A system and method for alleviating pain and accelerating healing associated with mouth ulcers

Abstract

Abstract Present invention discloses an oral ulcer patch which adheres to a surface of a mouth ulcer and reduces pain associated with the mouth ulcer while at the same time accelerating healing of the mouth mucosa. The oral ulcer patch comprises an anti-inflammatory agent, an analgesic agent; a healing agent; an agent that forms a protective barrier upon reacting5 with saliva in the mouth, wherein the patch adheres to the moist ulcer area inside the mouth, forms a protective barrier, releases active analgesic and anti-inflammatory agents, and wherein the application of the patch to the ulcer reduces the pain caused by the ulcer and reduces the healing time of the ulcer. 10 Abstract Present invention discloses an oral ulcer patch which adheres to a surface of a mouth ulcer and reduces pain associated with the mouth ulcer while at the same time accelerating healing of the mouth mucosa. The oral ulcer patch comprises an anti-inflammatory agent, 5 an analgesic agent; a healing agent; an agent that forms a protective barrier upon reacting with saliva in the mouth, wherein the patch adheres to the moist ulcer area inside the mouth, forms a protective barrier, releases active analgesic and anti-inflammatory agents, and wherein the application of the patch to the ulcer reduces the pain caused by the ulcer and reduces the healing time of the ulcer. 10 20 24 28 71 87 23 D ec 2 02 4 2 0 2 4 2 8 7 1 8 7 2 3 D e c 2 0 2 4 A b s t r a c t 5 1 0

