IT202000004582A1 - PHARMACEUTICAL COMPOSITION USEFUL FOR THE TREATMENT AND PREVENTION OF ATROPHY AND VAGINAL DRYNESS. - Google Patents
PHARMACEUTICAL COMPOSITION USEFUL FOR THE TREATMENT AND PREVENTION OF ATROPHY AND VAGINAL DRYNESS. Download PDFInfo
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- IT202000004582A1 IT202000004582A1 IT102020000004582A IT202000004582A IT202000004582A1 IT 202000004582 A1 IT202000004582 A1 IT 202000004582A1 IT 102020000004582 A IT102020000004582 A IT 102020000004582A IT 202000004582 A IT202000004582 A IT 202000004582A IT 202000004582 A1 IT202000004582 A1 IT 202000004582A1
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/02—Drugs for genital or sexual disorders; Contraceptives for disorders of the vagina
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- 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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
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- 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
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K31/716—Glucans
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- 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
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K31/726—Glycosaminoglycans, i.e. mucopolysaccharides
- A61K31/728—Hyaluronic acid
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- 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)
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- 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)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/886—Aloeaceae (Aloe family), e.g. aloe vera
Description
Descrizione del brevetto per invenzione avente per titolo: Description of the patent for an invention entitled:
?COMPOSIZIONE FARMACEUTICA UTILE PER IL TRATTAMENTO E LA PREVENZIONE DELL?ATROFIA E DELLA SECCHEZZA VAGINALE? ? PHARMACEUTICAL COMPOSITION USEFUL FOR THE TREATMENT AND PREVENTION OF ATROPHY AND VAGINAL DRYNESS?
Oggetto dell?Invenzione Object of the Invention
? descritta una composizione per uso topico in forma di gel, idrogel, crema, ovuli e/o schiuma vaginale, comprendenti un estratto oleoso di Hippopha? rhamnoides (olivello spinoso), insieme con eccipienti farmaceuticamente accettabili, utile per la prevenzione e il trattamento dell?atrofia e della secchezza vaginale. ? disclosed a composition for topical use in the form of a gel, hydrogel, cream, ovules and / or vaginal foam, comprising an oily extract of Hippopha? rhamnoides (sea buckthorn), together with pharmaceutically acceptable excipients, useful for the prevention and treatment of vaginal atrophy and dryness.
? descritto anche un processo per l?ottenimento di tale composizione. ? a process for obtaining this composition is also described.
Stato dell?arte State of the art
I corpi delle donne subiscono molti cambiamenti nel tempo, dalla pubert? agli anni fertili, alla post-menopausa. Il livello di ormoni nel corpo oscilla durante questi periodi e la produzione di estrogeni, testosterone e progesterone cambia. Le donne possono manifestare sintomi come: cicli mestruali irregolari, vampate di calore, insonnia, sudorazione notturna, irregolarit? del sonno, confusione, malumore, affaticamento, alterazioni dell'umore, secchezza vaginale, dolore vaginale, urgenza urinaria, disagio durante i rapporti sessuali, tenerezza del seno, basso desiderio sessuale e perdita di densit? ossea. Do women's bodies undergo many changes over time, from puberty? to the fertile years, to the post-menopause. The level of hormones in the body fluctuates during these times and the production of estrogen, testosterone and progesterone changes. Women can experience symptoms such as: irregular menstrual cycles, hot flashes, insomnia, night sweats, irregularity. sleep, confusion, moodiness, fatigue, mood changes, vaginal dryness, vaginal pain, urinary urgency, discomfort during intercourse, breast tenderness, low sex drive and loss of density. bone.
? Un problema comune che si verifica durante i periodi di oscillazione ormonale ? la secchezza dei tessuti. Questa secchezza pu? verificarsi nel tessuto epiteliale di qualsiasi parte del corpo, anche se ? un problema particolarmente rilevante nei tessuti delicati e sensibili come il seno, la vulva, la vagina, le labbra e il viso. ? A common problem that occurs during periods of hormone fluctuation? dryness of the tissues. This dryness can? occur in the epithelial tissue of any part of the body, even if? a particularly relevant problem in delicate and sensitive tissues such as the breasts, vulva, vagina, lips and face.
Sebbene si verifichino cambiamenti ormonali nel corso della vita, le donne sperimentano quelli maggiori durante la perimenopausa e la menopausa. La perimenopausa ? il periodo di tempo che intercorre prima che una donna raggiunga la menopausa durante il quale il corpo femminile subisce una transizione nella produzione di ormoni e in altre funzioni biologiche correlate alla perdita di fertilit?. Mentre per la maggior parte delle donne la perimenopausa inizia intorno ai quaranta anni, per alcune pu? iniziare gi? alla fine dei trenta anni. L'et? media per raggiungere la menopausa ? di circa cinquantadue anni ma, in alcuni casi, la perimenopausa pu? durare anche pi? di dieci anni. Although hormonal changes occur throughout life, women experience major changes during perimenopause and menopause. Perimenopause? the period of time before a woman reaches menopause during which the female body undergoes a transition in hormone production and other biological functions related to the loss of fertility. While for most women, perimenopause begins around the age of forty, for some it may be. start already? at the end of his thirties. The age? average to reach menopause? of about fifty-two years but, in some cases, perimenopause can? last even more? ten years old.
Mentre per atrofia vaginale si intende soprattutto la problematica tipica della donna di et? avanzata dovuto alla menopausa, la secchezza vaginale ? un problema che accomuna anche donne in et? fertile, tanto che si stima che ne possa soffrire circa il 15% (Edwards, D. et al. in Climacteric, 19 (2), 151-61, 2016). While by vaginal atrophy we mean above all the typical problem of the woman of age? advanced due to menopause, vaginal dryness? a problem that also unites women of age? fertile, so much so that it is estimated that about 15% can suffer from it (Edwards, D. et al. in Climacteric, 19 (2), 151-61, 2016).
Sia l?atrofia che la secchezza vaginale provocano dolore e disagio, bruciore e secrezione vaginale; prurito genitale; bruciore o urgenza correlate alla minzione; disagio durante e lieve sanguinamento dopo il rapporto sessuale; riduzione della lubrificazione vaginale durante l'attivit? sessuale; accorciamento e irrigidimento del canale vaginale; convulsioni muscolari del pavimento pelvico; e chiusura atrofica della vagina incluso cicatrici e prolasso d?organo attraverso la vagina. Both vaginal atrophy and dryness cause pain and discomfort, burning and vaginal discharge; genital itching; burning or urgency related to urination; discomfort during and slight bleeding after intercourse; reduction of vaginal lubrication during activity? sexual; shortening and tightening of the vaginal canal; pelvic floor muscle seizures; and atrophic closure of the vagina including scarring and organ prolapse through the vagina.
? Per alleviare alcuni dei sintomi causati dalle oscillazioni ormonali, spesso sono somministrati trattamenti ormonali, come cerotti contenenti ormoni a lento rilascio. ? noto in letteratura che mentre la terapia ormonale sostitutiva pu? ridurre alcuni sintomi, come vampate di calore, sudorazione e cambiamenti dell'umore, ? meno efficace nel trattamento dei sintomi connessi all?atrofia e alla secchezza vaginale e vulvare. ? To relieve some of the symptoms caused by hormone fluctuations, hormone treatments, such as patches containing slow-release hormones, are often given. ? known in the literature that while hormone replacement therapy can? reduce some symptoms, such as hot flashes, sweating and mood changes,? less effective in treating symptoms related to vaginal and vulvar atrophy and dryness.
Mitchell CM et al. in JAMA, Intern. Med 178 (5), 681-690, 2018 descrive l?efficacia dell?estradiolo per trattare i sintomi connessi con la vulvo vaginosi nella postmenopausa. Mitchell CM et al. in JAMA, Intern. Med 178 (5), 681-690, 2018 describes the efficacy of estradiol to treat symptoms associated with postmenopausal vulvo vaginosis.
C?? sempre maggiore interesse per l?uso di prodotti naturali per il trattamento della secchezza vaginale, ma non possono essere utilizzati prodotti di origine animale per la difficolt? di utilizzarli nell?uomo. Un altro aspetto importante da considerare ? che i prodotti utilizzati a livello topico devono essere efficaci per portare e mantenere il pH a valori minori di 6 per prevenire infezioni batteriche. C ?? increasing interest in the use of natural products for the treatment of vaginal dryness, but products of animal origin cannot be used due to the difficulty? to use them in humans. Another important aspect to consider? that the products used topically must be effective to bring and maintain the pH below 6 to prevent bacterial infections.
WO 2018/191296 A1 descrive composizioni in crema per la cura della pelle comprendenti sodio ialuronato e un estratto solido (polvere) di Hippopha? rhamnoides (olivello spinoso), prive di acqua e alcol. Sono descritti anche ovuli vaginali per il trattamento della secchezza vaginale, ed ? descritto l?effetto di tali ovuli somministrati a pazienti affette da secchezza vaginale dovuta a radioterapia. WO 2018/191296 A1 discloses skin care cream compositions comprising sodium hyaluronate and a solid extract (powder) of Hippopha? rhamnoides (sea buckthorn), free from water and alcohol. Vaginal pessaries are also described for the treatment of vaginal dryness, and? described the effect of these eggs administered to patients suffering from vaginal dryness due to radiotherapy.
