DESC:FORM 2

THE PATENTS ACT 1970
(SECTION 39 OF 1970)

&

THE PATENT RULES, 2003

COMPLETE SPECIFICATION
(Section 10)

STABILIZED MOUTH FRESHENER STRIPS

We, Azista Industries Pvt Ltd,
a company incorporated under the companies act, 1956 having address at Sy. No. 80-84, 4th Floor, C Wing, Melange Towers, Patrika Nagar, Madhapur,
Hyderabad, Telangana- 500 081, India

The following specification particularly describes the invention and the manner in which it is to be performed.

FIELD OF THE INVENTION
The present invention relates to a physically stabilized mouth freshener strips with good long lasting mouth feel and antimicrobial activity. The present invention more specifically relates to a physically stabilized mouth freshener strips comprising polyols to give good mouth feel as well as adsorbents and plasticizers to increase the physical stability of strip.
BACKGROUND OF THE INVENTION
Oral malodor is an undesirable condition that affects many people. Malodor of the oral cavity, also known as halitosis or bad breath has been estimated to afflict many million people in the world. To combat oral cavity malodor, the art has developed a variety of products including breath freshening gums, lozenges and mints. The use of these products is not always socially acceptable as they require a sucking or chewing action on the part of the consumer over an extended period of time which can be distracting in a social or business setting. Commercial mouth freshner pills, gums and lozenzes have slow disintegration causing delayed mouth freshening effect where as mouth freshner films disintegrates fast and provide immediate mouth freshening effect. Commercial mouth freshener sprays are inconvient to carry and too prominent to be tolerable .
Oral films are also called as oral wafers. From the past few years the oral thin films are evolved in confection and oral care markets in the form of breath strips. These are novel and widely accepted form by consumers for delivering vitamins and personal care products. Today, FDFs are a proven and accepted technology for the systemic delivery of APIs for over-the counter (OTC) medications and are in the early to mid development stages for prescription drugs. This has been attributed to the success of the breath freshener products by consumers such as Listerine Pocket Packs in the US consumer market. Such systems use a variety of hydrophilic polymers to produce a 50- 200 mm film. The film is manufactured as a large sheet and then cut into individual dosage units for packaging in a range of pharmaceutically acceptable formats.
US Pat. No. 6,923,981 discloses edible films with Pullulan having antimicrobial effect. The product includes basic film forming excipients with essential oils and gluconate salt. The product mainly free from humectants like sorbitol and glycerol and don’t adhere to itself. None of polyols were mentioned as suitable ingredients
IN Pat. No. 200301 discloses a water soluble film system comprising at least one water soluble film adopted to embed/entrap/spray at least one active material of selective concentration and depth such that said active material is delivered in desired quantity when dissolved in water.
US Publication No. 2004/0043134 A1 discloses rolled edible thin films and methods of making same. The rolled edible thin film comprises a body that is designed to be segmented by a consumer into a plurality of products that can be separately placed in a mouth of a consumer.
US Pat. No. 6,419,903 B1 discloses a rapidly dissolvable orally consumable film composition for delivering breath freshening agents to the oral cavity wherein the composition is formed from a homogeneous mixture of a water soluble, low viscosity hydroxyalkylmethyl cellulose and a water dispersible starch and a flavoring agent.
US Pat. No. 6,231,957 B1 discloses a sheet-shaped flavored film that rapidly disintegrates when placed on the surface of certain substrates and releases a natural or artificial flavor to the substrate to enhance or modify the intrinsic flavor of the substrate is provided. The flavored film includes one or more water-soluble polymers, one or more surfactants, and one or more flavoring agents. The flavored film has numerous applications in the food and food service industry wherein an easy to use, inexpensive and reproducible method of flavoring food products is desired.
Japan Patent publication JP 5-236885 A discloses the use of an edible film as a vehicle for unobtrusively delivering breath-freshening agents. This Japanese patent application does not, however, teach the inclusion of antimicrobial agents in the film, using the film to decrease the amount of undesirable bacteria within the oral cavity, or stimulating saliva. Furthermore, this patent application does not disclose employing its film for purposes other than breath freshening or within cavities other than the mouth.
US Pat. No. US 7,067,116 B1 discloses a fast dissolving orally consumable films containing an agent to mask the taste of a pharmaceutically active agent therein, and more specifically to such films containing an ion exchange resin as the taste masking agent.
Despite the existence in the prior art of rapidly dissolvable orally consumable films, there is still room for improvement in such films, which are physically stabilized mouth freshener strips comprising polyols to give good mouth feel as well as adsorbents and plasticizers to increase the physical stability of film.
OBJECTIVE OF THE INVENTION
The main objective of the present invention is to provide a physically stabilized mouth freshener strips with good long lasting mouth feel and antimicrobial activity.
Another objective of the present invention is to provide a physically stabilized mouth freshener strips comprising polyols to give good mouth feel as well as adsorbents and plasticizers to increase the physical stability of strip which can withstand extreme range of humidity conditions from low to high humidity.
SUMMARY OF THE INVENTION
Accordingly, the present invention provides a physically stabilized mouth freshener strip with good long lasting mouth feel and antimicrobial effect which dissolves immediately in oral cavity.
In one embodiment, the present invention provides a physically stabilized mouth freshener strip for delivering oral care product with good acceptable mouth feel.
In another embodiment, the present invention provides a physically stabilized mouth freshener strip comprising polyols.
In another embodiment, the present invention provides a physically stabilized mouth freshener strip comprising adsorbents and plasticizers.
In still another embodiment, the present invention provides a physically stabilized mouth freshener strip comprising polyols, adsorbents and plasticizers.
In a preferred embodiment, the present invention provides physically stabilized mouth freshener strip with good long lasting mouth feel and antimicrobial effect which dissolves immediately in oral cavity comprising polyols to give good mouth feel as well as adsorbents and plasticizers to increase the physical stability of film which can withstand extreme range of humidity conditions from low to high humidity.
In a preferred embodiment, the present invention provides a physically stabilized mouth freshener strip comprising one or more of antimicrobial agents, polyols, adsorbents, plasticizers, film forming agents, cooling agents, surfactants, stabilizing agents, flavouring agents, thickening agents, binding agents, sweeteners and solvents.
In another preferred embodiment, the present invention provides a physically stabilized mouth freshener strips with good mouth feel, comprising a film former such as HPMC, pullulan, PEO, starch used alone or in combination, a polyols used alone or in combination, having individual concertation of about 0.1%-40% of each polyols, an adsorbent used in combination, having individual concertation of about 0.1%-25% of each adsorbent, and at least one plasticizer used in concentration of about 0.5%-20%, whereby the product remains non-sticky in high relative humidity (<90%) and non-fragile in low relative humidity (>30%) with good mouth feel.
DETAILED DESCRIPTION OF THE INVENTION
The mouth freshener strip as used herein include any strip or film that can be used interchangeably. These films are effective against malodour and gives freshness immediately and extends up to sometime in oral cavity. Palatability is a very important concern when preparing oral care products.
Some of the ingredients which are used as herein may act as antimicrobial agents. For example Menthol, Eucalyptus oil and peppermint oil.
Polyols has the effect of cooling and sweetening which can help to increase palatability. By using polyols can get good mouth feel which will enhance the palatability.
Most of the polyols were hygroscopic so using polyols alone causes self-adhering strips. Polyols as used in the present invention include and are not limiting to Erythritol, xylitol, maltitol, mannitol, sorbitol, isomalt, lactitol, glycerin, polyethylene glycol, propylene glycol, glycerol monoesters with fatty acids or other pharmaceutically acceptable polyalcohols and combinations thereof, can be used in the range of 0.1% to 40%.
Using adsorbents can decrease the hygroscopic nature and used include and are not limiting to calcium carbonate, magnesium oxide, Sodium bicarbonate, dibasic calcium phosphate, magnesium carbonate, kaolin, cellulose, titanium dioxide and colloidal silicon dioxide, can be used in the range of 0.1% to 25%.
Combination of adsorbents and plasticizers (including polyols) in the ratio of 10:90 to 40:60 can give non-self-adhering, non-brittle, physically stabilized films with good mouth feel at extreme moisture conditions of storage.
The plasticizing agents as used herein include and are not limiting to Propylene glycol, sucrose, glycerine, low molecular weight polyethylene glycols (PEGs), phthalate derivatives like dimethyl, diethyl and dibutyl phthalate, citrate derivatives such as tributyl, triethyl, acetyl citrate, triacetin, castor oil, triethyl citrate, glycerin, a polysorbate, a, a polyol, lecithin, a starch hydrolysate and combinations thereof, can be used in the range of 0.5% to 20%.
