Abstract:
Disclosed herein is a herbal dental care composition comprising extracts of herbs  Punica granatum, Acacia Arabica, Terminalia chebula, Terminalia bellerica, Emblica officinalis  and  Embelia ribes,  optionally extract of  Azadirachta indica  and pharmaceutical acceptable excipients. Also disclosed are the methods of making the composition, formulating the same into different delivery systems and use thereof for preventing various dental diseases.

Description:
FIELD OF THE INVENTION  
       [0001]    This invention, in general relates to a dental care composition. In particular, the present invention provides an herbal dental care composition comprising extracts of  Punica granatum, Acacia arabica, Terminalia chebula, Terminalia bellerica, Emblica officinalis  and  Embelia ribes  and excipients of natural origin, methods of manufacturing the composition and use thereof. 
       BACKGROUND OF THE INVENTION  
       [0002]    Dental care is one of the primary health concerns of people worldwide. The main diseases of teeth include plaque, dental carries and pyorrhoea. The use of various herbal powders for dental diseases is well known in the prior art. 
         [0003]    There are many dentifrices in the form of paste, gel and powders available for cleaning, whitening and preserving teeth. These compositions include humectants, abrasives, surfactants, sweeteners and flavors. The compositions employed in the form of paste and/or powder contain additional ingredients for special functional or aesthetic reasons, for example, fluoridating or coloring agents. The additional ingredients may increase the cost of the product and lead to several side affects. 
         [0004]    Another drawback of pastes and gels is to ensure that the products have right consistency, stability, and compatibility of the ingredients employed in the formulation. 
         [0005]    Toothpastes and gels are widely accepted dental care agents than tooth powders, since they are more convenient to use. These dental care agents may be delivered as other formulations such as tablets and capsules which will have certain advantages over the most preferred toothpastes and tooth powders. 
         [0006]    Humectants, thickeners, coloring agents and water serve no useful purpose in the actual cleaning of teeth, but are employed to impart desirable properties to form paste or gel. These ingredients can be avoided in the delivery system of dental care tablets or capsules. 
         [0007]    Capsules of tooth cleansing composition available in the market consist of the same composition as that of toothpaste and gel. However, the mode of delivery of these toothpaste and gel is in capsule form. Such forms of delivery system would not help in reducing cost or avoiding side affects of many synthetic ingredients. 
         [0008]    It is therefore necessary to develop a dental care agent that is devoid of unnecessary ingredients to provide a composition containing different herbal extracts of selected herbs and naturally derived excipients. 
       Related Art 
       [0009]    U.S. Patent application No. 20070154409 by Annis David et al. teaches the method of converting the composition of toothpowder in to a tablet form. Wherein, the tablet dimensioned and configured to be easily inserted into the mouth and broken up into a paste by chewing for teeth cleaning. 
         [0010]    U.S. Pat. No, 7,074,390 by Mackinnon et al. reveals about the preparation of single use dentifrice in a capsule form. The dentifrice may include miswak fibers along with choline and albumin for coating purpose. 
       SUMMARY OF THE INVENTION  
       [0011]    It is a principal object of the present invention to provide a herbal dental care composition comprising extracts of selective natural aromatic and medicinal herbs and the naturally derived excipients, which obviates the drawbacks associated with the dental care composition known in the art. 
         [0012]    Further object is to provide high-quality herbal dental care composition having ability to provide the effective protection to the user&#39;s teeth and free them from any toxicity, toxic residues and irritation when used. 
         [0013]    The above and the other objects of the present invention are attend according to following preferred embodiments of the present invention, however the scope of the invention is not restricted to the particular embodiment. 
         [0014]    In accordance with one preferred embodiment of the present invention, there is provided a herbal dental care composition, wherein said composition comprising a herbal extract blend containing effective amount of the extracts of  Punica granatum, Acacia arabica, Terminalia chebula, Terminalia bellerica, Emblica officinalis,  and  Embelia ribes  and pharmaceutically acceptable naturally derived excipients. 
         [0015]    In accordance with one preferred embodiment of the present invention, there is provided a herbal dental care composition, wherein said herbal extract blend containing effective amount of the extracts of  Punica granatum, Acacia arabica, Terminalia chebula, Terminalia bellerica, Emblica officinalis,  and  Embelia ribes  is optionally mixed with extract of  Azadirachta indica.    
         [0016]    In accordance with another preferred embodiment of the present invention, there is provided a herbal dental care composition, wherein said composition comprising therapeutically effective amount of extract of  Azadirachta indica  and herbal extract blend containing extracts of  Punica granatum, Acacia arabica, Terminalia chebula, Terminalia bellerica, Emblica officinalis,  and  Embelia ribes  and pharmaceutically acceptable naturally derived excipients. 
         [0017]    In accordance with another embodiment of the present invention, there is provided a process for extraction of said extracts of herbs, wherein said extraction process is performed using any suitable extraction technique, preferably a hot-soxhlation or percolation technique and wherein a selective solvent or solvent system are used to yield high extractive value and rich content of stable bioactive ingredients. Said solvent is selected from a group of organic solvents and water, preferably lower chain alcohol/s and water, most preferably selected from methanol and water alone or in combination thereof. 
