|Title of Invention||
A LIQUID FORMULATION FOR HYGIENE AND TREATMENT OF AILMENTS OF THROAT AND MOUTH
|Abstract||The present invention provides turmeric-based formulations, which are easy to carry, convenient to use, which can be readily mixed with plain or warm water and can be used to treat sore throat, periodontal diseases. The formulation can also be used as a mouthwash to improve general hygiene of mouth/ teeth/ gums and to prevent bad breath. The formulations in solid or powder or granule forms are generally more convenient to consumers as they are easy to carry along in tablet or capsule or sachet forms and can be easily dissolved or suspended in a glass of water & used immediately, or in chewable tablets or pills. Formulation disclosed in the present invention are also available in aqueous solution form after incorporation of suitable surfactant and packed in containers such as bottles, on a ready-to-use form or in a concentrated, water-based syrup form which can be readily diluted in a glass of water and used immediately.|
|Full Text||FORM 2
THE PATENTS ACT 1970
(39 of 1970)
The Patent Rules, 2003
(See section 10 and rule 13)
A Novel Pharmaceutical Formulation for Throat and Oral Hygiene and A
Novel Dosage Delivery Form '
Joshi, Vinayak Narahaf,
Tejpal Scheme, Road No 3, Near Union Bank
Vile Parle (E), Mumbai 400057, India
An Indian National
The following specification describes the invention:
A Novel Pharmaceutical Formulation for Throat and Oral Hygiene and A
Novel Dosage Delivery Form
Field of Invention:
This invention generally relates to the field of hygiene of throat, mouth, gums & teeth and related ailments. More particularly, it relates to the preventive and curative treatment of the same using compositions comprising mainly of turmeric &/ or curcumin and surfactant. Such compositions are fortified with ingredients like common-salt, alum, clove oil, bactericides, coagulants, hemostats, astringents, soothing agents, neutralizing agents flavoring agents, colours and sweeteners. Such compositions, in their solid, powder or liquid form, are then meant to be used as mouth-wash & gargling products.
Background of Invention:
Mouth & throat conditions, including the presence of nutrients, suitable pH, temperature, and moisture allow growth of various kinds of bacteria & viruses. These bacteria and viruses give rise to throat infections, gum diseases, decay of teeth (caries), ulcers of mouth, bad breath etc. In diseased states such as common cold, influenza, etc. and in some allergic conditions throat irritation is a common symptom. It is commonly manifested as sore throat, laryngitis, mouth and throat ulcers, etc. Microbial flora in the mouth can also cause some periodontal diseases such as inflammation of supportive tissues of teeth, tooth-ache etc. Moreover, there are regular occurrences of throat & oral cancers.
Several over-the-counter remedies are available to treat sore throat, and periodontal diseases. These could be in the form of mouth-washes, lozenges, chewing gums, gargling solutions, etc. People have been using several household remedies1 to treat sore throats and periodontal diseases. In some cases, physician may prescribe an antibiotic to treat throat & gums infections.
Warm solution of Sodium Chloride (common salt) and a mild solution of Aluminium Ammonium Sulphate (alum) in water are also commonly used as a mouth-wash & gargling solutions (household-remedies). Clove oil is also used for tooth and gum problems. However, these agents have a limited efficacy as preventive, healing & curative agents as compared to that of turmeric powder/ curcumin.
Turmeric & turmeric powder has been used since ancient times as a preventive and curative agent for many illnesses, diseases.
Turmeric is known to act in various capacities such as an antiseptic, bactericidal, anti-allergic, anti-viral, anti-inflammatory, anti-oxidant, as an agent promoting 'natural healing', as an agent strengthening body's immune system etc. Turmeric is also reported to have anti-cancer activity. It is a known fact that very small quantities of active chemicals in turmeric are absorbed and utilized by the human body; while most of them get excreted upon oral administration. Scientific references are available citing the excretion of active turmeric-chemicals mainly through faecal matter and through urine. This low bio-availability of active chemicals in turmeric limits its effectiveness. It is probably due the fact that some active chemicals in turmeric (including curcumin) are hydrophobic and are insoluble in water.
