di alterazioni dell’apparato uro-genitale, quali ad esempio la prostatite batterica cronica. I fattori che possono essere la causa di tali alterazioni della funzionalità dell’apparato uro-vescicale sono diversi, tra questi il più frequente à ̈ l’Escherichia coli, responsabile di circa il 90% delle infezioni persistenti o recidivanti di vescica e uretra. Alterations in the functionality of the uro-bladder system, especially in the lower urinary tract, are particularly common in young women, during pregnancy and in the peri- and postmenopausal period. In many cases these are caused by normally non-pathogenic bacteria present in the intestinal microflora or in the vagina, which find conditions that allow them to adhere to the urothelium and to develop in the sterile urovesical tract. Man is also subject to important forms of alterations of the uro-genital system, such as chronic bacterial prostatitis. The factors that can be the cause of these alterations in the functionality of the urobladder system are different, among these the most frequent is Escherichia coli, responsible for about 90% of persistent or relapsing infections of the bladder and urethra .
L’Escherichia coli à ̈ un batterio Gram (-) di provenienza intestinale, che colonizza il perineo e i genitali esterni e si insedia per via ascendente a vari livelli del tratto urinario, originando uretriti, cistiti e pielonefriti, a seconda della profondità dell’infezione. Escherichia coli is a Gram (-) bacterium of intestinal origin, which colonizes the perineum and external genitalia and settles ascending to various levels of the urinary tract, originating urethritis, cystitis and pyelonephritis, depending on the depth of the ™ infection.
Molti batteri Gram (-), tra cui ad esempio l’Escherichia coli, quando colonizzano gli organismi viventi, assumono una forma che à ̈ diversa da quella che si incontra nei test di laboratorio. Per resistere in un ambiente ostile come quello del tratto urinario, ad esempio, essi sviluppano una forma sessile caratterizzata dalla formazione di biofilm, che à ̈ rappresentata da compatte colonie adese alla superficie e protette da una matrice extracellulare contenente polisaccaridi o altri carboidrati. Malgrado renda più difficile la distribuzione dei nutrienti all’interno della matrice, questa forma rende la colonia batterica molto resistente all’azione della risposta immunologica e all’azione degli antibiotici. Many Gram (-) bacteria, including Escherichia coli, when colonizing living organisms, take on a form that is different from that encountered in laboratory tests. To resist in a hostile environment such as that of the urinary tract, for example, they develop a sessile form characterized by the formation of biofilms, which is represented by compact colonies adhering to the surface and protected by an extracellular matrix containing polysaccharides or other carbohydrates. Although it makes the distribution of nutrients inside the matrix more difficult, this form makes the bacterial colony very resistant to the action of the immunological response and to the action of antibiotics.
Le infezioni urinarie vengono solitamente trattate con antibiotici come, per esempio, fosfomicina, cefalosporine e chinolonici. Gli obiettivi dell'impiego di antibiotici nelle infezioni del tratto urinario sono l'eradicazione dell'organismo infettante, la prevenzione e/o il controllo della batteremia e delle susseguenti complicanze sistemiche. Urinary infections are usually treated with antibiotics such as, for example, fosfomycin, cephalosporins and quinolones. The objectives of the use of antibiotics in urinary tract infections are the eradication of the infecting organism, the prevention and / or control of bacteremia and subsequent systemic complications.
Affinché il trattamento antibatterico delle vie urinarie sia efficace deve associare sostanze in grado di esercitare un’azione diretta verso i Gram (-). Le recidive delle alterazioni della funzionalità dell’apparato uro-vescicale sono frequenti e rappresentano un problema di non facile gestione da parte del medico, poiché l’infezione può solo essere eradicata mediante la somministrazione di antibiotici adeguati, che tuttavia determinano significativi problemi di tossicità come, per esempio, nausea, vomito, gastrite, cefalea, tachicardia, sudorazione, rash cutanei, shock anafilattico, e/o possono comportare l’insorgenza di ceppi resistenti. For the antibacterial treatment of the urinary tract to be effective, it must combine substances capable of exerting a direct action towards Gram (-). The relapses of alterations in the functionality of the uro-bladder system are frequent and represent a problem that is not easy to manage by the doctor, since the infection can only be eradicated through the administration of adequate antibiotics, which however cause significant problems toxicities such as, for example, nausea, vomiting, gastritis, headache, tachycardia, sweating, skin rash, anaphylactic shock, and / or may lead to the onset of resistant strains.
