WO2009107098A2

WO2009107098A2 - An oral treatment composition

Info

Publication number: WO2009107098A2
Application number: PCT/IB2009/050797
Authority: WO
Inventors: Nozizwe Ndlovu
Original assignee: Nozizwe Ndlovu
Priority date: 2008-02-27
Filing date: 2009-02-27
Publication date: 2009-09-03
Also published as: WO2009107098A3

Abstract

An oral treatment composition for local application is provided. The composition includes a combination of potassium nitrate and hexylene glycol. The composition also includes a fluoride compound, preferably sodium fluoride. 100ml of the composition will include about 7.Og potassium nitrate, about 30ml hexylene glycol and about 0.25g of sodium fluoride. The composition is conveniently provided as an aqueous mouthwash solution and is suited for use in the treatment of mucositis and other oral ailments in patients that have a compromised immune system or that have undergone radiotherapy and/or chemotherapy. The composition may also be a cream or paste suitable for oral application.

Description

AN ORAL TREATMENT COMPOSITION

FIELD OF THE INVENTION

The invention relates to an oral treatment composition, particularly such a composition for treating patients subjected to head and/or neck radiation therapy and chemotherapy.

BACKGROUND TO THE INVENTION

Radiation in this area of the body is often combined with chemotherapy as either the definitive or preoperative treatment of cancer. Palliative radiation is effective in relieving dysphagia (difficulty in swallowing) in patients who cannot be cured. Post-operative radiation is sometimes used to kill cancer cells where surgical removal is difficult.

Radiation therapy to the head and neck adversely affects operation of the saliva glands. Less saliva or none at all is produced. This impairment of salivary function is often accompanied by oro-pharyngeal candidiasis, xerostomia (dry mouth), gingivitis, dental caries (tooth decay), halitosis, dysphagia, difficulty in speaking and poor nutritional intake. The other major complication associated with radiotherapy treatment is mucositis that can lead to ulcers in the oropharyngeal area.

Mucositis results from both the systemic effects of cytotoxic chemotherapy agents and the local effects of radiation to the oral mucosa. Patients with a damaged oral mucosa and reduced immunity from chemotherapy and radiotherapy are also susceptible to other opportunistic infections.

Furthermore, it has been demonstrated that Candida albicans, Staphylococcus aureus and Streptococcus mutans count in a patients mouth increases after subjecting the head and neck area to radiation therapy. This is because saliva is very important in keeping the mouth healthy and preventing the build up of microorganisms.

Candida is a yeast-like imperfect fungi which is normally present, amongst other places, in the mucous membranes of the mouth. Though usually benign, the Candida can become pathogenic causing candidiasis or thrush. The high level of Streptococcus mutans combined with decreased quality and quantity of saliva lead to dental caries.

It can take a long time (6 months or more) for saliva production to return to normal after radiotherapy treatment. Where radiotherapy has been administered directly to the salivary glands, they may never completely recover. These problems are even worse in patients that are immuno-compromised, such as those infected by HIV.

OBJECT OF THE INVENTION

It is an object of this invention to provide a mouth treatment composition which will at least partially alleviate the above problems.

SUMMARY OF THE INVENTION

In accordance with the invention there is provided an oral treatment composition comprising a combination of: potassium nitrate; and hexylene glycol. The invention further provides for the composition to be topical; for the composition to include 5.Og to 10.Og potassium nitrate and 10ml to 35ml hexylene glycol per 100ml of composition; and for the composition to include about 7.Og potassium nitrate and about 30ml hexylene glycol per 100ml of composition.

Further features of the invention provide for the composition to include a suitable fluoride compound; for the fluoride compound to be sodium fluoride; for the composition to include 0.02g to 2.Og of sodium fluoride per 100ml of composition; and for the composition to include about 0.25g of sodium fluoride per 100ml of composition.

Further features of the invention provide for the composition to be an aqueous mouthwash solution or a cream or a paste.

Further features of the invention provide for the solution to include a non-nutritive sweetener, flavourant and colourant; and for the sweetener to be sucralose.

Another aspect of the invention provides for the composition as defined above to be for use in the treatment of patients with a compromised immune system; for the patients to have undergone radiation therapy and/or chemotherapy; or for the patients to have leukemia.

