DESC:FIELD OF INVENTION
The present invention relates to oral hygiene composition and in particular to an herbal dentifrice composition having a novel combination of anti-sensitivity agents along with Akarkara extract and method of preparing the same.
BACKGROUND OF INVENTION
Dentifrice compositions are extensively used for providing oral health. Dentifrices are available in several forms like toothpaste, mouthwash, tooth powder, chewing gum, foam etc. These comprise a variety of organic or non-organic active ingredients to provide one or more benefits to the user. Some of these benefits include anti-sensitivity, antibacterial, anti-inflammatory and antioxidant properties. These properties of dentifrices make them useful for prevention or treatment of a number of oral health conditions like hypersensitivity, cavities, gingivitis, plaque, tartar, periodontal disease etc.
The condition known as hypersensitivity is very common. It may be caused in response to various external stimuli on the surface of the teeth such as temperature changes, change in pH, high osmotic pressures in the oral cavity etc. The problem is particularly acute in people who have lost some of the protective enamel on tooth surfaces due to erosion or abrasion, caries, chipping of the enamel etc. This exposes the inner sensitive parts of the teeth like dentin and pulp to the external stimuli.
The causes of pain due to hypersensitivity are not clear since the dentin does not have nerves for transmission of impulses. Dentin is composed of 70% of the mineral hydroxylapatite, 20% organic material and 10% water. The organic fraction mainly consists of odontoblastic fibrils and dentinal tubules which are microscopic channels that radiate outward through the dentin from the pulp to the exterior cementum or enamel border. These tubules contain fluid and cellular structures. It is believed that the dentinal tubules and odontoblastic fibrils in dentin are capable of transmitting neural impulses from the tooth structure to the dental pulp. The pulp has several nerve cells which transmit neural impulses leading to the sensation of pain.
Several methods for treating hypersensitivity are known, which can be invasive in nature or noninvasive. Invasive procedures may include gingival surgery, application of resins, pulpectomy, laser treatment etc. Non-invasive treatment options are topical agents and dentifrices that contain a desensitizing active ingredient. These are considered to be the simplest, cost-effective, and efficacious first line of treatment for most patients. According to the literature, the most widely available desensitizing toothpaste ingredient is potassium nitrate. The potassium ions are thought to block the synapse between nerve cells, reducing nerve excitation and the associated pain. Another active ingredient that exhibits a similar mechanism is potassium chloride.
Other treatments are designed to block the neural impulse from the tooth structure into the dentin tubules by occluding or sclerosing the tubules using topical agents. These topical agents include active ingredients such as stannous fluoride, strontium chloride hexahydrate and aluminum, potassium or ferric oxalates and fluorides. Other active agents that have proven to be effective as a desensitizing agent are dentin sealers (resins), sodium citrate and sodium monofluorophosphate.
Narhi, M., et al., in Proceedings of the Finnish Dental Society disclosed that hypersensitivity may sometimes persist despite effective blocking of the tubules and that this may indicate that some other mechanisms may operate in the nerve activation instead of, or in addition to the hydrodynamic one. Inflammation may sensitize the nerve endings to such an extent that smaller fluid shifts would be sufficient for nerve activation. The disclosure also suggested that bacterial invasion of dentin may be one of the causes of hypersensitivity and sensitive teeth may also develop as a result of inflammation induced sensitization of the nerves in the pulp-dentin border in teeth with open tubules.
Many agents assumed to be effective in the treatment of sensitive teeth are known in the prior arts. Some of these treatments have been demonstrated to be capable of occluding the dentinal tubules. Granted European Patent EP 0390456 B1 discloses a desensitizing oral composition comprising water-soluble strontium and potassium salts and it is asserted that a combination of anti-sensitivity agents leads to particularly effective anti-sensitivity activity. US Patent No. 5,015,465 is directed to strontium salts such as acetates, chlorides, nitrates, lactates and bromides in oral hygiene composition.
Of late the ayurvedic toothpaste market in India is on the bloom. People are opening up to the idea of natural toothpastes because of its enormous benefits. To start off, natural toothpaste contain no artificial chemicals, preservatives or sweeteners hence cannot have any side effect at all. These teeth whitening toothpastes utilize plant and fruit extracts in lieu of sodium lauryl sulfate which causes the foaming and lathering effect. Sodium lauryl sulfate is known to burn human skin and cause liver inflammation.
Moreover, natural oral care products are effective in removing bacteria and help to keep oral cavity hygienic. Peppermint and spearmint oils are present in herbal toothpaste which helps in destroying the bacteria. Herbal toothpastes for anti-sensitivity are not much explored.
Anacyclus pyrethrum (Akarkara) is a perennial herb found in North Africa, North India, Arabian countries and in Mediterranean region. It has a hard, compact, fusiform root and having a pungent efficacy in relieving ache and promotes a free flow of saliva. It is also popular as a spice and has an anesthetic effect, anti-microbial effect, anti-inflammatory effect etc.
The object of the present invention is to provide an Akarkara based hypersensitivity toothpaste to exploit its anesthetic, anti-microbial and anti-inflammatory properties.
The present invention provides a novel combination of anti-sensitivity agents along with Akarkara for achieving better anti-sensitivity activity.