For the present invention, "bio-availability" of turmeric has been defined as the rate and extent of active ingredients of turmeric (including curcumin) made available for action/ absorption in the mouth & throat region at tissue level.
Turmeric mixed with warm milk is sometimes used to provide soothing action to the sore throat. Here, it is theorized that the active ingredients in turmeric (including curcumin) dissolve in milk-fat and get dispersed in milk (milk itself being an emulsion). This treatment does give a soothing effect, but is not curative.
There are several patents on gargling & mouth wash products which are cited below.
US Patent 6,629,603 (2003) describes the preparation of portable gargling solution packets. It discloses a saline solution, which gets warmed up by the exothermic reaction once the chemical in the lining of the packet reacts with the outside air after opening of the packet. The formulations disclosed in this patent do not have improved efficacy over the then existing offerings, but are related only to a convenience of usage.
US Patent 6,641,801 (2003) describes a solution to be used as mouthwash and to gargle with. It contains ethanol, which is a useful antiviral agent. A drawback of the solution disclosed in this patent is that the addition of ethanol may pose safety concerns, especially for children.
US Patent 4,457,909 (1984) discloses a mixture of a salt, preferably sodium chloride, and ascorbic acid for bathing and cleansing mouth and throat tissues. Ascorbic acid being sour in taste may not be appealing to patients.
US Patent 5,028,412 (1991) proposes an oral composition containing an aluminum salt and an aliphatic carboxylic acid or water-soluble salt thereof capable of complexing with aluminum. It works by preventing formation and growth of calculus on the dental enamel. The patent is not intended to treat sore throat or throat infections. A limitation of this patent therefore, is that the formulations disclosed therein have very limited applications.
US Patent 6,797,260 (2004) describes composition of a paste containing aluminum chloride, ferric sulfate, regenerated oxidized cellulose, aluminum ammonium sulfate, absorbable gelatin and a solvent to be used to stop or
control bleeding and seal open blood vessels in gum and skin tissues. The formulation is specifically designed for open wounds in the mouth and thus the scope of application of this patent is very limited.
US Patent 4,775,525 (1988) provides a composition containing sodium alginate, benzalkonium chloride and zinc sulfate to reduce dental plaque. The usage of this formulation is more towards the mouthwash.
US Patents 6,355,229 (2002) provides cetylpyridium chloride and guar hydroxypropyltrimonium chloride to treat plaques, gingivitis and periodontal disease. Similar to patent 4,775,525, its usage is more towards the mouthwash.
None of the solutions disclosed in any of these patents makes use of turmeric and/or curcumin. None has ingredients exhibiting anti-cancer property and the property to promote "natural" healing as those of turmeric powder & curcumin.
Objectives & Advantages of the Invention
Accordingly, one objective of the current invention is to provide compositions made out of naturally occurring and widely available substance, turmeric and or its active ingredient - curcumin, which can be used for gargling & as a mouthwash.
Another objective of the invention is to increase bio-availability of active ingredients of turmeric & or of curcumin so that the effectiveness of the treatment increases considerably.
Yet another object of the present invention is to provide a gargling solution & mouth wash that is more economical than the currently available compositions
and which will have more medicinal effectiveness (in terms of antiseptic, bactericidal, anti-allergic, anti-viral, anti-inflammatory, anti-oxidant, anti-cancer properties and 'natural healing' activity).
A still further objective of the present invention is to provide a gargling solution & mouth-wash that will provide relief against bacterial infection, allergic reactions, inflammation, irritation, viral infection, fall in immunity, bleeding of gums, bad breath, tooth ache, ulcers of mouth, sore throat etc .
A further objective of the present invention is to provide a gargling solution & mouth-wash that will be attractive and palatable through the use of flavour enhancers, sweeteners & taste enhancers.
Still another objective of the present invention is to provide a consumer friendly method of administration (dispensation/ delivery) of the proposed compositions by the way of increasing the convenience of administration, ease of use, making the product (formulation) attractive visibly and in taste, and providing fragrances to suit the consumer's moods.
Still another objective of the invention is to provide a "choice" to consumers of taste & fragrance of resulting gargling solution/ mouth-wash by usage of "colour-coding" system.
Another objective of this invention is to provide consumers with an easy-to-use formulation, which can be carried easily and can be used easily with a glass of water.
