SPRAY COMPOSITION OF AVERSIVE AGENT

Abstract

The present invention relates to a composition comprising bittering agent for defense against human or animal attacker. The present invention more particularly relates to a composition comprising denatonium compound for self-defense, method of making and use of said composition as a personal protectant against human or animal attacker.

Claims

1. A composition comprising a bittering agent, wherein the bittering agent provides defense against an attacker.

2. The composition as claimed in claim 1, wherein said bittering agent is selected from natural and synthetic bitterants.

3. The composition as claimed in claim 1, wherein said bittering agent is a denatonium compound.

4. The composition as claimed in claim 3, wherein said denatonium compound is denatonium chloride, denatonium citrate, denatonium saccharide, denatonium carbonate, denatonium acetate, denatonium benzoate, denatonium benzoate monohydrate or a mixtures thereof.

5. The composition as claimed in claim 1, wherein said denatonium compound is denatonium benzoate.

6. The composition as claimed in claim 1, wherein said denatonium compound is used in an amount of less than 50% w/v of the total volume of the composition.

7. The composition as claimed in claim 1, wherein said denatonium compound is used in an amount of 0.01 to 50% w/v of the total volume of the composition.

8. The composition as claimed in claim 1, wherein the composition further comprising a carrier selected from water, surfactant, dispersing agent, solvent, colorants, flavors, stabilizers, buffers, thickening agent, solubilizing agent, and mixtures thereof.

9. The composition as claimed in claim 8, wherein said carrier is used in an amount of 0.1 to 50% w/v of the total volume of the composition.

10. The composition as claimed in claim 1, in the form of a liquid, a paste, a gel, or a cream formulation.

11. The composition as claimed in claim 10, wherein said liquid formulation is an aqueous or non-aqueous formulation, solution, suspension, or emulsion.

12. An aqueous composition comprising a denatonium compound as a bittering agent for defense against an attacker.

13. The composition of claim 12 in the form of an aqueous suspension.

14. The composition of claim 12 in the form of a spray.

15. (canceled)

16. A method of deterring an attack, comprising spraying a composition comprising a denatonium compound at an attacker, wherein the denatonium compound acts as a bittering agent.

17. The method of claim 16, wherein the composition is sprayed in self-defense.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0023] For the purposes of the following detailed description, it is to be understood that the invention may assume various alternative variations and step sequences, except where expressly specified to the contrary. Moreover, other than in any operating examples, or where otherwise indicated, all numbers expressing, for example, quantities of materials/ingredients used in the specification are to be understood as being modified in all instances by the term “about”. The term “about” used to qualify the amounts of active agent shall be interpreted to mean “approximately” or “reasonably close to” and any statistically insignificant variations therefrom.

[0024] Thus, before describing the present invention in detail, it is to be understood that this invention is not limited to particularly exemplified systems or process parameters that may of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments of the invention only and is not intended to limit the scope of the invention in any manner. The use of examples anywhere in this specification including examples of any terms discussed herein is illustrative only, and in no way limits the scope and meaning of the invention or of any exemplified term. Likewise, the invention is not limited to various embodiments given in this specification. It must be noted that, as used in this specification, the singular forms “a,” “an” and “the” include plural referents unless the content clearly dictates otherwise. The terms “preferred” and “preferably” refer to embodiments of the invention that may afford certain benefits, under certain circumstances.

[0025] The terms “aversive agent” and “bittering agent” are used interchangeably and included to mean bitter substance in the specification.

[0026] As used herein, the terms “comprising” “including,” “having,” “containing,” “involving,” and the like are to be understood to be open-ended, i.e., to mean including but not limited to.

[0027] The present invention relates to a composition comprising bittering agent, used for defense.

[0028] The bittering agent is selected from natural or synthetic bitterants.

[0029] In an aspect of the present invention, there is provided a composition comprising denatonium compound for defense against attacker.