WO 2020/006191 A1 descrive emulsioni contenenti molti ingredienti tra cui sodio ialuronato, Aloe vera e gomma xantana per il trattamento della secchezza e pi? in generale dell?atrofia vaginale. WO 2020/006191 A1 discloses emulsions containing many ingredients including sodium hyaluronate, Aloe vera and xanthan gum for the treatment of dryness and more. in general of vaginal atrophy.
CN 108853311 descrive una composizione in gel contenente molti componenti naturali tra cui Aloe vera e olio di semi di un estratto oleoso di Hippopha? rhamnoides (olivello spinoso) per il trattamento di disturbi vaginali quali secchezza e bruciore CN 108853311 describes a gel composition containing many natural components including Aloe vera and seed oil of an oily extract of Hippopha? rhamnoides (sea buckthorn) to treat vaginal disorders such as dryness and burning
? vaginale. Il documento non riporta quali siano i componenti essenziali per ottenere una composizione efficace. ? vaginal. The document does not mention what are the essential components to obtain an effective composition.
CN 101485702 descrive composizioni in forma di ovuli vaginali contenenti estratto di Hippopha? rhamnoides (olivello spinoso) e polifenoli del t? per il trattamento di affezioni dell?apparato genitale, in particolare vaginiti. Non sono riportati dati che dimostrano l?efficacia delle composizioni descritte. CN 101485702 discloses compositions in the form of vaginal ovules containing Hippopha extract? rhamnoides (sea buckthorn) and polyphenols of tea? for the treatment of affections of the genital system, in particular vaginitis. There are no data showing the efficacy of the compositions described.
Larmo et al. (Maturitas 79, 2014; 316?321) descrive uno studio clinico randomizzato in doppio cieco su 116 donne per il trattamento dell?atrofia vaginale in cui sono state somministrate composizioni in forma di capsule contenenti 3 g/die di olio di un estratto oleoso di Hippopha? rhamnoides (olivello spinoso) per un periodo di 90 giorni in confronto al placebo. Le pazienti riportano un significativo miglioramento dei sintomi, ma le composizioni sono poco accettate per gli effetti indesiderati all?apparato gastrointestinale. Larmo et al. (Maturitas 79, 2014; 316? 321) describes a randomized double-blind clinical study of 116 women for the treatment of vaginal atrophy in which capsule compositions containing 3 g / day of an oily extract of Hippopha? rhamnoides (sea buckthorn) for a period of 90 days compared to placebo. Patients report a significant improvement in symptoms, but the compositions are poorly accepted for gastrointestinal side effects.
Oltre alle donne in menopausa, perimenopausa, gravidanza o allattamento, anche pazienti sottoposte ad interventi chirurgici all?apparato genitale, o che sono o sono state trattate con chemioterapici o sottoposte a trattamenti radioterapici, o che hanno patologie come IBS o diabete, o che fanno uso di antidepressivi possono avere disturbi connessi con l?atrofia vaginale vulvare. In addition to women in menopause, perimenopause, pregnancy or breastfeeding, also patients who have undergone surgery on the genital system, or who are or have been treated with chemotherapy or radiotherapy treatments, or who have diseases such as IBS or diabetes, or who have use of antidepressants can have disorders associated with vulvar vaginal atrophy.
C?? quindi il bisogno di avere a disposizione nuove composizioni farmaceutiche efficaci nel trattamento dell?atrofia e della secchezza vaginale e che siano prive di ormoni. ? anche importante che le composizioni siano ben accettate dalle pazienti, in una forma farmaceutica che consenta una facile applicazione e una somministrazione limitata ad un massimo di una volta al giorno in modo da non condizionare il normale C ?? hence the need to have available new pharmaceutical compositions that are effective in the treatment of vaginal atrophy and dryness and that are hormone-free. ? It is also important that the compositions are well accepted by patients, in a pharmaceutical form that allows easy application and administration limited to a maximum of once a day so as not to affect the normal
? svolgimento delle attivit? quotidiane. Inoltre, ? necessario che la somministrazione di tali composizioni non abbia effetti collaterali. ? carrying out the activities? daily. Furthermore, ? it is necessary that the administration of such compositions does not have side effects.
? stato trovato che una composizione comprendente un estratto oleoso di Hippopha? rhamnoides (olivello spinoso) in una quantit? da 0,1% al 5,0% (p/v), acido ialuronico da 0,1% a 5,0% (p/v), acido glicirretico da 0,1% a 5,0% (p/v), glicogeno da 0,1% a 5,0% (p/v) e Aloe vera da 0,1% a 5,0% (p/v) ? efficace nel trattamento e nella prevenzione dell?atrofia e della secchezza vaginale, non ha effetti collaterali ed ? ben accettata dalle pazienti e pu? essere associata con altre terapie concomitanti. ? it has been found that a composition comprising an oily extract of Hippopha? rhamnoides (sea buckthorn) in a quantity? 0.1% to 5.0% (w / v), hyaluronic acid 0.1% to 5.0% (w / v), glycyrrhetic acid 0.1% to 5.0% (w / v ), glycogen from 0.1% to 5.0% (w / v) and Aloe vera from 0.1% to 5.0% (w / v)? effective in the treatment and prevention of vaginal atrophy and dryness, it has no side effects and? well accepted by patients and can? be associated with other concomitant therapies.
Sommario dell?invenzione Summary of the invention
? descritta una composizione comprendente un estratto oleoso di Hippopha? rhamnoides (olivello spinoso) in una quantit? da 0,1% al 5,0% (p/v), acido ialuronico da 0,1% a 5,0% (p/v), acido glicirretico da 0,1% a 5,0% (p/v), glicogeno da 0,1% a 5,0% (p/v) e Aloe vera da 0,1% a 5,0% (p/v), rispetto al volume della composizione finita. ? disclosed a composition comprising an oily extract of Hippopha? rhamnoides (sea buckthorn) in a quantity? 0.1% to 5.0% (w / v), hyaluronic acid 0.1% to 5.0% (w / v), glycyrrhetic acid 0.1% to 5.0% (w / v ), glycogen from 0.1% to 5.0% (w / v) and Aloe vera from 0.1% to 5.0% (w / v), relative to the volume of the finished composition.
La composizione pu? comprende uno o pi? componenti in una quantit? da 0,6% al 30,0% (p/v), uno o pi? agenti emollienti in una quantit? da 0,5% a 5,0% (p/v), uno o pi? agenti bioadesivi in una quantit? da 1,0% a 5,0% (p/v), uno o pi? agenti antiossidanti da 0,1% a 5,0% (p/v), uno o pi? agenti tamponanti da 0,01% a 5,0% (p/v), uno o pi? agenti solubilizzanti da 0,5% a 3,0% (p/v) rispetto alla composizione finita, in cui il rimanente ? dato da acqua per preparazioni farmaceutiche. The composition can? includes one or more? components in a quantity? from 0.6% to 30.0% (w / v), one or more? emollient agents in a quantity? from 0.5% to 5.0% (w / v), one or more? bioadhesive agents in a quantity? from 1.0% to 5.0% (w / v), one or more? antioxidant agents from 0.1% to 5.0% (w / v), one or more? buffering agents from 0.01% to 5.0% (w / v), one or more? solubilizing agents from 0.5% to 3.0% (w / v) with respect to the finished composition, wherein the remainder? given by water for pharmaceutical preparations.
? descritto un processo per la preparazione di una composizione per uso topico comprendente gli stadi di: ? described a process for the preparation of a composition for topical use comprising the steps of:
a) preparare una soluzione idrofila aggiungendo ad un volume di acqua da 500 a 800 ml ad una temperatura compresa tra 50 e 80?C, acido ialuronico da 0,1% a a) prepare a hydrophilic solution by adding to a volume of water from 500 to 800 ml at a temperature between 50 and 80 ° C, hyaluronic acid from 0.1% to
? 5,0% (p/v), acido glicirretico da 0,1% a 5,0% (p/v), Aloe vera da 0,1% a 5,0% (p/v), glicogeno da 0,1% a 5,0% (p/v) e uno o pi? eccipienti scelti nel gruppo comprendente agenti bioadesivi, antiossidanti e preservanti; ? 5.0% (w / v), glycyrrhetic acid 0.1% to 5.0% (w / v), Aloe vera 0.1% to 5.0% (w / v), glycogen 0, 1% to 5.0% (w / v) and one or more? excipients selected from the group comprising bioadhesive agents, antioxidants and preservatives;
b) preparare una miscela lipofila mescolando ad una temperatura tra 50 e 80?C, uno o pi? eccipienti scelti nel gruppo comprendente agenti emollienti, solubilizzanti, emulsionanti e antiossidanti; b) prepare a lipophilic mixture by mixing at a temperature between 50 and 80 ° C, one or more? excipients selected from the group comprising emollient, solubilizing, emulsifying and antioxidant agents;
c) aggiungere la miscela lipofila ottenuta dallo stadio b) alla miscela idrofila ottenuta dallo stadio a) sotto agitazione; c) adding the lipophilic mixture obtained from step b) to the hydrophilic mixture obtained from step a) under stirring;
d) portare la temperatura dell?emulsione ottenuta dallo stadio c) ad una temperatura tra 25?C e 35?C, aggiungere un estratto oleoso di Hippopha? rhamnoides (olivello spinoso) in una quantit? da 0,1% a 5,0% (p/v) e acido lattico in una quantit? da 0,1% a 5,0% (p/v); d) bring the temperature of the emulsion obtained from step c) to a temperature between 25 ° C and 35 ° C, add an oily extract of Hippopha? rhamnoides (sea buckthorn) in a quantity? from 0.1% to 5.0% (w / v) and lactic acid in an amount? from 0.1% to 5.0% (w / v);
e) regolare il pH ad un valore tra 4,0 e 4,5. e) adjust the pH to a value between 4.0 and 4.5.