Summary of the invention:
The present invention provides formulations, which are easy to carry, convenient to use, which can be readily mixed with plain or warm water and can be used to treat sore throat, periodontal diseases. The formulations can also be used as a mouthwash to improve general hygiene of mouth/ teeth/ gums and to prevent bad breath.
The formulations comprise of two key components, namely turmeric/ turmeric powder (or curcumin), and surfactant. Alternatively, one of the formulations disclosed in the present invention comprises turmeric, curcumin, and a surfactant. Several other agents such as inorganic salts, clove oil, coagulants, antibacterial agents, diluents, excipients, hemostat and/or astringent, lubricating agents, and additives such as flavouring agents, sweeteners, colours, and soothing agents, are also used in various combinations and proportions to give synergistic effect.
The present invention also presents various pharmaceutical dosage delivery forms such as water soluble capsules, easy to open and use capsules, fast disintegrating/ effervescent tablets, tear & use packets/ sachets of various materials. It may be noted that the formulations in solid/ powder forms are generally more convenient to consumers as they are easy to carry along and can be easily dissolved in water & used immediately.
Formulation disclosed in the present invention are also available in "water-dissolved state" (aqueous solution) and packed in containers such as bottles, in a ready-to-use form. In such cases, lubricants, granulating agents etc need to be excluded (as they are used only to aid capsule/ sachet filling & tablet making). Instead, for "water-dissolved state" (aqueous solution) of such formulations, one needs to use dispersants, stabilizers etc (known to pharmaceutical formulators).
Detailed description of the present invention:
Turmeric has been long known in India to have several medicinal properties,
including antiseptic properties. Botanical name for the turmeric-plant is Curcuma
Longa and it belongs to the Zingiberaceae family. It is well known that the rhizome of the plant has much higher medicinal properties than other parts of the plant. The rhizome is cleaned, dried and pulverized into a powder-form giving rise to yellow coloured turmeric or turmeric powder as is known to the world at large. Most active and scientifically recognized ingredient of turmeric/ turmeric powder is Curcumin. It is present at about 3 to 5% w/w in turmeric/ turmeric powder and is also available commercially in a pure form.
The inventor has observed that turmeric in any form, or its extracted active ingredient - curcumin, is not used in any of the presently available gargling solutions, mouth Washes or solutions to treat sore throats and other ailments of mouth.
Accordingly, the present invention discloses a turmeric & or curcumin-based solid dosage formulation to be used to produce a gargling solution/ mouthwash for the treatment of ailments of mouth and throat. Several other agents such as inorganic salts, coagulants, antibacterial agents, diluents, excipients, hemostat and/or astringent, lubricating agents, and additives such as flavouring agents, sweeteners, colours, and soothing agents, are also used in various combinations and proportions to give synergistic effect. The formulations disclosed in the present application are described below as various embodiments.
Accordingly, a preferred embodiment of the present invention, referred to as the preferred embodiment no. 1, describes a formulation comprising two key components, namely turmeric powder and a surfactant.
The inventor has found several advantages of using the surfactant. It helps to dissolve the plaque, & release food particles in-between teeth. Another purpose of the surfactant is to dissolve the hydrophobic active ingredients of turmeric, such as curcumin, in various formulations. This increases the bio-availability of active
ingredients of turmeric by many folds. Bio-availability of turmeric, for the purpose of the present invention, has been defined as the rate and extent of active principles of turmeric [including curcumin] made available for action/ absorption in the mouth & throat region at tissue level. The surfactant also provides a sense of cleanliness to the mouth. The surfactant is selected from group of chemicals comprising cationic compounds such as quaternary ammonium compounds, anionic compounds such as sodium lauryl sulfate, and nonionic compounds such as PEG ester or glycerol esters of fatty acids etc , either alone or any combination thereof (ensuring that they are not harmful to human beings).
Addition of surfactant is also found to be useful in wetting the turmeric powder when the formulation is added to water. It will help to distribute turmeric in the aqueous system to produce a desirable solution/ suspension. The surfactant is selected preferably from a group comprising PEG esters, glycerol esters, sorbitan esters, poloxomers, sodium lauryl sulfate, polysorbate etc, or any combination thereof.