Description

Field of the invention Disclosed herein is a system and method for alleviating pain and accelerating healing process associated with mouth ulcers. More specifically, the present invention discloses an oral ulcer patch which adheres to a surface of a mouth ulcer and reduces pain associated with the mouth ulcer while at the same time accelerating healing of the mouth mucosa. Background Mouth ulcers are small sores that develop on the inside of the mouth or at the base of the gums. Mouth ulcers are sometimes called aphthous ulcers or canker sores. Usually mouth ulcers are caused by minor trauma, such as biting the cheek, sharp food damaging the mouth musosa, dental braces, dentures, acidic foods, hormonal changes or stress. It is also presumed that infections, diseases, and vitamin deficiencies may contribute to development of the mouth ulcers. Oral mucosal ulcers affect about 20% of the population. Sores from the ulcers appear as shallow sores with a white or gray top and a red rim. Most mouth ulcers are small (less than 5mm) and can occur as a single ulcer or in clusters. Common locations include inside the lips, cheeks and on the bottom of the mouth or gums. Healing time for mouth ulcers varies from 10 to 14 days, but it can take up to 2 to 3 months to heal for severe lesions. Moreover, mouth ulcers are very painful and can be recurrent. Current over-the-counter treatments available for mouth ulcers include antiseptic gels or mouthwashes which usually contain benzocaine or hydrogen peroxide, topical creams or ointments which contain corticosteroids or antibiotics. Other treatments include pain-relieving lozenges which provide temporary relief by numbing the affected area. Other active ingredients used in the mouth ulcer treatments include benzocaine, fluocinonide, alcohol, or choline salicylate. The present drawbacks of these treatments include side effects of steroids and antibiotics and short-lasting effects of ointments. Additional 2024287187   23 Dec 2024 disadvantages of these treatments are that people may apply them too often in an attempt to reduce pain or to speed up the healing process, and every so often, the frequent application may result in overdosing with the active ingredients found in these treatments. Further disadvantage of these treatments is that these treatments are scheduled medications which can only be found in pharmacies with limited accessibility for everyday consumer. Moreover, although current treatments work, unfortunately they may not always be safe for use in individuals sensitive to medications, such as pregnant women, young children or elderly people. Therefore, there is a need to address the above, and / or at least provide a useful alternative. Summary According to a first aspect of the present invention, there is provided an oral ulcer patch for the treatment of mouth ulcers, comprising: an anti-inflammatory agent; an analgesic agent; a healing agent; an agent that forms a protective barrier upon reacting with saliva in the mouth; wherein, when the oral ulcer patch is applied to a moist ulcer surface located on a mucosal surface inside the mouth, the oral ulcer patch adheres to the moist ulcer area inside the mouth, forms a protective barrier, releases active analgesic and anti-inflammatory agents, and wherein the application of the oral ulcer patch to the ulcer reduces the pain caused by the ulcer and reduces the healing time of the ulcer. According to a preferred embodiment, the oral ulcer patch provides a consistent and sustained release of the anti-inflammatory agent, the analgesic agent and the healing agent into the mouth ulcer. According to another preferred embodiment, the anti-inflammatory agent and the analgesic agent in the oral ulcer patch is phosphorus oxide, preferably in the amount of 1.6% to 5% by weight. 2024287187   23 Dec 2024 According to yet another embodiment, the oral ulcer patch further comprises silicon dioxide which acts as a healing agent. Preferably, silicon dioxide is present in the amount of 9% to 20% by weight. According to a further embodiment, the oral ulcer patch comprises the agent that forms the protective barrier, which is preferably calcium oxide, preferably present in the amount of 4% to 15% by weight. According to another embodiment, the oral ulcer patch comprises at least one polymer selected from, but not limited to hydroxypropyl methylcellulose or polyvinyl acetate, wherein the polymer creates the oral ulcer patch form and allow for effective adhesion of the oral ulcer patch to the ulcer on the mucosal surface. According to a further embodiment, the oral ulcer patch remains non-dissolvable in a person’s mouth for at least 20 minutes after its application to the mouth ulcer. According to a preferred embodiment, the oral ulcer patch starts to dissolve in a person’s mouth within a period of 20 to 30 minutes after its application to the mouth ulcer. The dissolution time of the oral ulcer patch is approximately 8 hours. In another embodiment, the oral ulcer patch does not adhere to the healthy mouth mucosal surface. In another aspect, the present invention provides a method of treatment of an mouth ulcer using the oral ulcer patch described above. In yet a further aspect, the present invention provides a process for making an oral ulcer patch in accordance with the above description. Detailed description There is described herein an oral ulcer patch for the treatment of mouth ulcers. The patch comprises: an anti-inflammatory agent; an analgesic agent; a healing agent; and an agent that forms a protective barrier upon reacting with saliva in the mouth. When the patch is applied to a moist ulcer surface located on a mucosal surface inside the mouth, the patch adheres to the moist ulcer area inside the mouth, forms a 2024287187   23 Dec 2024 protective barrier, releases active analgesic and anti-inflammatory agents. The application of the oral ulcer patch to the ulcer reduces the pain caused by the ulcer and reduces the healing time of the ulcer. The oral ulcer patch can deliver anti-inflammatory, analgesic and healing effects. The oral ulcer patch can be in the form of a white round patch. The oral ulcer patch can be applied to an existing mouth ulcer inside the mouth. During the application of the patch, once the patch is placed on the ulcer, the user (or the person applying the patch) applies pressure to the oral ulcer patch for 3 to 5 seconds to ensure that the patch adheres correctly and to the affected area. The patch may not start to dissolve immediately, but can stay intact for at least 20 minutes following its application to the mouth ulcer. Subsequently, disintegration of the patch starts at 20 to 30 minutes, upon reacting with saliva in the mouth. The patch then dissolves and forms an adhesive matrix in the form of a protective barrier around the ulcer. The protective barrier shields the mouth ulcer from damaging factors such as food, dental braces or dentures, which may cause physical abrasion. In addition to protecting the ulcer from further irritation, the oral ulcer patch also accelerates the healing process of the ulcer. The dissolution time of the oral ulcer patch is approximately 8 hours. This time can vary depending on the person’s mouth environment, such as the composition of the person’s saliva and the amount of saliva produced. An advantage of the oral ulcer patch is that it can adhere to a moist surface of mouth mucosa. A further advantage is that the patch can only adhere to a rough surface of the mucosa, where roughness of the mucosa is caused by the lesion due to mouth ulcer. The patch will not adhere to a smooth healthy surface of oral mucosa. This way, the patch provides targeted release of active agents specifically to the mouth ulcer, and not the surrounding healthy mucosa. The composition of the mouth ulcer patch is shown in Table 1. Table 1. Composition (ingredients) Content (% by weight) SiO2 9 - 20 CaO 4.2 - 15 P2O5 1.6 - 5 2024287187   23 Dec 2024 Hydroxypropyl methylcellulose 40 - 50 Polyvinyl acetate 20 - 30 The oral ulcer patch provides a consistent and sustained release of the active ingredients including an anti-inflammatory agent, an analgesic agent and a healing agent into the lesion of the mouth ulcer. In the presently described patch, phosphorus oxide (P2O5) acts as an antiinflammatory agent. The presence of phosphorous oxide reduces the secretion of proinflammatory cytokines by white blood cells, which reduces the inflammatory