         [0018]    In accordance with another preferred embodiment of the present invention, wherein said extract of herbs can be prepared using all parts of said herbs, preferably bark of  Azadirachta indica  and  Acacia arabica,  preferably fruit rind of  Punica granatum,  preferably fruits of  Terminalia chebula, Terminalia bellerica, Emblica officinalis  and  Embelia ribes.    
         [0019]    In yet another preferred embodiment, there is provided a process for reparation of herbal dental care composition, wherein, the process comprises of extracting the herbal blend of  Punica granatum, Acacia arabica, Terminalia chebula, Terminalia bellerica, Emblica officinalis  and  Embelia ribes  employing suitable solvent, filtering the plant extract, concentrating the plant extract to dryness on a rotatory evaporator or on a steam bath at optimum temperature and producing a herbal composition comprising the resultant dry blend extract and pharmaceutically acceptable naturally derived excipients. 
         [0020]    In yet another preferred embodiment, there is provided a process for preparation of herbal dental care composition, wherein, the process comprises of extracting the herbal blend of  Punica granatum, Acacia arabica, Terminalia chebula, Terminalia bellerica, Emblica officinalis  and  Embelia ribes  employing suitable solvent, filtering the plant extract, concentrating the plant extract to dryness on a rotatory evaporator or on a steam bath at optimum temperature and producing a herbal composition by mixing the resultant blend extract with the extract of the herb  Azadirachta indica  and pharmaceutically acceptable naturally derived excipients. 
         [0021]    In accordance with another embodiment of the present invention, there is provided a herbal dental care composition, wherein said composition is formulated in various oral delivery system including tablets, capsules, gel, paste, impregnated dental floss etc., preferably tablets, paste or gels, most preferably tablet formulation. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS  
         [0022]      FIG. 1  is a graph showing the radical scavenging activity of various extracts as disclosed herein. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0023]    While this specification concludes with claims particularly pointing out and distinctly claiming that, which is regarded as the invention, it is anticipated that the invention can be more readily understood through reading the following detailed description of the invention and study of the included examples. 
         [0024]    The present invention provides an herbal dental care composition comprising extracts of  Azadirachta indica, Punica granatum, Acacia arabica, Terminalia chebula, Terminalia bellerica, Emblica officinalis  and  Embelia ribes  and excipients of natural origin. Further, the process to prepare the composition is also disclosed according to present invention. 
         [0025]    The disclosed herbal dental care composition, according to the present invention is prepared using effective combination of extract of said herbs  Azadirachta indica, Punica granatum, Acacia arabica, Terminalia chebula, Terminalia bellerica, Emblica officinalis, and    Embelia ribes  along with the pharmaceutically acceptable naturally derived excipients. The composition is preferably prepared by using herbal extract blend containing extracts of  Punica granatum, Acacia arabica, Terminalia chebula, Terminalia bellerica, Emblica officinalis,  and  Embelia ribes  and the pharmaceutically acceptable naturally derived excipients. 
         [0026]    In accordance with further embodiment, said composition can be prepared by mixing herbal extract blend containing extracts of  Punica granatum, Acacia arabica, Terminalia chebula, Terminalia bellerica, Emblica officinalis,  and  Embelia ribes  optionally with herbal extract of  Azadirachta indica  and pharmaceutically acceptable naturally derived excipients, wherein the extract of  Azadirachta indica  used in the composition is preferably in an amount of 0.1% and wherein said herbal extract blend of said herbs in an amount of 0.1% to 5% preferably 1% of herbal blend extract. 
         [0027]    The herbal dental care composition according to the present invention possess antibacterial, antiviral, antiseptic, antioxidant and wound healing properties to address the dental disorders such as plaque, dental carries and pyorrhoea. 
         [0028]    The used pharmaceutically acceptable naturally derived excipients in the composition, preferably selected from binder, diluent, sweetener, gelling agent, abrasive, foaming agent, flavoring agent and preservative as a carrier or otherwise, wherein, the term “naturally derived excipients” means that excipients used herein are solely selected from the naturally occurring or naturally regenerable resources. 
         [0029]    The binder used herein in the composition, according to the present invention, is selected from the group consisting of cellulose per se, esters of cellulose, polymers, gelatins and/or traditional binders alone or in combination thereof, preferably selected from sodium carboxymethylcellulose, hydroxypropyl cellulose, hydroxy propyl methylcellulose, methyl cellulose, polyvinyl pyrrolidone, polyethylene glycol, hydrolyzed gelatin, natural gums, most preferably, selected from hydroxy propyl methyl cellulose (HPMC), corn starch alone or in combination thereof. 
         [0030]    The sweetener according to the present invention is selected from natural, artificial, water soluble, water insoluble or intense sweeteners, preferably selected from sucrose, glucose, fructose, fructose syrup, glycyrrhizin, molasses, caramel, mono ammonium salt of glycyrrhizin, mono-, di- or ti-sodium salt of glycyrrhizin, mono-, di- or tri-potassium salt of glycyrrhizin, and calcium salt of glycyrrhizin, sugar alcohols, such as mannitol, sorbitol, xylitol, maltitol alone or in combination thereof. Most preferably, selected from xylitol and glycyrrhizin alone or in combination thereof. 
         [0031]    The abrasive according to the present invention is selected from the group comprising natural and synthetic abrasive particulate materials alone or in combination thereof, most preferably, selected from calcium carbonate of natural origin. 
         [0032]    The gelling agent according to the present invention is selected from the group comprising natural or synthetic origin alone or in combination thereof, most preferably, selected from xanthum gum of natural origin. 
