Abstract:
An ingestible formulation for a malodor eliminator for animals that works systemically and comprises a formulation of a chlorophyll derivative combined with  Spirulina  and alfalfa wherein the chlorophyll derivative is at least 90 percent of the formulation is presented. In the preferred embodiment, the chlorophyll derivative is chlorophyllin. The formulation may be a capsule, liquid, tablet, or gelcap when in its usable form with the preferred embodiment being in a capsule formulation. When produced in tablet form, the formulation may also include a tableting agent. The formulation has a dissolution time generally sufficient to allow the formulation to pass an animal&#39;s stomach before beginning to breakdown. The formulation is dose dependent and will vary depending on the size of the animal to which it is given.

Description:
TECHNICAL FIELD 
       [0001]    The present invention relates to deodorizer products for animals and, more particularly, to a malodor eliminator for animals which is ingested and provides odor elimination properties through systemic mechanisms as opposed to localized effects. 
       BACKGROUND OF THE INVENTION AND PRIOR ART 
       [0002]    Malodors are a common complaint of pet owners. Halitosis, or bad breath, is probably the most common complaint. Most often bad breath is caused by oral conditions, such as malodorous food or periodontal disease. Less commonly, bad breath is caused by an extra-oral, or systemic, problem. 
         [0003]    Body odors can also be troubling. They can be caused by external elements such as those picked up by rolling or internal such as those caused by GI or shin disorders. 
         [0004]    Over the years, many attempts to address the problem of animal odor have been advanced. Attempts have generally involved the use of chew toys or edible products that have an odor reducing agent contained within them, teeth brushing, or a mouth wash. Many formulations for product ingredients have been used, including, among others, chlorhexidine, alcohol and hydrogen peroxide based products. More recently, products containing chlorophyll or a derivative thereof have been used. Chlorophyll and its derivatives have long been known to act as excellent breath fresheners. 
         [0005]    However, the general shortcoming of the prior art, including those containing chlorophyll or a derivative, is that they are focused on the oral cavity and do not provide a systemic solution. Accordingly, prior art products, if they have any true efficacy at all, provide immediate, temporary relief or more often do nothing more than mask the odor. 
         [0006]    Another short coming of the prior art is that prior art products have used ingredients which are not generally optimally effective for the reason that they generally not fresh. 
         [0007]    Another short coming of the prior art is that they generally contains an ineffective amount of active ingredient. 
         [0008]    Yet another shortcoming of the prior art is that they are of a “one size fits all” variety; they do not take in to account the weight of the animal being given the deodorizer. 
         [0009]    There is need, therefore, for an ingestible malodor eliminator for animals which provides systemic effects on a longer term basis, and is provided in clinically effective amounts based upon animal weight. The present invention provides such a solution. 
       OBJECTS AND ADVANTAGES OF THE PRESENT INVENTION 
       [0010]    It is an object of the present invention to provide a malodor eliminator for animals that contains effective levels of chlorophyll or a derivative. 
         [0011]    It is a further object of the present invention to provide a malodor eliminator wherein the chlorophyll derivative is chlorophyllin. 
         [0012]    It is a further object of the present invention to provide a malodor eliminator that contains alfalfa that functions as, among other things, as a balancing agent. 
         [0013]    It is a further object of the present invention to provide a malodor eliminator that further contains  Spirulina  that functions as, among other things, a nutrient source. 
         [0014]    It is a further object of the present invention to provide a malodor eliminator for animals that is ingestible. 
         [0015]    It is yet a further object of the present invention to provide a malodor eliminator for animals that is available in a capsule, liquid, tablet, gelcap, or other ingestible form. 
         [0016]    It is yet a further object of the present invention to provide a malodor eliminator for animals that is formulated to weight specifications of animals. 
         [0017]    It is yet a further object of the present invention to provide a malodor eliminator for animals that works systemically. 
         [0018]    It is yet a further object of the present invention to provide a malodor eliminator for animals that works on a longer term basis. 
         [0019]    It is yet a further object of the present invention to provide a malodor eliminator for animals that has a dissolution time sufficient that the formulation passes an animal&#39;s stomach before beginning to breakdown. 
         [0020]    Those skilled in the arts will see additional objects and advantages of the present invention, which invention is not to be limited by the foregoing objects and advantages paragraphs. Those skilled in the arts will also recognize additional formulations, methods, and systems for carrying out the several purposes of the present invention. It is important, therefore, that the claims be regarded as including such equivalent constructions in so far as they do not depart from the spirit and scope of the present invention. These together with other objects of the present invention, along with the various features of novelty which characterize the present invention, are pointed out with particularity in the claims annexed to and forming a part of this disclosure. 