La composizione comprendente un estratto oleoso di Hippopha? rhamnoides (olivello spinoso) in una quantit? da 0,1% al 5,0% (p/v), acido ialuronico da 0,1% a 5,0% (p/v), acido glicirretico da 0,1% a 5,0% (p/v), glicogeno da 0,1% a 5,0% (p/v), Aloe vera da 0,1% a 5,0% (p/v) e acido lattico da 0,1% a 5,0% (p/v) ? utile nel trattamento e/o nella prevenzione dell?atrofia e della secchezza vaginale. The composition comprising an oily extract of Hippopha? rhamnoides (sea buckthorn) in a quantity? 0.1% to 5.0% (w / v), hyaluronic acid 0.1% to 5.0% (w / v), glycyrrhetic acid 0.1% to 5.0% (w / v ), glycogen from 0.1% to 5.0% (w / v), Aloe vera from 0.1% to 5.0% (w / v) and lactic acid from 0.1% to 5.0% ( p / v)? useful in the treatment and / or prevention of vaginal atrophy and dryness.
La composizione ? utile per essere compresa in un dispositivo medico. The composition ? useful to be included in a medical device.
La composizione pu? essere compresa in kit. The composition can? be included in the kit.
Descrizione dell?Invenzione Description of the Invention
La presente invenzione descrive una composizione comprendente un estratto oleoso di Hippopha? rhamnoides (olivello spinoso) per uso nel trattamento dell?atrofia e della secchezza vaginale. The present invention describes a composition comprising an oily extract of Hippopha? rhamnoides (sea buckthorn) for use in the treatment of vaginal atrophy and dryness.
? Le bacche di olivello spinoso, pianta tipica delle regioni europee, caucasiche e asiatiche sono ricche di composti ad alto potere nutrizionale: acidi grassi insaturi, omega 9, omega 7 (acido palmitoleico), omega 6 (GLA), omega 3, vitamina C, carotenoidi (carotene, licopene), vitamina E, acido folico e flavonoidi. ? Sea buckthorn berries, a typical plant of the European, Caucasian and Asian regions, are rich in compounds with high nutritional power: unsaturated fatty acids, omega 9, omega 7 (palmitoleic acid), omega 6 (GLA), omega 3, vitamin C, carotenoids (carotene, lycopene), vitamin E, folic acid and flavonoids.
Insieme con un estratto oleoso di olivello spinoso, la composizione pu? comprendere altri componenti come acido ialuronico, acido glicirretico, glicogeno e Aloe vera o loro miscele. Together with an oily extract of sea buckthorn, the composition can? include other components such as hyaluronic acid, glycyrrhetic acid, glycogen and Aloe vera or their mixtures.
L?acido ialuronico ? un glicosamminoglicano non solforato e privo di core proteico, dalla catena polisaccaridica non ramificata prodotta dalla condensazione di migliaia di unit? disaccaridiche formate a loro volta da residui di acido glucuronico e N-acetilglucosammina legati tra di loro alternativamente da legami glicosidici ?1?4 e ?1?3, nonch? da legami a idrogeno intramolecolari, che ne stabilizzano le conformazioni. A pH fisiologico, i gruppi carbossilici delle unit? glucuroniche sono ionizzati, conferendo alla molecola di acido ialuronico elevata polarit?, e un?elevata solubilit? in acqua. Grazie a questa sua propriet?, l?acido ialuronico ? in grado di complessarsi con moltissime molecole di acqua raggiungendo un elevato grado di idratazione. Hyaluronic acid? a non-sulphured glycosaminoglycan without a protein core, from the unbranched polysaccharide chain produced by the condensation of thousands of units? disaccharides formed in turn by residues of glucuronic acid and N-acetylglucosamine linked together alternately by glycosidic bonds? 1? 4 and? 1? 3, as well as? by intramolecular hydrogen bonds, which stabilize its conformations. At physiological pH, the carboxyl groups of the units? glucuronics are ionized, giving the hyaluronic acid molecule high polarity, and a high solubility. in water. Thanks to this property, hyaluronic acid? able to complex with many water molecules reaching a high degree of hydration.
L?acido glicirretico o enoxolone, o acido 18-?-glicirretico, ? un acido organico triterpenico pentaciclico, derivato dalle beta-amirine, ottenuto dall'idrolisi dell'acido glicirrizico, che viene estratto dalla liquirizia ed ha azione emolliente e antiflogistica. L? Glycyrrhetic acid or enoxolone, or 18 -? - glycyrrhetic acid,? a pentacyclic organic triterpene acid, derived from beta-amirines, obtained from the hydrolysis of glycyrrhizic acid, which is extracted from licorice and has an emollient and anti-inflammatory action.
Il glicogeno ? un polimero (omopolimero) del glucosio ed ? utile per la sua attivit? prebiotica per la flora batterica. Glycogen? a polymer (homopolymer) of glucose and d? useful for his business? prebiotic for bacterial flora.
L?Aloe vera ? una pianta succulenta della famiglia delle Aloeaceae. Il succo delle foglie di Aloe vera ? un succo mucillaginoso ottenuto dai tessuti parenchimatici Aloe vera? a succulent plant from the Aloeaceae family. The juice of Aloe vera leaves? a mucilaginous juice obtained from parenchymal tissues
? delle foglie di Aloe barbadensis Miller, comunemente conosciuta come Aloe vera. L?Aloe vera, come altre piante succulenti, per poter vivere in aree geografiche con poca disponibilit? d?acqua ha sviluppato un sistema tissutale in grado di immagazzinarne grandi quantit?. Il contenuto medio di acqua in una pianta di Aloe vera pu? variare dal 99 al 99,5%, mentre il restante 0,5-1% di materiale solido contiene pi? di 75 composti inclusi polisaccaridi, vitamine liposolubili e idrosolubili e altri agenti antiossidanti. ? of the leaves of Aloe barbadensis Miller, commonly known as Aloe vera. Aloe vera, like other succulent plants, to be able to live in geographic areas with little availability? d? water has developed a tissue system capable of storing large quantities. The average water content in an Aloe vera plant can be? vary from 99 to 99.5%, while the remaining 0.5-1% of solid material contains pi? of 75 compounds including polysaccharides, fat-soluble and water-soluble vitamins and other antioxidant agents.
L?acido lattico a pH fisiologico ? in forma di ione lattato. Lactic acid at physiological pH? in the form of lactate ion.
L?acido lattico nella vagina mantiene il pH acido (circa 4,5), utile per mantenere una condizione di eubiosi. Lactic acid in the vagina maintains the acidic pH (about 4.5), which is useful for maintaining a condition of eubiosis.
La composizione dell?invenzione ? in forma di gel, idrogel, crema, ovuli e/o schiuma per uso topico. The composition of the invention? in the form of gel, hydrogel, cream, pessary and / or foam for topical use.
La composizione dell?invenzione ? in forma di gel, idrogel, crema, ovuli e/o schiuma per uso vaginale. The composition of the invention? in the form of gel, hydrogel, cream, pessary and / or foam for vaginal use.
La composizione comprende almeno un composto scelto tra un estratto oleoso di Hippopha? rhamnoides (olivello spinoso), acido ialuronico, acido glicirretico, glicogeno, acido lattico, Aloe vera e/o loro miscele ad una concentrazione da 0,6% al 30,0% (p/v) rispetto al volume della composizione finita, in cui il rimanente ? dato da acqua per preparazioni farmaceutiche. Does the composition include at least one compound selected from an oily extract of Hippopha? rhamnoides (sea buckthorn), hyaluronic acid, glycyrrhetic acid, glycogen, lactic acid, Aloe vera and / or their mixtures at a concentration from 0.6% to 30.0% (w / v) with respect to the volume of the finished composition, in which the remaining? given by water for pharmaceutical preparations.
La composizione acquosa comprende un estratto oleoso di Hippopha? rhamnoides (olivello spinoso) in una quantit? da 0,1% al 5,0% (p/v), acido ialuronico da 0,1% a 5,0% (p/v), acido glicirretico da 0,1% a 5,0% (p/v), glicogeno da 0,1% a 5,0% (p/v) e Aloe vera da 0,1% a 5,0% (p/v), rispetto al volume della composizione finita. Does the aqueous composition include an oily extract of Hippopha? rhamnoides (sea buckthorn) in a quantity? 0.1% to 5.0% (w / v), hyaluronic acid 0.1% to 5.0% (w / v), glycyrrhetic acid 0.1% to 5.0% (w / v ), glycogen from 0.1% to 5.0% (w / v) and Aloe vera from 0.1% to 5.0% (w / v), relative to the volume of the finished composition.