         [0033]    The diluent according to the present invention is selected from the group comprising spray-dried mannitol (Pearlitol.™ SD200), methyl carboxy cellulose alone or in combination thereof. 
         [0034]    The foaming agent according to the present invention is selected from the group comprising salts of lauroyl sarcosinate, preferably sodium salt of lauroyl sarcosinate. 
         [0035]    The preservative according to the present invention is selected from the group comprising citric acid, sodium benzoate, cetylpyridinium chloride, potassium sorbate and alkyl parabens alone or in combination thereof, preferably potassium sorbate. 
         [0036]    The flavoring agent according to the present invention is selected from the group comprising essential oils, flavoring chemicals alone or in combination thereof. Wherein, the essential oils includes oils of spearmint, peppermint, wintergreen, sassafras, clove, sage, eucalyptus, marjoram, cinnamon, lemon, lime, grapefruit and orange and flavoring chemical includes menthol, carvone and anethole. The most preferable flavoring is selected from spearmint oil and menthol alone or in combination thereof. 
         [0037]    In accordance with still another embodiment of the present invention is provided with selection and identification of the herbs and obtaining the extracts by subjecting the same to solvent extraction, standardization of these extracts and preparation of the herbal dental care composition using these extracts and other natural origin pharmaceutically acceptable excipients and deliver in the form of chewable tablets for tooth cleansing and treatment for dental disorders. 
       EXAMPLE-1  
       [0038]    Preparation of the Extract from  Azadirachta Indica  by Percolation Method: 
         [0039]    The dried material of the bark of  Azadirachta indica  was pulverized to a coarse powder and about 2 kg each of the powdered material was placed in different flasks and extracted with n-hexane, dichloromethane, chloroform, ethyl acetate, acetone, ethanol, methanol and water at room temperature for 24 to 48 h. The plant extracts were then filtered and concentrated to dryness on a rotatory evaporator or on a steam bath at optimum temperature and under reduced pressure. The methanol and water extracts were found to be in good yield. 
       EXAMPLE-2  
       [0040]    Preparation of the Extract from  Azadirachta Indica  by Hot-Soxhlation Method: 
         [0041]    The coarse, powdered material of the bark of  Azadirachta indica  was subjected to hot-soxhlation using solvents n-hexane, dichloromethane, chloroform, ethyl acetate, acetone, ethanol, methanol and water at optimum temperature and recycled until the extraction was complete. The plant extracts were then filtered and concentrated to dryness on a rotatory evaporator or on a steam bath at optimum temperature. All the extracts were qualitatively similar to the extracts prepared by the percolation method. 
       EXAMPLE-3  
       [0042]    Preparation of the Extract from  Punica Granatum  by Percolation Method: 
         [0043]    The dried material of the fruit rind of  Punica granatum  was pulverized to a coarse powder and about 2 kg of the powdered material was placed in different flasks and extracted with n-hexane, dichloromethane, chloroform, ethyl acetate, acetone, ethanol, methanol and water at room temperature for 24 to 48 h. The plant extracts were then filtered and concentrated to dryness on a rotatory evaporator or on a steam bath at optimum temperature and under reduced pressure. The methanol and water extracts were found to be in good yield. 
       EXAMPLE-4  
       [0044]    Preparation of the Extract from  Punica Granatum  by Hot-Soxhlation Method: 
         [0045]    The coarse, powdered material of the fruit rinds of  Punica granatum  was subjected to hot-soxhlation using solvents n-hexane, dichloromethane, chloroform, ethyl acetate, acetone, ethanol, methanol and water at optimum temperature and recycled until the extraction was complete. The plant extracts were then filtered and concentrated to dryness on a rotatory evaporator or on a steam bath at optimum temperature. All the extracts were qualitatively similar to the extracts prepared by the percolation method. 
       EXAMPLE-5  
       [0046]    Preparation of the Extract from  Acacia Arabica  by Percolation Method: 
         [0047]    The dried material of the bark of  Acacia arabica  was pulverized to a coarse powder and about 2 kg of the powdered material was placed in different flasks and extracted with n-hexane, dichloromethane, chloroform, ethyl acetate, acetone, ethanol, methanol and water at room temperature for 24 to 48 h. The plant extracts were then filtered and concentrated to dryness on a rotatory evaporator or on a steam bath at optimum temperature and under reduced pressure. The methanol and water extracts were found to be in good yield. 
       EXAMPLE-6  
       [0048]    Preparation of the Extract from  Acacia Arabica  by Hot-Soxhlation Method: 
         [0049]    The coarse, powdered material of the bark of  Acacia arabica  was subjected to hot-soxhlation using solvents n-hexane, dichloromethane, chloroform, ethyl acetate, acetone, ethanol, methanol and water at optimum temperature and recycled until the extraction was complete. The plant extracts were then filtered and concentrated to dryness on a rotatory evaporator or on a steam bath at optimum temperature. All the extracts were qualitatively similar to the extracts prepared by the percolation method. 
       EXAMPLE-7  
       [0050]    Preparation of the Extract from  Terminalia Chebula  by Percolation Method: 
         [0051]    The dried material of the fruits of  Terminalia chebula  was pulverized to a coarse powder and about 2 kg of the powdered material was placed in different flasks and extracted with n-hexane, dichloromethane, chloroform, ethyl acetate, acetone, ethanol, methanol and water at room temperature for 24 to 48 h. The plant extracts were then filtered and concentrated to dryness on a rotatory evaporator or on a steam bath at optimum temperature and under reduced pressure. The methanol and water extracts were found to be in good yield. 
       EXAMPLE-8  
       [0052]    Preparation of the Extract from  Terminalia Chebula  by Hot-Soxhlation Method: 