         [0021]    Further, the purpose of the abstract is to enable the US Patent and Trademark Office and the public generally, and especially the scientists, engineers and practitioners in the art who are not familiar with the patent or legal terms or phraseology, to determine quickly from what cursory inspection the nature and essence of the technical disclosure of the application. The abstract is neither intended to define the invention of the application, which is measured by the claims, nor is it intended to be limiting as to the scope of the present invention in any way. 
       BRIEF DESCRIPTION OF THE INVENTION 
       [0022]    The present invention is an ingestible formulation for a malodor eliminator for animals that works systemically and comprises a formulation of a chlorophyll derivative combined with  Spirulina  and alfalfa wherein the chlorophyll derivative is at least 90 percent of the formulation. 
         [0023]    Further, in the preferred embodiment the chlorophyll derivative is chlorophyllin. The chlorophyllin should be fresh when used in the inventive formula. The Inventor has discovered that using chlorophyll that is 180 days or less from harvest to use in a product increases the efficacy of the final product. 
         [0024]    The inventive formulation has a dissolution time of greater than 60 minutes with a preferred dissolution time of 90 minutes in order to insure that the active elimination ingredients pass the stomach and can be absorbed in an effective state and is intended to be given to an animal on a daily basis to provide consistent and effective malodor elimination, with a steady state efficacy period of 48 to 72 hours. 
         [0025]    The formulation is dose dependent and will vary depending on the size of the animal to which it is given. 
         [0026]    The formulation may be a capsule, liquid, tablet, or gelcap when in its usable form with the preferred embodiment being in a capsule formulation. When produced in tablet form, the formulation may also include a tableting agent. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0027]      FIG. 1  is a chart illustrating the effectiveness of the inventive formula against  Streptococcus Sanguis.    
           [0028]      FIG. 2  is a chart illustrating the ineffectiveness of the inventive formula against  Streptococcus Salivarious.    
           [0029]      FIG. 3  is a chart illustrating the ineffectiveness of the inventive formula against  Prevotella Nigrescens.    
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
       [0030]    Before explaining the preferred embodiment of the present invention in detail, it is to be understood that the present invention is not limited in its application to the details set forth in the following description. The present invention is capable of other embodiments and of being practiced and carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein are for the purpose of description and should not be regarded as limiting. 
         [0031]    The present invention is a malodor eliminator designed for animals. The inventive formulation comprises a combination of a chlorophyll derivative, blue-green algae, and a balancing agent. 
         [0032]    Chlorophyll is the green pigment found in higher plants, as well as algae. Chlorophyll is the principal photoreceptor in photosynthesis, the light-driven process in which carbon dioxide is “fixed” to yield carbohydrates and oxygen. Chlorophyll is a cyclic tetrapyrolle, similar in structure to the heme group of globins (hemoglobin, myoglobin) and cytochromes. 
         [0033]    There are several types of chlorophyll. Higher plants and green algae, such as  chlorella  (see  Chlorella ) contain chlorophyll a and chlorophyll b in the approximate ratio of 3:1. Chlorophyll a is found with chlorophyll c in many types of marine algae. Red algae contain principally chlorophyll a and also chlorophyll d. 
         [0034]    Research has shown that an effective chlorophyll derivative is chlorophyllin. Chlorophyllin is a semi-synthetic derivative of chlorophyll typically found sodium/copper, zinc/copper, or magnesium/copper forms. In contrast to chlorophyll, chlorophyllin is water-soluble. Chlorophyllin, like chlorophyll, has deodorizing activity. 
         [0035]    The Inventor has discovered that any form of Chlorophyllin is suitable and that the use of fresh Chlorophyllin is best. Traditionally, products that do use a chlorophyll in them use processed chlorophyll. The Inventor has discovered that using chlorophyll that is 180 days or less from harvest to use in a product increases the efficacy of the final product. (Throughout the specification, the term chlorophyll, when used, is meant to also include a chlorophyll derivative and, especially, chlorophyllin, and the use of chlorophyll derivative or chlorophyllin is meant to include chlorophyll.) 
