GB2541490B

GB2541490B - Odontalgic preparation

Info

Publication number: GB2541490B
Application number: GB1607347.0A
Authority: GB
Inventors: Liam O'brien Sean
Original assignee: Sean Liam Obrien
Current assignee: Sean Liam Obrien
Priority date: 2015-04-29
Filing date: 2016-04-27
Publication date: 2019-09-25
Anticipated expiration: 2036-04-27
Also published as: GB2541490A; WO2016174112A1; GB201507279D0; GB2541490A9

Description

ODONTALGIC PREPARATION

The present invention relates to a liquid formulation or preparation comprising naturally derived organic plant or herbal extract oils for use in the treatment of oral and dental disease and for providing pain relief from dental or oral disease. The formulation of the present invention has anti-inflammatory and anti-microbial or anti-septic properties and is of particular but not exclusive use in the treatment of conditions such as oral abscesses, gingivitis, periodontal disease, pulpitis, dental sensitivity, pericoronitis, ulcers and thrush and other painful conditions or infections of the oral /buccal cavity.

BACKGROUND

Dental pain is estimated to affect between 12-40% of community dwelling adults at some time during their lifetime. Dental pain is a symptom of a wide range of clinical conditions, for example pulpitis. Pulpitis is characterised by acute and intense pain and is one of the most frequent reasons that patients attend for emergency dental care. In irreversible pulpitis, apart from removal of the tooth, the customary way of relieving pain is by drilling into the tooth, removing the inflamed pulp (nerve) and cleaning the root canal. A patient is typically prescribed with two classes of manufactured medicines, namely antibiotics and analgesics. The antibiotic medicine is given systemically i.e, by the oral route and the analgesic medicine may be given either systemically or locally or by both routes, the analgesic when given locally can be in the form of a gel or spray or mouthwash.

It is known in the prior art, for conditions which manifest with symptoms of dental or oral pain that the primary course of action is pain relief by way of analgesics, the most commonly used analgesics for this purpose contain the active ingredient Ibuprofen®, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). A patient will self administer on an as need basis, sometimes over several days. In cases of oral or dental infections an antibiotic may also be prescribed, the antibiotic of choice is usually amoxocillin. The patient will typically complete a course of several days of antibiotics.

There is a need for alternative formulations for dental/oral pain relief that act as both anti-inflammatory agents and anti-infective agents. There is also a need for odontalgic preparations that act rapidly and may be purchased off the shelf without recourse to prescription.

BRIEF SUMMARY OF THE DISCLOSURE

According to a first aspect of the invention there is provided a liquid formulation consisting essentially of tea tree oil, lavender oil and Manuka oil for use in relieving pain associated with an oral/buccal condition selected from the group comprising abscesses, gingivitis, periodontal disease, pulpitis, dental sensitivity, pericoronitis, ulcers and thrush; wherein the formulation comprises a greater volume of tea tree oil than Manuka or lavender oil

Throughout the description and claims of this specification, the words “comprise” and “contain” and variations ofthe words, for example “comprising” and “comprises”, means “including but not limited to”, and is not intended to (and does not) exclude other moieties, additives, components, integers or steps.

Throughout the description and claims of this specification, the singular encompasses the plural unless the context otherwise requires. In particular, where the indefinite article is used, the specification is to be understood as contemplating plurality as well as singularity, unless the context requires otherwise.

Features, integers, characteristics, compounds, chemical moieties or groups described in conjunction with a particular aspect, embodiment or example of the invention are to be understood to be applicable to any other aspect, embodiment or example described herein unless incompatible therewith.

Reference herein to “tea tree oil” is intended to include an oil derived or obtainable from the plant Melaleuca Alterniflora. Tea tree oil is an essential oil obtained by steam distillation ofthe leaves of Melaleuca alternifolia, a plant native to Australia.

Reference herein to “Manuka oil” is intended to include an oil derived or obtainable from Leptospermum scoparium or Manuka tree found predominantly in New Zealand.

Reference herein to “lavender oil” is intended to include an oil derived or obtainable from a plant of the genus Lavandula, especially L. angustifolia,

Preferably, the formulation is an aqueous formulation.

The liquid formulation comprises a greater proportion of tea tree oil by volume than either lavender oil or Manuka oil.

Preferably, the volume of tea tree oil present in the formulation is in an amount of 90% greater than the lavender oil.

Preferably, the volume of tea tree oil present in the formulation is in an amount of 137.5% greater than the Manuka oil.