E’ pertanto sentita la necessità di individuare alternative, preferibilmente non antibiotiche, in grado di essere efficaci per il trattamento e/o la profilassi delle infezioni urinarie, senza generare effetti collaterali. The need is therefore felt to identify alternatives, preferably non-antibiotic, capable of being effective for the treatment and / or prophylaxis of urinary infections, without generating side effects.
Punica granatum L., o melograno, à ̈ una pianta originaria dell’Asia, ma coltivata fin dal tempo preromano anche nell’area mediterranea. E’ una pianta che raggiunge l’altezza di 4-5 metri, sviluppa molti rami e produce un frutto chiamato melagrana, composto da numerosi semi separati da un pericarpo bianco e membranoso e rivestiti da una polpa rossa, aspra e succosa. Punica granatum L., or pomegranate, is a plant native to Asia, but cultivated since pre-Roman times also in the Mediterranean area. It is a plant that reaches a height of 4-5 meters, develops many branches and produces a fruit called pomegranate, composed of numerous seeds separated by a white and membranous pericarp and covered with a red, sour and juicy pulp.
L’estratto del frutto di melagrana contiene un complesso polifenolico comprendente acido ellagico, acidi fenolici, gallotannini, ellagitannini, punicalagini, proantocianidine, flavonoidi e vitamina C. The pomegranate fruit extract contains a polyphenolic complex including ellagic acid, phenolic acids, gallotannins, ellagitannins, punicalagins, proanthocyanidins, flavonoids and vitamin C.
Al complesso polifenolico sono state da tempo riconosciute attività antiinfiammatorie (Schubert S.Y. et al, J Ethnopharmacol; 1999; 66:11-17; Gonzales-Sarrias A. et al, Mol. Nutr. Food Res; 2010; 54(3): 311-322) e spiccate attività antiossidanti (Halvorsen B. L. et al, J. Nutr.; 2002; 132:461-471). The polyphenolic complex has long been recognized as anti-inflammatory activities (Schubert S.Y. et al, J Ethnopharmacol; 1999; 66: 11-17; Gonzales-Sarrias A. et al, Mol. Nutr. Food Res; 2010; 54 (3): 311 -322) and strong antioxidant activities (Halvorsen B. L. et al, J. Nutr .; 2002; 132: 461-471).
Studi nell’uomo hanno dimostrato che la maggior parte dell’acido ellagico e degli ellagitannini contenuti negli estratti di melagrana, e assunti per via orale, vengono rapidamente assorbiti dopo aver subito una trasformazione metabolica in Urolitin A e Urolitin B; tali metaboliti persistono per 48-96 ore dopo l’assunzione di succo di melagrana e vengono poi eliminati per via renale. La lunga permanenza nelle urine dei derivati metabolici suggerisce che questi siano i responsabili della prolungata azione antiossidante dei polifenoli. Studies in humans have shown that most of the ellagic acid and ellagitannins contained in pomegranate extracts, and taken orally, are rapidly absorbed after undergoing a metabolic transformation into Urolitin A and Urolitin B; these metabolites persist for 48-96 hours after the intake of pomegranate juice and are then eliminated by the kidney. The long stay in the urine of the metabolic derivatives suggests that these are responsible for the prolonged antioxidant action of the polyphenols.