? La composizione comprende un estratto oleoso di Hippopha? rhamnoides (olivello spinoso) in una quantit? da 0,1% al 5,0% (p/v), acido ialuronico da 0,1% a 5,0% (p/v), acido glicirretico, da 0,1% a 5,0% (p/v), glicogeno da 0,1% a 5,0% (p/v), Aloe vera da 0,1% a 5,0% (p/v) e acido lattico da 0,1% a 5,0% (p/v) rispetto al volume della composizione finita. ? Does the composition include an oily extract of Hippopha? rhamnoides (sea buckthorn) in a quantity? 0.1% to 5.0% (w / v), hyaluronic acid 0.1% to 5.0% (w / v), glycyrrhetic acid, 0.1% to 5.0% (w / v), glycogen from 0.1% to 5.0% (w / v), Aloe vera from 0.1% to 5.0% (w / v) and lactic acid from 0.1% to 5.0% (w / v) relative to the volume of the finished composition.
La composizione pu? anche comprendere uno o pi? agenti emollienti in una quantit? da 0,5% a 5,0% (p/v), uno o pi? agenti bioadesivi in una quantit? da 1,0% a 5,0% (p/v), uno o pi? agenti antiossidanti da 0,1% a 5,0% (p/v), rispetto alla composizione finita, in cui il componente rimanente ? dato da acqua per preparazioni farmaceutiche. The composition can? also include one or more? emollient agents in a quantity? from 0.5% to 5.0% (w / v), one or more? bioadhesive agents in a quantity? from 1.0% to 5.0% (w / v), one or more? antioxidant agents from 0.1% to 5.0% (w / v), relative to the finished composition, in which the remaining component? given by water for pharmaceutical preparations.
La composizione comprende un estratto oleoso di Hippopha? rhamnoides (olivello spinoso), acido ialuronico, acido glicirretico, glicogeno, Aloe vera e acido lattico, in una quantit? da 0,6% a 30,0% (p/v), uno o pi? agenti emollienti in una quantit? da 0,5% a 5,0% (p/v), uno o pi? agenti bioadesivi in una quantit? da 1,0% a 5,0% (p/v), uno o pi? agenti antiossidanti da 0,1% a 5,0% (p/v) rispetto al volume della composizione finita, in cui il componente rimanente ? dato da acqua per preparazioni farmaceutiche. Does the composition include an oily extract of Hippopha? rhamnoides (sea buckthorn), hyaluronic acid, glycyrrhetic acid, glycogen, Aloe vera and lactic acid, in a quantity? from 0.6% to 30.0% (w / v), one or more? emollient agents in a quantity? from 0.5% to 5.0% (w / v), one or more? bioadhesive agents in a quantity? from 1.0% to 5.0% (w / v), one or more? antioxidant agents from 0.1% to 5.0% (w / v) relative to the volume of the finished composition, in which the remaining component? given by water for pharmaceutical preparations.
L?agente emolliente ? utile per rendere la mucosa morbida ed elastica ed ? scelto tra il gruppo comprendente alchile benzoato (C12-C15), alcoli polivalenti come la glicerina e il sorbitolo, oli vegetali (di mandorle, di oliva) o minerali (vaselina), cere, stearati, glicoli e loro miscele. The emollient agent? useful to make the mucosa soft and elastic and? selected from the group comprising alkyl benzoate (C12-C15), polyvalent alcohols such as glycerin and sorbitol, vegetable oils (almond, olive) or mineral (vaseline), waxes, stearates, glycols and their mixtures.
L?agente bioadesivo favorisce l?adesione del composto ed ? scelto nel gruppo comprendente polimeri naturali come pectine, zeine, caseina, gelatina, albumina, collagene, chitosano, oligosaccaridi e polisaccaridi come per esempio cellulosa, The bioadhesive agent promotes the adhesion of the compound and? selected from the group comprising natural polymers such as pectins, zeins, casein, gelatin, albumin, collagen, chitosan, oligosaccharides and polysaccharides such as cellulose,
? destrano, polisaccaridi da semi di tamarindo, gomma xantana, gomma arabica, acido alginico, sodio alginato e loro miscele; polimeri sintetici, come poliammidi, policarbonati, polialcheni, polialchilen glicoli, polialchilen ossidi, polialchilen tereftalati, polivinil alcoli, polivinil esteri, polivinil pirrolidone, polisilossani, poliuretani, poliesteri, polimeri acrilici come acido acrilico cross-linkato con allil saccarosio o allil pentaeritritolo, C10-C30 alchil acrilato cross-linkato con allil pentaeritritolo, polimeri dell?acido acrilico e metacrilico, polianidridi, poliortoesteri , polimeri dell'acido poliacrilico (Carbopol<?>) e loro miscele. ? dextran, polysaccharides from tamarind seeds, xanthan gum, arabic gum, alginic acid, sodium alginate and their mixtures; synthetic polymers, such as polyamides, polycarbonates, polyalkenes, polyalkylene glycols, polyalkylene oxides, polyalkylene terephthalates, polyvinyl alcohols, polyvinyl esters, polyvinyl pyrrolidone, polysiloxanes, polyurethanes, polyesters, acrylic polymers such as acrylic acid cross-linked with allyl silyl -C30 alkyl acrylate cross-linked with allyl pentaerythritol, polymers of acrylic and methacrylic acid, polyanhydrides, polyorthoesters, polymers of polyacrylic acid (Carbopol <?>) And their mixtures.
L?agente antiossidante ? scelto tra il gruppo comprendente resveratrolo, vitamina E, vitamina C, carotenoidi, Coenzima Q10 e idrossiacetofenone. The antioxidant agent? chosen from the group comprising resveratrol, vitamin E, vitamin C, carotenoids, Coenzyme Q10 and hydroxyacetophenone.
La composizione pu? anche comprendere uno o pi? agenti tamponanti in una quantit? da 0,01% a 5,0% (p/v), uno o pi? agenti solubilizzanti da 0,5% a 3,0% (p/v), uno o pi? agenti emulsionanti da 0,5% a 5,0% (p/v), uno o pi? agenti preservanti da 0,01% a 5,0% (p/v) rispetto alla composizione finita, in cui il componente rimanente ? dato da acqua per preparazioni farmaceutiche. The composition can? also include one or more? buffering agents in a quantity? 0.01% to 5.0% (w / v), one or more? solubilizing agents from 0.5% to 3.0% (w / v), one or more? emulsifying agents from 0.5% to 5.0% (w / v), one or more? preservative agents from 0.01% to 5.0% (w / v) with respect to the finished composition, in which the remaining component? given by water for pharmaceutical preparations.
La composizione pu? comprendere anche agenti lenitivi, coloranti e agenti in grado di provvedere una profumazione. The composition can? also include soothing agents, dyes and agents capable of providing a fragrance.
L?agente tamponante o correttore di pH ? scelto tra il gruppo comprendente sali di potassio o sodio, idrossido di sodio o potassio e loro miscele. The buffering agent or pH corrector? selected from the group comprising potassium or sodium salts, sodium or potassium hydroxide and mixtures thereof.
L?agente solubilizzante ? scelto nel gruppo comprendente tensioattivi ionici e non ionici, polisorbati, composti etossilati, olio di ricino idrogenato PEG 40. The solubilizing agent? selected from the group comprising ionic and non-ionic surfactants, polysorbates, ethoxylated compounds, PEG 40 hydrogenated castor oil.
L?agente emulsionante ? scelto nel gruppo comprendente gliceril stearato, glicole decilenico, alcoli grassi, acidi grassi, poliossipropilene, esteri del sorbitano, esteri del polietilenglicole, alchilsolfati. The emulsifying agent? selected from the group comprising glyceryl stearate, decylene glycol, fatty alcohols, fatty acids, polyoxypropylene, sorbitan esters, polyethylene glycol esters, alkylsulfates.
? L?agente preservante ? scelto tra il gruppo comprendente metilparabeni, etilparabeni, sodio etilendiamminotetraacetato, benzoato di sodio, sorbato di potassio e loro miscele. ? The preservative agent? selected from the group comprising methylparabens, ethylparabens, sodium ethylenediaminetetraacetate, sodium benzoate, potassium sorbate and their mixtures.
La composizione pu? anche comprendere agenti in grado di provvedere una profumazione, preferibilmente aromi naturali. The composition can? also comprising agents capable of providing a fragrance, preferably natural flavors.
In un aspetto, la composizione comprende un estratto oleoso di Hippopha? rhamnoides (olivello spinoso) da 0,5 a 5,0 mg, acido ialuronico da 0,1 a 5,0 mg, acido glicirretico da 0,1 a 5,0 mg, Aloe vera da 0,1 a 5,0 mg, glicogeno da 0,1 a 5,0 mg, in un volume di gel o crema da 3 a 10 ml totali, insieme con composti farmaceuticamente accettabili. In one aspect, does the composition include an oily extract of Hippopha? rhamnoides (sea buckthorn) 0.5 to 5.0 mg, hyaluronic acid 0.1 to 5.0 mg, glycyrrhetic acid 0.1 to 5.0 mg, Aloe vera 0.1 to 5.0 mg , glycogen from 0.1 to 5.0 mg, in a volume of gel or cream of 3 to 10 ml total, together with pharmaceutically acceptable compounds.