The film forming agents as used herein include and are not limiting to HPMC, pullulan, PEO, Starch, Carboxymethyl cellulose, Pectin, polymethacrylates, hydroxyethyl cellulose, hydroxypropyl cellulose, polyvinyl pyrrolidone, polyvinyl alcohol, sodium alginate, glycolide, polylactide, polyacrylic acid, carboxyvinyl polymer, amylose, high amylose starch, hydroxypropylated high amylose starch, dextrin, pectin, chitin, chitosan, levan, elsinan, polyethylene glycol, locust bean gum, carrageenan gum, xanthan gum, tragacanth gum, guar gum, acacia gum, arabic gum, collagen, gelatin, zein, gluten, Maltodextrin, polyvinyl alcohol–polyethylene glycol graft copolymer, soy protein isolate, whey protein isolate and combinations thereof, can be used in the range of 30% to 70%
Preferred cooling agents as used herein include and are not limiting to such as are menthol, menthone, camphor, pulegol, isopulegol, cineole, Japanese mint oil, peppermint oil, spearmint oil, eucalyptus oil, 3-1-menthoxypropane-1,2-diol, N-alkyl-p-menthane-3-carboxamide, 3-1-menthoxy-2-methylpropane-1, 2-diol, p-menthane-3,8-diol, 2-1-menthoxyethane-1-ol, 3-1-menthoxypropane-1-ol, 4-1-menthoxybutane-1-ol (menthyl 3-hydroxybutanate), menthyl lactate, menthol glycerin ketal, and N-methyl-2,2-isopropylmethyl-3-methylbutanamide and combination thereof. Can be used in the range of 2% to 20 %.
Preferred surfactants include as used here in include and are not limiting to non-ionic surfactants, cationic surfactants, anionic surfactants example of which include and are not limited to Sorbitan Esters (Sorbitan Fatty Acid Esters), Polyoxyethylene Sorbitan Fatty Acid Esters, polyoxyethylene alkyl ether, polyoxyethylene castor oil derivative or a mixture thereof. can be used in of the range of 0.1% to 5.0%..
Preferred stabilizing agents as used herein include and are not limiting to calcium carbonate, magnesium hydroxide, calcium acetate, calcium gluconate, calcium glycerophosphate, or aluminum hydroxide and combinations thereof.
Preferred flavouring agents as used herein include and are not limiting to to peppermint, spearmint, wintergreen, cinnamon, menthol, cherry, strawberry, watermelon, grape, banana, peach, pineapple, apricot, pear, raspberry, lemon, grapefruit, orange, plum, apple, fruit punch, passion fruit, chocolate (white, milk, dark), vanilla, caramel, coffee, hazelnut, mixtures thereof, and the like. can be used in of the range of 0.5% to 15.0%..
Preferred thickening agents as used here in include and are not limiting to xanthum gum, konjac gum, gum of natural source, synthetical polymer compound, polypeptide, polysaccharide dextran, alginate gum, arabic gum, guar gum, agar, HMC, carrageenan, pectin and a mixture thereof.
Preferred binding agents as used here in include and are not limiting to Carbohydrates that are dissolvable in the mouth of a patient such as various celluloses, starches, gums, sugars, various fats, proteins, hydrocarbons, waxes, hydrogels, and dissolvable resins. More specifically, xanthan gum, carrageenan gum, loctus beangum, can be used in of the range of 0.5% to 2.0%..
Suitable sweeteners include herein both natural and artificial sweeteners examples which include and are not limiting to Neotame, Sucralose, aspartame, Acesulfame Potassium, saccharin, cyclamate, dextrose, fructose, glucose, liquid glucose, maltose in the range of 1% to 20%
Suitable sweeteners include water-soluble sweetening agents such as monosaccharides, disaccharides and polysaccharides such as xylose, ribose, glucose (dextrose), mannose, galactose, fructose (levulose), sucrose (sugar), maltose, invert sugar (a mixture of fructose and glucose derived from sucrose), partially hydrolyzed starch, corn syrup solids, dihydrochalcones, monellin, steviosides, and glycyrrhizin; water-soluble artificial sweeteners such as the soluble saccharin salts, i.e., sodium or calcium saccharin salts, cyclamate salts, the sodium, ammonium or calcium salt of 3,4-dihydro-6-methyl-1,2,3-oxathiazine-4-one-2,2-dioxide, the potassium salt of 3,4-dihydro-6-methyl-1,2,3-oxathiazine-4-one-2,2-dioxide (acesulfame-K), the free acid form of saccharin, and the like; dipeptide based sweeteners, such as L-aspartic acid derived sweeteners, such as L-aspartyl-L-phenylalanine methyl ester (aspartame) and materials described in U.S. Pat. No. 3,492,131, L-alpha-aspartyl-N-(2,2,4,4-tetramethyl-3-thietanyl)-D-alaninamide hydrate, methyl esters of L-aspartyl-L-phenylglycerin and L-aspartyl-L-2,5, dihydrophenyl-glycine, L-aspartyl-2,5-dihydro-L-phenylalanine, L-aspartyl-L-(1-cyclohexyen)-alanine, and the like; water-soluble sweeteners derived from naturally occurring water-soluble sweeteners, such as a chlorinated derivative of ordinary sugar (sucrose), known, for example, under the product description of sucralose; and protein based sweeteners such as thaumatoccous danielli (Thaumatin I and II).
In general, an effective amount of auxiliary sweetener is utilized to provide the level of sweetness desired for a particular composition, and this amount will vary with the sweetener selected. This amount will normally be 0.01% to about 10% by weight of the composition when using an easily extractable sweetener. The water-soluble sweeteners described in category A above, are usually used in amounts of about 0.01 to about 10 wt %, and preferably in amounts of about 2 to about 5 wt %. Some of the sweeteners in category A (e.g., glycyrrhizin) can be used in amounts set forth for categories B-E below dued to the sweeteners' known sweetening ability. In contrast, the sweeteners described in categories B-E are generally used in amounts of about 0.01 to about 10 wt %, with about 2 to about 8 wt % being preferred and about 3 to about 6 wt % being most preferred. These amounts may be used to achieve a desired level of sweetness independent from the flavor level achieved from any optional flavor oils used. Of course, sweeteners need not be added to films intended for non-oral administration.
Suitable solvents that can be used herein include and are not limiting to Acetone, Ethanol, IPA, water or mixtures thereof.
Other additives used in the the preparations to the pharmaceutical compositions of this invention, the following can be used and there were no limitations: stabilizer, surfactant, plasticizer, lubricant, reducing agent, buffer agent, film forming agents, sweetening agent, base, adsorbent, corrigent, binder, suspending agent, antioxidant, polish, coating, wetting agent, wet modifier, filler, antifoaming agent, refrigerative agent, thickening agent, coloring matter, flavoring agent, perfume, sugar coating agent, isotonizing agent, softener, emulsifying agent, foaming agent, pH modifier, anti-frothing agents, diluent, excipient, dispersing agent, disintegrator, fragrance, desiccant, antiseptics, preservative, solubilizing agent, solubilizer, solvent, superplasticizer, antistatic agent, extender, moisturizing agent, and the like.
The present invention also provides a process for the manufacture of stabilized mouth freshener strip comprising the steps of:
i) providing a formulation solution of all the ingredients of the mouth freshener strip
ii) providing a liner upon which to cast a mouth freshener strip;
iii) casting the formulation of step (ii) or (iii) on the liner to form a mouth freshener strip; and
iv) drying the cast a mouth freshener strip on said liner.
The present invention is further illustrated by the following examples which are provided merely to be exemplary of the inventions and is not intended to limit the scope of the invention. Certain modifications and equivalents will be apparent to those skilled in the art and are intended to be included within the scope of the present invention.
Example 1:
Ingredients mg/strip %w/w
Eucalyptus oil 3.00 5.00
Tween 80 0.80 1.33
Xanthan gum 0.30 0.50
Erythritol 10.00 16.67
Neotame 2.00 3.33
Maltodextrin 9.89 16.48
PEO 2.00 3.33
FD&C Blue 1 0.01 0.02
HPMC 12.00 20.00
Pullulan 12.00 20.00
Peppermint 2.00 3.33
Menthol 5.00 8.33
Propylene glycol 1.00 1.67
Acetone 12.00* -
P Water 167.00* -
Total weight 60.00 100%
*These ingredients will evaporate during manufacturing process.
Manufacturing process:
Batch quantities of tween 80 was dissolved in batch quantity of eucalyptus oil to give an oil phase which was emulsified with purified water (20% of batch quantity) under homogenization. Subsequently, batch quantities of xanthan gum was added to the above emulsion under stirring (the emulsion phase).
Batch quantities of Pullulan, Maltodextrin, Erythritol, Neotame, PEO and HPMC were mixed under stirring in 78% of batch quantity of purified water (the polymer phase). Batch quantity of color FD&C Blue 1 was dissolved in 2% of batch quantity of purified water, propylene glycol (the color phase).
Emulsion phase and color phase were added to the polymeric phase under stirring and subjected for homogenization till homogenous slurry was obtained. Peppermint and Menthol were dissolved in Acetone & mixed this solution to above slurry under stirring.
The obtained slurry was coated on PET liner using film coating machine. The coating knife was adjusted to get appropriate wet coating thickness to get desired film weight/area. Solvents were evaporated using heat at 70º C for 30 minutes in hot air oven having a facility of blower and exhaust. obtained transparent film which changed its appearance to hazy after 12 hours of storage at ambient condition (250C/50%RH) in roll form.
Example 2:
Ingredients mg/strip %w/w
Eucalyptus oil 3.00 4.35
Tween 80 0.80 1.16
Xanthan gum 0.30 0.43
Erythritol 10.00 14.49
Neotame 3.00 4.35
Maltodextrin 8.33 12.07
PEO 2.00 2.90
FD&C Blue 1 0.02 0.03
HPMC 12.00 17.39
Pullulan 12.00 17.39
Peppermint 2.00 2.90
Menthol 10.00 14.49
Calcium carbonate 3.80 5.51
Silicon dioxide 0.60 0.87
Titanium dioxide 0.15 0.22
Propylene glycol 1.00 1.45
Acetone 12.00* 0.00
P Water 167.00* 0.00
Total weight 69.00 100%

