IT202100011210A1 - COMBINATION COMPOSITION FOR THE PREVENTION AND TREATMENT OF PROSTATE AND UROLOGICAL DISORDERS - Google Patents
COMBINATION COMPOSITION FOR THE PREVENTION AND TREATMENT OF PROSTATE AND UROLOGICAL DISORDERS Download PDFInfo
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- IT202100011210A1 IT202100011210A1 IT102021000011210A IT202100011210A IT202100011210A1 IT 202100011210 A1 IT202100011210 A1 IT 202100011210A1 IT 102021000011210 A IT102021000011210 A IT 102021000011210A IT 202100011210 A IT202100011210 A IT 202100011210A IT 202100011210 A1 IT202100011210 A1 IT 202100011210A1
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- prostate
- quercetin
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Classifications
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/105—Plant extracts, their artificial duplicates or their derivatives
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/16—Inorganic salts, minerals or trace elements
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
- A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/04—Sulfur, selenium or tellurium; Compounds thereof
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K33/24—Heavy metals; Compounds thereof
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/24—Heavy metals; Compounds thereof
- A61K33/34—Copper; Compounds thereof
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- 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)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/889—Arecaceae, Palmae or Palmaceae (Palm family), e.g. date or coconut palm or palmetto
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- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/43—Enzymes; Proenzymes; Derivatives thereof
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- A61K9/00—Medicinal preparations characterised by special physical form
Description
TITOLO TITLE
COMPOSIZIONE DI COMBINAZIONE PER LA PREVENZIONE E IL TRATTAMENTO DI DISTURBI ALLA PROSTATA E UROLOGICI COMBINATION COMPOSITION FOR THE PREVENTION AND TREATMENT OF PROSTATE AND UROLOGICAL DISORDERS
DESCRIZIONE DESCRIPTION
CAMPO DELL'INVENZIONE FIELD OF THE INVENTION
La presente invenzione concerne una composizione di combinazione per la prevenzione e trattamento di disturbi alla prostata e/o urologici. The present invention relates to a combination composition for the prevention and treatment of prostate and/or urological disorders.
La presente invenzione origina nel settore dei prodotti per la nutrizione e la salute dell?uomo. The present invention originates in the sector of products for nutrition and human health.
In particolare, la presente invenzione riguarda un integratore per la somministrazione orale contenente una composizione a base di selezionati ingredienti attivi la cui combinazione riduce i disturbi della prostata e gli associati disturbi urologici. In particular, the present invention relates to a supplement for oral administration containing a composition based on selected active ingredients the combination of which reduces prostate disorders and the associated urological disorders.
TECNICA ANTERIORE PRIOR TECHNIQUE
I disturbi della prostata generalmente interessano una ampia fetta della popolazione maschile con et? superiore ai 50 anni. Generalmente questi disturbi sono riconducibili a cambiamenti dei livelli ormonali e sovente si associano a disturbi urogenitali, quali aumento della frequenza di minzione, o difficolt? alla minzione. Tra i disturbi della prostata l?iperplasia prostatica benigna, nota con l?acronimo IPB o come adenoma prostatico, rappresenta uno dei disturbi di origine benigna pi? comuni. Tipicamente, si riscontra nella met? degli uomini con et? superiore a 60 anni ed ? dovuto all?ingrossamento della ghiandola prostatica. Prostate disorders generally affect a large proportion of the male population aged over 50 years old. Generally these disorders are attributable to changes in hormone levels and are often associated with urogenital disorders, such as increased frequency of urination, or difficulty to urination. Among prostate disorders, benign prostatic hyperplasia, known by the acronym BPH or prostate adenoma, represents one of the most common disorders of benign origin. common. Typically, it is found in the middle of men with age over 60 years old and ? due to enlargement of the prostate gland.
I soggetti affetti da questo disturbo sono asintomatici nel 55% circa dei casi, nella restante percentuale di individui porta allo schiacciamento dell?uretra e pertanto si accompagna a difficolt? ad urinare o a una irregolarit? nel flusso di urina. Subjects affected by this disorder are asymptomatic in about 55% of cases, in the remaining percentage of individuals it leads to crushing of the urethra and therefore it is accompanied by difficulties? to urinate or an irregularity? in the urine stream.
La principale sintomatologia che si accompagna all?iperplasia prostatica ricomprende disuria, ovvero una sensazione dolorosa mentre si urina, un aumento nello stimolo frequenza alla minzione detta pollachiuria. The main symptomatology that accompanies prostatic hyperplasia includes dysuria, or a painful sensation while urinating, an increase in the urination frequency stimulus called pollakiuria.
La ritenzione urinaria, ovvero l?incapacit? di svuotare, del tutto o parzialmente, la vescica, rappresenta un altro disturbo della prostata. A questo disturbo sono sovente associate infezioni delle vie urinarie (IVU) e calcoli vescicale che si formano come conseguenza del ristagno di urina e dell?elevata concentrazione di insoluti. La prostatite ? un altro disturbo della prostata che ha una elevata incidenza nella popolazione maschile superiore a 50 anni. The urinary retention, or the? inability? to empty, completely or partially, the bladder, represents another prostate disorder. This disorder is often associated with urinary tract infections (UTI) and bladder stones which form as a result of urine stagnation and the high concentration of unsolved substances. Prostatitis ? another prostate disorder that has a high incidence in the male population over 50 years old.
Si tratta della infiammazione della ghiandola prostata riconducibile a diversi fattori quali infezioni, traumi alla zona pelvica o danni ai nervi del tratto urinario. This is the inflammation of the prostate gland due to various factors such as infections, trauma to the pelvic area or damage to the nerves of the urinary tract.