In un aspetto, la composizione comprende un estratto oleoso di Hippopha? rhamnoides (olivello spinoso) da 0,5 a 5,0 mg, acido ialuronico da 0,1 a 5,0 mg, acido glicirretico da 0,1 a 5,0 mg, Aloe vera da 0,1 a 5,0 mg, acido lattico da 0,1 a 5,0 mg, glicogeno da 0,1 a 5,0 mg, in un volume di gel o crema da 3 a 10 ml totali, insieme con composti farmaceuticamente accettabili. In one aspect, does the composition include an oily extract of Hippopha? rhamnoides (sea buckthorn) 0.5 to 5.0 mg, hyaluronic acid 0.1 to 5.0 mg, glycyrrhetic acid 0.1 to 5.0 mg, Aloe vera 0.1 to 5.0 mg , lactic acid from 0.1 to 5.0 mg, glycogen from 0.1 to 5.0 mg, in a total volume of gel or cream of 3 to 10 ml, together with pharmaceutically acceptable compounds.
In un aspetto, la composizione comprende un estratto oleoso di Hippopha? rhamnoides (olivello spinoso) da 0,5 a 2,5 mg, acido ialuronico da 0,1 a 2,5 mg, acido glicirretico da 0,1 a 2,5 mg, Aloe vera da 0,1 a 2,5 mg e glicogeno da 0,1 a 2,5 mg, in un volume di gel o crema da 3 a 10 ml totali insieme con composti farmaceuticamente accettabili. In one aspect, does the composition include an oily extract of Hippopha? rhamnoides (sea buckthorn) from 0.5 to 2.5 mg, hyaluronic acid from 0.1 to 2.5 mg, glycyrrhetic acid from 0.1 to 2.5 mg, Aloe vera from 0.1 to 2.5 mg and glycogen from 0.1 to 2.5 mg, in a total volume of gel or cream of 3 to 10 ml together with pharmaceutically acceptable compounds.
In un altro aspetto, la composizione comprende un estratto oleoso di Hippopha? rhamnoides (olivello spinoso) da 0,5 a 2,5 mg, acido ialuronico da 0,1 a 2,5 mg, acido glicirretico da 0,1 a 2,5 mg, Aloe vera da 0,1 a 2,5 mg, acido lattico da 0,1 a 2,5 mg In another aspect, does the composition include an oily extract of Hippopha? rhamnoides (sea buckthorn) from 0.5 to 2.5 mg, hyaluronic acid from 0.1 to 2.5 mg, glycyrrhetic acid from 0.1 to 2.5 mg, Aloe vera from 0.1 to 2.5 mg , lactic acid from 0.1 to 2.5 mg
? glicogeno da 0,1 a 2,5 mg, in un volume di gel o crema da 3 a 10 ml totali insieme con composti farmaceuticamente accettabili. ? glycogen from 0.1 to 2.5 mg, in a gel or cream volume of 3 to 10 ml total together with pharmaceutically acceptable compounds.
In un altro aspetto, la composizione comprendente un estratto oleoso di Hippopha? rhamnoides (olivello spinoso) da 0,5 a 5,0 mg, acido ialuronico da 0,1 a 5,0 mg, acido glicirretico da 0,1 a 5,0 mg, Aloe vera da 0,1 a 5,0 mg, acido lattico da 0,1 a 5,0 mg, glicogeno da 0,1 a 5,0 mg, in un volume di gel o crema da 3 a 10 ml totali ? caratterizzata da valori di viscosit? da 20.000 mPa?s a 50.000 mPa?s. In another aspect, the composition comprising an oily extract of Hippopha? rhamnoides (sea buckthorn) 0.5 to 5.0 mg, hyaluronic acid 0.1 to 5.0 mg, glycyrrhetic acid 0.1 to 5.0 mg, Aloe vera 0.1 to 5.0 mg , lactic acid from 0.1 to 5.0 mg, glycogen from 0.1 to 5.0 mg, in a volume of gel or cream of 3 to 10 ml total? characterized by viscosity values? from 20,000 mPa? s to 50,000 mPa? s.
In un altro aspetto la composizione comprendente un estratto oleoso di Hippopha? rhamnoides (olivello spinoso) da 0,5 a 5,0 mg, acido ialuronico da 0,1 a 5,0 mg, acido glicirretico da 0,1 a 5,0 mg, Aloe vera da 0,1 a 5,0 mg, acido lattico da 0,1 a 5,0 mg, glicogeno da 0,1 a 5,0 mg, in un volume di gel o crema da 3 a 10 ml totali ? caratterizzata da valori di densit? da 0,9 a 1 g/ml. In another aspect the composition comprising an oily extract of Hippopha? rhamnoides (sea buckthorn) 0.5 to 5.0 mg, hyaluronic acid 0.1 to 5.0 mg, glycyrrhetic acid 0.1 to 5.0 mg, Aloe vera 0.1 to 5.0 mg , lactic acid from 0.1 to 5.0 mg, glycogen from 0.1 to 5.0 mg, in a volume of gel or cream of 3 to 10 ml total? characterized by values of density? from 0.9 to 1 g / ml.
In un altro aspetto la composizione comprendente un estratto oleoso di Hippopha? rhamnoides (olivello spinoso) da 0,5 a 5,0 mg, acido ialuronico da 0,1 a 5,0 mg, acido glicirretico da 0,1 a 5,0 mg, Aloe vera da 0,1 a 5,0 mg, acido lattico da 0,1 a 5,0 mg, glicogeno da 0,1 a 5,0 mg, in un volume di gel o crema da 3 a 10 ml totali ? caratterizzata da valori di pH compresi tra 4,0 e 4,5. In another aspect the composition comprising an oily extract of Hippopha? rhamnoides (sea buckthorn) 0.5 to 5.0 mg, hyaluronic acid 0.1 to 5.0 mg, glycyrrhetic acid 0.1 to 5.0 mg, Aloe vera 0.1 to 5.0 mg , lactic acid from 0.1 to 5.0 mg, glycogen from 0.1 to 5.0 mg, in a volume of gel or cream of 3 to 10 ml total? characterized by pH values between 4.0 and 4.5.
In un aspetto particolare la composizione contiene 50,0 mg di un estratto oleoso di Hippopha? rhamnoides (olivello spinoso), 25,0 mg di acido ialuronico, 25,0 mg di acido glicirretico, 25,0 mg di Aloe vera, 10,0 mg di acido lattico, 25,0 mg di glicogeno, 100,0 mg di glicole propilenico, 100,0 mg di alchil benzoato (C12-C15), 75,0 mg di olio di ricino idrogenato PEG-40, 75,0 mg di gliceril stearato, 50,0 mg di un polimero dell'acido poliacrilico (Carbopol<?>), 50,0 mg di glicole decilenico, 50,0 mg di vitamina E, 35,0 mg di gomma xantana, 25,0 mg di idrossiacetofenone, 15,0 mg di policarbofilo, In one particular aspect the composition contains 50.0 mg of an oily extract of Hippopha? rhamnoides (sea buckthorn), 25.0 mg of hyaluronic acid, 25.0 mg of glycyrrhetic acid, 25.0 mg of Aloe vera, 10.0 mg of lactic acid, 25.0 mg of glycogen, 100.0 mg of propylene glycol, 100.0 mg of alkyl benzoate (C12-C15), 75.0 mg of PEG-40 hydrogenated castor oil, 75.0 mg of glyceryl stearate, 50.0 mg of a polyacrylic acid polymer (Carbopol <?>), 50.0 mg of decylene glycol, 50.0 mg of vitamin E, 35.0 mg of xanthan gum, 25.0 mg of hydroxyacetophenone, 15.0 mg of polycarbophil,
? 9,0 mg di sodio idrossido 1N, 5,0 mg di EDTA e 4,2 g di acqua per preparazioni farmaceutiche. ? 9.0 mg of 1N sodium hydroxide, 5.0 mg of EDTA and 4.2 g of water for pharmaceutical preparations.
La composizione pu? essere in forma di gel, idrogel, crema, schiuma vaginale e compresa in ovuli vaginali e compresse vaginali. The composition can? be in the form of gel, hydrogel, cream, vaginal foam and included in vaginal suppositories and vaginal tablets.
La composizione ? utile per essere compresa in un dispositivo medico e pu? essere compresa in tubi o contenitori monodose da 5 a 20 ml per uso vaginale. The composition ? useful to be included in a medical device and can? be included in single-dose tubes or containers of 5 to 20 ml for vaginal use.
La composizione in tubi o contenitori monodose con opportune cannule pu? essere compresa in kit contenenti 5, 7, 10 tubi/contenitori. The composition in tubes or single-dose containers with appropriate cannulas can? be included in kits containing 5, 7, 10 tubes / containers.
La composizione comprendente un estratto oleoso di Hippopha? rhamnoides (olivello spinoso) da 0,5 a 5,0 mg, acido ialuronico da 0,1 a 5,0 mg, acido glicirretico da 0,1 a 5,0 mg, Aloe vera da 0,1 a 5,0 mg, acido lattico da 0,1 a 5,0 mg, glicogeno da 0,1 a 5,0 mg, ? stabile a 25?C a RH 60? 5% per 36 mesi; a 30?C a RH 65?5% per 12 mesi e a 40?C RH 75?5% per 6 mesi. The composition comprising an oily extract of Hippopha? rhamnoides (sea buckthorn) 0.5 to 5.0 mg, hyaluronic acid 0.1 to 5.0 mg, glycyrrhetic acid 0.1 to 5.0 mg, Aloe vera 0.1 to 5.0 mg , 0.1 to 5.0 mg lactic acid, 0.1 to 5.0 mg glycogen,? stable at 25? C at RH 60? 5% for 36 months; at 30? C to 65? 5% RH for 12 months and at 40? C 75? 5% RH for 6 months.