         [0053]    The coarse, powdered material of the fruits of  Terminalia chebula  was subjected to hot-soxhlation using solvents n-hexane, dichloromethane, chloroform, ethyl acetate, acetone, ethanol, methanol and water at optimum temperature and recycled until the extraction was complete. The plant extracts were then filtered and concentrated to dryness on a rotatory evaporator or on a steam bath at optimum temperature. All the extracts were qualitatively similar to the extracts prepared by the percolation method. 
       EXAMPLE-9  
       [0054]    Preparation of the Extract from  Terminalia Bellerica  by Percolation Method: 
         [0055]    The dried material of the fruits of  Terminalia bellerica  was pulverized to a coarse powder and about 2 kg of the powdered material was placed in different flasks and extracted with n-hexane, dichloromethane, chloroform, ethyl acetate, acetone, ethanol, methanol and water at room temperature for 24 to 48 h. The plant extracts were then filtered and concentrated to dryness on a rotatory evaporator or on a steam bath at optimum temperature and under reduced pressure. The methanol and water extracts were found to be in good yield. 
       EXAMPLE-10  
       [0056]    Preparation of the Extract from  Terminalia Bellerica  by Hot-Soxhlation Method: 
         [0057]    The coarse, powdered material of the fruits of  Terminalia bellerica  was subjected to hot-soxhlation using solvents n-hexane, dichloromethane, chloroform, ethyl acetate, acetone, ethanol, methanol and water at optimum temperature and recycled until the extraction was complete. The plant extracts were then filtered and concentrated to dryness on a rotatory evaporator or on a steam bath at optimum temperature. All the extracts were qualitatively similar to the extracts prepared by the percolation method. 
       EXAMPLE-11  
       [0058]    Preparation of the Extract from  Emblica Officinalis  by Percolation Method: 
         [0059]    The dried material of the fruits of  Emblica officinalis  was pulverized to a coarse powder and about 2 kg of the powdered material was placed in different flasks and extracted with n-hexane, dichloromethane, chloroform, ethyl acetate, acetone, ethanol, methanol and water at room temperature for 24 to 48 h. The plant extracts were then filtered and concentrated to dryness on a rotatory evaporator or on a steam bath at optimum temperature and under reduced pressure. The methanol and water extracts were found to be in good yield. 
       EXAMPLE-12  
       [0060]    Preparation of the Extract from  Emblica Officinalis  by Hot-Soxhlation Method: 
         [0061]    The coarse, powdered material of the fruits of  Emblica officinalis  was subjected to hot-soxhlation using solvents n-hexane, dichloromethane, chloroform, ethyl acetate, acetone, ethanol, methanol and water at optimum temperature and recycled until the extraction was complete. The plant extracts were then filtered and concentrated to dryness on a rotatory evaporator or on a steam bath at optimum temperature. All the extracts were qualitatively similar to the extracts prepared by the percolation method. 
       EXAMPLE-13  
       [0062]    Preparation of the Extract from  Embelia Ribes  by Percolation Method: 
         [0063]    The dried material of the fruits of  Embelia ribes  was pulverized to a coarse powder and about 2 kg of the powdered material was placed in different flasks and extracted with n-hexane, dichloromethane, chloroform, ethyl acetate, acetone, ethanol, methanol and water at room temperature for 24 to 48 h. The plant extracts were then filtered and concentrated to dryness on a rotatory evaporator or on a steam bath at optimum temperature and under reduced pressure. The methanol and water extracts were found to be in good yield. 
       EXAMPLE-14  
       [0064]    Preparation of the Extract from  Embelia Ribes  by Hot-Soxhlation Method: 
         [0065]    The coarse, powdered material of the fruits of  Embelia ribes  was subjected to hot-soxhlation using solvents n-hexane, dichloromethane, chloroform, ethyl acetate, acetone, ethanol, methanol and water at optimum temperature and recycled until the extraction was complete. The plant extracts were then filtered and concentrated to dryness on a rotatory evaporator or on a steam bath at optimum temperature. All the extracts were qualitatively similar to the extracts prepared by the percolation method. 
       EXAMPLE-15  
       [0066]    Preparation of the Extract from the Herbal Blend by Percolation Method: 
         [0067]    About 2 kg of the dried, coarse, powdered herbal blend containing the fruit rinds of  Punica granatum  (25%), bark of  Acadia arabica  (20%), fruits of  Terminalia chebula  (10%), fruits of  Terminalia bellerica  (10%), fruits of  Emblica officinalis  (10%) and fruits of  Embelia ribes  (25%) in proportions mentioned in brackets was placed in different flasks and extracted with n-hexane, dichloromethane, chloroform, ethyl acetate, acetone, ethanol, methanol and water at room temperature for 24 to 48 h. The plant extracts were then filtered and concentrated to dryness on a rotatory evaporator or on a steam bath at optimum temperature and under reduced pressure. 
       EXAMPLE-16  
       [0068]    Preparation of the Extract from the Herbal Blend by Hot Soxhlation Method: 
         [0069]    About 2 kg of the dried, coarse, powdered herbal blend containing the fruit rinds of  Punica granatum  (25%), bark of  Acadia arabica  (20%), fruits of  Terminalia chebula  (10%), fruits of  Terminalia bellerica  (10%), fruits of  Emblica officinalis  (10%) and fruits of  Embelia ribes  (25%) in proportions mentioned in brackets was subjected hot sox halation extraction with n-hexane, dichloromethane, chloroform, ethyl acetate, acetone, ethanol, methanol and water at room temperature for 24 to 48 h. The plant extracts were then filtered and concentrated to dryness on a rotatory evaporator or on a steam bath at optimum temperature and under reduced pressure. All the extracts were qualitatively similar to those prepared by percolation method. 
       EXAMPLE-17  
       [0070]    The dried extracts and other pharmaceutically acceptable excipients are combined in a unique combination as described in formula I to V to make a chewable dental care tablets. 
       EXAMPLE-18  
       [0071]    The following composition comprises formula I (500 mg tablet) 
         [0000]    
       