I sintomi principali della prostatite sono dolore o bruciore durante la minzione nota come disuria, ritenzione urinaria, pollachiuria, soprattutto durante la notte, urine torbide e maleodoranti, talvolta con ematuria; dolore al basso ventre o nella zona perineale, sensazione di pesantezza dietro lo scroto, possibile febbre e brividi. Nei casi in cui i disturbi sono di lieve entit? pu? essere sufficiente adottare un idoneo regime dietetico accompagnato da un moderato aumento dell?attivit? fisica. The main symptoms of prostatitis are pain or burning during urination known as dysuria, urinary retention, pollakiuria, especially during the night, cloudy and foul-smelling urine, sometimes with hematuria; pain in the lower abdomen or perineal area, feeling of heaviness behind the scrotum, possible fever and chills. In cases where the disturbances are mild? can? be sufficient to adopt a suitable diet accompanied by a moderate increase in activity? physics.
Tuttavia, nella maggior parte dei casi si rende necessario approcciare la malattia per via farmacologica. However, in most cases it is necessary to approach the disease pharmacologically.
Tra i farmaci maggiormente utilizzati rientrano gli inibitori della 5-alfa-reduttasi quali la finasteride e la dutasteride. Questi farmaci trovano specifica indicazione di utilizzo nel trattamento dell'ipertrofia prostatica benigna e riducono l'ingrossamento della prostata. Tuttavia, l?uso di questi farmaci ? soggetto a prescrizione medica ed ? associato ad effetti collaterali anche seri che principalmente coinvolgono sia la sfera sessuale che neurologici. Tra i primi annoveriamo disfunzione erettile, riduzione della libido, dolori testicolari cronici, restringimento del pene, tra i secondi rientrano depressione, ansia, insonnia. Among the most commonly used drugs are the 5-alpha-reductase inhibitors such as finasteride and dutasteride. These drugs are specifically indicated for use in the treatment of benign prostatic hypertrophy and reduce the enlargement of the prostate. However, the use of these drugs is subject to medical prescription and ? associated with even serious side effects that mainly involve both the sexual and neurological spheres. Among the former we include erectile dysfunction, reduced libido, chronic testicular pain, penis shrinkage, among the latter there are depression, anxiety, insomnia.
Attualmente si sente quindi l?esigenza di disporre di prodotti idonei a trattare i disturbi della prostata e correlati disturbi urologici la cui dispensazione al pubblico non sia soggetta a prescrizione medica. Currently, therefore, there is a need to have products suitable for treating prostate disorders and related urological disorders whose dispensing to the public is not subject to medical prescription.
Uno scopo generale della presente invenzione consiste quindi nel provvedere una composizione per la prevenzione e trattamento dei disturbi della prostata e associati disturbi urologici la cui somministrazione sia sostanzialmente priva dei principali effetti collaterali dei farmaci comunemente utilizzati per queste affezioni benigne. A general object of the present invention therefore consists in providing a composition for the prevention and treatment of prostate disorders and associated urological disorders the administration of which is substantially free of the main side effects of the drugs commonly used for these benign conditions.
Un altro scopo consiste nel fornire un integratore a base di sostanze biologicamente attive la cui combinazione riduca i principali sintomi associati ad iperplasia prostatica agendo attraverso diversi meccanismi di azione o pathway. Another object is to provide a supplement based on biologically active substances the combination of which reduces the main symptoms associated with prostatic hyperplasia by acting through various mechanisms of action or pathways.
SOMMARIO DELL'INVENZIONE SUMMARY OF THE INVENTION
In accordo ad un primo aspetto della presente invenzione, gli inventori hanno trovato che combinando selezionati principi biologicamente attivi si consegue un effetto combinato antiandrogeno ed antinfiammatorio localizzato nei tessuti della prostata e limitrofi del tratto uro-genitale. Questo effetto ? assimilabile a quello ottenibile con i farmaci comunemente utilizzati per trattare l?ipertrofia prostatica benigna come la finasteride e la correlata sintomatologia. In accordance with a first aspect of the present invention, the inventors have found that by combining selected biologically active ingredients a combined anti-androgenic and anti-inflammatory effect localized in the prostate and adjacent tissues of the urogenital tract is achieved. This effect? comparable to that obtainable with drugs commonly used to treat benign prostatic hypertrophy such as finasteride and related symptoms.
La combinazione di componenti biologicamente attive che agiscono su differenti pathway biologici determina un effetto terapeutico sinergico che determina un miglioramento della sintomatologia che affligge i soggetti affetti da patologie prostatiche. The combination of biologically active components that act on different biological pathways determines a synergistic therapeutic effect which determines an improvement in the symptoms afflicting subjects suffering from prostate pathologies.
In accordo ad un aspetto generale, l?invenzione origina dall?avere individuato che una combinazione di selezionati enzimi proteolitici con una sostanza di origine vegetale ad azione antiandrogena ed un estratto vegetale provvisto di attivit? antiossidante ed antinfiammatoria, opzionalmente con selezionati micronutrienti inorganici o minerali, inibisce l?enzima 5 alfa reduttasi e gli ormoni sessuali che accelerano il metabolismo delle cellule dei tessuti, riducendo l?infiammazione. In accordance with a general aspect, the invention originates from having identified that a combination of selected proteolytic enzymes with a substance of vegetable origin with an antiandrogenic action and a vegetable extract having antiandrogenic activity. antioxidant and anti-inflammatory, optionally with selected inorganic or mineral micronutrients, inhibits the enzyme 5 alpha reductase and sex hormones that accelerate the metabolism of tissue cells, reducing inflammation.
Forma quindi oggetto della presente invenzione una composizione a base di una combinazione di serenoa repens, bromelina, papaina, quercetina ed opzionalmente un micronutriente scelto tra zinco, rame, selenio e loro miscele ed un veicolo fisiologicamente accettabile per l?uso nella prevenzione o trattamento di disturbi della prostata e associati disturbi urogenitali. The object of the present invention is therefore a composition based on a combination of saw palmetto, bromelain, papain, quercetin and optionally a micronutrient selected from zinc, copper, selenium and mixtures thereof and a physiologically acceptable vehicle for use in the prevention or treatment of prostate disorders and associated urogenital disorders.