? descritto un processo per la preparazione di una composizione acquosa comprendente gli stadi di: ? described a process for the preparation of an aqueous composition comprising the steps of:
a) preparare una soluzione idrofila aggiungendo ad un volume di acqua da 500 a 800 ml ad una temperatura compresa tra 50 e 80?C, acido ialuronico da 0,1% a 5,0% (p/v), acido glicirretico da 0,1% a 5,0% (p/v), Aloe vera da 0,1% a 5,0% (p/v), glicogeno da 0,1% a 5,0% (p/v), uno o pi? eccipienti scelti nel gruppo comprendente agenti bioadesivi, antiossidanti e preservanti; a) prepare a hydrophilic solution by adding to a volume of water from 500 to 800 ml at a temperature between 50 and 80 ° C, hyaluronic acid from 0.1% to 5.0% (w / v), glycyrrhetic acid from 0 , 1% to 5.0% (w / v), Aloe vera 0.1% to 5.0% (w / v), glycogen 0.1% to 5.0% (w / v), one or more? excipients selected from the group comprising bioadhesive agents, antioxidants and preservatives;
b) preparare una miscela lipofila mescolando ad una temperatura tra 50 e 80?C, uno o pi? eccipienti scelti nel gruppo comprendente agenti emollienti, solubilizzanti, emulsionanti e antiossidanti; b) prepare a lipophilic mixture by mixing at a temperature between 50 and 80 ° C, one or more? excipients selected from the group comprising emollient, solubilizing, emulsifying and antioxidant agents;
? c) aggiungere la miscela lipofila ottenuta dallo stadio b) alla miscela idrofila ottenuta dallo stadio a) sotto agitazione; ? c) adding the lipophilic mixture obtained from step b) to the hydrophilic mixture obtained from step a) under stirring;
d) portare la temperatura dell?emulsione ottenuta dallo stadio c) ad una temperatura tra 25?C e 35?C, aggiungere un estratto oleoso di Hippopha? rhamnoides (olivello spinoso) in una quantit? da 0,1% a 5,0% (p/v) e acido lattico in una quantit? da 0,1% a 5,0% (p/v); d) bring the temperature of the emulsion obtained from step c) to a temperature between 25 ° C and 35 ° C, add an oily extract of Hippopha? rhamnoides (sea buckthorn) in a quantity? from 0.1% to 5.0% (w / v) and lactic acid in an amount? from 0.1% to 5.0% (w / v);
e) regolare il pH ad un valore tra 4,0 e 4,5. e) adjust the pH to a value between 4.0 and 4.5.
In particolare, il processo comprende gli stadi di: In particular, the process includes the stages of:
a) preparare una soluzione idrofila aggiungendo ad un volume di acqua da 500 a 800 ml, ad una temperatura compresa tra 50 e 80?C, glicole propilenico in quantit? da 1,0% a 10,0% (p/v), un polimero dell'acido poliacrilico (Carbopol<?>) in una quantit? da 0,5% a 5,0% (p/v), gomma xantana da 0,5% a 2,0% (p/v), acido ialuronico da 0,1% a 5,0% (p/v), acido glicirretico da 0,1% a 5,0% (p/v), Aloe vera da 0,1% a 5,0% (p/v), glicogeno da 0,1% a 5,0% (p/v), idrossiacetofenone da 0,1% a 2,0% (p/v), policarbofilo da 0,1% a 1,5% (p/v), EDTA da 0,05% a 0,5% (p/v); a) prepare a hydrophilic solution by adding propylene glycol in quantity to a volume of water from 500 to 800 ml, at a temperature between 50 and 80 ° C. 1.0% to 10.0% (w / v), a polyacrylic acid polymer (Carbopol <?>) in an amount? 0.5% to 5.0% (w / v), xanthan gum 0.5% to 2.0% (w / v), hyaluronic acid 0.1% to 5.0% (w / v ), glycyrrhetic acid from 0.1% to 5.0% (w / v), Aloe vera from 0.1% to 5.0% (w / v), glycogen from 0.1% to 5.0% ( w / v), hydroxyacetophenone from 0.1% to 2.0% (w / v), polycarbophile from 0.1% to 1.5% (w / v), EDTA from 0.05% to 0.5% (w / v);
b) preparare una miscela lipofila mescolando ad una temperatura tra 50 e 80?C, alchile benzoato (C12-C15) in una quantit? da 1,0% a 10,0% (p/v), olio di ricino idrogenato PEG-40 da 0,5% a 5,0% (p/v), gliceril stearato da 0,5% a 5,0% (p/v), vitamina E da 0,5% a 5,0% (p/v); b) prepare a lipophilic mixture by mixing at a temperature between 50 and 80 ° C, alkyl benzoate (C12-C15) in a quantity? 1.0% to 10.0% (w / v), PEG-40 hydrogenated castor oil 0.5% to 5.0% (w / v), Glyceryl stearate 0.5% to 5.0 % (w / v), vitamin E from 0.5% to 5.0% (w / v);
c) aggiungere la miscela ottenuta dallo stadio b) alla miscela ottenuta dallo stadio a) sotto agitazione e aggiungere glicole decilenico da 0,5% a 5,0% (p/v); c) adding the mixture obtained from step b) to the mixture obtained from step a) under stirring and adding decylene glycol from 0.5% to 5.0% (w / v);
d) portare la temperatura dell?emulsione c) ad una temperatura tra 25?C e 35?C, aggiungere un estratto oleoso di Hippopha? rhamnoides (olivello spinoso) in d) bring the temperature of the emulsion c) to a temperature between 25? C and 35? C, add an oily extract of Hippopha? rhamnoides (sea buckthorn) in
? una quantit? da 0,1% a 5,0% (p/v) e acido lattico in una quantit? da 0,1% a 5,0% (p/v); ? a quantity? from 0.1% to 5.0% (w / v) and lactic acid in an amount? from 0.1% to 5.0% (w / v);
e) portare la temperatura dell?emulsione a temperatura ambiente e regolare il pH ad un valore tra 4,0 e 4,5 con l?aggiunta di una soluzione di NaOH 1N. e) bring the temperature of the emulsion to room temperature and adjust the pH to a value between 4.0 and 4.5 with the addition of a 1N NaOH solution.
La composizione ? aliquotata in dispositivi medici per l?uso. The composition ? aliquoted in medical devices for use.
La composizione della presente invenzione ? utile nella prevenzione, nel trattamento e/o nella riduzione dei sintomi associati all?atrofia e alla secchezza vaginale. The composition of the present invention? useful in the prevention, treatment and / or reduction of symptoms associated with vaginal atrophy and dryness.
In un aspetto particolare la composizione ? utile nella prevenzione, nel trattamento e/o nella riduzione dei sintomi associati all?atrofia e alla secchezza vaginale nella menopausa, perimenopausa, gravidanza, allattamento, interventi chirurgici all?apparato genitale e urogenitale, in pazienti sottoposte a chemioterapia o radioterapia, o correlati a patologie come IBS o diabete o l?uso di antidepressivi. In a particular aspect the composition? useful in the prevention, treatment and / or reduction of symptoms associated with vaginal atrophy and dryness in menopause, perimenopause, pregnancy, lactation, genital and urogenital surgery, in patients undergoing chemotherapy or radiotherapy, or related to diseases such as IBS or diabetes or the use of antidepressants.
La composizione dell?invenzione ? ben tollerata e non mostra irritazione delle mucose. The composition of the invention? well tolerated and shows no irritation of the mucous membranes.
La composizione della presente invenzione ? efficace senza la somministrazione di ormoni per l?uso nella prevenzione e/o nel trattamento dell?atrofia e della secchezza vaginale. The composition of the present invention? effective without the administration of hormones for use in the prevention and / or treatment of vaginal atrophy and dryness.
La composizione non ha effetti collaterali e pu? essere associata a terapie ormonali per la stessa indicazione terapeutica. The composition has no side effects and can? be associated with hormonal therapies for the same therapeutic indication.
La composizione in gel dell?invenzione ? stata analizzata in uno studio clinico in confronto con un placebo in pazienti con atrofia vaginale. The gel composition of the invention? tested in a clinical study compared with placebo in patients with vaginal atrophy.
La composizione dell?invenzione ? efficace per il trattamento dell?atrofia vaginale. L?invenzione descrive uno studio clinico eseguito su donne con diagnosi di The composition of the invention? effective for the treatment of vaginal atrophy. The invention describes a clinical study performed on women diagnosed with
? atrofia vaginale, fatta sulla base dei seguenti sintomi: secchezza vaginale, prurito e/o irritazione vulvare, sanguinamento, indice di salute vaginale (VHI) e una scala analogica visiva (VAS - Visual Analogue Scale). VAS ? una scala di valutazione soggettiva in cui viene misurata la percezione di una determinata sensazione da parte di un soggetto; nel caso della presente invenzione ? stato misurato il dolore vaginale associato all?attivit? sessuale. ? vaginal atrophy, made on the basis of the following symptoms: vaginal dryness, vulvar itching and / or irritation, bleeding, vaginal health index (VHI) and a visual analog scale (VAS - Visual Analogue Scale). VAS? a subjective evaluation scale in which the perception of a certain sensation by a subject is measured; in the case of the present invention? Was the vaginal pain associated with the activity measured? sexual.
