EP-4740931-A1 - ORAL CARE COMPOSITION FOR USE IN THE TREATMENT OF DRY MOUTH

EP4740931A1EP 4740931 A1EP4740931 A1EP 4740931A1EP-4740931-A1

Abstract

An oral care composition for use in the treatment of dry mouth comprising at least one thickening agent in an amount of 0.1 to 15 wt% based on the weight of the oral care composition, a pH buffering agent in an amount of 0.5 to 2 wt% based on the weight of the oral care composition, at least two humectants in an amount of 15 to 30 wt% based on the weight of the oral care composition, water in an amount of 66.5 to 83.6 wt% based on the weight of the oralcare composition, under the form of a gel.

Inventors

ORTIZ SANCHEZ, Virginia Beatrice

Assignees

Oral Care Solutions GmbH

Dates

Publication Date: 20260513
Application Date: 20241106

Claims (14)

An oral care composition for use in the treatment of dry mouth comprising at least one thickening agent in an amount of 0.1 to 15 wt% based on the weight of the oral care composition, preferably 0.5 to 10 wt% based on the weight of the oral care composition, more preferably 0.9 to 5 wt% based on the weight of the oral care composition, a pH buffering agent in an amount of 0.5 to 2 wt% based on the weight of the oral care composition, at least two humectants in an amount of 15 to 30 wt% based on the weight of the oral care composition, water in an amount of 66.5 to 83.6 wt% based on the weight of the oral care composition, under the form of a gel.
The oral care composition for use according to claim 1, wherein the at least one thickening agent is chosen in the group comprising carbomers, natural gums, modified starch, sodium alginate, pectin, gelatin.
The oral care composition for use according to claim 2, wherein the carbomers are carboxypolymethylene, preferably a Carbopol, more preferably Carbopol 974.
The oral care composition for use according to claim 2 or 3, wherein the natural gum is chosen in the group comprising arabic gum, xanthan gum, guar gum, carob bean gum, gellan gum, gum tragacanth.
The oral care composition for use according to any of the preceding claims, wherein said at least one thickening agent comprises 2, 3, 4, 5, 6, or 7 different thickening agents, in a total amount corresponding to the amount of said at least one thickening agent.
The oral care composition for use according to claim 1 or 2, wherein the pH buffering agent is tris(hydroxymethyl)aminomethane.
The oral care composition for use according to any of the preceding claims, further comprising a chelating agent, preferably sodium ethylenediaminetetraacetic acid.
The oral care composition for use according to claim 5, wherein the chelating agent is present in an amount from 0,05 to 0,5 wt% based on the weight of the oral care composition, and wherein water is present in an amount of 67 to 83.55 wt% based on the weight of the oral care composition.
The oral care composition for use according to any of the preceding claims, wherein the at least two humectants are chosen in the group comprising hyaluronic acid, propylene glycol, glycerin, xylitol, sorbitol, polyethylene glycol, lactic acid, mono and di glyceride, tremella fuciformis.
The oral care composition for use according to claim 9, wherein the at least two humectants are a mixture of hyaluronic acid, xylitol, propylene glycol and glycerin.
The oral care composition for use according to any of the preceding claims, further comprising one or more additive, which can be an aroma, a preservative and/or a plant extract, preferably chosen in the group comprising chamomile extract, ratanhia extract, clove essential oil, aloe vera, licorice root extract, calendula extract, peppermint extract, sage extract, slippery elm, marshmallow root extract, green tea extract, honey extract, lemon extract, citric acid, sorbic acid, parabens, potassium sorbate, phenoxyethanol, benzyl alcohol, sorbitan caprylate, caprylyl glycol, 1,2-hexanediol, sodium benzoate, chlorhexidine, sodium methylparaben.
The oral care composition for use according to any of the preceding claims, packaged in a liquid single dose sachet.
The oral care composition for use according to claim 12, wherein the liquid single dose sachet is packaged with a series of liquid single dose sachet in a box.
A method to improve oral health comprising applying an effective amount of the oral care composition described in any of the claims 1 to 17 to the oral cavity of a subject in need thereof, wherein the method is effective to treat dry mouth.