Vantaggiosamente le quattro selezionate componenti biologicamente attive agiscono sulle principali cause che determinano ipertrofia prostatica e correlata sintomatologia urogenitale agendo attraverso diversi target biologici. Advantageously, the four selected biologically active components act on the main causes that determine prostatic hypertrophy and related urogenital symptoms by acting through different biological targets.
Vantaggiosamente, la composizione dell?invenzione ? in una forma solida idonea alla somministrazione orale. Advantageously, the composition of the invention is in a solid form suitable for oral administration.
La somministrazione orale della composizione di combinazione qui descritta riduce la sintomatologia correlata ai disturbi della prostata evitando il ricorso ai farmaci che vengono pi? comunemente prescritti in questi casi. Oral administration of the combination composition described here reduces the symptoms related to prostate disorders, avoiding the use of drugs that are more commonly used. commonly prescribed in these cases.
Tipicamente nella composizione dell?invenzione le componenti ad attivit? terapeutica sono fornite in un quantitativo biologicamente e/o farmaceuticamente efficace. Typically in the composition of the invention the components with active therapeutics are supplied in a biologically and/or pharmaceutically effective amount.
Secondo alcune forme di realizzazione, la composizione ? contenuta in un integratore alimentare, nutraceutico, fitoterapico o medicinale. According to some embodiments, the composition is contained in a food supplement, nutraceutical, phytotherapeutic or medicinal.
DESCRIZIONE DETTAGLIATA DELL'INVENZIONE DETAILED DESCRIPTION OF THE INVENTION
La presente invenzione origina dalla necessit? di fornire una composizione attiva nel trattamento dei disturbi della prostata ovviando agli effetti collaterali connessi con la somministrazione dei farmaci comunemente utilizzati nel trattamento di questi disturbi come la finasteride. The present invention originates from the necessity? to provide an active composition in the treatment of prostate disorders obviating the side effects associated with the administration of drugs commonly used in the treatment of these disorders such as finasteride.
In accordo a certi aspetti gli inventori hanno osservato come combinando selezionati enzimi proteolitici con una sostanza antiandrogena ed un estratto di origine vegetale provvisto di attivit? antiossidante ed antinfiammatoria si ottiene una riduzione della sintomatologia che accompagna i disturbi e le malattie della prostata, in particolare l?ipertrofia prostatica. In accordance with certain aspects, the inventors have observed how by combining selected proteolytic enzymes with an antiandrogenic substance and an extract of vegetable origin provided with antioxidant and anti-inflammatory, a reduction in the symptoms that accompany prostate disorders and diseases, in particular prostatic hypertrophy, is obtained.
L?effetto terapeutico riscontrato ? sinergico e determina una riduzione o risoluzione della pi? comune sintomatologia correlata ad iperplasia prostatica assimilabile a quella ottenuta con trattamento con finasteride. Inoltre, la riduzione della sintomatologia riferibile al trattamento con la composizione qui descritta si accompagna ad un effetto antinfiammatorio sui tessuti della prostata che consente di mantenere la sua funzionalit? a livelli fisiologici, prevenendo o riducendo le recidive. The therapeutic effect found? synergistic and determines a reduction or resolution of the pi? common symptomatology related to prostatic hyperplasia comparable to that obtained with treatment with finasteride. Furthermore, the reduction of the symptoms attributable to the treatment with the composition described herein is accompanied by an anti-inflammatory effect on the tissues of the prostate which allows it to maintain its functionality. at physiological levels, preventing or reducing recurrences.
Forma quindi un oggetto dell?invenzione una composizione per gli usi secondo la acclusa rivendicazione 1. Therefore, a composition for the uses according to the enclosed claim 1 forms an object of the invention.
Ulteriori forme di realizzazione della composizione per l?uso qui descritto formano oggetto delle accluse rivendicazioni dipendenti 2-9. Further embodiments of the composition for the use described herein form the subject of the attached dependent claims 2-9.
Specificatamente, la composizione dell?invenzione combina i due enzimi proteolitici bromelina e papaina con serenoa repens provvista di attivit? antiandrogena ed un estratto di quercetina provvisto di attivit? antinfiammatoria e antiossidante. Specifically, the composition of the invention combines the two proteolytic enzymes bromelain and papain with saw palmetto having activity? antiandrogen and an extract of quercetin provided with activity? anti-inflammatory and antioxidant.
La composizione pu? ulteriore comprendere uno o pi? minerali la cui presenza migliora l?attivit? proteolitica degli enzimi. The composition can further include one or more? minerals whose presence improves the? activity? enzyme proteolytics.
La combinazione delle componenti biologicamente attive della composizione dell?invenzione determina i seguenti concomitanti effetti: The combination of the biologically active components of the composition of the invention causes the following concomitant effects:
-inibisce l?enzima 5 alfa reduttasi; - inhibits the enzyme 5 alpha reductase;
-inibisce la produzione di ormoni sessuali che stimolano la replicazione delle cellule dei tessuti della prostata; -inhibits the production of sex hormones that stimulate the replication of prostate tissue cells;
-hanno effetti antiandrogeni e anti-estrogeni -have antiandrogenic and anti-estrogenic effects
-riducono la proliferazione cellulare del parenchima della prostata. - they reduce the cellular proliferation of the prostate parenchyma.
Questi effetti sono conseguiti in sostanziale assenza di effetti collaterali tipici dei farmaci utilizzati per trattare l?ipertrofia prostatica e correlata sintomatologia. These effects are achieved in the substantial absence of side effects typical of drugs used to treat prostatic hypertrophy and related symptoms.