SUMMARY OF INVENTION
The present invention relates to a novel herbal dentifrice composition for the sensitivity relief, wherein the anti-sensitivity agents are used along with Akarkara having anti-sensitivity property. The sensitivity may be in response to sudden changes in temperature, sudden changes in pH, high osmotic pressure in oral cavity and the like. The herbal dentifrice composition of present invention benefits from the useful properties of herbal extracts as well as inorganic salts and provides sensitivity relief within minutes. The dentifrice composition can conveniently be used in paste form and does not have any adverse effects on the teeth and mouth.
According to an embodiment of the invention there is provided a herbal dentifrice composition comprising strontium acetate, Akarkara (Anacyclus pyrethrum) extract and an herbal extract as active ingredients present in an effective amount.
According to another embodiment of the invention, the strontium acetate is present in an amount of 6-10%.
According to another embodiment of the invention, Akarkara (Anacyclus pyrethrum) extract is present in an amount of 0.1-0.5%.
According to another embodiment of the invention, the herbal extract is present in an amount of 0.01-0.5%.
According to another embodiment of the invention, the herbal extract comprises Piper nigrum, Piper longum, Zingiber officinale, Zanthoxylum armatum or a combination thereof. Each of these components has one or more useful properties that are beneficial for promoting overall oral health.
According to another embodiment of the invention, the herbal dentifrice composition further comprises of suitable foaming agents that provide a cleansing effect and help remove the trapped particles within the teeth. In addition, they may also aid other ingredients to work better. The foaming agents are selected from a group consisting of sodium methyl cocoyl taurate, sodium lauryl sulfate or a combination thereof; present in an amount of 1.8-2.4%.
According to another embodiment of the invention, the herbal dentifrice composition further comprises of a suitable orally acceptable thickening agents and more preferably thickening silica; present in an amount of 5-10%.
According to another embodiment of the invention, the herbal dentifrice composition further comprises of a suitable abrasive selected from the group consisting of abrasive silica, insoluble phosphates, alumina, resinous abrasives or a combination thereof and more preferably abrasive silica; present in an amount of 10-15%.
According to another embodiment of the invention, the herbal dentifrice composition further comprises of water and at least one humectant to help retain the water content in the dentifrice composition, wherein the humectants are selected from a group consisting of glycerine, sorbitol, propylene glycol or a combination thereof; present in an amount of 24-28%.
According to another embodiment of the invention, the herbal dentifrice composition further comprises of suitable binding agents, sweetening agents, coloring agents, flavoring agents, preservatives or a combination thereof.
According to another embodiment of the invention, the binding agents are selected from a group consisting of xanthan gum, carrageenan, carboxymethyl cellulose or a combination thereof; present in an amount of 0.5-1.4%.
According to another embodiment of the invention, the sweetening agents are selected from the group consisting of saccharin, stevia, sucralose, aspartame or a combination thereof; present in an amount of 0.2-0.4%.
According to another embodiment of the invention, the coloring agents are selected from the group consisting of gairic, red ochre, iron oxide or combination thereof; present in an amount of 0.1-1.0%.
According to another embodiment of the invention, the flavoring agents are selected from a group consisting of spearmint oil, peppermint oil, clove oil, eucalyptus oil; present in an amount of 0.6-2.0%.
According to another embodiment of the invention, the preservatives are selected from the group consisting of suitable parabens, sodium benzoate, phenoxy ethanol or a combination thereof; present in an amount of 0.2-0.4%.
The dentifrice composition of present invention is preferably formulated in the form of conventional toothpaste. The toothpaste is a very convenient form for dentifrices which is easy to use and carry. The composition may also be in the form of other oral hygiene compositions, for example, the ingredients may be incorporated into a mouthwash or into a dental powder formulation or into compositions which can be chewed by the user, for example, chewing gum, tablets, pastilles and lozenges. These compositions will contain the base materials together with suitable flavors and sweetening agents and are formulated in the known manner.
BRIEF DESCRIPTION OF DRAWINGS:
The invention can be described in the terms of the following figures where-
Figure 1 shows the graphical representation for clinical testing of the relief of hypersensitivity
DETAILED DESCRIPTION OF INVENTION
Discussed below are some representative embodiments of the present invention. The invention in its broader aspects is not limited to the specific details and representative methods. The illustrative examples are described in this section in connection with the embodiments and methods provided. The invention according to its various aspects is particularly pointed out and distinctly claimed in the attached claims read in view of this specification.
It is to be noted that, as used in the specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to a composition containing “a compound” includes a mixture of two or more compounds. It should also be noted that the term “or” is generally employed in its sense including “and/or” unless the content clearly dictates otherwise.
The expression of various quantities in terms of “%” means the percentage by weight of the total solution or composition unless otherwise specified.