Description

The present invention relates to an oral care composition for use in the treatment of dry mouth. Xerostomia, commonly known as dry mouth, is a condition where the salivary glands don't produce enough saliva to keep the mouth properly moist. This can lead to discomfort and various oral health problems. Dry mouth is typically a symptom of underlying conditions rather than a disease on its own. The symptoms of xerostomia include a persistent dry and sticky feeling in the mouth and throat, difficulty chewing, swallowing, or speaking, and a burning or tingling sensation in the mouth, particularly on the tongue. Complications from xerostomia can be significant. Saliva helps to wash away food particles and bacteria while neutralizing acids that can damage tooth enamel, so without it, there is a greater risk of tooth decay. Additionally, the lack of moisture in the mouth can lead to gum disease and oral infections, such as oral thrush (a fungal infection). People with dry mouth may also find it difficult to wear dentures comfortably because there isn't enough natural lubrication in the mouth. Moisturizing the mouth is more challenging than moisturizing the skin due to differences in environment and tissue types. The mouth's mucous membranes are constantly exposed to saliva, food, and enzymes, making it harder to retain moisture and active ingredients compared to the skin, where creams can form a lasting barrier. Treating the mouth requires non-toxic, biocompatible ingredients because products are often ingested, unlike skin treatments. Additionally, the mucosa is more sensitive and easily irritated, increasing the need for safe, gentle formulations. Taste is another key factor in oral moisturizers, as any unpleasant flavor can discourage use, unlike skin care products where taste isn't a concern. The product must also dissolve smoothly in the mouth without interfering with eating or speaking, further complicating formulation. In summary, moisturizing the mouth requires products that are safe to ingest, gentle on sensitive tissues, effective at maintaining moisture, and pleasant in taste. Known oral moisturizers in gel form are developed to manage and treat dry mouth. These products are designed to stimulate temporary saliva production. These gels are formulated with flavors that help activate the salivary glands, encouraging natural saliva flow. Flavored gels stimulate saliva production by activating taste receptors in the mouth. When applied, the flavors, especially sour or sweet, trigger the salivary glands to produce more saliva. This natural response helps relieve dry mouth by combining the gel's moisture with increased saliva flow. The additional saliva aids in digestion, cleanses the mouth, and helps protect teeth and gums, making these gels an effective treatment for xerostomia. Some disadvantages can limit the effectiveness of flavored gels designed to stimulate saliva production. One of the main issues is their short-lived efficacy, as the limited increase in saliva production often provides only temporary relief, requiring frequent reapplication to keep the mouth moist. Further, taste receptors are quickly saturated and further intake of the flavored gel does not reactivate the saliva production stimulation because of the saturation of the receptors. Accordingly, the user should delay one intake from another one to keep the saliva production stimulation effect. Additionally, the flavors used in these gels may not be appealing to everyone. Strong or tangy flavors, such as sour or minty ones, can be unpleasant for some users, making it uncomfortable and reducing their willingness to use the product regularly. There is also the potential for irritation, particularly in individuals with sensitive oral mucosa or allergies to certain ingredients. Over time, repeated exposure to the same flavor can lead to taste fatigue, where users grow tired of the flavor, which may further decrease consistent use. For individuals with severe dry mouth conditions, like advanced cases of Sjogren's syndrome, the gels may not be able to stimulate enough saliva to provide significant relief. These factors collectively make flavored oral gels less suitable or less effective for all users. Most flavoured oral gels currently used to treat dry mouth contain ingredients with aquatic toxicity, contributing to water pollution. These compounds often include cellulose-based thickening agents, such as carbomethoxy cellulose, hydroxyethyl cellulose, or hydroxymethyl cellulose. Whether users spit out or swallow these gels, they ultimately enter the wastewater system, creating challenges for water treatment plants where such facilities exist. In areas without treatment plants, these toxic substances are directly released into the environment. The present invention encounters to solve at least a part of these drawbacks by providing an oral care composition offering both immediate and prolonged relief from dry mouth symptoms without harming the