ITMI20132056A1 - COMPOSITIONS FOR AFTE AND AFTOSE STOMATITIS TREATMENT - Google Patents
COMPOSITIONS FOR AFTE AND AFTOSE STOMATITIS TREATMENTInfo
- Publication number
- ITMI20132056A1 ITMI20132056A1 IT002056A ITMI20132056A ITMI20132056A1 IT MI20132056 A1 ITMI20132056 A1 IT MI20132056A1 IT 002056 A IT002056 A IT 002056A IT MI20132056 A ITMI20132056 A IT MI20132056A IT MI20132056 A1 ITMI20132056 A1 IT MI20132056A1
- Authority
- IT
- Italy
- Prior art keywords
- composition
- leaves
- composition according
- dried
- ground
- Prior art date
Links
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- 238000011282 treatment Methods 0.000 title claims description 19
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- 235000002961 Aloe barbadensis Nutrition 0.000 claims description 12
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- YWIVKILSMZOHHF-QJZPQSOGSA-N sodium;(2s,3s,4s,5r,6r)-6-[(2s,3r,4r,5s,6r)-3-acetamido-2-[(2s,3s,4r,5r,6r)-6-[(2r,3r,4r,5s,6r)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-2-carboxy-4,5-dihydroxyoxan-3-yl]oxy-5-hydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-3,4,5-trihydroxyoxane-2- Chemical compound [Na+].CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O[C@H]3[C@@H]([C@@H](O)[C@H](O)[C@H](O3)C(O)=O)O)[C@H](O)[C@@H](CO)O2)NC(C)=O)[C@@H](C(O)=O)O1 YWIVKILSMZOHHF-QJZPQSOGSA-N 0.000 claims description 11
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Classifications
-
- 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)
- A61K36/33—Cactaceae (Cactus family), e.g. pricklypear or Cereus
-
- 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
- A61K31/16—Amides, e.g. hydroxamic acids
- A61K31/164—Amides, e.g. hydroxamic acids of a carboxylic acid with an aminoalcohol, e.g. ceramides
-
- 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)
- A61K36/63—Oleaceae (Olive family), e.g. jasmine, lilac or ash tree
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
Landscapes
- Health & Medical Sciences (AREA)
- Natural Medicines & Medicinal Plants (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Medical Informatics (AREA)
- Botany (AREA)
- Biotechnology (AREA)
- Alternative & Traditional Medicine (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Description
Descrizione del brevetto per invenzione industriale avente per titolo: Description of the patent for industrial invention entitled:
“COMPOSIZIONI PER IL TRATTAMENTO DELLE AFTE E DELLE STOMATITI AFTOSE” "COMPOSITIONS FOR THE TREATMENT OF AFTE AND APHTHOSUS STOMATITIS"
Campo dell’invenzione Field of the invention
La presente invenzione si riferisce a composizioni per il trattamento delle afte e delle stomatiti aftose. The present invention relates to compositions for the treatment of canker sores and aphthous stomatitis.
Sfondo dell’invenzione Background of the invention
La stomatite aftosa è una comune malattia che colpisce le mucose della cavità orale. Si manifesta con la comparsa di piccole ulcere biancastre chiamate afte o ulcere aftose le quali possono essere molto dolorose ed irritanti, fino ad interferire con l’assunzione di cibi e liquidi. Viene stimato che circa il 20% della popolazione adulta e circa il 35% dei bambini ed adolescenti soffre di questa malattia. Aphthous stomatitis is a common disease that affects the mucous membranes of the oral cavity. It manifests itself with the appearance of small whitish ulcers called canker sores or aphthous ulcers which can be very painful and irritating, to the point of interfering with the intake of food and liquids. It is estimated that about 20% of the adult population and about 35% of children and adolescents suffer from this disease.
La causa dell’insorgenza delle afte è sconosciuta ed è probabilmente multifattoriale. Si ritiene che alcune afte siano correlate a una risposta immunitaria mediata dalle cellule T e scatenata da fattori quali deficienze nutrizionali, traumi locali, stress, influenze ormonali, allergie e predisposizione genetica. The cause of the onset of canker sores is unknown and is probably multifactorial. Some canker sores are thought to be related to a T cell mediated immune response triggered by factors such as nutritional deficiencies, local trauma, stress, hormonal influences, allergies, and genetic predisposition.