All cited references are incorporated herein by reference in their entireties. Citation of any reference is not an admission regarding any determination as to its availability as prior art to the claimed invention.
The present invention, in its product and process aspects, is described in detail as follows.
The present invention relates to an herbal dentifrice composition having anti-sensitivity property comprising strontium acetate, Akarkara (Anacyclus pyrethrum) extract and an herbal extract as active ingredients present in an effective amount.
The term “sensitivity” refers to painful and irritating condition of tooth exposed to external stimuli such as heat, cold, chemicals, physical and mechanical pressure such as brushing and flossing causing inward or outward displacement of fluid in the dentinal tubule activating the nerve endings at the pulp-dentin interface. The term “sensitivity” can be interchangeably referred to as “hypersensitivity” or “tooth sensitivity”.
Strontium is an element similar to calcium and succeeds calcium in Group-2 of the periodic table. Thus, strontium ions released from strontium salt can replace some of the calcium lost from the dentin and thereby block or occlude the exposed tubules in the dentinal tissue. This helps prevent the movement of the fluid within the tubules in response to a sensitivity stimulus that could otherwise cause tooth pain.
The preferred strontium salt is strontium acetate, but other examples which may be used include strontium chloride, strontium nitrate, strontium lactate, strontium bromide. The preferred strontium salt, strontium acetate, is usually employed in the form of its hemihydrate, and is present in an amount of 6-l0% in the herbal dentifrice composition of present invention.
Anacyclus pyrethrum (Akarakara) is a perennial herb found in North Africa, North India, Arabian countries and in Mediterranean region. It has a hard, compact, fusiform root and has a pungent efficacy in relieving ache and promotes free flow of saliva. It is also popular as a food spice. It is known to have an anesthetic effect, antimicrobial effect, anti-inflammatory effect etc. In an embodiment of the invention Akarkara (Anacyclus pyrethrum) extract is present in an amount of 0.1-0.5%. The Akarakara extract was prepared in house from Akarkara that was sourced from Himalayan region of India.
The herbal extract present in the herbal dentifrice composition of present invention comprises Piper nigrum, Piper longum, Zingiber officinale, Zanthoxylum armatum or a combination thereof. Each of these components has one or more useful properties that are beneficial for promoting overall oral health. In an embodiment of the invention, the herbal extract is present in an amount of 0.01-0.5%.
Piper nigrum, from which black pepper is derived, contains volatile oils, piperine, piperdine, chavicin and other active ingredients and is recognized to have carminative and mildly antipyretic properties. In addition, it has been found to enhance the cleansing of teeth and to assist in the prevention of tooth diseases. In this invention, Piper nigrum is in the form of a powder. In an embodiment of the invention, Piper nigrum is present in an amount of 0.0005-0.025%. Piper nigrum was obtained from Southern region of India.
Piper longum, also known as Long pepper, Pippali or Indian long pepper, is a flowering vine in the family Piperaceae, cultivated for its fruit, which is usually dried and used as a spice and for seasoning. The fruit of this plant is also used to make medicine. Indian long pepper is sometimes used in combination with other herbs in Ayurvedic medicine. Indian long pepper is used to improve appetite and digestion, as well as treat stomach ache, heartburn, indigestion, intestinal gas, diarrhea, and cholera. It contains a chemical called piperine. Piperine is known to fight certain parasites that can infect people. It is also known to change the lining of the intestines. This change allows some drugs and other substances taken by mouth to be better absorbed by the body. In an embodiment of the invention, Piper longum is present in an amount of 0.0005-0.025%. Piper longum was obtained from Southern region of India.
Zingiber officinale, also commonly known as ginger has been in medical use since ancient times and has a wide range of properties alleged to be useful for a wide range of ailments. Zingiber officinale has been investigated for anti-inflammatory, analgesic, antipyretic, antimicrobial and hypoglycemic activities (Mascolo, N., et al., "Ethnopharmacologic Investigation of ginger (Zingiber officinale), J. Ethnopharmacol., 27, pp. 129-140, Nov. 1989). Certain components of ginger, specifically, gingerol, have been reported to possess antimicrobial activity against oral bacteria (Park, et al., “Antibacterial activity of (10)-Gingerol and (12)-Gingerol isolated from Ginger Rhizome against periodontal bacteria”, J. Phytother. Res., 22(11), pp. 1446-1449, Nov. 2008). In an embodiment of the invention, Zingiber officinale is present in an amount of 0.0005-0.025%. Zingiber officinale was obtained from Southern region of India.
Zanthoxylum armatum plant has its main use is in toothache. Fruits of Zanthoxylum armatum contain essential oil (1.5%). The main constituent of oil is linalool. The oil is disinfectant and antiseptic; therefore, fruit powder is used for toothache. Therefore, Zanthoxylum armatum fruits are used as a component in the preparation of this formulation. In an embodiment of the invention, Zanthoxylum armatum present in an amount of 0.0005-0.025%. Zanthoxylum armatum was obtained from India.
The herbal dentifrice composition of present invention further comprises of suitable foaming agents that provide a cleansing effect and help remove the trapped particles within the teeth. In addition, they may also aid other ingredients to work better. In accordance to another embodiment of the invention, the foaming agents are selected from a group consisting of sodium methyl cocoyl taurate, sodium lauryl sulfate or a combination thereof. The foaming agents are present in an amount of 1.8-2.4%.