A further aspect of the invention provides for the composition as defined above to be for use in the manufacture of a mouthwash for the treatment of mucositis. The mouthwash can generally be used for the treatment of patients with a compromised immune system; for patients that have undergone radiation therapy and/or chemotherapy; or for patients that have leukemia. DETAILED DESCRIPTION OF THE INVENTION

A preferred embodiment of the oral treatment composition of this invention is made by dissolving three main components into water. These active components that are so provided in combination are: sodium fluoride, potassium nitrate and hexylene glycol. The result is an aqueous mouthwash solution.

An alternative fluorine-containing compound or fluoride that is suitable for use in a dental care product can also be used. For example, sodium monofluorophosphate may replace the sodium fluoride in the composition.

The mouthwash is suited for use in patients that have undergone head and neck radiation therapy and/or chemotherapy. It is also suited for use in patients with leukemia or other immuno-compromised patients.

The fluoride serves to re-mineralize dentine and enamel. This protects against tooth decay. The composition also combats and resists formation of carious lesions.

As mentioned, the problem of mucositis accompanied by severe ulceration (amongst others) is common in these patients. Where surgery to remove cancer cells has taken place, prosthodontists must often see to the restoration of oral function by making suitable prostheses. The procedure for taking impressions is uncomfortable and painful to the patient due to open wounds in the mouth. An improvement in the condition of health with respect to mouth ulcers will improve the circumstances of this procedure. The use of prostheses will also be more comfortable in a treated mouth.

Potassium nitrate acts to relieve pain, which may persist with these patients. The hexylene glycol is used as an antimicrobial agent. This will act against pathogenic Candida albicans, Streptococcus mutans and also Staphylococcus since the count of these pathogenic micro-organisms is increased in patients whose immune is compromised.

In addition, the hexylene glycol also serves to moisturize the mouth in the absence of proper saliva production.

In solution made up to 100ml, the active components can be present in quantities of: sodium fluoride 0.02g to 2.Og; potassium nitrate 5.Og to 10.Og; and hexylene glycol 10ml to 35ml.

The following more specific approximations appear suitable for a specific embodiment of the composition (also in a solution made up to 100ml): sodium fluoride about 0.25g; potassium nitrate about 7.Og; and hexylene glycol about 30ml.

The amount of sodium fluoride is selected to provide a suitable amount of fluoride.

Additives which will also be added to the solution include a sweetener, a flavourant and a colourant. The sweetener will preferably be sucralose or some other alternative which has a negligible nutritive value.

The patients described can treat the problems under simple directions which can be provided with the bottled product. An alcohol free mouthwash is provided which is convenient to use even for children or patients who cannot take alcohol for religious reasons.

It will be understood that the invention extends to a composition for use in the treatment of patients that of the kind described and also to the use of the composition in the manufacture of a mouthwash for the treatment of such patients and, in particular, for the treatment of mucositis and other oral ailments common to these patients.

The composition may also be provided as a cream or paste suitable for oral, local application. The fluoride compound may be omitted where the patients do not have any teeth or where the teeth are to be treated by a separate fluoride containing product.

A suitably skilled person will appreciate that variations to the specific embodiment may be made without departing from the scope of this invention.

Claims

1. An oral treatment composition comprising a combination of: potassium nitrate; and hexylene glycol.

2. A composition as claimed in claim 1 which includes 5.Og to 10.Og potassium nitrate and 10ml to 35ml hexylene glycol per 100ml of composition.

3. A composition as claimed in claim 2 which includes about 7.Og potassium nitrate and about 30ml hexylene glycol per 100ml of composition.

4. A composition as claimed in any one of claims 1 to 3 which includes a suitable fluoride compound.

5. A composition as claimed in claim 4 in which the fluoride compound is sodium fluoride.

6. A composition as claimed in claim 5 which includes 0.02g to 2.Og of sodium fluoride per 100ml of composition.

7. A composition as claimed in claim 6 which includes about 0.25g of sodium fluoride per 100ml of composition.

8. A composition as claimed in any of the preceding claims for use in the treatment of patients that have a compromised immune system.

9. A composition as claimed in any of claims 1 to 7 for use in the treatment of patients that have undergone radiation therapy and/or chemotherapy.

10. A composition as claimed in any of claims 1 to 7 for use in the treatment of patients that have mucositis.

11. Use of a composition as claimed in any of claims 1 to 7 in the manufacture of a mouthwash for the treatment of patients that have a compromised immune system.

12. Use of a composition as claimed in any of claims 1 to 7 in the manufacture of a mouthwash for the treatment of patients that have undergone radiation therapy and/or chemotherapy.

13. Use of a composition as claimed in any of claims 1 to 7 in the manufacture of a mouthwash for the treatment of mucositis.