response initiated as a result of the mouth ulcer. Phosphorus also has an analgesic effect and therefore assists with pain reduction. This is again due to the fact that phosphorus reduces inflammatory response at the site of the lesion. The oral ulcer patch also comprises silicon dioxide, which acts as a healing agent. Silica improves collagen production and has previously been shown to help form the building blocks of collagen formation found in skin, blood, cartilage and connective tissues. In the present oral ulcer patch, another ingredient is calcium oxide which may provide a protective barrier that forms around the ulcer and reduces further irritation from tissue disruptive factors such as food, dental braces or dentures. Calcium enables the adhesion of the patch to the surface of the ulcer and in particular, calcum assists with the targeted adhesion of the patch to the rough surface of the ulcer. When coming into contact with saliva, the oral ulcer patch changes from its hard form into an adhesive matrix and creates a protective barrier over the ulcer. The carrier of the active ingredients in the oral ulcer patch is a soluble medical cellulose. Preferably, it is hydroxypropyl methylcellulose, which may function to control the rate of release of active ingredients and may also act to maintain patch integrity. A further ingredient of the patch is polyvinyl acetate. Polyvinyl acetate may allow for the effective adhesion of the patch to the ulcer on the mouth mucosal surface. Polyvinyl acetate can slow down the release of the active ingredients in the oral ulcer patch. The advantages of the oral ulcer patch of the present invention are that the oral ulcer patch which may not dissolve once it is placed into the mouth, unlike current ulcer 2024287187   23 Dec 2024 treatments, such as lozenges and topical creams and ointments. Instead, the oral ulcer patch can remain in a person’s mouth for at least 20 minutes without dissolving. Further advantages of the oral ulcer patch include the fact that the patch can have an alcohol-free formulation, which improves adhesion times and patient comfort. The patch can use healing properties of silicon thereby ensuring a favourable environment to aid and speed up the recovery process. The oral ulcer patch is made by evenly mixing all the ingredients listed in Table 1. The active ingredients including phosphorus oxide, silicon dioxide, calcium oxide are evenly mixed with the carrier such as soluble medical cellulose, preferably hydroxypropyl methylcellulose, and with polyvinyl acetate. Saliva may slowly dissolve the cellulose carrier, and the active ingredients are released. The oral ulcer patch can be manufactured using the following method. 1. The main and auxiliary materials as per the formula are weighed out. 2. Dissolve the material. Dissolve the weighed auxiliary material 1 and 2 (hydroxypropyl methylcellulose and polyvinyl acetate) in a certain amount of pure water with temperatures of 90 ± 5 °C and the speed of 45 ± 10 cycles per minute, stirring for 2 hours, then add auxiliary material 3 and continue stirring for 2 hours. 3. Mix the materials. Turn on the cooling water of the mixer to cool down to 40 C and adjust its speed to 26 ± 5 cycles per minute. Add the main materials (phosphorus oxide, silicon dioxide, calcium oxide) and stir the mixture for one hour to ensure the uniformity of the mixture. Let stand for 30 minutes. Take the mixture out, and spread it to a glass plate. 4. Bake into a form. Place the glass plates into the oven in a regular manner, with the temperature of 40 ± 2C. The glass plates needs to be held flat and not tilted. The baking time is more than 3 hours.h The active ingredients in the oral ulcer patch accelerate the healing process by stimulating the proliferation of epithelial cells, stimulating the synthesis and secretion of type IV collagen and epithelial growth factor. Examples Clinical trials were conducted to test for the effect of pain relief and healing time of the oral ulcer patch of the present invention. 2024287187   23 Dec 2024 Clinical trial 1 involved 45 patients. Exclusion criteria included recent participation in other clinical studies, use of certain drugs, history of psychological disorders, hypersensitivity, and significant disorders of major organs. Patients were randomly assigned to study or control groups. Study groups were treated with the mouth ulcer patch four times per day before meals and bedtime. Control group was followed without treatment. The following observations were made: oral ulcers were measured for size using a dental instrument ruler and photographs were taken at the start and on the 4th and 7th day of the treatment. Clinical trial 2 involved 50 patients, aged between 18 and 65 years old. Patients were selected based on the following criteria: ability to read the consent form, and having recent oral mucosal ulcers with a history of recurrence and self-healing taking more than 7 days; and onset of a new lesion of oral ulcer less than 48 hours at the time of joining the trial. The following criteria were basis for exclusion: discovery of any condition listed in the exclusion criteria during the trial; and undergoing treatment for other diseases affecting wound or ulcer healing. As part of the trial, physical examinations and blood tests were conducted. Patients were instructed on the use of oral ulcer patch and the use of selfrecording form for prognosis. Pain index was recorded at the time of eating food using the Visual Analog Scale (VAS) grading system. The results from both trials were combined and are shown below. Graph 1. Pain index measurements before and during treatment with the mouth ulcer patch (90 cases). 2024287187   23 Dec 2024 The black bar corresponds to patient group that was treated with the mouth ulcer patch. The grey bar corresponds to the control group. As can be seen from Graph 1, the pain index between the treatment group and the 5 control group has reduced significantly due to the treatment with the oral ulcer patch. No significant side effects were observed, either locally or systematically. Graph 2. Comparison of Ulcer Area Size (90 cases) 10 The black bar corresponds to patient group that was treated with the oral ulcer patch. The grey bar corresponds to the control group. 2024287187   23 Dec 2024 As can be seen from Graph 2, the ulcer size has been significantly reduced by the treatment with the oral ulcer patch. The ulcer size shows that the patch has promoted accelerated healing of the ulcer when compared to the ulcers of the control group. These results show that treatment with the oral ulcer patch has significantly reduced healing time and pain in oral ulcer patients, confirming the efficacy of the patch. The advantage of the present invention is that the oral ulcer patch can provide effective sustained delivery of the anti-inflammatory, analgesic and healing agents to the ulcer lesion over an extended period of time. A further advantage of the oral ulcer patch of the present invention is that the patch does not contain any biological or steroid additives, and therefore it should not have detrimental side effects. Another advantage is that the oral ulcer patch can be alcohol free, so it can be used by young children, pregnant women and elderly people. A further advantage of the oral ulcer patch is that due to its ingredients it can be classified as an unscheduled medicine and therefore it can be retailed and purchased without restriction. The ulcer patch can be purchased by people of all ages and can be sold in pharmacies and supermarkets. Many modifications of the above embodiments will be apparent to those skilled in the art without departing from the scope of the present invention. Throughout this specification and the claims which follow, unless the context requires otherwise, the word “comprise”, and variations such as “comprises” and “comprising”, will be understood to imply the inclusion of a stated integer or step or group of integers or steps but not the exclusion of any other integer or step or group of integers or steps. The reference in this specification to any prior publication (or information derived from it), or to any matter which is known, is not, and should not be taken as an acknowledgment or admission or any form of suggestion that that prior publication (or information derived from it) or known matter forms part of the common general knowledge in the field of endeavour to which this specification relates.