In the preferred embodiment no. 1, the turmeric powder is preferably of a superfine grade, the particle size being in the range of about 10 microns to about 250 microns. Coarser turmeric can be used; however, it will be gritty to the mouth during gargling or mouthwash. Also, the rate of dissolution of the active ingredients from coarse turmeric powder will be slower due to larger particle size. It is therefore important to use fine turmeric powder in these formulations (preferred particle size less than 250 microns). Quantity of turmeric powder per dose/ capsule/ sachet/ tablet is in the range from about 20 mg to about 4000 mg, preferably from about 50 mg to about 400 mg, more preferably, from about 100 mg to about 200 mg.
[n the preferred embodiment no.l, turmeric and surfactant are present in a proportion from about 100:1 to about 1:1, preferably from about 50:1 to about 4:1.
It is important to ensure that the surfactant quantity is sufficient to dissolve/ emulsify active hydrophobic ingredients in turmeric powder so as to make it more bio-available. In this embodiment, the formulation is in a ready-to-use form.
In another preferred embodiment of the present invention, referred to as the preferred embodiment no.2, turmeric powder of the formulation of the preferred embodiment no. 1 is substituted by pure curcumin. In the present embodiment, the amount of curcumin used is in the range from about lmg to about 200 mg, preferably about 2.5mg to about 20 mg, more preferably about 5 mg to about 10 mg per dose/ capsule/ sachet/ tablet. The proportion of curcumin to surfactant is in the range from about 5:1 to about 0.05:1, preferably from about 2.5:1 to about 0.2:1.
In yet another preferred embodiment of the present invention, referred to as the preferred embodiment no.3, pure curcumin is used along with turmeric and surfactant.
In another embodiment of the present invention, the formulations of the preferred embodiments also contain hemostat and/or astringent, preferably ferric sulphate which has both coagulant and astringent properties, to control bleeding in dental tissues. Hemostats and astringents are used in a proportion from about 0 mg to about 100 mg per dose/ capsule/ sachet/ tablet; preferably about 5 mg to about 25 mg per dose/ capsule/ sachet/ tablet. They need to be present in fine sized particles in order to achieve uniformity of distribution in the formulation mixtures and to enhanced solubility. Other possible embodiments in the preferred embodiments are hyaluronic acid, chondroitin sulfate & collagen.
In a further embodiment of the present invention, the formulations of the preferred embodiments also contain antibacterial/ antimicrobial agents. These are used in small quantities and hence they need to be present in fine sized particles in order
to achieve uniformity of distribution in the formulation mixtures. Preferred antibacterial agents are benzalkonium chloride or cetylpyridium chloride (not to be used in combination). One can also use Chlorhexidine or its derivatives. These embodiments may be used in a proportion from about 0 mg to about 50 mg per dose/ capsule/ sachet/ tablet; preferably from about 5 mg to about 30 mg per dose/ capsule/ sachet/ tablet.
In still another embodiment of the present invention, inorganic salts are added to the formulation of the preferred embodiments. Preferred inorganic salts are the common salt (Sodium Chloride) and alum (Aluminium Ammonium Sulfate), which are added either singly or in combination. Common salt available in the market is normally granular. It may be necessary to pulverize it so as to assure the uniformity of distribution in the formulation. Alum is generally available in a big crystalline form and it may be necessary to micronize it to a superfine, powder form. Alum is added in a superfine form in order to improve its solubility and also to ensure uniformity of its distribution in the formulation. Common salt may be used in a proportion from about 0 mg to about 1500 mg per dose/ capsule/ sachet/ tablet; preferably from about 200 mg to about 1000 mg and more preferably from about 400 mg to about 800 mg per dose/ capsule/ sachet/ tablet. Alum may be used in a proportion from about 0 mg to about 500 mg per dose/ capsule/ sachet/ tablet; preferably from about 5 mg to about 250 mg and more preferably from about 7 mg to about 150 mg per dose/ capsule/ sachet/ tablet.
In another embodiment of the present invention, clove oil is added to the formulations of the preferred embodiments in a proportion from about 0 mg to about 100 mg per dose/ capsule/ sachet/ tablet; preferably from about 0.2 mg to about 10 mg and more preferably from about 0.5 mg to about 5 mg per dose/ capsule/ sachet/ tablet. Inventor has found that the surfactant used in preferred embodiments helps to dissolve/ emulsify clove oil in gargling solution & mouthwash making clove oil far more effective.