Preferibilmente la composizione dell?invenzione ? un nutraceutico o integratore alimentare che trova applicazione nel trattamento di disturbi della prostata e nella correlata sintomatologia del tratto urogenitale. Preferably the composition of the invention ? a nutraceutical or food supplement that finds application in the treatment of prostate disorders and in the related symptoms of the urogenital tract.
Vantaggiosamente, la composizione dell?invenzione comprende almeno i quattro ingredienti biologicamente attivi, riferiti anche come ingredienti attivi nel seguito, la cui combinazione ? efficace nel ridurre la sintomatologia correlata a patologie della prostata. Advantageously, the composition of the invention comprises at least the four biologically active ingredients, also referred to as active ingredients below, the combination of which is? effective in reducing the symptoms related to prostate diseases.
Questi ingredienti sono veicolati o dispersi in un veicolo fisiologicamente accettabile o edibile. These ingredients are delivered or dispersed in a physiologically acceptable or edible vehicle.
Due componenti della composizione sono bromelina e papaina, enzimi proteolitici. La bromelina ? un enzima estratto da frutto o gambo dalla pianta di ananas o Ananas comosus. L?estratto enzimatico comprende una miscela di enzimi che digeriscono le proteine, tipicamente sulfidril proteasi. Two components of the composition are bromelain and papain, proteolytic enzymes. Bromelain? an enzyme extracted from the fruit or stem of the pineapple plant or Ananas comosus. The enzyme extract comprises a blend of protein-digesting enzymes, typically sulfhydryl proteases.
La bromelina ? provvista di attivit? antinfiammatoria ed antiedemigena. Bromelain? endowed with activity anti-inflammatory and anti-edema.
Nella composizione di combinazione qui descritta la bromelina pu? essere presente in un quantitativo compreso dal 5 al 30%, dal 9 al 25% dal 12 al 22% in peso rispetto al peso totale della composizione. In the combination composition described here bromelain can be present in an amount ranging from 5 to 30%, from 9 to 25% and from 12 to 22% by weight with respect to the total weight of the composition.
La papaina ? un enzima proteolitico, appartenente alla classe delle idrolasi, che si estrae dal frutto immaturo della papaia o Carica papaya. La papaina catalizza l'idrolisi di proteine, con alta specificit? per i legami peptidici, ma con preferenza per gli amminoacidi con catena laterale ingombrante in posizione P2. The papain? a proteolytic enzyme, belonging to the hydrolase class, which is extracted from the immature fruit of the papaya or Carica papaya. Papain catalyzes the hydrolysis of proteins, with high specificity for peptide bonds, but with preference for amino acids with a bulky side chain in the P2 position.
Nella composizione di combinazione qui descritta la papaina pu? essere presente in un quantitativo compreso dall?1 al 25%, dal 3 al 15% dal 6 al 10%, ad esempio all?8% in peso rispetto al peso totale della composizione. In the combination composition described here papain can be present in a quantity ranging from 1 to 25%, from 3 to 15%, from 6 to 10%, for example 8% by weight with respect to the total weight of the composition.
Una componente o ingrediente attivo della componente a) della composizione ? quercetina, un flavonoide di origine vegetale noto anche come 3,3?,4?5,7-pentaidrossiflavone, avente la seguente formula di struttura: A component or active ingredient of component a) of the composition? quercetin, a plant-derived flavonoid also known as 3,3?,4?5,7-pentahydroxyflavone, having the following structural formula:
Nella composizione la quercetina pu? essere in forma libera, ad esempio come quercetina aglicone oppure anche di suo derivato o metabolita, ad esempio di 3-metilquercetina. In the composition, quercetin can be in free form, for example as quercetin aglycone or also as a derivative or metabolite thereof, for example of 3-methylquercetin.
La quercetina ? una molecola biologicamente attiva provvista di attivit? antinfiammatoria ed antiossidante. Quercetin? a biologically active molecule provided with activity? anti-inflammatory and antioxidant.
Da un punto di vista biologico, la quercetina agisce come scavanger di radicali liberi, donando una coppia di elettroni attraverso o-chinone/chinone metile. From a biological point of view, quercetin acts as a free radical scavenger, donating an electron pair via o-quinone/methyl quinone.
La quercetina, una volta assunta, si ossida spontaneamente per formare O-semichinone e O-chinone / chinone methide (QQ), che pu? legarsi alle proteine tioli che formano composti tossici. Questo processo di effetti sia antiossidanti che proossidanti ? definito "quercetina paradosso ". Tuttavia, QQ pu? essere riciclato in quercetina da donatori di elettroni come NADH o ascorbato, o si formano insieme, con glutatione 6-glutationil-quercetina o 8-glutationilquercetina (GSQ). Quercetin, when taken, spontaneously oxidizes to form O-semiquinone and O-quinone / quinone methide (QQ), which can bind to protein thiols forming toxic compounds. Does this process have both antioxidant and prooxidant effects? termed "quercetin paradox". However, QQ can be recycled into quercetin by electron donors such as NADH or ascorbate, or are formed together, with glutathione 6-glutathionyl-quercetin or 8-glutathionylquercetin (GSQ).
Inoltre, la componente quercetina della composizione riducendo la risposta infiammatoria riduce l?edema e il dolore associato ai disturbi della prostata. In addition, the quercetin component of the composition by reducing the inflammatory response reduces edema and pain associated with prostate disorders.
La quercetina pu? essere presente nella composizione in un quantitativo che varia da 10 a 700mg, da 50 a 300mg, ad esempio 150mg per unit? di dosaggio. Quercetin can be present in the composition in a quantity ranging from 10 to 700mg, from 50 to 300mg, for example 150mg per unit? of dosage.