Likewise, numerous orally acceptable thickening agents have been indicated for the use in the herbal dentifrice composition of present invention. As used herein, the term "orally acceptable" means safe for use in the mouth at levels required. In general, all components of the compositions of the present invention are orally acceptable. Any orally acceptable thickening agent can be used in the herbal dentifrice composition of present invention and more preferably thickening silica is used. The thickening agents are present in an amount of 5-10%.
In accordance to another embodiment of the invention, the dentifrice composition comprises of one or more abrasives preferably abrasive silica for cleaning and polishing teeth. Said abrasives are selected from the group consisting of insoluble phosphates, alumina, calcium carbonate, resinous abrasives or a combination thereof. The abrasives are present in an amount of 10-15%.
The herbal dentifrice composition of present invention further comprises of water and at least one humectant to help retain the water content in the dentifrice composition. Water is present in the dentifrice composition in quantity sufficient. The term "quantity sufficient" used in reference to the amounts of ingredients is commonly understood in the art to mean the quantity required to make up volume of the composition and is generally readily determined by the persons skilled in the formulation arts. The term “quantity sufficient” can be interchangeably used as "q.s". The humectants contemplated for use in the herbal dentifrice composition of present invention include polyols, such as glycerine, sorbitol, propylene glycol and the like. According to an embodiment of the invention, the humectants are present in an amount of 24-28%.
The herbal dentifrice composition further comprises of suitable binding agents, sweetening agents, flavoring agents etc. One or more sweeteners and flavoring agents may be added for consumer satisfaction. Binding agents are included in a toothpaste composition to build viscosity and are selected from the group consisting of xanthan gum, carrageenan, carboxymethyl cellulose or a combination thereof. The binding agents are present in an amount of 0.5-1.4%.
Examples of sweetening agents include saccharin, stevia, aspartame or a combination thereof. In an embodiment of the invention, the sweetening agents are present in an amount of 0.2-0.3%.
The flavoring agents used to prepare the herbal dentifrice composition of present invention are selected from a group consisting of spearmint oil, peppermint oil, clove oil, eucalyptus oil and are present in an amount of 0.6-2%.
Other materials that are conventional components of toothpaste compositions, such as pharmaceutically acceptable preservatives and coloring agents may also be present in the herbal dentifrice composition of present invention. The term “pharmaceutically acceptable preservatives” as used herein, means naturally or synthetically produced substance which have the same general properties as the compounds from which they are derived and which are acceptable from a toxicity viewpoint. The coloring agents are selected from the group consisting of gairic, red ochre, iron oxide or a combination thereof and are present in an amount of 0.1-1.0%. The preservatives are selected from the group consisting of suitable parabens, sodium benzoate, phenoxy ethanol or a combination thereof. The preservatives are present in an amount of 0.2-0.4%.
The present invention also provides the process for preparation of dentifrice composition having anti-sensitivity property. The herbal dentifrice composition of present invention was formulated as toothpaste using the standard method of preparation. The toothpaste is prepared as follows:
(1) A binder and additives were dispersed in a humectant, an abrasive and medicinal components were added thereto, and then the mixture was stirred for 20 minutes; and
(2) A foaming agent and flavoring agent were added to the mixture of step 1 under slow speed agitation to minimize foaming, stirred under vacuum condition for 20 minutes to obtain an end product.
The dentifrice composition of present invention is preferably formulated in the form of conventional toothpaste. The toothpaste is a very convenient form for dentifrices which is easy to use and carry. The composition may also be in the form of other oral hygiene compositions, for example, the ingredients may be incorporated into a mouthwash or into a dental powder formulation or into compositions which can be chewed by the user, for example, chewing gum, tablets, pastilles and lozenges. These compositions will contain the base materials together with suitable flavors and sweetening agents and formulated in the known manner.
The present invention is more particularly described in the following non-limiting examples that are intended as illustrations only, since numerous modifications and variations within the scope of the present invention will be apparent to a skilled artisan. Unless otherwise noted, all parts, percentages, and ratios reported in the following examples are on a weight basis, and all reagents used in the examples were obtained or made available from the chemical suppliers.
Examples
Example 1
In this example, representative herbal dentifrice compositions of present invention comprising strontium acetate, Akarkara (Anacyclus pyrethrum) extract and an herbal extract are described that are prepared by the aforementioned process and are formulated as toothpaste. Table 1 shows the components and their amounts to be used in the dentifrice composition of Examples 1 to 3. The unit of each value is % by weight.
Table 1: Components used for preparing the dentifrice composition of present invention