Attualmente non esiste una cure per le ulcere aftose. Sono invece disponibili vari trattamenti palliativi che possono alleviare il dolore e l’infiammazione provocati dalle lesioni. There is currently no cure for aphthous ulcers. Instead, various palliative treatments are available that can relieve pain and inflammation caused by injuries.
Nella terapia contro le afte della bocca vengono generalmente usati composizioni topiche a base di antisettici, antibiotici e anestetici (ad esempio gel contenenti benzocaina e lidocaina) per portare un immediato ma temporaneo sollievo dal dolore bruciante che accompagna le afte orali. In the therapy against mouth ulcers, topical compositions based on antiseptics, antibiotics and anesthetics (for example gels containing benzocaine and lidocaine) are generally used to bring immediate but temporary relief from the burning pain that accompanies oral ulcers.
Nei casi più gravi la terapia farmacologica prevede l’impiego di preparati a base di Clorexidina, quali Disinfene crema e Golasan colluttorio. Sottoforma di colluttorio, questo farmaco appare in grado di ridurre il dolore e di velocizzare i tempi di guarigione, tuttavia esso non riduce la frequenza delle recidive. In severe cases, drug therapy involves the use of chlorhexidine-based preparations, such as Disinfene cream and Golasan mouthwash. In the form of mouthwash, this drug appears to reduce pain and speed up healing, however it does not reduce the frequency of relapses.
Vengono a volta impiegate anche preparazioni topiche a base di corticosteroidi di sintesi, ad esempio: betametasone, disponibile sotto forma di compresse da sciogliere da appoggiare direttamente sulla lesione, fino a completo scioglimento; idrocortisone applicato localmente, sottoforma di crema o pasta dentale; fluocinonide sotto forma di gel, lozione o pomata. A causa della loro elevata potenza e dei potenziali seri effetti collaterali queste sostanze devono essere utilizzate sotto stretto controllo medico. At times, topical preparations based on synthetic corticosteroids are also used, for example: betamethasone, available in the form of tablets to be dissolved to be placed directly on the lesion, until completely dissolved; hydrocortisone applied locally, in the form of a dental cream or paste; fluocinonide in the form of a gel, lotion or ointment. Due to their high potency and potential serious side effects these substances must be used under strict medical supervision.
Altre preparazioni commercialmente disponibili per il trattamento di sintomi delle afte sono a base di agenti antiinfiammatori non steroidei quale la benzidamina, disponibile sottoforma di spray orale o crema aventi blandi effetti analgesici. Other preparations commercially available for the treatment of symptoms of canker sores are based on non-steroidal anti-inflammatory agents such as benzydamine, available in the form of an oral spray or cream having mild analgesic effects.
Per il trattamento delle afte della bocca vengono utilizzati anche preparati a base di antibiotici quale la tetraciclina (tetraciclina Cloridrato capsule) per il trattamento loco-regionale. Il contenuto di una capsula viene disciolto in acqua, ottenendo così una sospensione di tetraciclina da tenere in bocca per un paio di minuti e poi espulso. L’impiego di questa sospensione può però portare alla formazione di macchie sui denti. For the treatment of mouth ulcers, antibiotic-based preparations such as tetracycline (tetracycline hydrochloride capsules) are also used for loco-regional treatment. The contents of a capsule are dissolved in water, thus obtaining a suspension of tetracycline to be kept in the mouth for a couple of minutes and then expelled. However, the use of this suspension can lead to the formation of stains on the teeth.
Esistono in commercio anche preparati anti-afta che non richiedono prescrizione medica. I più utilizzati sono formulazioni in gel in grado di creare una barriera protettiva tra la lesione e i principali elementi di disturbo quali lingua, saliva e cibo, riducendo così il dolore e i rischi di ulteriori irritazioni. Tra questi vi sono gel a base di acido ialuronico (Afta Med®, Bracco) o di una combinazione di Aloe vera e acido ialuronico (Alovex®, Recordati), sostanze che aiutano la naturale rigenerazione e la cicatrizzazione dei tessuti. There are also anti-canker preparations on the market that do not require a doctor's prescription. The most used are gel formulations capable of creating a protective barrier between the lesion and the main disturbing elements such as tongue, saliva and food, thus reducing pain and the risk of further irritation. These include gels based on hyaluronic acid (Afta Med®, Bracco) or a combination of Aloe vera and hyaluronic acid (Alovex®, Recordati), substances that help the natural regeneration and healing of tissues.