Manufacturing process:
Batch quantities of tween 80 was dissolved in batch quantity of eucalyptus oil to give an oil phase which was emulsified with purified water (20% of batch quantity) under homogenization. Subsequently, batch quantities of xanthan gum was added to the above emulsion under stirring (the emulsion phase).
Batch quantities of Pullulan, Maltodextrin, Erythritol, Neotame, PEO, Calcium carbonate, HPMC and Silicon dioxide were mixed under stirring in 78% of batch quantity of purified water (the polymer phase). Batch quantity of color FD&C Blue 1 and Titanium dioxide were dissolved in 2% of batch quantity of purified water, propylene glycol (the color phase).
Emulsion phase and color phase were added to the polymeric phase under stirring and subjected for homogenization till homogenous slurry was obtained. Peppermint and Menthol were dissolved in Acetone & mixed this solution to above slurry under stirring.
The obtained slurry was coated on PET liner using film coating machine. The coating knife was adjusted to get appropriate wet coating thickness to get desired film weight/area. Solvents were evaporated using heat at 70º C for 30 minutes in hot air oven having a facility of blower and exhaust.
Example 3:
Ingredients mg/strip %w/w
Eucalyptus oil 3.00 4.48
Tween 80 0.80 1.19
Xanthan gum 0.30 0.45
Erythritol 10.00 14.93
Neotame 1.80 2.69
Maltodextrin 8.94 13.34
PEO 2.00 2.99
FD&C Blue 1 0.01 0.01
HPMC 13.00 19.40
Pullulan 13.00 19.40
Peppermint 2.00 2.99
Menthol 6.00 8.96
Calcium carbonate 3.40 5.07
Silicon dioxide 0.60 0.90
Titanium dioxide 0.15 0.22
Sorbitol 1.00 1.49
Propylene glycol 1.00 1.49
Acetone 12.00* 0.00
P Water 167.00* 0.00
Total weight 67.00 100%