Secondo alcune forme di realizzazione, la composizione dell'invenzione contiene quercetina in un quantitativo compreso da 0,1 a 50% in peso, dall?1 a 40% in peso, da 5 a 30%, ad esempio il 20% in peso. According to some embodiments, the composition of the invention contains quercetin in an amount ranging from 0.1 to 50% by weight, from 1 to 40% by weight, from 5 to 30%, for example 20% by weight.
Un?altra componente della composizione ? rappresentata da Serenoa repens pianta appartenente alla famiglia delle Palmaceae. Another component of the composition? represented by Serenoa repens, a plant belonging to the Palmaceae family.
La composizione dell'invenzione pu? contenere Serenoa repens come tale, ad esempio una sua porzione o come estratto da una parte della pianta. The composition of the invention can contain Serenoa repens as such, for example a portion thereof or as an extract from a part of the plant.
Con l?uso della pianta si intende la pianta intera o una sua porzione contenente componenti biologicamente attiva. La pianta pu? essere utilizzata intera, macinata, o come estratto. Parti della pianta includono foglie, semi, frutti, radici o lo stelo/fusto. Preferibilmente parte utilizzata sono i frutti macinati, costituiti da bacche globose tipicamente di colore blu-nero a maturit?. The use of the plant means the whole plant or a portion thereof containing biologically active components. The plant can be used whole, ground, or as an extract. Parts of the plant include leaves, seeds, fruit, roots, or the stem/stem. Preferably the part used is the ground fruit, consisting of globular berries typically blue-black when ripe.
In alternativa ? possibile usare un estratto della pianta tipicamente i frutti (bacche). Le bacche possono essere pulite, essiccate e opzionalmente tagliate in pezzi o sminuzzate, macinate o polverizzate ed usate tal quali oppure ottenendo un estratto utilizzando metodi convenzionali. Alternatively ? It is possible to use an extract of the plant typically the fruits (berries). The berries can be cleaned, dried and optionally chopped or chopped, ground or pulverized and used as they are or obtained as an extract using conventional methods.
Preferibilmente l?estratto ? lipofilo ottenuto utilizzando un solvente organico. Preferably the extract? lipophilic obtained using an organic solvent.
Idonee tecniche di estrazione comprendono estrazione a fluido pressurizzato nota come PFE, estrazione Soxhlet, ad esempio con diclorometano e sonicazione. Nel caso di estrazione PFE, ? possibile usare un solvente organico ad esempio esano, acetone o loro miscela come una miscela di 4:1 (v/v) esano/acetone preferibilmente con estrazione a 4 ciclici statici a temperatura superiore a 100?C ad esempio 125?C e a 10.4 Mpa. La scelta del solvente, temperatura di estrazione e pressione di estrazione on incidono in maniera significativa sulla composizione dell?estratto la durata dell?estrazione ? preferibilmente di 30-45 ore, ad esempio 40 ore. E? possibile ottenere un idoneo estratto anche con estrazione con CO2 supercritica. Suitable extraction techniques include pressurized fluid extraction known as PFE, Soxhlet extraction, e.g. with dichloromethane, and sonication. In the case of PFE extraction, ? It is possible to use an organic solvent e.g. hexane, acetone or mixture thereof such as a mixture of 4:1 (v/v) hexane/acetone preferably with static 4-cycle extraction at a temperature above 100°C e.g. 125°C and at 10.4 Mpa . The choice of solvent, extraction temperature and extraction pressure do not significantly affect the composition of the extract the duration of the extraction ? preferably 30-45 hours, for example 40 hours. AND? It is possible to obtain a suitable extract also with extraction with supercritical CO2.
In alternativa l?estrazione pu? essere realizzata con idoneo solvente come un alcool come etanolo o una miscela idroalcolica ad esempio acqua-etanolo. Alternatively, the extraction pu? be made with a suitable solvent such as an alcohol such as ethanol or a hydroalcoholic mixture such as water-ethanol.
A titolo di esempio, il solvente idroalcolico pu? contenere dal 10% al 90% in volume di alcool, preferibilmente etanolo, preferibilmente dal 20% al 60% in volume, ancor preferibilmente dal 30% al 50% in volume, ad esempio il 40% in volume. By way of example, the hydroalcoholic solvent can? contain from 10% to 90% by volume of alcohol, preferably ethanol, preferably from 20% to 60% by volume, still preferably from 30% to 50% by volume, for example 40% by volume.
L?estrazione pu? essere fatta a freddo o a caldo, ad esempio a 40-70 gradi centigradi. The extraction can? be made cold or hot, for example at 40-70 degrees Celsius.
Il liquido estratto pu? essere filtrato se necessario. In una fase successiva l?estratto liquido ? essiccato per ottenere la componente biologicamente attiva in forma di polvere secca. L?essiccamento pu? essere realizzato con tecniche convenzionali ad esempio ad aria, riscaldamento o spray-drying. The extracted liquid can be filtered if necessary. In a subsequent phase, the liquid extract? dried to obtain the biologically active component in dry powder form. Drying can be made with conventional techniques such as air, heating or spray-drying.
Idonei metodi per ottenere l?estratto vegetale di Serenoa repens includono tecniche di estrazione mediante digestione, infusione, spremitura, decozione, percolazione, estrazione controcorrente, soxhlet, estrazione con gas supercritici o ultrasuoni. I La componente Serenoa repens riferita qui anche come S. repens, ha un effetto antiandrogeno, antinfiammatorio ed antiproliferativo. Suitable methods for obtaining Serenoa repens plant extract include extraction techniques by digestion, infusion, squeezing, decoction, percolation, countercurrent extraction, soxhlet, supercritical gas extraction or ultrasound. I The Serenoa repens component also referred to here as S. repens, has an antiandrogenic, anti-inflammatory and antiproliferative effect.