In a still further embodiment of the present invention, excipient selected from a group comprising corn syrup, glycerol, sorbitol, xylitol, and the like, or a combination thereof is added to the formulations of the preferred embodiments in the proportion which is in the range from about 0 mg to about 1000 mg per dose/ capsule/ sachet/ tablet, preferably from about 10 mg to about 200 mg.
In yet another embodiment of the present invention, a diluent selected from a group comprising lactose, sucrose, mannitol, and the like, or any combination thereof, is added to the formulations of the preferred embodiments in the proportion which is in the range from about 0 mg to about 1000 mg per dose/ capsule/ sachet/ tablet.
In yet another embodiment of the present invention, a granulating agent selected from a group comprising hydroxyproyl methylcellulose, gums, starches and povidone and the like, either alone or any combination thereof is added to the formulations of the preferred embodiments in the proportion which is in the range from about 0 mg to about 500 mg per dose/ capsule/ sachet/ tablet, more preferably from about 5 mg to about 50 mg
In a further embodiment of the present invention, suitable salts containing fluorides are also added to the formulations of the preferred embodiments for dental health in the proportion which is in the range from about 0 mg to about 100 mg per dose/ capsule/ sachet/ tablet.
In a still further embodiment of the present invention, additives such as flavouring agents, sweeteners, colours, and soothing agents are also added to the formulations of the preferred embodiments. Preferred flavouring agents are commonly used pharmaceutical or food grade flavoring agents such as oils of spearmint, wintergreen, peppermint, and other natural or synthetic agents, used
either singly or in any combination thereof. Flavouring agents may be used in the proportion which is in the range from about 0 mg to about 250 mg per dose/ capsule/ sachet/ tablet; preferably from about 1 mg to about 20 mg per dose/ capsule/ sachet/ tablet. Preferred sweeteners are selected from a group comprising pure sugars including sucrose, fructose, dextrose, laevulose and the like, and artificial sweeteners such as saccharin, cyclamate, and aspartame etc; used either singly or in any combination thereof in the proportion from about 0 mg to about 1000 mg per dose/ capsule/ sachet/ tablet; preferably in the range from about 1 mg to about 50 mg. Colours need to be necessarily food or pharmaceutical grade.
Commonly used lubricating agents such as talc and magnesium stearate may be included in all formulations of the present invention as they will aid the capsule/pouch filling, tablet making operations. Preferred range of the amount of lubricant is about 0 mg to about 30 mg per dose/ capsule/ sachet/ tablet.
In a still further embodiment of the present invention, various dosage delivery forms are disclosed. The dosage delivery forms can be selected from a group comprising water soluble capsules, easy-to-open & use capsules, fast disintegrating/ effervescent tablets and & tear and use packets/ sachets/ pouches thereby providing to consumers convenience of usage. Thus, as an added advantage of this invention, the consumer can conveniently carry these dosage delivery forms during travels or carry to the office/work place and use them conveniently wherever there is a glass of water available.
The capsules preferably used for dosage delivery are those commonly used in the pharmaceutical formulations and are prepared from gelatin or hydroxyproyl methylcellulose or made from a pharmaceutically accepted polymer. Capsules are available in various sizes and are number-coded according to their fill weight capacity. The coding system for starch fill weights for various capsules is as follows : # 000 = 1110 mg, # 00 - 775 mg, # 0 = 530 mg, # 1 - 365 mg, and # 2 =
300 mg. Based on the weight of the final composition, any suitable size capsules can be used in the formulations.
Easy to open & use capsules can be of any suitable material (not harmful to human beings) of suitable size. They can be disposed off after emptying the formulation-mixture into a glass of water.
Fast disintegrating and effervescent tablets would contain additional excipients known to pharmaceutical formulators.
In a yet further embodiment of the present invention, all formulation disclosed in the present invention are also available in water-dissolved state (aqueous solution) and packed in containers such as bottles, in a ready-to-use form (excluding lubricants, granulating agents etc and including agents like dispersants, stabilizers etc known to pharmaceutical formulators for usage in aqueous solutions).