Manufacturing process:
Batch quantities of tween 80 was dissolved in batch quantity of eucalyptus oil to give an oil phase which was emulsified with purified water (20% of batch quantity) under homogenization. Subsequently, batch quantities of xanthan gum was added to the above emulsion under stirring (the emulsion phase).
Batch quantities of Pullulan, Maltodextrin, Erythritol, Sorbitol, Neotame, PEO, Calcium carbonate, HPMC and Silicon dioxide were mixed under stirring in 78% of batch quantity of purified water (the polymer phase). Batch quantity of color FD&C Blue 1 and Titanium dioxide were dissolved in 2% of batch quantity of purified water, propylene glycol (the color phase).
Emulsion phase and color phase were added to the polymeric phase under stirring and subjected for homogenization till homogenous slurry was obtained. Peppermint and Menthol were dissolved in Acetone & mixed this solution to above slurry under stirring.
The obtained slurry was coated on PET liner using film coating machine. The coating knife was adjusted to get appropriate wet coating thickness to get desired film weight/area. Solvents were evaporated using heat at 70º C for 30 minutes in hot air oven having a facility of blower and exhaust.
Example 4:
Ingredients mg/strip %w/w
Eucalyptus oil 3.00 4.23
Tween 80 0.80 1.13
Xanthan gum 0.30 0.42
Erythritol 10.00 14.08
Neotame 1.80 2.54
Maltodextrin 5.00 7.04
PEO 2.00 2.82
FD&C Blue 1 0.01 0.01
HPMC 17.94 25.27
Pullulan 13.00 18.31
Peppermint 2.00 2.82
Menthol 4.00 5.63
Calcium carbonate 3.40 4.79
Silicon dioxide 0.60 0.85
Titanium dioxide 0.15 0.21
Sorbitol 6.00 8.45
Propylene glycol 1.00 1.41
Acetone 12.00* 0.00
P Water 167.00* 0.00
Total weight 71.00 100%