Nella medicina tradizionale gli estratti di piante contenenti polisaccaridi sono ampiamente utilizzati per il trattamento di ferite della pelle e dell’epitelio e per il trattamento dell’irritazione delle membrane mucose. In particolare, gli estratti dei cladodi di Opuntia ficus indica sono impiegati nella medicina popolare per le loro proprietà antiinfiammatoria, antiulcera e cicatrizzante. È stato dimostrato che mucillagini di Opuntia ficus indica mostrano nel ratto un effetto citoprotettore nei confronti della mucosa gastrica (Phytoher. Res. (2007), 21, 344-346). In traditional medicine, plant extracts containing polysaccharides are widely used for the treatment of skin and epithelial wounds and for the treatment of irritation of the mucous membranes. In particular, the extracts of Opuntia ficus indica cladodes are used in folk medicine for their anti-inflammatory, anti-ulcer and healing properties. It has been shown that mucilages of Opuntia ficus indica show a cytoprotective effect on the gastric mucosa in rats (Phytoher. Res. (2007), 21, 344-346).
La foglia dell’ulivo (Olea europaea L) è stata tradizionalmente utilizzata per secoli per trattare varie malattie. Viene impiegata per rafforzare il sistema immunitario, nelle malattie cardiache e come agente antimicrobico. Nella medicina popolare viene usata per il trattamento dell’ipertonia, arteriosclerosi, reumatismi, gotta, diabete mellito e febbre. L’estratto della foglia di ulivo possiede proprietà antiossidanti e recentemente è stato dimostrato possedere proprietà gastroprotettive nei ratti (Gen. Physiol. Biophys. (2009), Special Issue, 28, 135-142). The olive leaf (Olea europaea L) has traditionally been used for centuries to treat various diseases. It is used to strengthen the immune system, in heart disease and as an antimicrobial agent. In folk medicine it is used for the treatment of hypertonia, arteriosclerosis, rheumatism, gout, diabetes mellitus and fever. The olive leaf extract has antioxidant properties and has recently been shown to have gastroprotective properties in rats (Gen. Physiol. Biophys. (2009), Special Issue, 28, 135-142).
Il D-pantenolo è la forma alcoolica ridotta dell’acido pantotenico (vitamina B5). È noto anche con il nome di provitamina B5. Svolge un ruolo chiave nel metabolismo intermedio nell’uomo. Tra i tanti effetti, il prodotto stimola l’epitelizzazione, promuove la cicatrizzazione ed ha effetti antiinfiammatori. Composizioni adesive per il trattamento topico delle ulcere aftose contenenti, accanto ad altri principi attivi, D-pantenolo ed Aloe vera sono descritte in EP1964547A1. D-panthenol is the reduced alcohol form of pantothenic acid (vitamin B5). It is also known as provitamin B5. It plays a key role in the intermediate metabolism in humans. Among the many effects, the product stimulates epithelialization, promotes healing and has anti-inflammatory effects. Adhesive compositions for the topical treatment of aphthous ulcers containing, alongside other active ingredients, D-panthenol and Aloe vera are described in EP1964547A1.
Descrizione dell’invenzione Description of the invention
Oggetto della presente invenzione sono composizioni topiche per il trattamento delle afte del cavo orale e delle stomatiti aftose. Le composizioni sono sotto forma di gel e contengono: foglie di cactus (Opuntia ficus indica) essiccate e macinate, estratto idro-alcolico di foglie di ulivo (Olea europaea); Aloe vera; D-pantenolo; sodio ialuronato e clorexidina digluconato; oltre ad eccipienti accettabili per l’uso farmaceutico. Object of the present invention are topical compositions for the treatment of canker sores of the oral cavity and aphthous stomatitis. The compositions are in the form of a gel and contain: dried and ground cactus leaves (Opuntia ficus indica), hydro-alcoholic extract of olive leaves (Olea europaea); Aloe vera; D-panthenol; sodium hyaluronate and chlorhexidine digluconate; in addition to excipients acceptable for pharmaceutical use.