[0030] In yet another aspect of the present invention, there is provided a composition comprising bittering agent and a carrier. bittering agent is selected from natural or synthetic bitterants.

[0031] In yet another aspect of the present invention, there is provided a composition comprising denatonium compound.

[0032] The present composition further comprising a carrier selected from water, surfactant, dispersing agent, solvent, colorants, flavors, stabilizers, buffers, thickening agent, solubilizing agent or mixtures thereof.

[0033] The carrier is used in an amount of 0.1 to 50% w/v of the composition.

[0034] In an embodiment, the liquid composition comprising denatonium compound as aversive agent and a carrier.

[0035] In another embodiments, the present composition can be in the form of a liquid or solid such as paste, gel, cream, ointment and the like.

[0036] Accordingly, the present invention provides a liquid composition comprising denatonium compound as aversive agent.

[0037] In one embodiment, such liquid forms of the composition include solutions, suspensions, and emulsions. These liquid preparations may further contain, in addition to the active component, colorants, flavors, stabilizers, buffers, artificial and natural bitterants, dispersants, thickeners, solubilizing agents, and the like.

[0038] The liquid composition of the present invention may further comprise actives that are soluble in water and dissolve in the aqueous medium. In the composition of the invention both suspended and any dissolved active agents are distributed homogeneously.

[0039] In some embodiments the present composition may comprise about 10 wt % to about 80 wt % of the propellant.

[0040] In some embodiments the present composition may comprise about 10 wt % to about 90 wt % of at least one water-miscible solvent selected from monohydric alcohols, polyhydric alcohols and mixtures thereof. The water-miscible solvent can be selected from methyl alcohol, ethyl alcohol, isopropyl alcohol, n-propyl alcohol, iso-butyl alcohol, sec-butyl alcohol, n-butyl alcohol, ethylene glycol, propylene glycol and mixtures thereof.

[0041] The present composition may contain irritant for example pelargonic acid morpholide, or capsicum oleoresin, or [b,f]-1,4-oxazepine (CR) dibenz, or a mixture of these irritants. Oleoresin capsicum (OS) is a natural capsaicinoid, an extract of the most burning varieties of red pepper, an irritating substance of natural origin, which is becoming increasingly popular as a means of self-defense. If it enters the mucous membrane of the eyes, nose, upper respiratory tract, it causes a short-term irritating effect in the form of lacrimation, sneezing, salivation, nasal discharge, conjunctival redness. Oleoresin capsicum is considered the safest of all used irritants. The use of OS in the liquid composition as a irritant provides a decrease in the toxicity of the composition. Pelargonic acid morpholide (IPC) is an analogue of OS, with a similar effect on the affected object. It is an oily, transparent liquid with a yellowish tint, insoluble in water, soluble in polar organic solvents (acetone, propanol, dimethylformamide, benzene, alcohols), fats (sunflower, castor oil, etc.).

[0042] Dibenz [b,f]-1,4-oxazepine (CR) is a yellow crystal that has irritating effects on the eyes, nasopharynx and skin.

[0043] The use of these substances in the liquid composition as irritants makes it possible to provide criteria for the effectiveness of the irritating effect (blepharospasm, lacrimation, etc.).

[0044] In an embodiment the present composition is aqueous composition or non-aqueous composition or a hydroalcoholic composition.

[0045] In an embodiment the present composition comprises a bittering agent and water.

[0046] In an embodiment the present composition is a suspension.

[0047] In an embodiment the present composition is a solution.

[0048] In an embodiment the present composition is a gel.

[0049] In another embodiment the present composition is a clear aqueous suspension formulation.

[0050] In one embodiment, there is provided an aqueous composition comprising denatonium compound as aversive agent.

[0051] In an embodiment, the composition is in the form of a spray.

[0052] In one embodiment, the composition is a spray comprising an aqueous suspension of aversive agent.

[0053] In one embodiment, the composition is a spray comprising an aqueous suspension of denatonium compound.