Vantaggiosamente S. repens contiene acido laurico e acido linoleico che inibiscono l?enzima 5 alfa reduttasi, determinando un?attivit? antiandrogena. Advantageously S. repens contains lauric acid and linoleic acid which inhibit the enzyme 5 alpha reductase, resulting in an activity? antiandrogen.
Si ? inoltre osservato che S repens riduce la formazione di citochine proinfiammatorie e l?espressione di CCR7, CXCL6, IL-6 e IL-17 ed inoltre inibisce alcune fasi della trasduzione del segnale del recettore della prolattina e conseguentemente inibisce la crescita della prostata indotta da prolattina. Yes ? It was also observed that S repens reduces the formation of proinflammatory cytokines and the expression of CCR7, CXCL6, IL-6 and IL-17 and also inhibits some steps of prolactin receptor signaling and consequently inhibits prolactin-induced prostate growth.
L?estratto di S repens ha un effetto anti-androgeno periferico, per interazione sul metabolismo del testosterone a livello prostatico, ed un effetto inibitorio su lipossigenasi e ciclossigenasi con conseguente azione antiinfiammatoria sinergica con le altre componenti della composizione. The S repens extract has a peripheral anti-androgenic effect, through interaction on the metabolism of testosterone in the prostate, and an inhibitory effect on lipoxygenase and cyclooxygenase with a consequent synergistic anti-inflammatory action with the other components of the composition.
Serenoa repens o un suo estratto possono essere presenti nella composizione in un quantitativo che varia da 5 al 50%, dal 10 al 40% dal 22 al 30%. Serenoa repens or an extract thereof may be present in the composition in a quantity ranging from 5 to 50%, from 10 to 40% and from 22 to 30%.
La combinazione di S repens con le componenti proteolitiche e la quercetina determina un effetto sinergico di riduzione dei biomarkers della infiammazione in particolare in pazienti con iperplasia prostatica benigna. The combination of S repens with the proteolytic components and quercetin determines a synergistic effect of reduction of the biomarkers of inflammation, particularly in patients with benign prostatic hyperplasia.
Secondo alcune forme di realizzazione, la composizione dell'invenzione comprende ulteriormente uno o pi? micronutrienti e/o minerali scelti tra zinco, selenio, rame, come tali o in forma salificata e loro miscele. According to some embodiments, the composition of the invention further comprises one or more? micronutrients and/or minerals selected from zinc, selenium, copper, as such or in salified form and mixtures thereof.
In accordo ad alcune forme di realizzazione, lo zinco ? in un quantitativo da 1 a 30 mg, da 5 a 20 mg ad esempio 12 mg; il rame ? in un quantitativo da 0,05 a 10 mg, da 0,5 a 5 mg, ad esempio 2 mg; il selenio in un quantitativo da 0,001 a 1 mg da 0,01 a 0, 2 ad esempio 0, 083 mg. According to some embodiments, zinc is in an amount from 1 to 30 mg, from 5 to 20 mg for example 12 mg; the copper ? in an amount of 0.05 to 10 mg, 0.5 to 5 mg, for example 2 mg; selenium in an amount of 0.001 to 1 mg 0.01 to 0.2 for example 0.083 mg.
E? preferito l?uso di una miscela di zinco, rame e selenio. La miscela di questi tre minerali agisce aumentando l?attivit? delle altre componenti della composizione. Lo zinco attiva la componente enzimatica comprendente bromelina e papaina, il rame agisce in maniera sinergica con lo zinco ed il selenio aumenta l?attivit? antiossidante ed antinfiammatoria della quercetina contribuendo a ridurre l?infiammazione della prostata ed il suo volume. AND? preferred the use of a mixture of zinc, copper and selenium. The mixture of these three minerals acts by increasing the activity? of the other components of the composition. Zinc activates the enzymatic component including bromelain and papain, copper acts synergistically with zinc and selenium increases the activity? antioxidant and anti-inflammatory of quercetin helping to reduce inflammation of the prostate and its volume.
Le componenti biologicamente attive contenute nella composizione dell?invenzione possono essere presenti in quantitativi variabili, ad esempio compresi da 1% in peso al 95% in peso, da 10% in peso al 90% in peso da 60 a 85% in peso rispetto al peso totale della composizione. The biologically active components contained in the composition of the invention can be present in variable quantities, for example ranging from 1% by weight to 95% by weight, from 10% by weight to 90% by weight, from 60 to 85% by weight with respect to the total weight of the composition.
In alcune forme di realizzazione, i componenti della composizione possono essere combinati o miscelati come principi attivi in miscela intima con un veicolo commestibile adatto e/o un eccipiente secondo le tecniche farmaceutiche e dell?industria alimentare o nutrizionale tradizionale. In some embodiments, the components of the composition may be combined or blended as active ingredients in intimate admixture with a suitable edible carrier and/or excipient according to conventional pharmaceutical and food or nutritional industry techniques.
La composizione dell'invenzione pu? assumere un'ampia variet? di forme di preparazione, secondo la via di somministrazione desiderata. The composition of the invention can take on a wide variety of preparation forms, according to the desired route of administration.
La composizione dell'invenzione pu? essere in forma solida. The composition of the invention can be in solid form.
Quando la composizione dell'invenzione ? presentata in forma solida, pu? essere sotto forma di una compressa, capsula, polvere, granuli, pastiglia da sciogliere in bocca e polvere. When is the composition of the invention ? presented in solid form, pu? be in the form of a tablet, capsule, powder, granule, lozenge and powder.
Preferibilmente la composizione e l?integratore che la contiene sono in forma di compresse per la somministrazione orale. Preferably the composition and the supplement containing it are in the form of tablets for oral administration.
La forma solida in forma di granuli o granulare pu? essere idonea ad essere sciolta in acqua al momento dell?assunzione. The solid form in the form of granules or granular can? be suitable to be dissolved in water at the time of use.