         
               
               
               
             
               
               
               
             
           
               
                   
                   
               
               
                   
                 Extracts 
                 (quantity in mg/tablet) 
               
               
                   
                   
               
             
             
               
                   
               
             
          
           
               
                   
                 
                   Azadirachta indica 
                 
                 0.72 
               
               
                   
                 
                   Punica granatum 
                 
                 1.00 
               
               
                   
                 
                   Acacia arabica 
                 
                 0.50 
               
               
                   
                 
                   Terminalia chebula 
                 
                 1.00 
               
               
                   
                 
                   Terminalia bellerica 
                 
                 1.00 
               
               
                   
                 
                   Emblica officinalis 
                 
                 1.00 
               
               
                   
                 
                   Embelia ribes 
                 
                 0.50 
               
               
                   
                 Pearlitol SD 200 
                 239.78 
               
               
                   
                 Xylitol 
                 95.00 
               
               
                   
                 HPMC 
                 15.00 
               
               
                   
                 DC Calcium carbonate 
                 100.00 
               
               
                   
                 Potassium sorbate 
                 2.50 
               
               
                   
                 Sodium lauroyl Sarcosinate 
                 12.00 
               
               
                   
                 Xanthum gum 
                 15.00 
               
               
                   
                 Spearmint 
                 10.50 
               
               
                   
                 Menthol 
                 4.50 
               
               
                   
                   
               
             
          
         
       
     
       EXAMPLE-19  
       [0072]    The following composition comprises formula II (500 mg tablet) 
         [0000]    
       
         
               
               
               
             
               
               
               
             
           
               
                   
                   
               
               
                   
                 Extracts 
                 (quantity in mg/tablet) 
               
               
                   
                   
               
             
             
               
                   
               
             
          
           
               
                   
                   Azadirachta indica  extract 
                 0.72 
               
               
                   
                 2177 B Herbal blend extract 
                 5.00 
               
               
                   
                 Pearlitol SD 200 
                 239.78 
               
               
                   
                 Xylitol 
                 95.00 
               
               
                   
                 HPMC 
                 15.00 
               
               
                   
                 DC Calcium carbonate 
                 100.00 
               
               
                   
                 Potassium sorbate 
                 2.50 
               
               
                   
                 Sodium lauroyl Sarcosinate 
                 12.00 
               
               
                   
                 Xanthum gum 
                 15.00 
               
               
                   
                 Spearmint 
                 10.50 
               
               
                   
                 Menthol 
                 4.50 
               
               
                   
                   
               
             
          
         
       
     
       EXAMPLE-20  
       [0073]    The following composition comprises formula III (500 mg tablet) 
         [0000]    
       
         
               
               
               
             
               
               
               
             
           
               
                   
                   
               
               
                   
                 Extracts 
                 (quantity in mg/tablet) 
               
               
                   
                   
               
             
             
               
                   
               
             
          
           
               
                   
                   Azadirachta indica  extract 
                 0.72 
               
               
                   
                 2177B Herbal extract blend 
                 5.00 
               
               
                   
                 Pearlitol SD 200 
                 200.28 
               
               
                   
                 Xylitol 
                 95.00 
               
               
                   
                 Glycyrrhizin 
                 4.50 
               
               
                   
                 Corn starch 
                 50.00 
               
               
                   
                 DC Calcium carbonate 
                 100.00 
               
               
                   
                 Potassium sorbate 
                 2.50 
               
               
                   
                 Sodium lauroyl Sarcosinate 
                 12.00 
               
               
                   
                 Xanthum gum 
                 10.50 
               
               
                   
                 Spearmint 
                 10.50 
               
               
                   
                 Menthol 
                 4.50 
               
               
                   
                   
               
             
          
         
       
     
       EXAMPLE-21  
       [0074]    The following composition comprises formula IV (500 mg tablet) 
         [0000]    
       
         
               
               
               
             
               
               
               
             
           
               
                   
                   
               
               
                   
                 Extracts 
                 (quantity in mg/tablet) 
               
               
                   
                   
               
             
             
               
                   
               
             
          
           