La combinazione di foglie di fico d’India (Opuntia ficus indica) con l’estratto di foglie di ulivo (Olea europaea) e con gli altri componenti attivi sopra citati consente di ottenere un effetto sinergico nel trattamento delle afte, favorendo in particolare il processo di cicatrizzazione e rigenerazione dei tessuti lesionati rispetto a quanto ottenibile con i singoli componenti della composizione. The combination of prickly pear leaves (Opuntia ficus indica) with olive leaf extract (Olea europaea) and with the other active components mentioned above allows to obtain a synergistic effect in the treatment of canker sores, favoring in particular the process healing and regeneration of injured tissues compared to what can be obtained with the individual components of the composition.
Le foglie di fico d’India sono preparate mediante un procedimento che comprende il lavaggio delle stesse, il taglio, l’essiccamento, la macinazione e la setacciatura. Le foglie di ulivo vengono invece sottoposte a estrazione con soluzione idroalcolica seguito da essiccamento della soluzione fino a ottenere una polvere fine di colore bruno-verdastro e avente un titolo HPLC di oleuropeina ≥12,0%. The prickly pear leaves are prepared using a process that includes washing them, cutting, drying, grinding and sieving. The olive leaves are instead subjected to extraction with hydroalcoholic solution followed by drying of the solution until obtaining a fine powder of brown-greenish color and having an HPLC title of oleuropein ≥12.0%.
In una realizzazione dell’invenzione le foglie di fico d’India essiccate e macinate e l’estratto di foglie di ulivo sono presenti in un rapporto ponderale 1:1. In one embodiment of the invention, dried and ground prickly pear leaves and olive leaf extract are present in a 1: 1 weight ratio.
Il sodio ialuronato impiegato nella presente invenzione ha un peso molecolare compreso tra 1000 e 2500 kDa, preferibilmente ca. 2000 kDa. The sodium hyaluronate used in the present invention has a molecular weight comprised between 1000 and 2500 kDa, preferably approx. 2000 kDa.
Nelle composizioni preferite dell’invenzione la suddetta combinazione di foglie di cactus (fico d’India) e di estratto di foglie di ulivo è presente in percentuale da 0,1 a 10%, il D-pantenolo è presente in percentuale da 0,5 a 15%, l’Aloe vera, come gel, è presente in percentuale da 1 a 20%, il sodio ialuronato è presente in percentuale da 0,1 a 2% e la clorexidina è presente in percentuale da 0,01 a 0.3%, dove dette percentuali sono percentuali in peso rispetto al peso totale della composizione. In the preferred compositions of the invention the aforementioned combination of cactus leaves (prickly pear) and olive leaf extract is present in a percentage from 0.1 to 10%, D-panthenol is present in a percentage from 0.5 at 15%, Aloe vera, as a gel, is present in a percentage from 1 to 20%, sodium hyaluronate is present in a percentage from 0.1 to 2% and chlorhexidine is present in a percentage from 0.01 to 0.3% , where said percentages are percentages by weight with respect to the total weight of the composition.
In una realizzazione preferita la combinazione di foglie di cactus (fico d’India) e di estratto di foglie di ulivo è presente in percentuale del 2%, il D-pantenolo è presente in percentuale del 2%, l’Aloe vera, come gel, è presente in percentuale del 5%, il sodio ialuronato è presente in percentuale del 0.5% e la clorexidina è presente in percentuale del 0,05%, dove dette percentuali sono percentuali in peso rispetto al peso totale della composizione. In a preferred embodiment, the combination of cactus leaves (prickly pear) and olive leaf extract is present in a percentage of 2%, D-panthenol is present in a percentage of 2%, Aloe vera as a gel , is present in a percentage of 5%, sodium hyaluronate is present in a percentage of 0.5% and chlorhexidine is present in a percentage of 0.05%, where said percentages are percentages by weight with respect to the total weight of the composition.
Le composizioni dell’invenzione possono contenere uno o più eccipienti accettabili per l’uso farmaceutico, quali addensanti, conservanti, fragranze, coloranti, agenti chelanti, agenti tamponanti, agenti umettanti ed acqua. The compositions of the invention may contain one or more excipients acceptable for pharmaceutical use, such as thickeners, preservatives, fragrances, dyes, chelating agents, buffering agents, wetting agents and water.