[0054] In an embodiment, denatonium compound is selected from the group comprising denatonium chloride, denatonium citrate, denatonium saccharide, denatonium carbonate, denatonium acetate, denatonium benzoate, denatonium benzoate monohydrate and mixtures thereof.

[0055] In an embodiment, denatonium salt is denatonium benzoate.

[0056] In one embodiment, there is provided an aqueous composition comprising denatonium benzoate as bittering agent and a carrier.

[0057] In one embodiment, there is provided an aqueous composition comprising denatonium compound as bittering agent for defense against attacker.

[0058] In one embodiment, there is provided an aqueous suspension comprising denatonium benzoate as bittering agent for defense against human or animal attacker.

[0059] In one embodiment, there is provided a spray comprising an aqueous composition comprising denatonium compound as bittering agent for protection against attacker.

[0060] In one embodiment, there is provided use of denatonium benzoate as bittering agent for self-defense.

[0061] In one embodiment, the present composition is a spray comprising an aqueous suspension of denatonium compound.

[0062] In one embodiment, the present composition is a spray comprising an aqueous suspension of denatonium benzoate.

[0063] The present spray comprising denatonium compound is particularly used for defense against attackers.

[0064] The present invention more particularly relates to use of denatonium compound in the present composition which may be formed into water or an aerosol or placed in a pressure sprayer to form a personal protectant for defense against attackers.

[0065] The present invention relates to a spray comprising denatonium compound used for defense.

[0066] According to an aspect of the present invention, there is provided a method of preparing a composition comprising aversive agent.

[0067] The compositions can be prepared by the convention methods known to a person skilled in the art. Typically the method of preparing the present spray composition comprises mixing the active agent with suitable carrier and stirring the mixture to obtain a clear composition ready to spray.

[0068] The composition according to the present invention may be mixed with water and sprayed on the mob. Advantageously, such spraying is also helpful in controlling riots or taming violent protest by mob. The bitterant effect of denatonium compound for example denatonium benzoate would disperse the angry mob and help control the riots or violent protest.

[0069] Preferably, the carrier is water and forms an aqueous solution containing the other ingredients.

[0070] In some embodiments, the composition comprises an oil-based carrier solution containing the ingredients is an alternative to the aqueous carrier solution.

[0071] Accordingly, the composition can comprise essential oil for example sesame oil, olive oil, corn oil, soybean oil, cottonseed oil, peanut oil, lanolin, petroleum jelly, paraffin, silicone oil, fatty acids of 6 to 30 carbon atoms or the corresponding glycerol or alcohol esters.

[0072] Alternative embodiments of the present invention provide a gel formulation comprising solid carriers containing the active ingredients. The solid carrier further contains thickening agents to provide the composition with the consistency of wax or paraffin.

[0073] In an embodiment, the concentration of the aversive agent in the compositions of the invention may vary depending on the particular bittering agent employed, and on the application for which the composition is intended, with the proviso that the concentration employed may not be toxic or below the targeted toxicity level.

[0074] In an embodiment, the composition comprises denatonium compound as aversive agent, the denatonium compound is typically present in the composition at a concentration in the range of about 0.01 to 50% wt/v, preferably 0.01 to 20% w/v, more preferably in the range of about 0.01 to 10% w/v which include 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8% and 9% w/v.

[0075] The composition may be formed into an aerosol or placed in a pressure sprayer to form a personal protectant for defense against attackers.

[0076] According to another aspect of the present invention, there is provided a method of deterring an attack comprising spraying the composition at a human or animal attacker.

[0077] In an embodiment, the method of deterring human attack comprising spraying the composition comprising denatonium compound at a human attacker.

[0078] In an embodiment, the composition further comprises surfactant selected from the below list.