Manufacturing process:
Batch quantities of tween 80 was dissolved in batch quantity of eucalyptus oil to give an oil phase which was emulsified with purified water (20% of batch quantity) under homogenization. Subsequently, batch quantities of xanthan gum was added to the above emulsion under stirring (the emulsion phase).
Batch quantities of Pullulan, Maltodextrin, Erythritol, Sorbitol, Neotame, PEO, Calcium carbonate, HPMC and Silicon dioxide were mixed under stirring in 78% of batch quantity of purified water (the polymer phase). Batch quantity of color FD&C Blue 1 and Titanium dioxide were dissolved in 2% of batch quantity of purified water, propylene glycol (the color phase).
Emulsion phase and color phase were added to the polymeric phase under stirring and subjected for homogenization till homogenous slurry was obtained. Peppermint and Menthol were dissolved in Acetone & mixed this solution to above slurry under stirring.
The obtained slurry was coated on PET liner using film coating machine. The coating knife was adjusted to get appropriate wet coating thickness to get desired film weight/area. Solvents were evaporated using heat at 70º C for 30 minutes in hot air oven having a facility of blower and exhaust.
Example 5:
Ingredients mg/strip %w/w
Eucalyptus oil 3.00 4.17
Tween 80 0.80 1.11
Xanthan gum 0.30 0.42
Erythritol 10.00 13.89
Neotame 1.80 2.50
Maltodextrin 5.00 6.94
PEO 2.00 2.78
FD&C Blue 1 0.01 0.01
HPMC 17.94 24.92
Pullulan 13.00 18.06
Peppermint 2.00 2.78
Menthol 5.00 6.94
Calcium carbonate 3.40 4.72
Silicon dioxide 0.60 0.83
Titanium dioxide 0.15 0.21
Sorbitol 6.00 8.33
Propylene glycol 1.00 1.39
Acetone 12.00* 0.00
P Water 167.00* 0.00
Total weight 72.00 100%