Preferably, the liquid formulation comprises between 0.05 to 2.5% by volume of tea tree oil, more preferably the range is from 0.1 to 1.5% by volume and more preferably still the range is from 0.2 to 1% by volume.

Preferably, the liquid formulation comprises between 0.05 to 2.0% by volume of lavender oil, more preferably the range is from 0.1 to 1.5% by volume and more preferably still the range is from 0.2 to 0.5 % by volume.

Preferably, the liquid formulation comprises between 0.05 to 2.0% by volume of Manuka oil, more preferably the range is from 0.1 to 1.5% by volume and more preferably still the range is from 0.2 to 0.5 % by volume.

In a specific embodiment of the invention, the formulation comprises by volume 0.20 to 0.70 ml of tea tree oil, 0.15 to 0.30 ml of lavender oil and 0.15 to 0.30 ml of Manuka oil. Some specific embodiments comprise between 0.4 to 6.5% of tea tree oil, 0.2 to 0.50 ml of lavender oil and 0.15 to 0.50 ml of Manuka oil.

In a further specific embodiment of the invention, the formulation comprises by volume 0.45 to 0.75 ml of tea tree oil, 0.30 to 0.60 ml of lavender oil and 0.30 to 0.60 ml of Manuka oil.

It will be appreciated that the final total volume of the liquid formulation is 100 ml and that the ranges given may include any integer therebetween

Preferably, the tea tree oil, lavender oil and Manuka oil are dissolved or mixed in an alcohol base or alternatively in Pharma-grade pure glycerine.

Preferably, the alcohol is ethanol.

Preferably, the tea tree, lavender and Manuka oils dissolved or mixed in between 1-10 ml of alcohol and more preferably are mixed in between 3 to 5 ml of alcohol.

Preferably, the tea tree, lavender and Manuka oils in alcohol are then made up to a final volume with water. Preferably, the final volume is 100 ml.

It will be appreciated that the volumes may be scaled up for production purposes and that the volumes herein are described with respect to 100ml for convenience only. A particular advantage of the formulation of the present invention is that it comprises naturally occurring plant derived active ingredients and obviates the need for manufactured pharmaceuticals. Moreover, each of the oils has a very low level of associated toxicity making the dental formulation of the present invention particularly attractive to users.

Both tea tree oil and Manuka oil have long been associated with antimicrobial activity and have also been reported to possess anti-inflammatory properties. Lavender oil also has been used historically as an antiseptic and for its soothing properties for burns. The unique combination of the tea tree, Manuka and lavender oils, provides set of active ingredients that act together to impact extremely effectively on polymicrobial flora associated with the oral/buccal cavity and associated infections. The unique combination may also stimulate the immune system against the infection and aid regeneration of affected tissue. In the results of the clinical trial (see Examples 3, 4 and 5), the formulation of the present invention has been shown to act rapidly and provide effective pain relief and in some instances to provide a more effective treatment than systemic analgesics.

It will be appreciated that the formulation of the present invention may be a mouth wash however, in an alternative embodiment ofthe invention the tea tree oil, Manuka oil and lavender oil may be formulated into a spray or gel or semi-liquid form.

Preferably, the formulation may include a flavourant. Preferably, the flavourant is naturally or non-rsaturally occurring and preferably is a flavour selected from the group comprising: bergamot, clove, cinnamon, ginger, vanilla, peppermint, spearmint, mint, menthol, rose, violet, coffee, chocolate, hazelnut, sesame, coconut or any other nut, aniseed, liquorice, honey, maple syrup, citrus, lemon, lime, orange, nectarine, tangerine, grapefruit, pear, apple, rhubarb, strawberry, raspberry, cherry, blackcurrant, blackberry, blueberry, pear, pineapple, mango, peach, apricot, grape or and other spice, fruit or nut or combinations thereof. It will be appreciated that the selection of flavourant is dependent on a consumer’s personal choice and is not intended to limit the scope of the invention.

Preferably, the favourant is an oil or concentrate or in a form suitable to be incorporated into the liquid formulation.

Some formulations may also include a colourant.

Preferably, the medicament is in the form of a mouthwash or spay or gel.

The formulation of the present invention not only provides oral or dental pain relief from acute conditions but also, used on a regular basis, can also ensure general oral hygiene and maintenance of oral and dental health. It is envisaged that in this embodiment of the invention the formulation will be provided as a mouthwash and that the concentrations of the active components will be suitably reduced as compared to a formulation that is intended for the treatment of pain relief. A user may simply rinse the buccal cavity with the mouthwash, swilling around the entire cavity to ensure contact with all surfaces within the mouth before spitting the mouthwash out.