Many further embodiments are possible that are created by addition of any or all of the agents selected from a group comprising hemostat and/or astringent, antibacterial agents, inorganic salts, exipients, diluents, fluoride-containing salts, flavouring agents, sweeteners, colours, and soothing agents, or any combination thereof. It has been hypothesized by the inventor that a combination of some or all of the above mentioned agents along with the preferred embodiments (turmeric/curcumin & surfactant combination) would be more effective in the treatment of sore throat and periodontal diseases than any single agent (synergistic effect).
In another embodiment of present invention a colour-coding system based on taste and flavour combinations is disclosed. Various "outside" colours of the dosage-form (capsule/ sachets/ tablets etc) would indicate a particular taste & flavour combination (viz blue colour may indicate sweet taste and peppermint
flavour whereas red colour may indicate sweet & sour taste and spearmint flavour etc). Thus out of options of two or more "colours" (indicating taste & flavour combination) and depending upon the mood / sentimental preference/ emotional state, a customer would be able to select one particular "colour" he/ she likes the most at a particular point of time for his/ her gargling solution or mouth wash. Though this colour-coding is not a must for the various gargling & mouth-wash formulations described above; the inventor theorizes that selection of taste/ flavour combination of a formulation by a customer would aid his/ her "natural-healing" process.
Illustrative preparations are listed hereinafter by the way of examples. It should be understood that such examples are presented for the purposes of illustrations, but are not limitation. Each example denotes one dose (either by way of capsule/ sachet/ tablet etc). For each example, a method of preparation has been suggested to get consistent results. Formulators can vary it to suit their local conditions. As long as the basic concepts behind this invention are maintained, preventive and curative effects in the treatment of throat & mouth ailments would be guaranteed.
It will be apparent from the above description that the present invention has the following key features. It offers:
- a combination of turmeric powder and/or curcumin with suitable surfactant (basic components) so that the active ingredients of turmeric & curcumin would dissolve in the aqueous phase making them more bio-available and as the consequence, the resultant mixture is much more effective in the to treatment of mouth, periodontal & throat ailments.
- inorganic salts like common salt, alum and fluoride salts in a suitable proportion to make the basic components (turmeric powder/ curcumin & surfactant) much more effective in treatment of throat & mouth ailments.
- other active ingredients such a hemostat & or astringents, antibacterial agents making the formulation more comprehensive and having much wider applications.
- other excipients such as flavouring agents, sweeteners which improve patient/ consumer acceptability and compliance.
- a convenient delivery systems such as capsules (soluble and easy-to-open & use capsules) or pouches/ sachets or fast disintegrating/ effervescent tablets that will help patients/ consumers carry it with them to offices/ work places etc allowing easy access when it is needed.
an innovative colour-coding-system which allows a customer to SELECT a particular taste & flavour "combination" for his/ her gargling solution or mouthwash to suit his/ her mood/ liking at that particular point of time.
Examples: Example I
Fine Turmeric powder - 150 mg
Sodium chloride powder (common salt) - 750 mg
Aluminum Ammonium Sulfate powder (alum) - 10 mg
Sodium lauryl sulfate powder - 10 mg
Peppermint flavour - 5 mg
Suggested Method of Preparation - Mix sodium lauryl sulfate with Alum (in fine
powder form). Add Peppermint flavor to the mixture and mix again. Add sodium
chloride (in fine powder form) to the mixture and mix well. Mix the resultant
mixture with the fine turmeric powder. Fill the final mixture into suitable capsules
or paper/ plastic pouches. The mixture has to be added to a glassful (about 250
mL) of water/ warm water, stir well for a few seconds till a uniform solution/
suspension is obtained. It can be then used as a mouthwash or as a gargling
solution. This method of preparation of the formulation is not specific & critical.
One may make use of other sequences of addition of components with a sole aim being making a truly uniform mixture which is convenient to fill. Various other flavours, including fruit/ flower fragrances could also be incorporated.