[0079] Anionic surfactant: sulfate, sulfonate, and phosphate, carboxylate derivatives: Anionic surfactants contain anionic functional groups at their head, such as sulfate, sulfonate, phosphate, and carboxylates. Prominent alkyl sulfates include ammonium lauryl sulfate, sodium lauryl sulfate (sodium dodecyl sulfate, SLS, or SDS), and the related alkyl-ether sulfates sodium laureth sulfate (sodium lauryl ether sulfate or SLES), and sodium myreth sulfate. Carboxylates are the most common surfactants and comprise the carboxylate salts (soaps), such as sodium stearate. More specialized species include sodium lauroyl sarcosinate and carboxylate-based fluorosurfactants such as perfluorononanoate, perfluorooctanoate (PFOA or PFO).

[0080] Cationic surfactant: pH-dependent primary, secondary, or tertiary amines; primary and secondary amines become positively charged at pH<10: octenidine dihydrochloride.

[0081] Permanently charged quaternary ammonium salts: cetrimonium bromide (CTAB), cetylpyridinium chloride (CPC), benzalkonium chloride (BAC), benzethonium chloride (BZT), dimethyl dioctadecyl ammonium chloride, and dioctadecyl dimethyl ammonium bromide

[0082] Zwitterionic: Zwitterionic (amphoteric) surfactants have both cationic and anionic centers attached to the same molecule. The cationic part is based on primary, secondary, or tertiary amines or quaternary ammonium cations. The anionic part can be more variable and include sulfonates, as in the sultaines CHAPS (3-[(3-cholamidopropyl)dimethylammonio]-1-propanesulfonate) and cocamide. Betaines such as cocamidopropyl betaine have a carboxylate with the ammonium. The most common biological zwitterionic surfactants have a phosphate anion with an amine or ammonium, such as the phospholipids phosphatidylserine, phosphatidylethanolamine, phosphatidylcholine, and sphingomyelins.

Non-Ionic Surfactants

[0083] Non-ionic surfactants have covalently bonded oxygen-containing hydrophilic groups, which are bonded to hydrophobic parent structures. The water-solubility of the oxygen groups is the result of hydrogen bonding. Hydrogen bonding decreases with increasing temperature, and the water solubility of non-ionic surfactants therefore decreases with increasing temperature.

Ethoxylates

[0084] Fatty alcohol ethoxylate, Narrow-range ethoxylate, Octaethylene glycol monododecyl ether, Pentaethylene glycol monododecyl ether

Alkylphenol Ethoxylates (APEs): Nonoxynols, Triton X-100

[0085] Fatty acid ethoxylates, Fatty acid ethoxylates are a class of very versatile surfactants, which combine in a single molecule the characteristic of a weakly anionic, pH-responsive head group with the presence of stabilizing and temperature responsive ethyleneoxide units.

Special Ethoxylated Fatty Esters and Oils

[0086] Ethoxylated amines and/or fatty acid amides: Polyethoxylated tallow amine, Cocamide monoethanolamine, Cocamide diethanolamine, Terminally blocked ethoxylate, Poloxamers

Fatty Acid Esters of Polyhydroxy Compounds

[0087] Fatty acid esters of glycerol: Glycerol monostearate, Glycerol monolaurate