Examples
Components 1 2 3
Humectants
Binding agent Glycerine
Xanthan gum 24.00
1.00 28.00
0.50 24.00
1.40
Strontium acetate
Preservatives
Akarkara extract
Herbal Extract
Sweetening agent
Thickening silica
Abrasive silica
Coloring agent
Foaming agent

Flavoring agent
Water -

Sodium benzoate
-

-
Sodium saccharin

Mfil-P

Absil-100
Gairic, red ochre
Sodium methyl cocoyl taurate

-

- 8.00

0.25
0.20

0.10*
0.25

6.90

13.50
0.50
2.20

1.20

q.s. 6.00

0.20
0.10

0.01**
0.20

10.00

14.00
0.10
1.80

0.80

q.s. 10.00

0.40
0.50

0.50***
0.40

5.00

10.00
1.00
2.40

2.00

q.s.
*q.s = quantity sufficient
Table 2 indicates the composition of the herbal extracts used for preparing the dentifrice compositions of Examples 1 to 3.
Table 2: Composition of herbal extracts used in dentifrice composition of present invention
Components *Herbal extract composition **Herbal extract composition ***Herbal extract composition
Piper nigrum 0.0050 0.0005 0.025
Piper longum 0.0050 0.0005 0.025
Zingiber officinale 0.0050 0.0005 0.025
Zanthoxylum armatum 0.0050 0.0005 0.025
Water 0.0800 0.0080 0.400