I sintomi sono stati valutati attraverso questionari validati compilati dalle pazienti in cui ad ogni sintomo ? associata una scala con un valore minimo e massimo. Ai sintomi considerati nello studio sono state associate le seguenti scale di valutazione: i) Secchezza vaginale: valori da 0 a 3 a seconda della percezione del fastidio provocato, dove 0 indica assenza di fastidio e 3 indica fastidio intenso; The symptoms were assessed through validated questionnaires filled out by the patients in which each symptom? associated with a scale with a minimum and maximum value. The following evaluation scales were associated with the symptoms considered in the study: i) Vaginal dryness: values from 0 to 3 depending on the perception of the discomfort caused, where 0 indicates absence of discomfort and 3 indicates intense discomfort;
ii) Prurito e/o irritazione vulvare: valori da 0 a 3, dove 0 indica assenza di prurito e 3 indica prurito intenso. ii) Vulvar itching and / or irritation: values from 0 to 3, where 0 indicates no itching and 3 indicates intense itching.
iii) pH: valori di pH maggiori di 5 sono indicativi di un alterato sistema vaginale; iv) Dolore vaginale: misurato tramite VAS con indice da 0 a 10, dove 0 indica assenza di dolore e 10 indica dolore intenso; iii) pH: pH values greater than 5 are indicative of an altered vaginal system; iv) Vaginal pain: measured by VAS with an index from 0 to 10, where 0 indicates no pain and 10 indicates intense pain;
v) Dolore vaginale associato all?attivit? sessuale: misurato tramite VAS con indice da 0 a 10, dove 0 indica assenza di dolore e 10 indica dolore intenso; v) Vaginal pain associated with activity? sexual: measured by VAS with an index from 0 to 10, where 0 indicates no pain and 10 indicates intense pain;
vi) Bruciore: valori da 0 a 3, dove 0 indica assenza di bruciore; 3 indica bruciore intenso; vi) Burning: values from 0 to 3, where 0 indicates no burning; 3 indicates intense burning;
vii) Indice di salute vaginale (VHI): questo indice considera l?elasticit? complessiva della mucosa, la secrezione, il pH, l?aspetto della mucosa epiteliale e l?idratazione della mucosa. VHI pu? variare da 5 a 25 e punteggi pi? bassi corrispondono a maggiore atrofia urogenitale; se il punteggio ? minore di 15, la vagina ? considerata atrofica. vii) Vaginal health index (VHI): this index considers the elasticity? of the mucosa, secretion, pH, appearance of the epithelial mucosa and hydration of the mucosa. VHI can? vary from 5 to 25 and scores more? low correspond to greater urogenital atrophy; if the score? less than 15, the vagina? considered atrophic.
? La composizione della presente invenzione porta alla riduzione di almeno uno dei valori associati a questa patologia: ? The composition of the present invention leads to the reduction of at least one of the values associated with this pathology:
- l?indice di salute vaginale (VHI) aumenta da un valore di circa 7 prima del trattamento ad un valore 20 dopo un periodo di almeno due settimane; - the vaginal health index (VHI) increases from a value of about 7 before treatment to a value of 20 after a period of at least two weeks;
- il pH vaginale diminuisce da un valore maggiore di 6,0 ad un valore minore di 4,5; - la secchezza vaginale diminuisce; - the vaginal pH decreases from a value greater than 6.0 to a value less than 4.5; - vaginal dryness decreases;
- il prurito diminuisce da intenso a nullo (scala da 3 a 0); - itching decreases from intense to none (scale from 3 to 0);
- il bruciore diminuisce da intenso a nullo (scala da 3 a 0) - the burning decreases from intense to none (scale from 3 to 0)
- la VAS per il dolore associato a rapporti sessuali diminuisce da intenso a nullo (scala da 10 a 0). - the VAS for pain associated with sexual intercourse decreases from intense to none (scale from 10 to 0).
La composizione della presente invenzione ? utile nella prevenzione e/o nel trattamento dei sintomi associati all?atrofia vaginale, quando assunta una volta al giorno per un periodo di almeno 14 giorni. L?efficacia ? mantenuta con un trattamento di mantenimento di una, due o tre volte/settimana. Il trattamento di mantenimento pu? essere continuato per uno, due o tre mesi e/o fino al bisogno. Il trattamento pu? essere ripetuto con trattamenti ciclici. The composition of the present invention? useful in the prevention and / or treatment of symptoms associated with vaginal atrophy, when taken once a day for a period of at least 14 days. The effectiveness? maintained with a maintenance treatment of one, two or three times / week. The maintenance treatment can? be continued for one, two or three months and / or as needed. The treatment can? be repeated with cyclic treatments.
La composizione dell?invenzione ? utile nella prevenzione e/o nel trattamento di pazienti che hanno sintomi associati con l?atrofia e la secchezza vaginale nella perimenopausa, menopausa, gravidanza, allattamento o che hanno subito interventi ginecologici. La composizione ? utile anche nella prevenzione e/o nel trattamento di pazienti trattate con chemioterapici o radioterapici, o con patologie come IBS o diabete o che fanno uso di antidepressivi per alleviare i sintomi correlati con l?atrofia e la secchezza vaginale. The composition of the invention? useful in the prevention and / or treatment of patients who have symptoms associated with vaginal atrophy and dryness in perimenopause, menopause, pregnancy, lactation or who have undergone gynecological interventions. The composition ? also useful in the prevention and / or treatment of patients treated with chemotherapy or radiotherapy, or with diseases such as IBS or diabetes or who use antidepressants to relieve symptoms related to vaginal atrophy and dryness.
? ESEMPI ? EXAMPLES
Esempio 1: Preparazione della composizione Example 1: Preparation of the composition
In un miscelatore contenente circa 800 ml di acqua per preparazioni farmaceutiche riscaldata ad una temperatura di 70?2?C, sono stati sciolti 20,0 g di glicole propilenico, 10,0 g di Carbopol<?>, 7,0 g di gomma xantana, 5,0 g di acido ialuronico, 5,0 g di acido glicirretico, 5,0 g di Aloe vera e 5,0 g di glicogeno, 5,0 g di idrossiacetofenone, 3,0 g di policarbofilo, e 1,0 g di EDTA. La miscela ? stata omogeneizzata fino a completa dispersione. In a mixer containing about 800 ml of water for pharmaceutical preparations heated to a temperature of 70? 2? C, 20.0 g of propylene glycol, 10.0 g of Carbopol <?>, 7.0 g of rubber were dissolved xanthan, 5.0 g of hyaluronic acid, 5.0 g of glycyrrhetic acid, 5.0 g of Aloe vera and 5.0 g of glycogen, 5.0 g of hydroxyacetophenone, 3.0 g of polycarbophil, and 1, 0 g of EDTA. The mixture ? been homogenized until complete dispersion.
Separatamente, ? stata preparata la fase lipofila, miscelando 20,0 g di alchile benzoato (C12-C15), 15,0 g di olio di ricino idrogenato PEG-40, 15,0 g di gliceril stearato e 10,0 g di vitamina E, sotto agitazione fino ad ottenere una miscela omogenea. Separately,? the lipophilic phase was prepared by mixing 20.0 g of alkyl benzoate (C12-C15), 15.0 g of hydrogenated castor oil PEG-40, 15.0 g of glyceryl stearate and 10.0 g of vitamin E, under stirring until a homogeneous mixture is obtained.
La fase lipofila ? stata aggiunta alla fase acquosa precedentemente ottenuta e posta sotto agitazione per ottenere un?emulsione. Sotto agitazione, sono stati addizionati 10,0 g di glicole decilenico, la temperatura portata a 30?2?C e poi aggiunti 10,0 g di un estratto oleoso di Hippopha? rhamnoides (olivello spinoso) e 2,0 g di acido lattico. The lipophilic phase? was added to the previously obtained aqueous phase and stirred to obtain an emulsion. Under stirring, 10.0 g of decylene glycol were added, the temperature brought to 30? 2? C and then added 10.0 g of an oily extract of Hippopha? rhamnoides (sea buckthorn) and 2.0 g of lactic acid.
L?emulsione ? stata portata ad una temperatura di 25?C e il pH ? stato portato ad un valore tra 4,0 e 4,5 con l?aggiunta di una soluzione di NaOH 1N e infine portata ad un volume di 1 litro con acqua. The emulsion? been brought to a temperature of 25? C and the pH? was brought to a value between 4.0 and 4.5 with the addition of a 1N NaOH solution and finally brought to a volume of 1 liter with water.
La composizione unitaria ? riportata in tabella 1. The unitary composition? shown in table 1.
La composizione ? stata aliquotata in tubi monodose da 5 ml e conservata a temperatura ambiente. The composition ? was aliquoted into 5 ml single-dose tubes and stored at room temperature.