Il complesso polifenolico possiede inoltre una dimostrata attività antibatterica verso i batteri Gram (+) (Kalina M. et al, J. Cell. Biol.; 1977, 74:726-741; Jepson R.G. et al, Mol. Nutr. Food Res.; 2007; 51:738-745). Il complesso polifenolico, essendo ricco di punicalagini, di ellagitannini e di acido ellagico, à ̈ in grado di inibire l’adesività dei batteri alle cellule ospiti e, di conseguenza, à ̈ capace di inibire la formazione del biofilm tipico dei batteri patogeni e di interferire con il loro sistema difensivo, indicato come quorum sensing, che consente ai batteri di rimanere invisibili ai sistemi difensivi dell’organismo finché i batteri non abbiano raggiunto una popolazione estesa e siano diventati virulenti. Disgregato il biofilm, i batteri restano in sospensione e ne à ̈ favorita l’eliminazione tramite il flusso urinario. The polyphenolic complex also has a demonstrated antibacterial activity against Gram (+) bacteria (Kalina M. et al, J. Cell. Biol .; 1977, 74: 726-741; Jepson R.G. et al, Mol. Nutr. Food Res. ; 2007; 51: 738-745). The polyphenolic complex, being rich in punicalagins, ellagitannins and ellagic acid, is able to inhibit the adhesiveness of bacteria to host cells and, consequently, is capable of inhibiting the formation of the typical biofilm of pathogenic bacteria and to interfere with their defensive system, referred to as quorum sensing, which allows bacteria to remain invisible to the body's defensive systems until the bacteria have reached a large population and become virulent. Once the biofilm is broken down, the bacteria remain in suspension and their elimination is favored through the urinary stream.
Il D-mannosio à ̈ uno zucchero aldoesoso, in particolare à ̈ un epimero C2 del glucosio. Diversamente dal glucosio, il D-mannosio non viene metabolizzato, se non in minime quantità , ed à ̈ rapidamente eliminato attraverso la via renale. Per questo motivo può essere utilizzato anche da bambini, donne in gravidanza e pazienti diabetici. D-mannose is an aldohexose sugar, in particular it is a C2 epimer of glucose. Unlike glucose, D-mannose is not metabolized, except in very small quantities, and is rapidly eliminated via the kidney. For this reason it can also be used by children, pregnant women and diabetic patients.
Il D-mannosio à ̈ in grado di saturare le fimbrie di Escherichia coli, rendendolo incapace di aderire alle pareti della vescica. Il batterio quindi mantiene la forma planctonica e viene eliminato tramite la minzione. D-mannose is able to saturate the fimbriae of Escherichia coli, making it unable to adhere to the walls of the bladder. The bacterium then retains the planktonic form and is eliminated by urination.
DESCRIZIONE DELL’INVENZIONE DESCRIPTION OF THE INVENTION
La presente invenzione à ̈ diretta ad una combinazione di estratto di melagrana e D-mannosio e/o una composizione farmaceutica, dietetica e/o alimentare che contiene tale combinazione in associazione ad almeno un eccipiente fisiologicamente accettabile. The present invention is directed to a combination of pomegranate extract and D-mannose and / or a pharmaceutical, dietary and / or food composition which contains such combination in association with at least one physiologically acceptable excipient.
La presente invenzione à ̈ inoltre diretta ad una combinazione di estratto di melagrana e D-mannosio, così come a una composizione farmaceutica, dietetica e/o alimentare che la contiene in associazione ad almeno un eccipiente fisiologicamente accettabile, per uso nella prevenzione e/o nel trattamento di infezioni delle vie urinarie, preferibilmente infezioni ricorrenti e/o recidivanti quali, per esempio, cistite o uretrite, sia femminili che maschili, a insorgenza in età adulta o pediatrica. The present invention is also directed to a combination of pomegranate extract and D-mannose, as well as to a pharmaceutical, dietary and / or food composition which contains it in association with at least one physiologically acceptable excipient, for use in prevention and / o in the treatment of urinary tract infections, preferably recurrent and / or relapsing infections such as, for example, cystitis or urethritis, both female and male, with onset in adulthood or in children.
Preferibilmente, la cistite, secondo la presente invenzione può essere cistite acuta o cronica, cistite post-coitale, cistite recidivante o cistite ricorrente. Dette composizioni farmaceutiche, dietetiche e/o alimentari contenenti la combinazione dell’invenzione ed almeno un eccipiente fisiologicamente accettabile sono preferibilmente integratori alimentari. Preferably, cystitis according to the present invention can be acute or chronic cystitis, postcoital cystitis, relapsing cystitis or recurrent cystitis. Said pharmaceutical, dietary and / or food compositions containing the combination of the invention and at least one physiologically acceptable excipient are preferably food supplements.