Described but not claimed is a method of providing oral or dental pain relief comprising: a) contacting the affected area with a formulation comprising tea tree, lavender oil and Manuka oils; b) leaving the formulation in contact with the affected area for a period of time; c) rinsing the mouth following the prolonged contact; d) repeating steps a) b) and c) over a selected time interval until pain has subsided.

Preferably, the period of contact is between 2 to 10 minutes.

Preferably, the initial contact is repeated every 5 to 10 minutes for severe pain or every 10 to 15 for less severe pain and even every 30 to 120 minutes for even less severe pain, and thereafter on a patient regulated as needed basis. Thus the treatment may be over several days and comprises initial frequent application with subsequent applications being applied with longer intervals. EXAMPLE 1 A formulation per 100 ml of final liquid formulation was prepared comprising the following volumes of active ingredients: 0.20 ml of tea tree oil; 0.15 ml of Manuka oil; 0.15 ml of lavender oil. The three active ingredient oils were then mixed with 3-5 ml of alcohol and made up to a final volume of 100 ml with water. A stronger formulation was prepared per 100 ml of final liquid formulation comprising the following volumes of active ingredients: 0.60 ml of tea tree oil; 0.45 ml of lavender oil 0.45 ml of Manuka oil. The three active ingredient oils were then mixed with 3-5 ml of alcohol and made up to a final volume of 100 ml with water

Tables 1 to 3 show exemplary dosage measurements for the regular, extra strong and tincture liquid formulations.

It will be appreciated that the strength or potency of the formulation may be varied depending on its use, so for example a regular oral hygiene mouthwash may contain lower concentrations of the three ingredients as opposed to a formulation intended for acute and severe pain relief.

Table 1

Exact Dosage Measurements for Regular & Extra Strong Mouthwash and Tincture Using 40% Ethanol

Table 2

Exact Dosage Measurements for Regular & Extra Strong Mouthwash and Tincture Using Pure 100% Ethanol

Table 3

Exact Dosage Measurements for Regular & Extra Strong Mouthwash and Tincture Using Pure Ethanol for 100 ml of Final Solution

If a non-alcoholic mouthwash is desired, it is also possible to use 10 ml. of pure vegetable Glycerine (instead of Ethanol) to emulsify the oils prior to diluting with water to create a 100 ml of final aqueous solution.

EXAMPLE 2 A formulation per 100 ml of final liquid formulation was prepared comprising the following volumes of active ingredients: 0.475 ml of tea tree oil; 0.25 ml of lavender oil 0.20 ml of Manuka oil. The three active ingredient oils were then mixed with 3-5 ml of alcohol and made up to a final volume of 100 ml with water. EXAMPLE 3 A number of volunteer patients with a variety of dental conditions or oral conditions that caused discomfort or pain were each given a liquid formulation according to the present invention. Patients sex and age were recorded, M being male and F being female with age beside (see column 1 of Table 1). The liquid formulation comprised the concentrations as hereinbefore described in Example 2. Patients were directed to use the liquid formulation as a mouthwash and to soak the affected area for 1-2 minutes before ejecting the mouthwash and rinsing several times with water. It was advised to repeat application of the mouthwash of the present invention on a regular basis (every 30 minutes or so) until the pain subsided which was usually after 3-5 further applications.

Patients were asked to subjectively score the pain level experienced on a range of 0 to 4. The pain level experienced was assessed as none (0); mild (1); moderate (2); strong (3); severe (4). Patients were asked to record the number of applications of the mouthwash used to reduce the initial pain level experienced to a score of 1 (mild) and to also record the number of further applications required to reduce the pain level experienced to 0 (none) and to assess the time interval between successive applications. The results of the clinical trial are summarised below in Table 4.

Table 4

All patients stated that the dental preparation mouthwash had an effect in ameliorating pain suffered from the various conditions.

All patients stated that the dental preparation of the present invention was effective in relieving the level of pain and discomfort experienced.

In a subjective assessment of rating the effectiveness of the preparation on a scale of 1 to 10, 1 being low and 10 being high, patients 1, 2, 8, 9, 10, 11 and 12 each rated the preparation with a score of 10. Patients 7 gave a score of 9 and patients 4, 5 and 6 gave a score of 8. Patient 3 omitted to complete this part of the questionnaire.