[0088] Fatty acid esters of sorbitol

[0089] Spans: Sorbitan monolaurate, Sorbitan monostearate, Sorbitan tristearate,

[0090] Tweens: Tween 20,Tween 40,Tween 60,Tween 80

Fatty Acid Esters of Sucrose

[0091] Alkyl polyglucosides

[0092] Alkyl polyglycoside: Decyl glucoside, Lauryl glucoside, Octyl glucoside

[0093] Amine oxides: Lauryldimethylamine oxide

[0094] In some embodiments, other bitter (aversive) agents which can used in the composition either alone or in combination or the composition comprising at least one bittering agent can be prepared according to the present invention for desired purpose, include but not limited to, natural bitter substance or a member selected from the group consisting of: denatonium salts or a derivative thereof; quercetin (3,3′,4′,5,7-pentahydroxyflavone); Naringin (4′,5,7-Trihydroxyflavanone-7-rhamnoglucoside); Aucubin; Amarogentin; Dihydrofoliamentin; Gentiopicroside; Gentiopicrin; Swertiamarin; Swerosid; Gentioflavosid; Centaurosid; Methiafolin; Harpagoside; Centapikrin; Sailicin; Kondurangin; Absinthin; Artabsin; Cnicin; Lactucin; Lactucopicrin; Salonitenolid; α-thujone; β-thujone; Desoxy Limonene; Limonin; Ichangin; iso-Obacunoic Acid; Obacunone; Obacunoic Acid; Nomilin; Ichangin; Nomilinoic acid; Marrubin; Pramarrubin; Carnosol; Carnosic acid; Quassin; Quinine hydrochloride; Quinine sulfate; Quinine dihydrochloride; Columbine; Caffeine; Threonine; Methionine; Phenylalanine; Tryptophan; Arginine; Histidine; Valine; Aspartic acid; Sucrose octaacetate; Qunine bisulfate; hop extract; and mixtures thereof.

[0095] According to the present invention a particularly preferred bittering agent is denatonium benzoate, also known as phenylmethyl-[2-[(2,6-dimethylphenyl)amino]-2-oxoethyl]-diethylammonium benzoate.

[0096] In one preferred embodiment the composition comprising denatonium benzoate as aversive agent and at least one carrier selected from poly vinyl pyrrolidone, poly vinyl pyridine, polyvinyl alcohol or mixtures thereof.

[0097] In one embodiment, the present invention provides use of denatonium compound for example denatonium benzoate as bittering agent for self-defense against human or animal attacker.

[0098] In another aspect of the present invention, there is provided a method of deterring a human attack comprising spraying the present composition comprising denatonium compound for example denatonium benzoate at a human attacker.

[0099] According to an embodiment of the present invention, a kit comprising stable composition according to the present invention for self-defense.

[0100] In another aspect the present invention provides a spray device comprising a composition of denatonium benzoate in an amount of less than 50% w/v.

[0101] In another aspect the present invention provides a spray device comprising a composition of denatonium benzoate in an amount of 0.01 to 50% w/v.

[0102] In another aspect the present invention provides a personal defense device carried by a user, for spraying a liquid composition comprising denatonium benzoate in an amount of 0.01 to 50% w/v.

[0103] In another aspect the present invention provides a defense spray pack comprising an aqueous composition of denatonium benzoate in an amount of 0.01 to 50% w/v and instructions manual to use the same.

[0104] In another aspect the present invention provides a defense spray pack comprising a non-aqueous composition of denatonium benzoate in an amount of 0.01 to 50% w/v.

Advantages of the Present Invention

[0105] 1. The present formulation is environment friendly. [0106] 2. The present formulation doesn't cause any physical damages to skin and eyes. [0107] 3. The present product is physiochemically stable and environmentally safe. [0108] 4. The formulation also gives sustain release effect because of addition of polymers. [0109] 5. The advantage of using polymer is bitter effect remains on the surface for a longer period and hence the efficacy of the formulation is extended to a longer period. [0110] 6. The formulation has excellent spray ability. [0111] 7. The formulation has improved efficacy.

[0112] It will be understood that the specification and examples are illustrative but not limitative of the present invention and that other embodiments within the spirit and scope of the present invention will suggest themselves to those skilled in the art. Other embodiments can be practiced that are also within the scope of the present invention. The following examples illustrate the invention, but by no means intend to limit the scope of the claims.

[0113] The composition described above is safe, efficacious and stable at various temperatures, and even when the stable agrochemical composition undergoes shear forces for example on mixing.

[0114] In order that the present invention may be more readily understood, reference will now be made, by way of example, to the aforesaid description.

EXAMPLES

[0115] The compositions described in following examples were taken further to evaluate physicochemical parameters. Stability features associated with the composition developed according to the present invention were studied. It was found that all the compositions remained stable when tested at ambient conditions i.e. room temperature and pressure. The compositions also passed 0° C. and Accelerated Heat Stability (AHS) test for 14 days and remained clear and flowable suspension.