Con il termine “estratto di melagrana†secondo la presente invenzione si intende un estratto secco dell’intero frutto di melagrana, con un contenuto in polifenoli preferibilmente compreso tra il 75 e il 100%; detti polifenoli preferibilmente comprendono almeno il 25% circa di punicalagini e una quantità compresa tra 1 e 5% di acido ellagico. The term â € œpomegranate extractâ € according to the present invention means a dry extract of the whole pomegranate fruit, with a polyphenol content preferably between 75 and 100%; said polyphenols preferably comprise at least about 25% of punicalagins and an amount comprised between 1 and 5% of ellagic acid.
L’estratto secco secondo la presente invenzione presenta le seguenti caratteristiche: polvere secca di colore rosso e di odore caratteristico, con densità 0,3-0,5 Kg/l, solubile in acqua, di gusto astringente. The dry extract according to the present invention has the following characteristics: dry powder with a red color and characteristic odor, with a density of 0.3-0.5 kg / l, soluble in water, with an astringent taste.
E’ stato evidenziato che la combinazione dell’estratto di melagrana con una quantità adeguata di D-mannosio consente ai due componenti di esercitare un’attività sinergica; tale combinazione infatti favorisce l’azione antiadesiva e competitiva del D-mannosio nei confronti di colonie batteriche Gram (-), indebolite dall’azione dei componenti dell’estratto di melagrana sul biofilm. It has been shown that the combination of pomegranate extract with an adequate quantity of D-mannose allows the two components to exert a synergistic activity; this combination in fact favors the anti-adhesive and competitive action of D-mannose against Gram (-) bacterial colonies, weakened by the action of the components of the pomegranate extract on the biofilm.
L’azione del D-mannosio, grazie alla specificità nei confronti delle lectine presenti sulle fimbrie dell’Escherichia coli, contrasta l’adesione del batterio alle pareti della vescica urinaria e quindi la formazione di colonie infettive. L’Escherichia coli in questo modo viene più facilmente allontanato dall’organismo attraverso la minzione. The action of D-mannose, thanks to the specificity towards the lectins present on the fimbriae of Escherichia coli, counteracts the adhesion of the bacterium to the walls of the urinary bladder and therefore the formation of infectious colonies. In this way, Escherichia coli is more easily removed from the body through urination.
La combinazione e/o composizione della presente invenzione rappresenta pertanto un trattamento naturale, alternativo e migliorato rispetto agli antibiotici per la profilassi e/o il trattamento delle infezioni urinarie, in particolare se ricorrenti e/o recidivanti. The combination and / or composition of the present invention therefore represents a natural, alternative and improved treatment with respect to antibiotics for the prophylaxis and / or treatment of urinary infections, in particular if recurrent and / or relapsing.
La combinazione e/o composizione della presente invenzione può essere inoltre impiegata come coadiuvante nella terapia con antibiotici per il trattamento di tali infezioni, consentendo di ridurne l’assunzione e contrastando, di conseguenza, l’insorgere degli effetti indesiderati, in particolare delle antibiotico-resistenze batteriche. The combination and / or composition of the present invention can also be used as an adjuvant in the therapy with antibiotics for the treatment of such infections, allowing to reduce their intake and consequently counteracting the onset of undesirable effects, in particular of antibiotic-bacterial resistance.
La combinazione e/o composizione farmaceutica, dietetica e/o alimentare della presente invenzione può essere formulata in forma di compressa, capsula, granulato, polvere solubile, confetto, sciroppo, più preferibilmente polvere solubile in bustina, in confezioni multidose o monodose, più preferibilmente monodose. The pharmaceutical, dietary and / or food combination and / or composition of the present invention can be formulated in the form of tablet, capsule, granulate, soluble powder, dragee, syrup, more preferably soluble powder in sachet, in multidose or single dose packs, more preferably single-dose.
Detta combinazione e/o composizione può inoltre essere in forma deglutibile e/o effervescente. Said combination and / or composition may also be in swallowable and / or effervescent form.
Per “deglutibile†si intende una forma che può essere ingerita, eventualmente mediante la contemporanea assunzione di liquidi. By â € œdeglutableâ € we mean a form that can be ingested, possibly through the simultaneous intake of liquids.