Manufacturing process:
Batch quantities of tween 80 was dissolved in batch quantity of eucalyptus oil to give an oil phase which was emulsified with purified water (20% of batch quantity) under homogenization. Subsequently, batch quantities of xanthan gum was added to the above emulsion under stirring (the emulsion phase).
Batch quantities of Pullulan, Maltodextrin, Erythritol, Sorbitol, Neotame, PEO, Calcium carbonate, HPMC and Silicon dioxide were mixed under stirring in 78% of batch quantity of purified water (the polymer phase). Batch quantity of color FD&C Blue 1 and Titanium dioxide were dissolved in 2% of batch quantity of purified water, propylene glycol (the color phase).
Emulsion phase and color phase were added to the polymeric phase under stirring and subjected for homogenization till homogenous slurry was obtained. Peppermint and Menthol were dissolved in Acetone & mixed this solution to above slurry under stirring.
The obtained slurry was coated on PET liner using film coating machine. The coating knife was adjusted to get appropriate wet coating thickness to get desired film weight/area. Solvents were evaporated using heat at 70º C for 30 minutes in hot air oven having a facility of blower and exhaust.
Example 6:
Ingredients mg/strip %w/w
Eucalyptus oil 3.00 4.05
Tween 80 0.80 1.08
Xanthan gum 0.30 0.41
Erythritol 10.00 13.51
Neotame 1.80 2.43
Maltodextrin 8.94 12.08
PEO 2.00 2.70
FD&C Blue 1 0.01 0.01
HPMC 13.00 17.57
Pullulan 13.00 17.57
Peppermint 2.00 2.70
Menthol 7.00 9.46
Calcium carbonate 3.40 4.59
Silicon dioxide 0.60 0.81
Titanium dioxide 0.15 0.20
Sucrose 5.00 6.76
Starch 2.00 2.70
Propylene glycol 1.00 1.37
Acetone 12.00* 0.00
P Water 167.00* 0.00
Total weight 74.00 100%

Manufacturing process:
Batch quantities of tween 80 was dissolved in batch quantity of eucalyptus oil to give an oil phase which was emulsified with purified water (20% of batch quantity) under homogenization. Subsequently, batch quantities of xanthan gum was added to the above emulsion under stirring (the emulsion phase).
Batch quantities of Pullulan, starch, sucrose, Maltodextrin, Erythritol, Neotame, PEO, Calcium carbonate, HPMC and Silicon dioxide were mixed under stirring in 78% of batch quantity of purified water (the polymer phase). Batch quantity of color FD&C Blue 1 and Titanium dioxide were dissolved in 2% of batch quantity of purified water, propylene glycol (the color phase).
Emulsion phase and color phase were added to the polymeric phase under stirring and subjected for homogenization till homogenous slurry was obtained. Peppermint and Menthol were dissolved in Acetone & mixed this solution to above slurry under stirring.
The obtained slurry was coated on PET liner using film coating machine. The coating knife was adjusted to get appropriate wet coating thickness to get desired film weight/area. Solvents were evaporated using heat at 70º C for 30 minutes in hot air oven having a facility of blower and exhaust.
Example 7:
Ingredients mg/strip %w/w
Eucalyptus oil 3.00 4.48
Tween 80 0.80 1.19
Xanthan gum 0.30 0.45
Erythritol 10.00 14.93
Neotame 1.80 2.69
Maltodextrin 8.94 13.34
PEO 2.00 2.99
FD&C Blue 1 0.01 0.01
Calcium carbonate 3.40 5.07
Silicon dioxide 0.60 0.90
Titanium dioxide 0.15 0.22
Propylene glycol 1.00 1.49
HPMC 13.00 19.40
Pullulan 13.00 19.40
Peppermint 2.00 2.99
Menthol 6.00 8.96
Sorbitol 1.00 1.49
Acetone 12.00* 0.00
P Water 167.00* 0.00
Total weight 67 mg 100%