Claims

1. An oral ulcer patch for the treatment of mouth ulcers, comprising:an anti-inflammatory agent;an analgesic agent;a healing agent;an agent that forms a protective barrier upon reacting with saliva in the mouth; wherein, when the oral ulcer patch is applied to a moist ulcer surface located on a mucosal surface inside the mouth, the oral ulcer patch adheres to the moist ulcer area inside the mouth, forms a protective barrier, releases active analgesic and anti-inflammatory agents, and wherein the application of the oral ulcer patch to the ulcer reduces the pain caused by the ulcer and reduces the healing time of the ulcer.

2. The oral ulcer patch according to Claim 1, wherein there is a consistent and sustained release of the anti-inflammatory agent, the analgesic agent and the healing agent into the mouth ulcer.

3. The oral ulcer patch according to Claim 1, wherein the anti-inflammatory agent is phosphorus oxide.

4. The oral ulcer patch according to Claim 1, wherein the analgesic agent is phosphorus oxide.

5. The oral ulcer patch according to Claim 3 or Claim 4, comprising phosphorus oxide in the amount of 1.6% to 5% by weight.

6. The oral ulcer patch according to Claim 1, wherein the healing agent is silicon dioxide.

7. The oral ulcer patch according to Claim 6, comprising silicon dioxide in the amount of 9% to 20% by weight.2024287187   23 Dec 2024- 11 -8. The oral ulcer patch according to Claim 1, wherein the agent that forms the protective barrier is calcium oxide.5   9. The oral ulcer patch according to Claim 8, comprising calcium oxide in the amountof 4% to 15% by weight.

10. The oral ulcer patch according to any one of the preceding claims, the oral ulcer patch comprising at least one polymer selected from, but not limited to hydroxypropyl 10 methylcellulose or polyvinyl acetate,wherein the polymer creates the oral ulcer patch form and allows for effective adhesion of the oral ulcer patch to the ulcer on the mucosal surface.

11. The oral ulcer patch according to any one of the preceding claims, wherein the patch 15 remains non-dissolvable in a person’s mouth for at least 20 mintues after its application to the mouth ulcer.

12. The oral ulcer patch according to any one of the preceding claims, wherein the patch starts to dissolve in a person’s mouth within a period of 20 to 30 minutes after its application 20 to the mouth ulcer.

13. The oral ulcer patch according to any one of the preceding claims, wherein the oral ulcer patch does not adhere to healthy mouth mucosal surface.25   14. A method of treatment of a mouth ulcer using the oral ulcer patch according to anyof the preceeding claims.

15. A process for making an oral ulcer patch, the oral ulcer patch according to any one of Claims 1 to 13.

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