Il termine “effervescente†secondo l’invenzione à ̈ invece riferito a composizioni in grado di sviluppare anidride carbonica quando a contatto con acqua e/o con l’ambiente buccale, in presenza di saliva. The term â € œeffervescentâ € according to the invention refers instead to compositions capable of developing carbon dioxide when in contact with water and / or with the buccal environment, in the presence of saliva.
La combinazione e/o composizione della presente invenzione comprende una quantità di estratto di melagrana tra 50 e 500 mg ed una quantità di D-mannosio tra 100 e 1700 mg in peso. The combination and / or composition of the present invention comprises a quantity of pomegranate extract between 50 and 500 mg and a quantity of D-mannose between 100 and 1700 mg by weight.
Per ottenere le composizioni farmaceutiche, dietetiche e/o alimentari secondo la presente invenzione vengono preferibilmente utilizzate le seguenti classi di eccipienti: antiagglomeranti, edulcoranti, tensioattivi (cationici, anionici o non ionici), diluenti, aggreganti o leganti, lubrificanti, glidanti, stabilizzanti, solubilizzanti, emulsionanti, umidificanti, aromatizzanti, agenti di rivestimento, coloranti, regolatori di acidità , o una loro miscela. To obtain the pharmaceutical, dietary and / or food compositions according to the present invention, the following classes of excipients are preferably used: anti-caking agents, sweeteners, surfactants (cationic, anionic or non-ionic), diluents, aggregating or binders, lubricants, glidants, stabilizers, solubilizers, emulsifiers, humectants, flavorings, coating agents, dyes, acidity regulators, or a mixture thereof.
Questi eccipienti vengono utilizzati in quantità compresa tra 0,5 e 2000 mg, a seconda della tipologia dell’eccipiente selezionato. These excipients are used in quantities between 0.5 and 2000 mg, depending on the type of excipient selected.
In un aspetto particolare, l’invenzione à ̈ diretta ad una composizione comprendente D-mannosio ed estratto di melagrana, unitamente ad almeno un regolatore di acidità , almeno un aroma, almeno un edulcorante, almeno un antiagglomerante, almeno un colorante o una loro miscela. In a particular aspect, the invention is directed to a composition comprising D-mannose and pomegranate extract, together with at least one acidity regulator, at least one flavor, at least one sweetener, at least one anti-caking agent, at least one dye or one of them. blend.
Secondo una realizzazione preferita dell’invenzione, una bustina monodose della combinazione e/o composizione secondo la presente invenzione comprende una quantità di D-mannosio tra 1000 e 1700 mg e una quantità di estratto di melagrana tra 200 e 500 mg. According to a preferred embodiment of the invention, a single-dose sachet of the combination and / or composition according to the present invention comprises a quantity of D-mannose between 1000 and 1700 mg and a quantity of pomegranate extract between 200 and 500 mg.
Secondo un’altra realizzazione preferita, una compressa comprende una quantità di D-mannosio tra 100 e 250 mg e una quantità di estratto di melagrana tra 100 e 250 mg. According to another preferred embodiment, a tablet comprises a quantity of D-mannose between 100 and 250 mg and a quantity of pomegranate extract between 100 and 250 mg.
Secondo un’ulteriore realizzazione preferita, una capsula comprende una quantità di D-mannosio tra 150 e 400 mg e una quantità di estratto di melagrana tra 100 e 250 mg. According to a further preferred embodiment, a capsule comprises a quantity of D-mannose between 150 and 400 mg and a quantity of pomegranate extract between 100 and 250 mg.