               
                   
                   Azadirachta indica  extract 
                 0.72 
               
               
                   
                 2177B Herbal blend extract 
                 5.00 
               
               
                   
                 Pearlitol SD 200 
                 129.78 
               
               
                   
                 Xylitol 
                 95.00 
               
               
                   
                 DC MCC 
                 115.00 
               
               
                   
                 DC Calcium carbonate 
                 100.00 
               
               
                   
                 Potassium sorbate 
                 2.50 
               
               
                   
                 Sodium lauroyl Sarcosinate 
                 12.00 
               
               
                   
                 Xanthum gum 
                 15.00 
               
               
                   
                 Corn starch 
                 10.00 
               
               
                   
                 Spearmint 
                 10.50 
               
               
                   
                 Menthol 
                 4.50 
               
               
                   
                   
               
             
          
         
       
     
       EXAMPLE-22  
       [0075]    The following composition comprises formula V (500 mg tablet) 
         [0000]    
       
         
               
               
               
             
               
               
               
             
           
               
                   
                   
               
               
                   
                 Extracts 
                 (quantity in mg/tablet) 
               
               
                   
                   
               
             
             
               
                   
               
             
          
           
               
                   
                   Azadirachta indica  extract 
                 0.72 
               
               
                   
                 2177B Herbal blend extract 
                 5.00 
               
               
                   
                 Pearlitol SD 200 
                 234.78 
               
               
                   
                 Xylitol 
                 95.00 
               
               
                   
                 Starch 
                 20.00 
               
               
                   
                 DC Calcium carbonate 
                 100.00 
               
               
                   
                 Potassium sorbate 
                 2.50 
               
               
                   
                 Sodium lauroyl Sarcosinate 
                 12.00 
               
               
                   
                 Xanthum gum 
                 15.00 
               
               
                   
                 Spearmint 
                 10.50 
               
               
                   
                 Menthol 
                 4.50 
               
               
                   
                   
               
             
          
         
       
     
       EXAMPLE-23  
       [0076]    The following composition comprises formula VI (500 mg tablet) 
         [0000]    
       
         
               
               
               
             
               
               
               
             
           
               
                   
                   
               
               
                   
                 Extracts 
                 (quantity in mg/tablet) 
               
               
                   
                   
               
             
             
               
                   
               
             
          
           
               
                   
                 2177 B Herbal blend extract 
                 5.00 
               
               
                   
                 Pearlitol SD 200 
                 239.78 
               
               
                   
                 Xylitol 
                 95.00 
               
               
                   
                 HPMC 
                 15.00 
               
               
                   
                 DC Calcium carbonate 
                 100.72 
               
               
                   
                 Potassium sorbate 
                 2.50 
               
               
                   
                 Sodium lauroyl Sarcosinate 
                 12.00 
               
               
                   
                 Xanthum gum 
                 15.00 
               
               
                   
                 Spearmint 
                 10.50 
               
               
                   
                 Menthol 
                 4.50 
               
               
                   
                   
               
             
          
         
       
     
       EXAMPLE-24  
       [0077]    Manufacturing Process for formula I, II, V, &amp; VI 
         [0078]    Weigh accurately Azadirachta indica extract, 2177 B herbal blend extract, Pearlitol SD 200, Xylitol and Potassium sorbate as per quantities mentioned in formula I, II &amp; V and pass through #40 mesh for blending up to 5 minutes, weigh the required amount of HPMC (methocel E 15) to disperse in 40 ml of water and make a paste. Add paste into the above powder mix well and pass through #10 mesh and dry the wet granules at about 80-90° C. (Check the moisture content of the granules should between 2-3%) &amp; pass through #16 Mesh, weigh DC Calcium carbonate, Sodium lauroyl sarcosinate, and xanthan gum as per the formula I, II &amp; V and mix with the above granules. Dissolve the required quantities of menthol in spearmint oil and mix with above powder. Compress the final granules into 500 mg Tablets. 
       EXAMPLE-25  
     Manufacturing Process for Formula III &amp; IV 
       [0079]    Direct compression method: Weigh accurately  Azadirachta indica  extract, 2177B herbal blend extract, Pearlitol SD 200, Xylitol, and Potassium sorbate, Glycyrrhizin, Corn starch, calcium carbonate DC, Sodium lauroyl sarcosinate and xanthan gum of the required quantity mentioned in Formula III &amp; IV and pass individually through #40 mesh. Blend ingredients for 5 minutes. Dissolve menthol in spearmint and mix with above powder. Compress the above powder into 500 mg tablets. 
       EXAMPLE-26  
       [0080]    The dried extracts and other pharmaceutically acceptable excipients are combined in a unique combination as described in formula VII to VIII to make a Tooth paste and Tooth gel. 
       EXAMPLE-27  
       [0081]    The following composition comprises formula VII (Tooth paste) 
         [0000]    
       
         
               
               
               
             
               
               
               
             
           
               
                   
               
               
                 Phase 
                 Name of the Ingredients 
                 % use 
               
               
                   
               
             
             
               
                   
               
             
          
           
               
                 A 
                 Xanthan gum 
                 0.8 
               
               
                   
                 Glycerine 
                 5.0 
               
               
                 B 
                 Sorbitol 
                 45.0 
               
               
                 C 
                 Neem extract 
                 0.1 
               
               
                   