Example 2
Evaluation of the desensitizing efficacy of the herbal dentifrice composition of present invention
The study design and methods used for the evaluation of the desensitizing efficacy of the herbal dentifrice composition of present invention are described hereinafter.
Comparative study for evaluating the desensitizing efficacy of the herbal dentifrice composition of present invention was carried out as per the American Dental Association (ADA) guidelines. 139 subjects were divided into 4 groups as indicated in Table 3.
Table 3: Details of the study design used for evaluating desensitizing efficacy for herbal dentifrice composition of present invention
Group Subjects Dentifrice composition Active ingredient (s)
Group A n=35 Composition A:
Desensitizing toothpaste Strontium acetate
Group B n=34 Composition B:
Herbal dentifrice composition of present invention Strontium acetate + Akarkara+ Herbal extract*
Group C n=35 Composition C:
Herbal toothpaste with Akarkara. Herbal extract* + Akarkara
Group D n=35 Composition D:
Herbal toothpaste without Akarkara. Herbal extract*
*Herbal extract as elaborated in Table 2
Subjects of all the four groups applied pea-sized amounts of their respective toothpaste directly to the sensitive areas of two sensitive teeth with a fingertip and massaged each for a minute. Subjects then brushed normally with the same product for 6 weeks. Sensitivity to pressure and to air was measured in the form of the tactile test and evaporative blast test immediately after application. The study was further carried out after 3 weeks and again after 6 weeks. The details of these tests are provided hereinafter.
Tactile test
A sharp dental explorer was passed over the sensitive area of the tooth (usually the cemento-enamel junction), perpendicular to its long axis, at an approximated constant force. The test was repeated three times before a score was recorded and the response of the patient was graded on a severity scale from 0-3, wherein 0= no pain felt, 1= slight pain or discomfort, 2= severe pain, 3= severe pain that lasts.
A. Thermal test or Evaporative air blast test
A blast of air was directed onto the affected area of the tooth for 1s from a distance of 10mm (the adjacent teeth were isolated using cotton rolls) using a standard dental unit syringe of 40-65psi at a temperature of 17-21°C.
The test was repeated three times before a score was recorded and the response of the patient was graded on a severity scale from 0-3, wherein 0= no pain felt, 1= slight pain or discomfort, 2= severe pain, 3= severe pain that lasts.
The results of the tactile test and the evaporative air blast tests are summarized in Table 4 below.
Table 4: Effect of sensitivity of herbal dentifrice composition of present invention due to various stimuli
Test Group n Mean
Tactile Test score at base line A
B
C
D 35
35
34
35 1.6200
1.6667
1.6054
1.6800
Tactile Test score after 3 weeks A
B
C
D 35
35
34
35 0.9000
0.9833
1.4459
1.4200
Tactile Test score after 6 weeks A
B
C
D 35
35
34
35 0.7600
0.8444
1.3649
1.3400
Evaporative air blast test score at baseline A
B
C
D 35
35
34
35 5.2200
5.7139
5.2162
5.7400
Evaporative air blast test score after 3 weeks A
B
C
D 35
35
34
35 3.5200
3.9972
4.7973
5.1600
Evaporative air blast test score after 6 weeks A
B
C
D 35
35
34
35 2.7200
3.0833
4.5757
4.8800

Composition A was found to reduce tactile sensitivity better than composition B and much better than compositions C and D. But composition B was found to reduce evaporative air blast sensitivity slightly better than composition A and much better than compositions C and D.
Example 4
Clinical testing of the relief of hypersensitivity by the dentifrice composition of present invention
The herbal dentifrice composition of present invention was directly applied with a fingertip for 60 seconds and then response by 139 subjects was recorded for four different compositions A, B, C and D. The details of the study design are tabulated in Table 1 above. Subjects demonstrated a measurable improvement in sensitivity after 60 seconds. The percentage of subjects getting instant relief from the pain are tabulated in Table 5 and graphically indicated by Fig. 1.
Table 5: Percentage of subjects getting instant relief from the pain using dentifrice composition of present invention
Group Subjects getting instant relief (%) (approximate) Subjects with no instant reflief (%) (approximate)
A 63.00 37.00
B 66.00 34.00
C 0.00 100.00
D 0.00 100.00