Un aspetto ancora più particolare dell’invenzione à ̈ diretto a composizioni, in forma di polvere solubile in bustina monodose contenenti D-mannosio in quantità da 1000 a 1700 mg/bustina ed estratto di melagrana in quantità da 200 a 500 mg/bustina come principi attivi, in associazione ad almeno un regolatore di acidità (per esempio acido citrico) in quantità da 250 a 350 mg/bustina, almeno un aroma (per esempio aroma lampone) in quantità da 70 a 90 mg/bustina, almeno un edulcorante (per esempio sucralosio, in quantità da 6 a 10 mg/bustina, o fruttosio, in quantità da 500 a 2000 mg/bustina), almeno un antiagglomerante (per esempio biossido di silicio) in quantità da 4 a 7 mg/bustina, almeno un colorante (per esempio E120: carminio di cocciniglia) in quantità da 2 a 4 mg/bustina. An even more particular aspect of the invention is directed to compositions, in the form of soluble powder in single-dose sachet containing D-mannose in quantities from 1000 to 1700 mg / sachet and pomegranate extract in quantities from 200 to 500 mg / sachet as active ingredients, in association with at least one acidity regulator (for example citric acid) in quantities from 250 to 350 mg / sachet, at least one flavor (for example raspberry flavor) in quantities from 70 to 90 mg / sachet, at least one sweetener ( for example sucralose, in quantities from 6 to 10 mg / sachet, or fructose, in quantities from 500 to 2000 mg / sachet), at least one anti-caking agent (for example silicon dioxide) in quantities from 4 to 7 mg / sachet, at least one dye (for example E120: cochineal carmine) in quantities from 2 to 4 mg / sachet.
La dose giornaliera e la durata del trattamento variano secondo l’indicazione, l’età e la situazione clinica del paziente. The daily dose and duration of treatment vary according to the indication, age and clinical situation of the patient.
Come coadiuvante della terapia antibiotica nel trattamento delle infezioni urinarie, la suddetta combinazione e/o composizione à ̈ preferibilmente somministrata mediante una posologia di una dose, una oppure due volte al giorno per sette giorni. As an adjuvant to antibiotic therapy in the treatment of urinary infections, the above combination and / or composition is preferably administered by a single dose dosage, once or twice a day for seven days.
Nel trattamento di cistite post-coitale, la suddetta combinazione e/o composizione à ̈ preferibilmente somministrata mediante una posologia di una dose, una oppure due volte al giorno per due o tre giorni. In the treatment of post-coital cystitis, the aforementioned combination and / or composition is preferably administered by a one-dose posology, once or twice a day for two or three days.
In un aspetto preferito, la combinazione e/o la composizione della presente invenzione à ̈ somministrata a mammiferi, in particolar modo all’uomo inteso come soggetto adulto o popolazione pediatrica (dove con popolazione pediatrica si identifica la popolazione dalla nascita ai 18 anni). Gli esempi che seguono sono intesi a meglio definire l’invenzione, senza in alcun modo limitarla. In a preferred aspect, the combination and / or composition of the present invention is administered to mammals, in particular to humans intended as an adult subject or pediatric population (where the population from birth to 18 years is identified with the pediatric population) . The following examples are intended to better define the invention, without limiting it in any way.
ESEMPI EXAMPLES
Esempio 1: Polvere solubile a base di estratto di melagrana e D-mannosio Principi attivi: Example 1: Soluble powder based on pomegranate extract and D-mannose Active ingredients:
- D-mannosio 1500 mg (37,500%) - estratto di melagrana 250 mg (6,250%) Eccipienti: - D-mannose 1500 mg (37,500%) - pomegranate extract 250 mg (6,250%) Excipients:
- Fruttosio 1823 mg (45,575%) - acido citrico 330 mg (8,250%) - Fructose 1823 mg (45,575%) - citric acid 330 mg (8,250%)
- aroma lampone 80 mg (2,000%) - raspberry flavor 80 mg (2,000%)
- sucralosio 8 mg (0,200%) - sucralose 8 mg (0.200%)
- biossido di silicio 6 mg (0,150%) - silicon dioxide 6 mg (0.150%)
- E 120 (Carminio di Cocciniglia) 3 mg (0,075%) TOTALE 4000 mg (100,000%) Si ottiene una composizione in forma di polvere solubile in bustina con peso netto totale pari a 4 g. - E 120 (Cochineal Carmine) 3 mg (0.075%) TOTAL 4000 mg (100,000%) A composition in the form of a soluble powder in sachet is obtained with a total net weight of 4 g.
Il Mandatario The Agent
Dott. Roberto Pistolesi della Dragotti & Associati Srl (Iscr. Albo No.853) Dr. Roberto Pistolesi of Dragotti & Associati Srl (Registered No.853)
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