Una composizione particolarmente preferita dell’invenzione ha la seguente composizione ponderale: A particularly preferred composition of the invention has the following weight composition:
Acqua 84,15% Water 84.15%
Glicole propilenico 5,0% Propylene glycol 5.0%
Foglie di Opuntia ficus indica essiccate e macinate 1,0% Dried and ground Opuntia ficus indica leaves 1.0%
Estratto idro-alcolico di Olea europaea 1,0% Hydro-alcoholic extract of Olea europaea 1.0%
D-pantenolo 2,0% D-panthenol 2.0%
Aloe vera gel 5,0% Aloe vera gel 5.0%
EDTA sale disodico 0,05% EDTA disodium salt 0.05%
EDTA sale tetrasodico 0,05% EDTA tetrasodium salt 0.05%
Paraossibenzoati in fenossietanolo 0,3% Paraoxybenzoates in phenoxyethanol 0.3%
Sodio deidroacetato (prevan) 0,3% Sodium dehydroacetate (prevan) 0.3%
Sodio metabisolfito 0,05% Sodium metabisulfite 0.05%
Gomma xantano trasparente 0,3% Transparent xanthan gum 0.3%
Sodio ialuronato 0,5% Sodium hyaluronate 0.5%
Aroma menta 0,2% Mint flavor 0.2%
Clorexidina digluconato 20% 0,05% Chlorhexidine digluconate 20% 0.05%
Acido lattico 90% 0,05% Lactic acid 90% 0.05%
Le composizioni dell’invenzione possono essere preparate utilizzando procedure ben note al tecnico del ramo. In una tipica preparazione, glicole propilenico, foglie di Opuntia ficus indica essiccate e macinate, estratto di Olea europaea, D-pantenolo, Aloe vera gel, sodio deidroacetato, EDTA sale disodico, EDTA sale tetrasodico e paraossibenzoati in fenossietanolo, vengono solubilizzati e dispersi in acqua alla temperatura di circa 40°C. La soluzione ottenuta viene addensata mediante l’aggiunta di sodio ialuronato e di gomma xantano trasparente. Si lascia in agitazione per 30 minuti, quindi si raffredda il tutto a temperatura ambiente e si aggiungono l’aroma di menta e la clorexidina digluconato 20%. Si lascia in agitazione per 10 minuti, quindi si porta a pH tra 5,0 e 6,0 con acido lattico. La miscela viene scaricata dall’apparato di miscelazione e il semilavorato così ottenuto viene sottoposto a opportuni controlli di conformità e quindi dosato in opportuni contenitori finali che successivamente vengono etichettati. The compositions of the invention can be prepared using procedures well known to those skilled in the art. In a typical preparation, propylene glycol, dried and ground Opuntia ficus indica leaves, Olea europaea extract, D-panthenol, Aloe vera gel, sodium dehydroacetate, EDTA disodium salt, EDTA tetrasodium salt and paraoxybenzoates in phenoxyethanol, are solubilized and dispersed in water at a temperature of about 40 ° C. The solution obtained is thickened by adding sodium hyaluronate and transparent xanthan gum. It is left to stir for 30 minutes, then it is cooled to room temperature and the mint aroma and 20% chlorhexidine digluconate are added. It is left under stirring for 10 minutes, then it is brought to pH between 5.0 and 6.0 with lactic acid. The mixture is discharged from the mixing apparatus and the semi-finished product thus obtained is subjected to appropriate compliance checks and then dosed in appropriate final containers which are subsequently labeled.
Le composizioni dell’invenzione si presentano sotto forma di gel e possono essere vantaggiosamente utilizzate nel trattamento di afte, stomatiti aftose, piccole lesioni della bocca come quelle dovute al contatto con apparecchi ortodontici, protesi fisse e mobili. Detto trattamento rappresenta un ulteriore oggetto della presente invenzione. The compositions of the invention are in the form of a gel and can be advantageously used in the treatment of canker sores, aphthous stomatitis, small lesions of the mouth such as those caused by contact with orthodontic appliances, fixed and mobile prostheses. Said treatment represents a further object of the present invention.