Manufacturing process:
Batch quantities of tween 80 was dissolved in batch quantity of eucalyptus oil to give an oil phase which was emulsified with purified water (20% of batch quantity) under homogenization. Subsequently, batch quantities of xanthan gum was added to the above emulsion under stirring (the emulsion phase).
Batch quantities of Pullulan, Maltodextrin, Erythritol, Sorbitol, Neotame, PEO, Calcium carbonate, HPMC and Silicon dioxide were mixed under stirring in 78% of batch quantity of purified water (the polymer phase). Batch quantity of color FD&C Blue 1 and Titanium dioxide were dissolved in 2% of batch quantity of purified water, propylene glycol (the color phase).
Emulsion phase and color phase were added to the polymeric phase under stirring and subjected for homogenization till homogenous slurry was obtained. Peppermint and Menthol were dissolved in Acetone & mixed this solution to above slurry under stirring.
The obtained slurry was coated on PET liner using film coating machine. The coating knife was adjusted to get appropriate wet coating thickness to get desired film weight/area. Solvents were evaporated using heat at 70º C for 30 minutes in hot air oven having a facility of blower and exhaust.
Example 8:
Ingredients mg/strip %w/w
Eucalyptus oil 3.00 4.41
Tween 80 0.80 1.18
Xanthan gum 0.30 0.44
Erythritol 10.00 14.71
Neotame 1.80 2.65
Maltodextrin 8.94 13.15
PEO 2.00 2.94
FD&C Blue 1 0.01 0.01
Calcium carbonate 3.40 5.00
Silicon dioxide 0.60 0.88
Titanium dioxide 0.15 0.22
Propylene glycol 1.00 1.47
HPMC 13.00 19.12
Pullulan 13.00 19.12
Peppermint 2.00 2.94
Menthol 7.00 10.29
Sorbitol 1.00 1.47
Acetone 12.00* 0.00
P Water 167.00* 0.00
Total weight 68 mg 100%

Manufacturing process:
Batch quantities of tween 80 was dissolved in batch quantity of eucalyptus oil to give an oil phase which was emulsified with purified water (20% of batch quantity) under homogenization. Subsequently, batch quantities of xanthan gum was added to the above emulsion under stirring (the emulsion phase).
Batch quantities of Pullulan, Maltodextrin, Erythritol, Sorbitol, Neotame, PEO, Calcium carbonate, HPMC and Silicon dioxide were mixed under stirring in 78% of batch quantity of purified water (the polymer phase). Batch quantity of color FD&C Blue 1 and Titanium dioxide were dissolved in 2% of batch quantity of purified water, propylene glycol (the color phase).
Emulsion phase and color phase were added to the polymeric phase under stirring and subjected for homogenization till homogenous slurry was obtained. Peppermint and Menthol were dissolved in Acetone & mixed this solution to above slurry under stirring.
The obtained slurry was coated on PET liner using film coating machine. The coating knife was adjusted to get appropriate wet coating thickness to get desired film weight/area. Solvents were evaporated using heat at 70º C for 30 minutes in hot air oven having a facility of blower and exhaust.
The film as produced according to the examples present invention is characterized for
1) Disintegartion time,
2) Water conten and
3) Average weight.
The results obtained were summarized in the below tables 1-2:
Table 1
Product Name: Mouth Freshner Film of Example 7
30°C/75% RH 25°C/60% RH 40°C/75% RH
Tests Initial 1 M 3 M 6 M 1 M 3 M 6 M 1 M 3 M 6 M
Water content 3.58% 3.8% 4.04% 4.61% 3.71% 4.98% 4.63% 4.02% 5.36% 6.4%
Disintegration time 16 sec 17 sec 19 sec 17 sec 18 sec 18 sec 18 sec 17 sec 18 sec 18 sec
Average weight 74.5 mg 75.1 mg 75.9 mg 76.2 mg 74.5 mg 74.3 mg 73.5 mg 74.2 mg 74.1 mg 75.5 mg