                 2177 B Herbal blend extract 
                 1.0 
               
               
                   
                 Water 
                 Qs 
               
               
                   
                 Sodium Benzoate 
                 0.5 
               
               
                   
                 Sodium Saccharin 
                 0.2 
               
               
                   
                 Titanium Dioxide 
                 0.5 
               
               
                 D 
                 PEG 600 
                 4.0 
               
               
                 E 
                 Hydrated silica 
                 10.0 
               
               
                   
                 Abrasive silica 
                 8.0 
               
               
                 F 
                 Sodium lauroyl sarcosinate 
                 3.0 
               
               
                 G 
                 Flavor 
                 1.0 
               
               
                   
                 Menthol 
                 0.2 
               
               
                   
               
             
          
         
       
     
       EXAMPLE-28  
       [0082]    The following composition comprises formula VIII (Tooth gel) 
         [0000]    
       
         
               
               
               
             
               
               
               
             
           
               
                   
               
               
                 Phase 
                 Name of the Ingredients 
                 % use 
               
               
                   
               
             
             
               
                   
               
             
          
           
               
                 A 
                 Cellulose Gum 
                 0.5 
               
               
                   
                 Glycerine 
                 10.0 
               
               
                 B 
                 Sorbitol 
                 57.50 
               
               
                 C 
                 Neem extract 
                 0.1 
               
               
                   
                 2177 B Herbal blend extract 
                 1.0 
               
               
                   
                 Water 
                 Qs 
               
               
                   
                 Sodium Benzoate 
                 0.5 
               
               
                   
                 Sodium Saccharin 
                 0.2 
               
               
                 D 
                 PEG 400 
                 3.0 
               
               
                 E 
                 Hydrated silica 
                 8.0 
               
               
                   
                 Abrasive silica 
                 6.0 
               
               
                 F 
                 Sodium lauroyl sarcosinate 
                 3.0 
               
               
                 G 
                 Flavor 
                 1.0 
               
               
                   
                 Menthol 
                 0.2 
               
               
                 H 
                 Color 
                 q.s 
               
               
                   
               
             
          
         
       
     
       EXAMPLE-29  
     Manufacturing Process for Formula VII (Tooth Paste) 
       [0000]    
       
         
           
             1. Disperse xanthan gum in glycerine 
             2. Add sorbitol to Phase A and mix well 
             3. Dissolve extract, sodium benzoate, sodium saccharin in water. Disperse Titanium dioxide in phase C 
             4. Add Phase C to the gum dispersion. Mix Well 
             5. Add PEG 600 and Mix well 
             6. Add silica to the above mixture and mix well 
             7. Apply vacuum to remove entrapped air. Add Sod. Lauroyl sarcosinate under vacuum and mix well 
             8. Dissolve menthol in flavor and add to the product, mix till uniform 
           
         
       
     
       EXAMPLE-30  
     Manufacturing Process for Formula VIII (Tooth Gel) 
       [0000]    
       
         
           
             1. Disperse cellulose gum in glycerine 
             2. Add sorbitol to Phase A and mix well 
             3. Dissolve extract, sodium benzoate, and sodium saccharin in water. 
             4. Add Phase C to the gum dispersion. Mix Well 
             5. Add PEG 400 and Mix well 
             6. Add silica to the above mixture and mix well 
             7. Apply vacuum to remove entrapped air. Add Sod. Lauroyl sarcosinate under vacuum and mix well 
             8. Dissolve menthol in flavor and add to the product, mix till uniform Add color and mix well 
           
         
       
     
       EXAMPLE-31  
     Antioxidant Activity of Extracts and Herbal Blend Extract by DPPH Method 
       [0099]    Radical scavenging activity of individual extracts viz.  Azadirachta indica, Punica granatum, Acacia arabica,  Triphala ( Terminalia chebula, Terminalia bellerica  and  Emblica officinalis ) and  Embelia ribes  and herbal blend extract as per reported DPPH method and results are summarized in  FIG. 1 . 
       EXAMPLE-32  
     Antibacterial Activity of Herbal Blend Extract and Individual Extracts Against  Streptococcus Mutans    
       [0100]    The  Streptococcus mutans  strain was obtained from IMTECH, Chandigarh, was cultured and maintained on Brain heart Infusion agar media. The minimum inhibitory concentration (MIC) assay for the drugs were determined by using three different methods.
       a) E-test: Sterile filter paper discs were coated with different concentrations of the drug and placed over the inoculated lawn of the test organism on the Muller Hinkton agar media and incubated at 37° C. for 24 hrs. Clear zone of bacterial growth inhibition was determined visually, measured and recorded.   b) Micro-plate assay: The experiment was carried using 96 well micro titre-plates where the drugs were diluted as per the required concentration in muller hinkton broth and loaded in to the microtitre well later the test organism was inoculated in to it and incubated at 37° C. for 24 hrs. Growth or inhibition of bacteria was determined by absorbance at 630 nm and results were recorded.   c) Agar Dilution method: The experiment was carried out using sterile 30 mm Plastic petridishes. The required concentration of the drugs were added in to petridishes and mixed with the molten muller hinkton agar media and allowed for solidification. The test organism was spot inoculated over the agar media and incubated at 37° C. for 48 hrs. Results were recorded by visual observation of test organism grown.       
 