In particolare, le composizioni consentono non solo di ridurre rapidamente il dolore provocato dalle ulcere aftosa ma anche di promuovere la loro guarigione e di ridurne il numero grazie al controllo dei processi infiammatori e di cicatrizzazione e reidratazione dei tessuti. In particular, the compositions allow not only to rapidly reduce the pain caused by aphthous ulcers but also to promote their healing and reduce their number thanks to the control of inflammatory processes and tissue healing and rehydration.
Le composizioni dell’invenzione vengono preferibilmente applicate sulle mucose della bocca affette da afte mediante un opportuno dispositivo consistente in una paletta con applicatore. The compositions of the invention are preferably applied to the mucous membranes of the mouth affected by canker sores by means of a suitable device consisting of a scoop with applicator.
Un ulteriore oggetto della presente invenzione è pertanto un kit per il trattamento delle afte comprendente: A further object of the present invention is therefore a kit for the treatment of canker sores comprising:
- una composizione dell’invenzione all’interno di un contenitore dotato di un sistema di chiusura; - a composition of the invention inside a container equipped with a closure system;
- un mezzo per applicare la composizione sulle mucose della bocca colpite dalle afte; - a means of applying the composition on the mucous membranes of the mouth affected by canker sores;
- istruzioni per l’applicazione della composizione. - instructions for applying the composition.
Ulteriore oggetto dell’invenzione è un metodo per il trattamento delle afte che comprende l’applicazione di una composizione dell’invenzione sulle mucose della bocca affette da afte, mediante un kit come sopra definito. Preferibilmente si effettuano dalle due alle tre applicazioni giornaliere. La composizione dell’invenzione garantisce un’azione mirata già dalle prime applicazioni. A further object of the invention is a method for the treatment of canker sores which includes the application of a composition of the invention on the mucous membranes of the mouth affected by canker sores, using a kit as defined above. Preferably two to three daily applications are carried out. The composition of the invention guarantees targeted action from the very first applications.
L’invenzione viene ora illustrata dal seguente esempio. The invention is now illustrated by the following example.
Esempio Example
Glicole propilenico (5 kg), miscela di foglie di fico d’India essiccate e macinate e di estratto idro-alcolico di Olea europaea 1:1 in peso (2 kg), D-pantenolo (2 kg), Aloe vera gel (5 kg), sodio deidroacetato (0,3 kg), EDTA sale disodico (0,05 kg), EDTA sale tetrasodico (0,05 kg) e paraossibenzoati in fenossietanolo (0,3 kg), vengono solubilizzati e dispersi in acqua (84,15 kg) alla temperatura di circa 40°C. La soluzione ottenuta viene addensata mediante l’aggiunta di sodio ialuronato (0,5 kg) e di gomma xantano trasparente (0,3 kg). Si lascia in agitazione per 30 minuti, quindi si raffredda il tutto a temperatura ambiente e si aggiungono l’aroma di menta (0,2 kg) e la clorexidina digluconato 20% (0,05 kg). Si lascia in agitazione per 10 minuti, quindi si porta a pH tra 5,0 e 6,0 con acido lattico. La miscela viene scaricata dall’apparato di miscelazione e il semilavorato così ottenuto viene sottoposto agli opportuni controlli di conformità quindi dosato negli opportuni contenitori finali che infine vengono etichettati. Propylene glycol (5 kg), mixture of dried and ground prickly pear leaves and hydro-alcoholic extract of Olea europaea 1: 1 by weight (2 kg), D-panthenol (2 kg), Aloe vera gel (5 kg), sodium dehydroacetate (0.3 kg), EDTA disodium salt (0.05 kg), EDTA tetrasodium salt (0.05 kg) and paraoxybenzoates in phenoxyethanol (0.3 kg), are solubilized and dispersed in water (84 , 15 kg) at a temperature of about 40 ° C. The solution obtained is thickened by adding sodium hyaluronate (0.5 kg) and transparent xanthan gum (0.3 kg). It is left to stir for 30 minutes, then it is cooled to room temperature and the mint flavor (0.2 kg) and 20% chlorhexidine digluconate (0.05 kg) are added. It is left under stirring for 10 minutes, then it is brought to pH between 5.0 and 6.0 with lactic acid. The mixture is discharged from the mixing apparatus and the semi-finished product thus obtained is subjected to the appropriate compliance checks and then dosed in the appropriate final containers which are finally labeled.
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