Example 1

[0116]

TABLE-US-00001 TABLE 1 FORMULATION FORMULATION FORMULATION FORMULATION FORMULATION 1 2 2 3 4 No Ingredients Qty % w/v Qty % w/v Qty % w/v Qty % w/v Qty % w/v 1 Denatonium 0.5 1 5 15 20 Benzoate 2 Water Quantity q.s. q.s. q.s. q.s. sufficient (q.s.) 3 Irritant Not Used Not Used Not Used 0.05 Not Used (optional) Capsaicin OBSERVATIONS (14 days accelerated stability at 45 degrees) 1 Appearance Clear solution Clear solution Suspension Suspension Suspension 2 Viscosity 1.21 cP 1.21 cP 1.68 1.79 1.81 in CPS 3 Specific 1.2 1.2 1.2 2.1 2.4 Gravity 4 Observation Clear solution Clear solution Sediment Sediment Sediment formation formation formation which is easily which is easily which is easily dispersible dispersible dispersible There is no film formation. Drug remains on the surface and can get easily rub off. OBSERVATIONS (0 degrees/14 days) 1 Appearance Clear solution Clear solution Suspension Suspension Suspension 2 Viscosity 1.74 1.76 1.56 1.87 1.87 in CPS 3 Specific 1.87 1.9 1.8 2.0 2.7 Gravity 4 Observation Clear solution Clear solution Sediment Sediment Sediment formation formation formation which is easily which is easily which is easily dispersible dispersible dispersible There is no film formation. Drug remains on the surface and can get easily rub off. Process of Keep required quantity of water under stirring. Add weighed quantity of preparation denatonium Benzoate and stir. Filter if required.

Example 2

[0117]

TABLE-US-00002 TABLE 2 FORMU- FORMU- FORMU- FORMU- LATION 1 LATION 2 LATION 3 LATION 4 No Ingredients Qty % w/v Qty % w/v Qty % w/v Qty % w/v 1 Denatonium 0.5 1 15 20 Benzoate 2 Poly vinyl 0.01 20 3.5 5 Pyrrolidone 4 Water q.s. q.s. q.s. q.s. 5 Irritant Not Used Not Used Not Used Not Used (optional) Capsaicin OBSERVATIONS (14 days accelerated stability at 45 degrees) 1 Appearance Clear solution Clear solution Suspension Suspension 2 Viscosity in 1.21 cP 2.81 cP 1.68 1.79 CPS 3 Specific 1.2 3.3 1.2 2.1 Gravity 4 Observation Clear solution Clear solution Sediment Sediment formation formation which is which is easily easily dispersible dispersible Thin film formation with little tensile strength. OBSERVATIONS (0 degrees/14 days) 1 Appearance Clear solution Clear solution Suspension Suspension 2 Viscosity in 1.78 2.07 2.98 1.09 CPS 3 Specific 1.3 3.4 1.4 2.8 Gravity 4 Observation Clear solution Clear solution Sediment formation which is easily dispersible Thin film formation with little tensile strength. Process of Keep required quantity of water under stirring. preparation Add weighed quantity of Poly vinyl Pyrrolidone slowly till it forms a clear solution. Add weighed quantity of denatonium Benzoate and stir. Filter if required.