Thus, the herbal dentifrice composition of present invention B provided better instant sensitivity relief than the composition A and much better instant sensitivity relief than the compositions C and D. A significant symptomatic relief was seen after treatment for 6 weeks with the herbal dentifrice composition of present invention. No clinically significant adverse reactions were reported during the entire study period and overall compliance to the treatment was good.
While particular embodiments of the herbal dentifrice composition of present invention have been illustrated and described, it would be obvious to those skilled in the art that various other changes and modifications can be made within departing from the spirit and scope of the invention. It is thereof intended to cover in the appended claims such changes and modifications that are within the scope of the invention.
,CLAIMS:We claim:
1. An herbal dentifrice composition for sensitivity relief comprising strontium acetate, Akarkara (Anacyclus pyrethrum) extract and an herbal extract as active ingredients present in an effective amount.
2. The herbal dentifrice composition for sensitivity relief as claimed in claim 1, wherein the strontium acetate is present in an amount of 6-10%.
3. The herbal dentifrice composition for sensitivity relief as claimed in claim 1, wherein Akarkara (Anacyclus pyrethrum) extract is present in an amount of 0.1-0.5%.
4. The herbal dentifrice composition for sensitivity relief as claimed in claims 1 and 2, wherein the herbal extract is present in an amount of 0.01-0.5%.
5. The herbal dentifrice composition for sensitivity relief as claimed in claims 1 and 4, wherein the herbal extract comprises Piper nigrum, Piper longum, Zingiber officinale, Zanthoxylum armatum or a combination thereof.
6. The herbal dentifrice composition for sensitivity relief as claimed in claims 1 to 5, wherein the herbal dentifrice composition for sensitivity relief further comprises of suitable foaming agents that provide a cleansing effect and help remove the trapped particles within the teeth; wherein the foaming agents are selected from a group consisting of sodium methyl cocoyl taurate, sodium lauryl sulfate or a combination thereof; present in an amount of 1.8-2.4%.
7. The herbal dentifrice composition for sensitivity relief as claimed in claims 1 to 6, wherein the herbal dentifrice composition for sensitivity relief further comprises of a suitable orally acceptable thickening agents and more preferably thickening silica present in an amount of 5-10%.
8. The herbal dentifrice composition for sensitivity relief as claimed in claims 1 to 7, wherein the herbal dentifrice composition for sensitivity relief further comprises of a suitable abrasive selected from the group consisting of abrasive silica, insoluble phosphates, alumina, resinous abrasives or a combination thereof and more preferably abrasive silica present in an amount of 10-15%.
9. The herbal dentifrice composition for sensitivity relief as claimed in claims 1 to 8, wherein the herbal dentifrice composition for sensitivity relief further comprises of water and at least one humectant to help retain the water content in the dentifrice composition, wherein the humectants are selected from a group consisting of glycerine, sorbitol, propylene glycol or a combination thereof; present in an amount of 24-28%.
10. The herbal dentifrice composition for sensitivity relief as claimed in claims 1 to 9, wherein the herbal dentifrice composition for sensitivity relief further comprises of suitable binding agents, sweetening agents, coloring agents, flavoring agents, preservatives or a combination thereof.
11. The herbal dentifrice composition for sensitivity relief as claimed in claims 1 to 10, wherein the binding agents are selected from a group consisting of xanthan gum, carrageenan, carboxymethyl cellulose or a combination thereof; present in an amount of 0.5-1.4%.
12. The herbal dentifrice composition for sensitivity relief as claimed in claims 1 to 10, wherein the sweetening agents are selected from the group consisting of saccharin, stevia, sucralose, aspartame or a combination thereof; present in an amount of 0.2-0.4%.
13. The herbal dentifrice composition for sensitivity relief as claimed in claims 1 to 10, wherein the coloring agents are selected from the group consisting of gairic, red ochre, iron oxide or combination thereof; present in an amount of 0.1-1.0%.
14. The herbal dentifrice composition for sensitivity relief as claimed in claims 1 to 10, wherein the flavoring agents are selected from a group consisting of spearmint oil, peppermint oil, clove oil, eucalyptus oil present in an amount of 0.6-2.0%.
15. The herbal dentifrice composition for sensitivity relief as claimed in claims 1 to 10, wherein the preservatives are selected from the group consisting of suitable parabens, sodium benzoate, phenoxy ethanol or a combination thereof; present in an amount of 0.2-0.4%