? Tabella 1 ? Table 1
La composizione ha un aspetto di gel semi-consistente, un colore bianco avorio, un valore di viscosit? pari a 30.000 mPa?s e un valore di densit? pari a 0,95 g/ml. The composition has a semi-consistent gel appearance, an ivory white color, a viscosity value? equal to 30,000 mPa? s and a density value? equal to 0.95 g / ml.
La viscosit? ? stata misurata con lo strumento Anton Paar, modello MCR 101, a temperatura di 37?C con una geometria a cono-piatto di diametro 50 mm. The viscosity? ? was measured with the Anton Paar instrument, model MCR 101, at a temperature of 37 ° C with a cone-plate geometry with a diameter of 50 mm.
? Esempio 2: Stabilit? della composizione ? Example 2: Stability of the composition
a) Stabilit? a 25?C a) Stability at 25? C
La composizione ? stata posta a 25?C, a RH 60 ? 5% per 36 mesi e la stabilit? ? stata determinata con test chimico-fisici e microbiologici. The composition ? been placed at 25? C, at RH 60? 5% for 36 months and the stability? ? was determined with chemical-physical and microbiological tests.
Per i test chimico-fisici sono stati considerati: aspetto, odore, pH, viscosit? e densit? a 3, 6, 12, 24 e 36 mesi rispetto a T0. I parametri valutati sono risultati comparabili con quelli al T0. For the chemical-physical tests were considered: appearance, odor, pH, viscosity? and density? at 3, 6, 12, 24 and 36 months compared to T0. The parameters evaluated were comparable with those at T0.
Per i test microbiologici ? stata considerata la presenza di Pseudomas aeruginosa, Staphilococcus aureous e E.Coli a 12, 24 e 36 mesi su terreni TAMC, TYMC, rispetto a T0. I parametri valutati sono risultati comparabili con quelli al T0. For microbiological tests? The presence of Pseudomas aeruginosa, Staphilococcus aureous and E.Coli was considered at 12, 24 and 36 months on TAMC, TYMC, compared to T0 media. The parameters evaluated were comparable with those at T0.
b) Stabilit? a 30?C b) Stability at 30? C
La composizione ? stata posta a 30?C, a RH 65 ? 5% per 12 mesi e la stabilit? ? stata determinata con test chimico-fisici e microbiologici. The composition ? been placed at 30? C, at RH 65? 5% for 12 months and the stability? ? was determined with chemical-physical and microbiological tests.
Per i test chimico-fisici sono stati considerati: aspetto, odore, pH, viscosit? e densit? a 3, 6 e 12 mesi, rispetto a T0. I parametri valutati sono risultati comparabili con quelli al T0. For the chemical-physical tests were considered: appearance, odor, pH, viscosity? and density? at 3, 6 and 12 months, compared to T0. The parameters evaluated were comparable with those at T0.
Per i test microbiologici ? stata considerata la presenza di Pseudomas aeruginosa, Staphilococcus aureous e E.Coli a 12 mesi su terreni TAMC, TYMC rispetto a T0. I parametri valutati sono risultati comparabili con quelli al T0. For microbiological tests? The presence of Pseudomas aeruginosa, Staphilococcus aureous and E.Coli at 12 months on TAMC, TYMC versus T0 media was considered. The parameters evaluated were comparable with those at T0.
c) Stabilit? a 40?C c) Stability at 40? C
La composizione ? stata posta a 40?C, a RH 75 ? 5% per 6 mesi e la stabilit? ? stata determinata con test chimico-fisici e microbiologici. The composition ? been placed at 40? C, at RH 75? 5% for 6 months and the stability? ? was determined with chemical-physical and microbiological tests.
? Per i test chimico-fisici sono stati considerati: aspetto, odore, pH, viscosit? e densit? a 1, 3 e 6 mesi, rispetto a T0. I parametri valutati sono risultati comparabili con quelli al T0. ? For the chemical-physical tests were considered: appearance, odor, pH, viscosity? and density? at 1, 3 and 6 months, compared to T0. The parameters evaluated were comparable with those at T0.
Per i test microbiologici ? stata considerata la presenza di Pseudomas aeruginosa, Staphilococcus aureous e E.Coli a 6 mesi su terreni TAMC, TYMC rispetto a T0. I parametri valutati sono risultati comparabili con quelli al T0 For microbiological tests? The presence of Pseudomas aeruginosa, Staphilococcus aureous and E.Coli at 6 months on TAMC, TYMC versus T0 media was considered. The parameters evaluated were comparable with those at T0
Esempio 3: Studio Clinico Example 3: Clinical Study
L?efficacia della composizione secondo l?Esempio 1 ? stata determinata in uno studio clinico randomizzato controllato, in doppio cieco su 60 donne non gravide con un?et? compresa tra 50 e 65 anni, con diagnosi di atrofia vaginale. The effectiveness of the composition according to Example 1? was determined in a randomized controlled, double-blind clinical study of 60 non-pregnant women with an? between 50 and 65 years, diagnosed with vaginal atrophy.
Le pazienti sono state divise in 2 gruppi da 30. Un gruppo ha assunto la composizione come descritta nell?Esempio 1, che ? stata autosomministrata mediante tubi monodose contenenti 5 ml di composizione. L?altro gruppo ha assunto un placebo. The patients were divided into 2 groups of 30. One group took the composition as described in Example 1, which? was self-administered through single-dose tubes containing 5 ml of composition. The other group took a placebo.
Lo studio clinico ha previsto una somministrazione giornaliera di un solo tubo per i primi 14 giorni, seguita da una somministrazione per 2 volte a settimana per altri 75 giorni. The clinical study involved a single tube dosing daily for the first 14 days, followed by dosing twice a week for an additional 75 days.
I criteri di arruolamento delle pazienti sono stati: The patients' enrollment criteria were:
- donne in menopausa da almeno 2 anni; - women in menopause for at least 2 years;
- donne in menopausa con atrofia vaginale; - menopausal women with vaginal atrophy;
- donne con almeno uno dei sintomi della atrofia vaginale: - women with at least one of the symptoms of vaginal atrophy:
i) secchezza vaginale: valori da 0 a 3 a seconda della percezione del fastidio provocato, dove 0 indica assenza di fastidio e 3 indica fastidio intenso; i) vaginal dryness: values from 0 to 3 depending on the perception of the discomfort caused, where 0 indicates absence of discomfort and 3 indicates intense discomfort;
ii) prurito e/o irritazione vulvare: valori da 0 a 3, dove 0 indica assenza di prurito e 3 indica prurito intenso. ii) vulvar itching and / or irritation: values from 0 to 3, where 0 indicates no itching and 3 indicates intense itching.
? iii) pH: valori di pH maggiori di 5 sono indicativi di un alterato sistema vaginale; iv) dolore vaginale: misurato tramite VAS con indice da 0 a 10, dove 0 indica assenza di dolore e 10 indica dolore intenso; ? iii) pH: pH values greater than 5 are indicative of an altered vaginal system; iv) vaginal pain: measured by VAS with an index from 0 to 10, where 0 indicates no pain and 10 indicates intense pain;
v) dolore vaginale associato all?attivit? sessuale: misurato tramite VAS con indice da 0 a 10, dove 0 indica assenza di dolore e 10 indica dolore intenso; v) vaginal pain associated with activity sexual: measured by VAS with an index from 0 to 10, where 0 indicates no pain and 10 indicates intense pain;
vii) bruciore: Valori da 0 a 3, dove 0 indica assenza di bruciore; 3 indica bruciore intenso; vii) burning: Values from 0 to 3, where 0 indicates no burning; 3 indicates intense burning;
viii) indice di salute vaginale (VHI): questo indice considera l?elasticit? complessiva della mucosa, la secrezione, il pH, l?aspetto della mucosa epiteliale e l?idratazione della mucosa. VHI pu? variare da 5 a 25 e punteggi pi? bassi corrispondono a maggiore atrofia urogenitale; se il punteggio ? minore di 15, la vagina ? considerata atrofica. viii) vaginal health index (VHI): this index considers the elasticity? of the mucosa, secretion, pH, appearance of the epithelial mucosa and hydration of the mucosa. VHI can? vary from 5 to 25 and scores more? low correspond to greater urogenital atrophy; if the score? less than 15, the vagina? considered atrophic.
Alle pazienti ? stato chiesto di autosomministrarsi la composizione secondo l?Esempio 1 o un placebo in tubi da 5 ml una volta al giorno per i primi 14 giorni, seguita da un periodo di 75 giorni in cui la composizione ? stata autosomministrata 2 volte a settimana. To the patients? have been asked to self-administer the composition according to Example 1 or a placebo in 5 ml tubes once a day for the first 14 days, followed by a 75-day period in which the composition? was self-administered twice a week.
Le pazienti sono state visitate prima della terapia (V1), dopo 14 giorni (V2), dopo 30 giorni (V3) e dopo 90 giorni (V4). The patients were examined before therapy (V1), after 14 days (V2), after 30 days (V3) and after 90 days (V4).
Per ogni visita sono stati considerati i questionari relativi a tutti i parametri riportati nella tabella 2. For each visit, the questionnaires relating to all the parameters reported in table 2 were considered.
? Tabella 2 ? Table 2
p < 0,001 p <0.001
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