Example 3

[0118]

TABLE-US-00003 TABLE 3 FORMULATION FORMULATION FORMULATION FORMULATION 1 2 3 4 No COMPOSITION Qty % w/v Qty % w/v Qty % w/v Qty % w/v 1 Denatonium 0.5 1 15 20 Benzoate 2 Poly vinyl 0.01 20 3.5 5 pyridine 4 Water q.s. q.s. q.s. q.s. 5 Irritant (optional) Not Used Not Used Not Used Not Used Capsaicin OBSERVATIONS (14 days accelerated stability at 45 degrees) 1 Appearance Clear solution Clear solution Suspension Suspension 2 Viscosity in CPS 1.21 cP 2.88 cP 2.10 2.19 3 Specific Gravity 1.2 3.2 1.88 1.91 4 Observation Clear solution Clear solution Sedimentation Sedimentation which is easily which is easily dispersible dispersible Very thin film Film is little Very thin film Film is little thicker which releases thicker which which releases least 20-30 mins. active for at least releases active for active for at least But film may crack 20-30 mins. at least 20-30 20-30 mins. But after 10 mins or gets mins. But film film may crack easily wiped off. may crack after 10 after 10 mins or mins or gets easily gets easily wiped wiped off. off. OBSERVATIONS (0 degrees/14 days) 1 Appearance Clear solution Clear solution Suspension Suspension 2 Viscosity in CPS 1.4 1.98 1.99 2.09 3 Specific Gravity 1.42 2.99 1.07 2.87 4 Observation Clear solution Clear solution Sedimentation Sedimentation which is easily which is easily dispersible dispersible Very thin film Film is little Very thin film Film is little thicker which releases thicker which which releases least 20-30 mins. active for at least releases active for active for at least But film may crack 20-30 mins. at least 20-30 20-30 mins. But after 10 mins or gets mins. But film film may crack easily wiped off. may crack after 10 after 10 mins or mins or gets easily gets easily wiped wiped off. off. Process of Keep required quantity of water under stirring. Add weighed quantity of Poly preparation vinyl Pyridine slowly till it forms a clear solution. Add weighed quantity of denatonium Benzoate and stir. Filter if required.

Example 4

[0119]

TABLE-US-00004 TABLE 4 FORMULATION FORMULATION FORMULATION FORMULATION 1 2 3 4 No Composition Qty % w/v Qty % w/v Qty % w/v Qty % w/v 1 Denatonium 0.5 1 15 5 Benzoate 2 Polyvinyl 0.01 1 3.5 20 Alcohol 3 Water q.s. q.s. q.s. q.s. 4 Irritant Not Used Not Used Not Used Not Used (optional) Capsaicin OBSERVATIONS (14 days accelerated stability at 45 degrees) 1 Appearance Clear solution Clear solution Suspension Suspension 2 Viscosity in 1.21 cP 1.21 cP 1.06 cP Very thick CPS solution. Forms cake at the bottom 3 Specific Gravity 1.2 1.2 3.8 3.9 4 Observation Clear solution Clear solution Sedimentation Sedimentation which is easily which is easily dispersible dispersible Very thin film. Doesn't remain on surface for long time. Comparatively Effective to release drug for 10-15 mins. Can get easily rubbed thicker film. off. Doesn't remain on the surface for long time. Effective to release drug for 10- 15 mins. Can get easily rubbed off. OBSERVATIONS (0 degrees/14 days) 1 Appearance Clear solution Clear solution Suspension Suspension 2 Viscosity in 2.18 1.21 1.09 Very thick CPS solution. 3 Specific Gravity 1.12 1.56 3.06 4 4 Observation Clear solution Clear solution Sedimentation Sedimentation which is easily which is easily dispersible dispersible Very thin film. Doesn't remain on surface for long time. Comparatively Effective to release drug for 10-15 mins. Can get easily rubbed thicker film. off. Doesn't remain on the surface for long time. Effective to release drug for 10- 15 mins. Can get easily rubbed off. Process of Keep required quantity of water under stirring. Add weighed quanfty of Poly vinyl preparation Alcohol slowly till it forms a clear/milky solution. Add weighed quantity of denatonium Benzoate and stir. Filter if required.