         [0104]    Results: The herbal blend extract 2177 B showed MIC values at 5 mg/ml concentration while other extracts  Azadirachta indica, Punica granatum  and  Acacia arabica  showed at 10 mg/ml concentration and  Terminalia bellerica, Terminalia chebula, Emblica officinalis  and  Embelia ribes  did not show any activity against  Streptococcus mutans.  Results are summarized in Table-1 
         [0000]    
       
         
               
               
               
             
           
               
                 TABLE 1 
               
               
                   
               
               
                 S. No 
                 Name of the Extract 
                 MIC value (mg/mL) 
               
               
                   
               
             
             
               
                 1 
                 Herbal blend extract 
                  5 mg 
               
               
                   
                 2177 B 
               
               
                 2 
                 
                   Punica granatum 
                 
                 10 mg 
               
               
                 3 
                 
                   Azadirachta indica 
                 
                 10 mg 
               
               
                 4 
                 
                   Acacia arabica 
                 
                 10 mg 
               
               
                 5 
                 
                   Terminalia bellerica 
                 
                 Not detected 
               
               
                 6 
                 
                   Terminalia chebula 
                 
                 Not detected 
               
               
                 7 
                 
                   Emblica officinalis 
                 
                 Not detected 
               
               
                 8 
                 
                   Embelia ribes 
                 
                 Not detected 
               
               
                   
               
             
          
         
       
     
       EXAMPLE-33  
     Clinical Evaluation of Efficacy and Safety of Herbal Toothpaste in Plague Formation 
       [0105]    A clinical trial of herbal toothpaste was conducted in 60 normal healthy volunteers for 6 weeks. All volunteers were advised to brush the teeth with herbal toothpaste twice daily with soft brush. 
         [0106]    Results: A significant reduction (p&lt;0.01) was observed in both plaque index and gingival index in volunteers using Herbal Toothpaste after 6 weeks of usage. There was a significant reduction in microbial growth of  Staphylococcus saprophyticus  and  Staphylococcus ludgenesis  at the end of 6 weeks treatment compared to pretreatment values. There were no adverse drug reactions observed or reported during the entire study period. Results are given in table 2-3. 
         [0000]    
       
         
               
             
               
               
             
               
               
               
               
               
               
               
               
             
           
               
                 TABLE 2 
               
             
             
               
                   
               
               
                 Clinical Trial on the Effect of Herbal Toothpaste 
               
             
          
           
               
                   
                 Scores on week 
               
             
          
           
               
                 Parameter 
                 0 
                 1 
                 2 
                 3 
                 4 
                 5 
                 6 
               
               
                   
               
               
                 Plaque 
                 1.29 ± 0.41 
                 1.21 ± 0.36 
                 1.11 ± 0.34 
                 0.95 ± 0.42 
                 0.80 ± 0.35 
                 0.72 ± 0.35 
                 0.68 ± 0.29 
               
               
                 Index 
                   
                 NS 
                 p &lt; 0.01 
                 p &lt; 0.01 
                 p &lt; 0.01 
                 p &lt; 0.01 
                 p &lt; 0.01 
               
               
                 Gingival 
                 1.28 ± 0.45 
                 1.14 ± 0.38 
                 0.97 ± 0.34 
                 0.94 ± 0.72 
                 0.71 ± 0.38 
                 0.54 ± 0.30 
                 0.55 ± 0.35 
               
               
                 Index 
                   
                 NS 
                 p &lt; 0.01 
                 p &lt; 0.01 
                 p &lt; 0.01 
                 p &lt; 0.01 
                 p &lt; 0.01 
               
               
                   
               
               
                 Statistical analysis was carried out using repeated measures of ANOVA followed by Dunnett&#39;s multiple comparison posthoc test. 
               
               
                 All the values are expressed as Mean ± SD 
               
             
          
         
       
     
         [0000]    
       
         
               
             
               
               
             
               
               
               
               
             
               
               
               
               
               
               
             
               
               
               
               
               
               
             
           
               
                 TABLE 3 
               
             
             
               
                   
               
               
                 Clinical Trial on the Effect on Herbal Toothpaste on 
               
               
                   Staphylococcus saprophyticus  and  Staphylococcus   
               
               
                   ludgenesis  parameters 
               
             
          
           
               
                   
                 No. of patients 
               
             
          
           
               
                   
                 Pretreatment 
                 Post-treatment 
                   
               
             
          
           
               
                 Parameter 
                 Present 
                 Absent 
                 Present 
                 Absent 
                 Significance 
               
               
                   
               
             
          
           
               
                 
                   Staphylococcus 
                 
                 48 
                 13 
                 20 
                 41 
                 p &lt; 0.0001 
               
               
                 
                   saprophyticus 
                 
               
               
                 
                   Staphylococcus 
                 
                 14 
                 47 
                 0 
                 61 
                 p &lt; 0.0001 
               
               
                 
                   ludgenesis 
                 
               
               
                   
               
               
                 Statistical analysis was carried out using Fisher&#39;s Exact test. 
               
             
          
         
       
     
         [0107]    While this invention has been described in detail with reference to certain preferred embodiments, it should be appreciated that the present invention is not limited to those precise embodiments. Rather, in view of the present disclosure, which describes the current best mode for practicing the invention, many modifications and variations would present themselves to those skilled in the art without departing from the scope and spirit of this invention.