         [0036]      Spirulina  is an edible blue-green algae with a long history of safe human consumption. This tiny aquatic plant offers 60% all-vegetable protein, essential vitamins and phytonutrients such as the antioxidant beta carotene, the rare essential fatty acid GLA, sulfolipids, glycolipids and polysaccharides.  Spirulina  is rich in gamma-linolenic acid (GLA), and also provides alpha-linolenic acid (ALA), linoleic acid (LA), stearidonic acid (SDA), eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), and arachidonic acid (AA).  Spirulina  also contains vitamin B1 (thiamine), B2 (riboflavin), B3 (nicotinamide), B6 (pyridoxine), B9 (folic acid), B12 (cyanocobalamin), vitamin C, vitamin D, and vitamin E, and is a rich source of potassium, calcium, chromium, copper, iron, magnesium, manganese, phosphorus, selenium, sodium, and zinc.  Spirulina  is also a source for chlorophyll-a, among other pigments. 
         [0037]    Alfalfa is an excellent source of nutrients. Among its many benefits, it is known to act as a detoxifier and blood purifier and has been found to be beneficial for breath odor, liver disorders, infections, and disorders of the bones, joints and skin. 
         [0038]    The inventor has discovered that while other available deodorizers may use chlorophyll or a derivative and/or Alfalfa, they do not generally work systemically, have ineffective ranges of ingredients, and use aged ingredients which have lost much if not all of their beneficial properties. Unlike the prior art, the present invention is formulated to work on a systemic level to eliminate breath and body odor. 
         [0039]    A study conducted by the inventor on the inventive formula focused on bacterial species found in the oral cavity. Among the microorganisms studied were various  streptococci, actinomyces, lactobacilli,  and  staphylococci.  Also studied were black-pigmented bacteria that produce volatile sulfur compounds (VSC; hydrogen sulfide, methyl mercaptan and dimethyl sulfide) as a result of sulfur-containing amino acid (cysteine and cystine) metabolism and are the primary causes of malodor. 
         [0040]    The bacteria were cultured in Mueller-Hinton (MH) broth in a 5% CO2 incubator at 37° C. for 24 h. 105 cells/ml were inoculated into 1 ml of MH broth and dispensed into 96 well microtiter plates (180 ul in each well). The inventive formula, studied in a tablet material form, was dissolved in deionized H 2 O at the stated concentration and added to the wells (20 ul); the plates were then incubated for 18 h. The minimum inhibitory concentration (MIC) was determined by serial 2-fold dilutions of the product in the presence and in the absence of the material. MIC is defined as the concentration of the product that completely inhibits growth during the 18 h of incubation. Growth was assayed with a microplate reader (Molecular Devices, Menlo Park, Calif.) by following absorbance at 540 nm. 
         [0041]    Control Specimens were placed in MH broth not containing antimicrobial powder (negative control); and CHX at 0.12% (as a positive control). 
         [0042]    Results of the study showed the ability of the inventive formula to inhibit  S. mutans  which, in turn, is indicative of a strong ability to provide anti-caries activity. In addition, it is important to ascertain the ability of an antimicrobial agent to inhibit plaque formation particularly by early plaque colonizing organisms such as  S. sanguis  and  A. viscosus.    
         [0043]    However, the study confirmed that the inventive formula did not provide anti-bacterial effects against certain beneficial oral biofilm agents. Other important oral biofilm species examined in this study included  Lactobacci caseii, S. salivarius  and  P. nigrescens. P. nigrescens  was used in place of  P. intermedius  as it grew better and is also a strong VSC and odor-producing oral microbe.  S. salivarius  was used in place of  S. aureus  as it is a much more common oral bacterium. Inhibition of growth activity would reduce the ability of any of these microbes to adhere to salivary pellicle-coated tooth surfaces. 
         [0044]    The chlorophyll extract (test product) was assessed for growth inhibition of 6 different oral bacteria using a spectrophotometric assay. As noted above, the assay consisted of incubation of cultures of  S. mutans, S. sanguis, A. viscosus, L. caseii, S. salivarius  or  P. nigrescens  with the extract for 24 hours and the measurement of growth using spectrophotometry at 540 mn. Controls consisted of bacteria with PBS or media only with the product. The following figure is representative of a typical microtiter plate used in this study. 
         [0045]    The results are shown in  FIGS. 1 ,  2 , and  3 , each of which contains a graphical presentation of the results observed with that particular microorganism. Briefly,  FIG. 1  illustrates the results of the study showing that the inventive formulation inhibited  S. sanguis.  The diluted extract (as low as 10 ug/ml) significantly inhibited the growth of  S. sanguis.    
         [0046]    However, the extract did not inhibit  Lactobacci caseii, S. salivarius, S. mutans  and  P. nigrescens  at any concentration (See, e.g.,  FIGS. 2 and 3 ). 
         [0047]    Central to the present invention is the amount of Chlorophyll or a derivative that is used. To be effective, the inventor has found that a level of at least 90% chlorophyll, chlorophyllin, or another chlorophyll derivative should be incorporated into a product. The balance of the formulation is made up of  Spirulina  and Alfalfa. 
         [0048]    For example, a formulation that can be used in animals of less than 35 pounds may be comprised of: 
         [0000]                                                Organic Chlorophyllin   65 mg            Organic Spirulina   2 mg           Organic Alfalfa   2 mg                        
and a formulation that can be used in animals of more than 100 pounds may be comprised of:
 