Table 2
Product Name: Mouth Freshner Film of Example 8
30°C/75% RH 25°C/60% RH 40°C/75% RH
Tests Initial 1 M 3 M 6 M 1 M 3 M 6 M 1 M 3 M 6 M
Water content 3.69% 4.59% 4.85% 4.81% 4.64% 4.84% 4.78% 4.16% 5.20% 6.17%
Disintegration time 16 sec 18 sec 17 sec 18 sec 18 sec 18 sec 16 sec 16 sec 17 sec 17 sec
Average weight 72.8 mg 76.4 mg 75.8 mg 75.7 mg 71.8 mg 74.3 mg 74.7 mg 73.9 mg 75.5 mg 76.5 mg
,CLAIMS:We Claim:
1. A physically stabilized mouth freshener strip comprising polyols, adsorbents and plasticizers.
2. A physically stabilized mouth freshener strip as claimed in claim 1, further comprising one or more of antimicrobial agents, film forming agents, cooling agents, surfactants, stabilizing agents, flavouring agents, thickening agents, binding agents, sweeteners and solvents.
3. A physically stabilized mouth freshener strip as claimed in claim 1, the polyols as used in the present invention include and are not limiting to Erythritol, xylitol, maltitol, mannitol, sorbitol, isomalt, lactitol, glycerin, polyethylene glycol, propylene glycol, glycerol monoesters with fatty acids or other pharmaceutically acceptable polyalcohols and combinations thereof.
4. A physically stabilized mouth freshener strip as claimed in claim 1, the adsorbents used include and are not limiting to calcium carbonate, magnesium oxide, Sodium bicarbonate, dibasic calcium phosphate, magnesium carbonate, kaolin, cellulose, titanium dioxide and colloidal silicon dioxide.
5. A physically stabilized mouth freshener strip as claimed in claim 1, the plasticizing agents as used herein include and are not limiting to Propylene glycol, sucrose, glycerine, low molecular weight polyethylene glycols (PEGs), phthalate derivatives like dimethyl, diethyl and dibutyl phthalate, citrate derivatives such as tributyl, triethyl, acetyl citrate, triacetin, castor oil, triethyl citrate, glycerin, a polysorbate, a, a polyol, lecithin, a starch hydrolysate and combinations thereof.
6. A physically stabilized mouth freshener strip as claimed in claim 1 and 2, the antimicrobial agents as used herein include and are not limiting to Menthol, Eucalyptus oil, peppermint oil and combination thereof.
7. A physically stabilized mouth freshener strip as claimed in claim 1 and 2, the film forming agents as used herein include and are not limiting to HPMC, pullulan, PEO, Starch, Carboxymethyl cellulose, Pectin, polymethacrylates, hydroxyethyl cellulose, hydroxypropyl cellulose, polyvinyl pyrrolidone, polyvinyl alcohol, sodium alginate, glycolide, polylactide, polyacrylic acid, carboxyvinyl polymer, amylose, high amylose starch, hydroxypropylated high amylose starch, dextrin, pectin, chitin, chitosan, levan, elsinan, polyethylene glycol, locust bean gum, carrageenan gum, xanthan gum, tragacanth gum, guar gum, acacia gum, arabic gum, collagen, gelatin, zein, gluten, Maltodextrin, polyvinyl alcohol–polyethylene glycol graft copolymer, soy protein isolate, whey protein isolate and combinations thereof.
8. A physically stabilized mouth freshener strip as claimed in claim 1 and 2, the cooling agents as used herein include and are not limiting to such as are menthol, menthone, camphor, pulegol, isopulegol, cineole, Japanese mint oil, peppermint oil, spearmint oil, eucalyptus oil, 3-1-menthoxypropane-1,2-diol, N-alkyl-p-menthane-3-carboxamide, 3-1-menthoxy-2-methylpropane-1, 2-diol, p-menthane-3,8-diol, 2-1-menthoxyethane-1-ol, 3-1-menthoxypropane-1-ol, 4-1-menthoxybutane-1-ol (menthyl 3-hydroxybutanate), menthyl lactate, menthol glycerin ketal, and N-methyl-2,2-isopropylmethyl-3-methylbutanamide.
9. A physically stabilized mouth freshener strip as claimed in claim 1 and 2, the surfactants include as used here in include and are not limiting to non-ionic surfactants, cationic surfactants, anionic surfactants example of which include and are not limited to Sorbitan Esters (Sorbitan Fatty Acid Esters), Polyoxyethylene Sorbitan Fatty Acid Esters, polyoxyethylene alkyl ether, polyoxyethylene castor oil derivative or a mixture thereof.
10. A physically stabilized mouth freshener strip as claimed in claim 1 and 2, a process for the manufacture of stabilized mouth freshener strip comprising the steps of:
i) providing a formulation solution of all the ingredients of the mouth freshener strip;
ii) providing a liner upon which to cast a mouth freshener strip;
iii) casting the formulation of step (ii) or (iii) on the liner to form a mouth freshener strip; and
iv) drying the cast a mouth freshener strip on said liner.

Dated this Twentieth (20th) day of December 2017.

__________________________________
Dr. S. Padmaja
Agent for the Applicant
IN/PA/883