Example 5

[0120]

TABLE-US-00005 TABLE 5 FORMULATION FORMULATION FORMULATION FORMULATION 1 2 3 4 No Composition Qty % w/v Qty % w/v Qty % w/v Qty % w/v 1 Denatonium 0.5 10 15 20 Benzoate 2 Polyvinyl 20 8 3 5 Alcohol 5 Polyvinyl 0.2 0.2 0.3 0.2 pyridine 6 Water q.s. q.s. q.s. q.s. 7 Irritant Not Used Not Used Not Used Not Used (optional) Capsaicin OBSERVATIONS (14 days accelerated stabiity at 45 degrees) 1 Appearance Clear solution Suspension Suspension Suspension 2 Viscosity in 1.21 cP 1.5 cP 1.9 cP 2.2 CPS 3 Specific Gravity 1.2 1.2 3.5 4.1 4 Observations Clear solution Clear solution Uniform Uniform suspension. suspension. Easily It settles down, but dispersible. is easily re- dispersible Uniform film Uniform film formation. Film remains the surface for a long time formation. Film and releases drug. If film remains on the surface, will release remains the surface drug for 20-25 mins for a long time and releases drug. If film remains on the surface, will release drug for 20-25 mins OBSERVATIONS (0 degrees/14 days) 1 Appearance Clear solution Suspension Suspension Suspension 2 Viscosity in 2.1 1.45 1.88 2.20 CPS 3 Specific Gravity 2.22 1.98 3.89 3.87 4 Observations Clear solution Clear solution Uniform Uniform suspension. suspension. Easily It settles down, but dispersible. is easily re- dispersible Uniform film Uniform film Uniform film Uniform film formation. Film formation. Film formation. Film formation. Film remains the surface remains the remains the remains the surface for a long time and surface for a long surface for a long for a long time and releases drug. If time and releases time and releases releases drug. If film film remains on the drug. If film drug. If film remains on the surface, will remains on the remains on the surface, will release release drug for surface, will surface, will drug for 20-25 mins 20-25 mins release drug for release drug for 20-25 mins 20-25 mins Process of Keep required quantity of water under stirring. Add weighed quantity of Poly vinyl preparation Alcohol, polyvinyl Pyrrolidone and Polyvinyl Pyridine slowly till it forms a clear/milky solution. Add weighed quantity of denatonium Benzoate and stir. Filter if required.

Example 6

[0121]

TABLE-US-00006 TABLE 6 FORMULATION FORMULATION FORMULATION FORMULATION 1 2 3 4 No Ingredients Qty % w/v Qty % w/v Qty % w/v Qty % w/v 1 Denatonium 0.5 1 15 20 Benzoate 2 Non aqueous q.s. q.s. q.s. q.s. Solvent (compatible and approve for human consumption) Methanol 3 Water — 20 40 60 4 Irritant Not Used 0.05 Not Used 0.04 (optional) Capsaicin OBSERVATIONS (14 days accelerated stability at 45 degrees) 1 Appearance Clear solution Clear solution Suspension Suspension 2 Viscosity in 1.21 cP 1.21 cP 1.68 1.79 CPS 3 Specific Gravity 1.2 1.2 1.2 2.1 4 Observation Clear solution Clear solution Sediment Sediment formation formation which is which is easily easily dispersible dispersible There is no film formation. Drug remains on the surface and can get easily rub off. OBSERVATIONS (0 degrees/14 days) 1 Appearance Clear solution Clear solution Suspension Suspension 2 Viscosity in 2.08 2.11 1.67 2.01 CPS 3 Specific Gravity 2.10 2.67 2.11 1.98 4 Observation Clear solution Clear solution Sediment Sediment formation formation which is which is easily easily dispersible dispersible There is no film formation. Drug remains on the surface and can get easily rub off. Process for Keep required quantity of water under stirring. Add weighed quantity of denatonium preparation Benzoate and stir. Filter if required. (Optional: Add weighed quantity of Poly vinyl Alcohol, polyvinyl Pyrrolidone and Polyvinyl Pyridine slowly till it forms a clear/milky solution.)

[0122] From the above data, it was observed that the all the compositions of the present invention are stable and effective.