         [0000]    
       
         
               
               
               
             
           
               
                   
                   
               
             
             
               
                   
                 Organic Chlorophyllin 
                 130 mg  
               
               
                   
                 Organic Spirulina 
                 2 mg 
               
               
                   
                 Organic Alfalfa 
                 2 mg 
               
               
                   
                   
               
             
          
         
       
     
         [0049]    As illustrated above, a novel feature of the present invention is that the inventor has discovered that using dosing levels increases the efficacy of the product, an approach that the prior art has not taken. 
         [0050]    When creating a tablet formula, there is need for a tableting agent which does not effect the formulation. The inventor has found that the following agents are suitable: dicalcium phosphate, microcrystalline cellulose, stearic acid, croscarmellose sodium, magnesium stearate, silicon dioxide, and agueous coating. Although the exact tableting agent is not critical and any agent that is ingestible and does not effect the formulation can be used. 
         [0051]    The inventive formulation also provides significant advantage in that it has a dissolution time superior to that of the prior art. Prior art products generally have a dissolution time of 12 to 20 minutes. Such a short dissolution time does not provide adequate time for the product to work before breaking down. The inventive formula, on the other hand, has a dissolution time of such a length that the final product passes the stomach before breaking down. This helps to insure that effective amounts of ingredients having potency are biologically available for use. The inventive formula has a dissolution time ranging from about 60 minute to about 120 minutes with a preferred dissolution time of about 90 minutes. While a dissolution time range is provided herein, those skilled in the arts will immediately understand that the exact dissolution time is not critical to the invention. Instead, it is the fact that effective amounts of the formula&#39;s ingredients are biologically available passed the stomach where they can be appropriately absorbed in the gastrointestinal tract as effective ingredients. 
         [0052]    The inventor&#39;s research has shown that the use of organic ingredients, although not critical to the invention, increases the efficacy of the finished product. More importantly, the inventor has discovered that the use of fresh ingredients dramatically improves the efficacy of the finished product. 
         [0053]    It is to be understood, however, that even though numerous characteristics and advantages of the preferred and alternative embodiments have been set forth in the foregoing description, together with details of the structure and function of the embodiments, the disclosure is illustrative only. 
         [0054]    Such variations should be considered to be within the scope and spirit of the invention which is meant to cover a breath freshening product for animals that is ingested comprising a formulation of at least 90% chlorophyll derivative. Changes may be made in detail within the principles of the invention to the full extent indicated by the broad general meaning of the terms in which the appended claims are expressed.