Le preparazioni in forma solida possono comprendere uno o pi? eccipienti/come ad esempio amidi, zuccheri, cellulosa microcristallina e opzionalmente diluenti, agenti di granulazione, lubrificanti, aggreganti, agenti di disintegrazione. The preparations in solid form can include one or more? excipients/such as starches, sugars, microcrystalline cellulose and optionally diluents, granulating agents, lubricants, binders, disintegrating agents.
Tipicamente la composizione in forma solida pu? contenere un agente aggregante come gomma adragante, gomma, amido di mais o gelatina; eccipienti come fosfato bicalcico; un agente di disintegrazione come amido di mais, fecola di patate, acido alginico; un lubrificante come magnesio stearato; un agente dolcificante come saccarosio, lattosio o saccarina. Se lo si desidera, le compresse possono essere rivestite usando tecniche tradizionali. Typically the composition in solid form can? contain a binding agent such as tragacanth, gum, cornstarch, or gelatin; excipients such as dicalcium phosphate; a disintegrating agent such as corn starch, potato starch, alginic acid; a lubricant such as magnesium stearate; a sweetening agent such as sucrose, lactose or saccharin. If desired, the tablets can be coated using traditional techniques.
In alcune forme di realizzazione la composizione ? un integratore in forma di capsula, ad esempio in gelatina che preferibilmente pu? contenere un agente antiagglomerante, ad esempio mono e digliceridi degli acidi grassi, Magnesio Stearato Vegetale, Biossido di silicio e uno o pi? agenti di carica ad esempio Calcio fosfato bibasico, Cellulosa microcristallina. In some embodiments the composition ? a supplement in capsule form, for example in gelatin which preferably can? contain an anti-caking agent, such as mono and diglycerides of fatty acids, vegetable magnesium stearate, silicon dioxide and one or more? bulking agents e.g. dibasic calcium phosphate, microcrystalline cellulose.
Secondo alcune forme di realizzazione, la composizione dell'invenzione contiene un eccipiente a base di cellulosa. According to some embodiments, the composition of the invention contains a cellulose-based excipient.
In alcune forme di realizzazione, la composizione dell'invenzione comprende inoltre uno o pi? componenti aggiuntivi come additivi, cariche, stabilizzanti, emulsionanti, texturizzanti, agenti filmogeni, plastificanti, agenti umettanti e addensanti. In some embodiments, the composition of the invention further comprises one or more? add-ons such as additives, fillers, stabilizers, emulsifiers, texturizers, film-forming agents, plasticizers, wetting agents and thickeners.
Preferibilmente la composizione ? in forma di compressa o capsula contenente gli estratti vegetali sopra descritti. Preferably the composition? in the form of a tablet or capsule containing the plant extracts described above.
Nel caso di compresse queste possono essere rivestite con gomma lacca, zucchero o entrambi. Per prevenire la rottura durante il transito attraverso la parte superiore del tratto gastrointestinale, la composizione pu? essere una formulazione con un rivestimento gastroresistente o enterico. In the case of tablets these may be coated with shellac, sugar or both. To prevent disruption during transit through the upper gastrointestinal tract, the composition can be a formulation with an enteric or enteric-coated coating.
Nella composizione o capsule possono anche esserci agenti aromatizzanti, conservanti, agenti coloranti e simili. In the composition or capsules there may also be flavoring agents, preservatives, coloring agents and the like.
Secondo alcune forme di realizzazione, la composizione ? in una forma per il rilascio modulato o controllato di ingredienti attivi. A titolo di esempio, la composizione pu? essere una formulazione a rilascio ritardato, a rilascio rapido o a rilascio lentoveloce. According to some embodiments, the composition is in a form for modulated or controlled release of active ingredients. As an example, the composition can? be a delayed-release, rapid-release, or fast-release formulation.
In alcune forme di realizzazione, la composizione dell'invenzione comprende come un eccipiente, un acido grasso idrogenato, preferibilmente avente una catena con da 3 a 20 atomi di carbonio, da 14 a 18 atomi di carbonio. Un tipico esempio di un acido grasso idrogenato ? olio di palma idrogenato. In some embodiments, the composition of the invention comprises as an excipient, a hydrogenated fatty acid, preferably having a chain with 3 to 20 carbon atoms, 14 to 18 carbon atoms. A typical example of a hydrogenated fatty acid ? hydrogenated palm oil.
La composizione dell'invenzione pu? essere in forma liquida. The composition of the invention can be in liquid form.
Quando la composizione ? in forma liquida, pu? essere sotto forma di sospensione, emulsione, soluzione. In questi casi il veicolo ? liquido e pu? essere selezionato ad esempio da acqua, glicoli, oli, alcool e relative miscele. Tipicamente la soluzione pu? contenere un agente dolcificante come saccarosio e/o metil e propil-parabeni come conservanti, un agente colorante e un aroma come fragola, ciliegia o arancia aromatizzanti. When the composition? in liquid form, can? be in the form of a suspension, emulsion, solution. In these cases the vehicle? liquid and can be selected for example from water, glycols, oils, alcohols and related mixtures. Typically the solution pu? contain a sweetening agent such as sucrose and/or methyl and propyl parabens as preservatives, a coloring agent and a flavoring such as strawberry, cherry or orange flavoring.
Le composizioni possono essere idoneamente presentate in un'unica forma farmaceutica e preparate usando uno qualsiasi dei metodi ben noti nello stato dell?arte farmaceutico o dietetico. The compositions may suitably be presented in a single pharmaceutical form and prepared using any of the methods well known in the pharmaceutical or dietetic state of the art.
In alcune forme di realizzazione, nelle composizioni della presente invenzione, gli ingredienti attivi sono normalmente formulati in un'unit? di dosaggio. L'unit? di dosaggio pu? contenere da 0,1 a 1.000 mg di ciascun ingrediente attivo per unit? di dosaggio per una somministrazione giornaliera. In some embodiments, in the compositions of the present invention, the active ingredients are normally formulated in a single unit. of dosage. The unit? of dosage can? contain 0.1 to 1,000 mg of each active ingredient per unit? dosage for a daily administration.