These results show that the formulation comprising all the three active ingredients of the present invention is effective in reducing pain levels and that it acts rapidly. EXAMPLE 4

Patient 7 had suffered for 2-3 weeks with intermittent moderate pain before 3 days of severe pain. The patient found that over the counter pain killers and mouthwashes did little to reduce the discomfort experienced. However, after an initial application with the preparation of the present invention and the subsequent washes on a two hourly basis the pain subsided to 0 or none. EXAMPLE 5

Patient 9 had a filling become dislodged and had to wait over a week for a dental appointment with her dentist. In the period before seeing her dentist, she suffered strong pain (grade 3) and found that over the counter pain killers merely provided temporary respite. She used the dental preparation of the present invention 3-4 times and the pain reduced to mild and following two further washes the pain totally subsided to a subjective assessment score of 0. By the time she saw her dentist she was pain free. EXAMPLE 6 A further set of patients were tested using formulations with single active ingredients. The protocol and subjective scoring was as described in Example 3. Two patients each received either tea tree oil or lavender oil or Manuka oil as the single component in the formulation. Formulations were prepared as follows: (i) 0.475 ml of tea tree oil mixed with 3-5 ml of alcohol and made up to a final volume of 100 ml with water (ii) 0.25 ml of lavender oil mixed with 3-5 ml of alcohol and made up to a final volume of 100 ml with water; (iii) 0.20 ml of Manuka oil mixed with 3-5 ml of alcohol and made up to a final volume of 100 ml with water

Results are presented in Table 5 below

Table 5

Results showed that tea tree oil alone was more effective than either lavender oil alone or Manuka oil alone, with tea tree oil being slightly more effective than either the lavender oil or Manuka oil formulations, but notably still not as effective as the combination of all three active components. The average rating of effectiveness of the preparations on a scale of 1 to 10, 1 being low and 10 being high was 3.5 for tea tree oil, 2 for lavender oil and 1 for Manuka oil this is in comparison to 7 out of 12 patients

who tested the triple combination providing a score of 10. The lowest score recorded for the triple combination was 8 which was double the tea tree oil alone score.

Data shows that it is the unique combination of tea tree oil, lavender oil and Manuka oil rather than the individual components themselves, that provides a formulation that is both effective in reducing pain levels and that acts rapidly to reduce pain levels in a variety or oral and dental conditions.

Claims

1. A liquid formulation consisting essentially of tea tree oil, lavender oil and Manuka oil for use in relieving pain associated with an oral/buccal condition selected from the group comprising abscesses, gingivitis, periodontal disease, pulpitis, dental sensitivity, pericoronitis, ulcers and thrush; wherein the formulation comprises a greater volume of tea tree oil than Manuka or lavender oil.

2. A liquid formulation for use according to claim 1 wherein the volume of tea tree oil present in the formulation is in an amount of 90% greater than the lavender oil.

3. A liquid formulation for use according to either claim 1 or 2 wherein the volume of tea tree oil present in the formulation is in an amount of 137.5% greater than the Manuka oil.

4. A formulation for use according to any preceding claim wherein the tea tree oil comprises between 0.05 to 2.5% by volume.

5. A formulation for use according to claim 1 wherein the lavender oil comprises between 0.05 to 2.0% by volume.

6. A formulation for use according to claim 1 wherein the Manuka oil comprises between 0.05 to 2.0% by volume.

7. A formulation for use according to claim 1 comprising 0.20 to 0.60 ml of tea tree oil, 0.15 to 0.30 ml of lavender oil and 0.15 to 0.30 ml of Manuka oil in a final volume.

8. A formulation for use according to any preceding claim wherein the tea tree, Manuka and lavender oils are dissolved or mixed in alcohol or glycerine.

9. A formulation for use according to claim 8 wherein the alcohol is ethanol.

10. A formulation for use according to any preceding claim wherein the tea tree, Manuka and lavender oils in alcohol or glycerine are made up to a final volume with water.

11. A formulation for use according to claim 10 wherein the final volume is 100 ml.

12. A formulation for use according to any preceding claim including a flavourant.

13. A formulation for use according to claim 12 wherein the flavourant is naturally or non-naturally occurring and is a flavour selected from the group comprising: bergamot, clove, cinnamon, ginger, vanilla, peppermint, spearmint, mint, menthol, rose, violet, coffee, chocolate, hazelnut or any other nut, aniseed, liquorice, honey, maple syrup, citrus, lemon, lime, orange, nectarine, tangerine, grapefruit, pear, apple, rhubarb, strawberry, raspberry, cherry, blackcurrant, blackberry, blueberry, pear, pineapple, mango, peach, apricot, grape or and other spice, sesame, coconut or any other nut or combinations thereof.

14. A formulation for use according to any preceding claim wherein the tea tree, Manuka and lavender oils are formulated into a mouthwash or spray or gel or semiliquid form.