Fine Turmeric powder -
Sodium chloride powder (common salt) -
Aluminum Ammonium Sulfate powder (alum)
Sodium lauryl sulfate (SLS) -
Hydroxypropyl methylcellulose (HPMC) -
Prepare the mixture of actives sodium lauryl sulfate, alum, common salt, turmeric powder (all in fine particle form) as in Example I and mix with lactose. Prepare a dilute solution of HPMC in a small quantity of water. Excess granulating fluid will dissolve water-soluble active ingredients. Use the solution to granulate the above mentioned mixture. Dry the granules in suitable dryer (tray, fluid bed etc.) and pass through a suitable sieve. Add suitable lubricant such as Talc and mix well. The resultant free flowing granules can be easily filled in capsules or pouches. It is possible to compress tablets with this formulation. Prior to usage, consumer needs to dissolve such a tablet/ sachet, capsule containing granules in about 250 mL of water/ warm water by way of simple agitation. It is possible to convert this formulation to effervescent tablets by addition of other suitable excipients known to people working in the field. Various flavours, fragrances could be also incorporated.
Turmeric powder - 100 mg
Antibacterial agent - 25 mg
Hemostat/coagulant - 25 mg
Hyaluronic acid or chondroitin sulfate - 50 mg
Poloxamer 188 - 25 mg
Prepare the mixture of actives as in Example I and convert into a suitable dosage form (capsule or any other water soluble containers, pouches etc). The mixture is to be dissolved in about 250 mL of water and can be used to wash & heal the wounds, ulcers, inflammations in mouth or throat by way of a gargling solution or a mouth-wash. An enhanced antibacterial formula can be developed by addition of a known antibacterial agent such as benzalkonium chloride or cetylpyridium chloride Or Chlorhexidine. Such formulations can also be used to treat bad-breath. The formulation could be modified to treat open wounds in the mouth cavities. Turmeric is known to have healing effects. The formulation may also contain commonly used coagulants such as ferric sulfate and also alum.
Sodium chloride(common salt) 400 mg
Turmeric powder 105 mg
Aluminum Ammonium Sulfate powder (Alum) 24 mg
Sodium lauryl sulfate (SLS) 20 mg
Clove oil 1 mg
As in example I, mix fine powders of common salt, alum & turmeric powder. Then add & mix well sodium laury sulfate followed by clove oil. Pass the resultant uniform mixture through a fine sieve and fill it into capsules, sachets/ pouches. Consumer needs to dissolve such a pouche/ sachet, capsule in about 250 mL of water/ warm water by way of simple agitation and use the resultant solution/ dispersion as a gargling solution or as a mouth wash.
Flavoring agent, sweetener, coloring agent and soothing agents can be included in the formulations in appropriate quantities. They can be incorporated in the formulations using commonly used methods.
Colour coding:— Based on the combinations of taste & flavour, one can fill up different formulations into -a) appropriately coloured capsules (edible colours only) OR, b) appropriately coloured pouches/ sachets OR, c) incorporate into fast disintegrating tablets/ effervescent-tablets appropriate edible colouring agents. Each colour would represent a particular "taste & flavour" combination. Two or more "colours" would be made available to the consumer. Dependind upon his/ her mood, he/ she would select a particular "colour" representing a known "taste & flavour" combination. Inventor theorizes that this would enhance "effectiveness" of the formulations as it takes into consideration the "psychological" factor also.
While the above description contains many specificities, these should not be construed as limitation in the scope of the invention, but rather as an exemplification of the preferred embodiments thereof. Many other variations are possible to a person skilled in the art..
Dated this 15th Day of November, 2006
(Tase, Vijay Sharatchandra) Patent Agent for the Applicant Registration Number IN/PA 987
The Controller of Patents , The Patent Office, Mumbai Branch Baudhik Sanipada Bhavan, Antop Hill, Mumbai 400 037
|Indian Patent Application Number||1891/MUM/2006|
|PG Journal Number||24/2011|
|Date of Filing||15-Nov-2006|
|Name of Patentee||JOSHI, VINAYAK NARAHAR|
|Applicant Address||A-13, UDYAN PRABHA CHS, TEJPAL SCHEME, ROAD NO 3, NEAR UNION BANK VILE PARLE (E), MUMBAI 400057,|
|PCT International Classification Number||A61K7/00|
|PCT International Application Number||N/A|
|PCT International Filing date|