Il termine "veicolo" come utilizzato nella presente indica un mezzo, eccipiente, diluente con cui l'associazione di principi terapeutici o attivi ? somministrata. The term "vehicle" as used herein indicates a means, excipient, diluent with which the association of therapeutic or active principles? administered.
Qualsiasi veicolo e/o eccipiente adatto per la forma di preparazione desiderata per la somministrazione ad essere umani ? contemplato per l'uso con i composti descritti nella presente invenzione. Any vehicles and/or excipients suitable for the desired preparation form for administration to humans? contemplated for use with the compounds disclosed in the present invention.
Un veicolo fisiologicamente accettabile o edibile pu? essere un veicolo farmaceuticamente accettabile. A physiologically acceptable or edible vehicle can? be a pharmaceutically acceptable vehicle.
Con il termine di edibile si intende una sostanza solida o liquida fisiologicamente accettabile e commestibile che pu? essere assimilato dal corpo umano la cui assunzione dall?uomo ? approvate dalle autorit? preposte ad esempio EFSA per l'uso nelle applicazioni farmaceutiche, nutrizionali o alimentari. The term edible means a physiologically acceptable and edible solid or liquid substance that can be assimilated by the human body whose intake by? man ? approved by the authorities? approved for example by EFSA for use in pharmaceutical, nutritional or food applications.
Il veicolo, diluente o eccipiente fisiologicamente o farmaceuticamente e/o fisiologicamente accettabile pu? essere scelto in base alla via di somministrazione per cui ? intesa la risultante composizione farmaceutica. The physiologically or pharmaceutically and/or physiologically acceptable carrier, diluent or excipient may be chosen on the basis of the route of administration for which ? intended the resulting pharmaceutical composition.
Nell?ambito della presente domanda con il termine di combinazione si intende che uno o pi? principi attivi sono addizionati o miscelati con uno o altri ingredienti per dare la formulazione dell?invenzione. In the context of this application, the term combination means that one or more? active ingredients are added or mixed with one or other ingredients to give the formulation of the invention.
Secondo un altro aspetto viene fornito un integratore, un prodotto nutrizionale, o un fitoterapico contenente la composizione secondo una qualsiasi delle forme di realizzazione qui riportate. According to another aspect, a supplement, a nutritional product, or a phytotherapeutic product is provided containing the composition according to any of the embodiments reported herein.
In accordo ad alcune forme di realizzazione la composizione per la somministrazione orale ? un alimento funzionale, una composizione nutraceutica, un prodotto dietetico, un complemento o prodotto nutrizionale. According to some embodiments the composition for oral administration is a functional food, a nutraceutical composition, a dietetic product, a complement or nutritional product.
Alimento funzionale significa un qualsiasi alimento o ingrediente alimentare modificato che pu? fornire un beneficio o protezione contro un inconveniente o una affezione fisiologica, oltre ai nutrienti tradizionali che esso contiene. Functional food means any food or modified food ingredient that can provide a benefit or protection against an inconvenience or a physiological disease, in addition to the traditional nutrients it contains.
Prodotto nutraceutico significa un prodotto isolato o purificato da sostanze commestibili. Un nutraceutico ? tale quando si dimostra che possiede un beneficio fisiologico o che fornisce protezione contro un inconveniente o disordine fisiologico. Integratore dietetico o alimentare significa un prodotto che contiene una vitamina, minerale, estratto vegetale, aminoacido, metabolita, estratto, concentrato o miscele di questi ingredienti. Nutraceutical product means a product isolated or purified from edible substances. A nutraceutical? such when it is shown to possess a physiological benefit or to provide protection against a physiological inconvenience or disorder. Dietary or dietary supplement means a product that contains a vitamin, mineral, plant extract, amino acid, metabolite, extract, concentrate, or mixtures of these ingredients.
Il quantitativo somministrato e la frequenza della somministrazione della composizione dipendono dalla natura e gravit? della affezione da trattare. The amount administered and the frequency of administration of the composition depend on the nature and severity of the composition. of the condition to be treated.
I seguenti esempi sono forniti principalmente per illustrare la presente invenzione e non intendono limitare il campo di protezione come risulta dalle accluse rivendicazioni. The following examples are provided primarily to illustrate the present invention and are not intended to limit the field of protection as is apparent from the appended claims.
ESEMPIO 1 EXAMPLE 1
Integratore alimentare in forma di compressa per il trattamento di disturbi della prostata e/o urologici avente la seguente formulazione: Food supplement in tablet form for the treatment of prostate and/or urological disorders with the following formulation:
Claims (9)
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20010025059A1 (en) * | 2000-01-10 | 2001-09-27 | Kastke Floyd A. | Composition and method for treating non-bacterial prostatitis |
| US20080031940A1 (en) * | 2006-08-02 | 2008-02-07 | Al Rodriguez | Quercetin-containing composition, methods of making, and methods of using |
| WO2018025129A1 (en) * | 2016-08-03 | 2018-02-08 | Neilos S.r.l. | Pharmaceutical composition for use in the treatment of prostate pathologies |
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2021
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20010025059A1 (en) * | 2000-01-10 | 2001-09-27 | Kastke Floyd A. | Composition and method for treating non-bacterial prostatitis |
| US20080031940A1 (en) * | 2006-08-02 | 2008-02-07 | Al Rodriguez | Quercetin-containing composition, methods of making, and methods of using |
| WO2018025129A1 (en) * | 2016-08-03 | 2018-02-08 | Neilos S.r.l. | Pharmaceutical composition for use in the treatment of prostate pathologies |
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