CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Patent Application No.

62/840,229, filed on April 29, 2019. This application also claims priority to U.S. Patent Application No. 16/704,911, filed on December 5, 2019, which claims the benefit of and priority to U.S. Provisional Patent Application No. 62/840,229, filed on April 29, 2019, the entire contents of both applications are incorporated by reference herein.

FIELD OF DISCLOSURE

[0002] The present invention relates to an oral care composition for at least toothpaste, mouthwash, gel, chewing gum, and lozenges.

SUMMARY

[0003] One embodiment discloses an oral care composition that aids in cleaning teeth including greater than 0.0% by weight sodium bicarbonate and greater than 0.0% by weight of nisin to more effectively remove biofilm from a tooth surface than either sodium bicarbonate or nisin alone.

[0004] Another embodiment discloses a method of treating teeth including applying an oral care composition to a tooth surface. The composition includes greater than 0.0% by weight sodium bicarbonate and greater than 0.0% by weight of nisin to more effectively remove biofilm from a tooth surface than either sodium bicarbonate or nisin alone.

[0005] Another embodiment discloses an oral care composition that aids in cleaning teeth, the oral care composition including at least 15% by weight sodium bicarbonate and at least 0.000375% by weight of nisin, wherein a ratio of sodium bicarbonate to nisin is at least 500 to 1 and does not exceed 200,000 to 1.

[0006] Another embodiment discloses a method of treating teeth including applying an oral care composition to a tooth surface. The composition including at least 15% by weight sodium bicarbonate and at least 0.000375% by weight of nisin, wherein a ratio of sodium bicarbonate to nisin is at least 500 to 1 and does not exceed 200,000 to 1.

[0007] An oral care composition including a base formulation, sodium bicarbonate, and nisin, wherein the oral care composition removes biofilm from a tooth surface more effectively than the base formulation with the sodium bicarbonate or the nisin alone.

[0008] Other aspects of the invention will become apparent by consideration of the detailed description and accompanying figures.

BRIEF DESCRIPTION OF THE DRAWINGS

[0009] FIG. 1 graphically shows the results of Experiment 1.

[0010] FIG. 2 graphically shows the results of Experiment 2 in which sample solution numbers 10-13 include 0.0% by weight nisin and varying concentrations of sodium bicarbonate.

[0011] FIG. 3 graphically shows the results of Experiment 2 in which sample solution numbers 14-22 include varying concentrations of nisin and 0.0% by weight sodium bicarbonate.

[0012] FIG. 4 graphically shows the results of Experiment 2 in which sample solution numbers 23-32 include varying concentrations of nisin and 15.0% by weight sodium bicarbonate.

[0013] FIG. 5 graphically shows the results of Experiment 2 in which sample solution numbers 33-42 include varying concentrations of nisin and 51.0% by weight sodium bicarbonate.

[0014] FIG. 6 graphically shows the results of Experiment 2 in which sample solution numbers 43-52 include varying concentrations of nisin and 75.0% by weight sodium bicarbonate.

[0015] FIG. 7 graphically shows the results of Experiment 2 in which sample solution numbers 53-62 include varying concentrations of nisin and 90.0% by weight sodium bicarbonate.

DETAILED DESCRIPTION

[0016] It is to be understood that the invention is not limited in its application to the details set forth in the following description and the drawings. [0017] Removing and preventing biofilm formation is the key to maintaining oral health. Biofilm can consist of multiple species of bacteria excreting a slimy glue-like substance that sticks to the surface of teeth. The most efficient measure to remove biofilm is mechanical scrubbing by a toothbrush. However, it is difficult to effectively mechanically scrub hard-to- reach areas, such as interproximal or gingival pocket spaces. One embodiment of an oral composition (e.g., a toothpaste, dentifrice, gel, mouthwash, lozenges, etc.) comprises sodium bicarbonate and nisin. Together, sodium bicarbonate and nisin remove plaque effectively.

Sodium bicarbonate is widely used in oral care as anti-plaque (anti-biofilm) and anti-calculus component. Nisin has been used in oral care technology as a bactericide and has been used in food industry as a preservative for its antibacterial effect. Also, there are research reports to utilize Nisin in oral care to prevent or reduce biofilm. When used together in an oral care composition, sodium bicarbonate and nisin remove plaque more effectively than either of the two components alone.

[0018] The oral care composition may optionally include surfactants, soothing or

desensitizing agents, flavoring agents, sweetening agents, humectant agents, coloring agents, additional polishing or abrasive materials, additional antimicrobial agents, binders or thickening agents, fluoride, preservatives, and water.

[0019] In one aspect, the present disclosure provides an oral care composition comprising a base formulation, sodium bicarbonate, and nisin, wherein the oral care composition removes biofilm from a tooth surface more effectively than the base formulation with the sodium bicarbonate or the nisin alone. The term“base formulation” refers to a formulation that includes at least one of the oral care ingredients described herein, but does not include sodium bicarbonate or nisin. For example, the base formulation may have the same composition as the oral care composition, except that sodium bicarbonate and nisin are absent in the base formulation. Under the same testing conditions, the oral care composition as described herein can achieve higher efficacy in removing biofilm from a tooth surface than the base formulation, the base

formulation with sodium bicarbonate alone, and the base formulation with nisin alone.

[0020] Moreover, the oral care compositions discussed herein may be prepared by any suitable method. [0021] Experiment 1

[0022] Experiment 1 treated laboratory-created biofilms with different samples of the oral care solutions as noted in Table 1.

[0023] First, a streptococcus mutans (“S mutans”) solution was cultured in a brain heart infusion (“BHI”) medium overnight at 37 degrees Celsius and under anaerobic conditions. Then, the S mutans solution was diluted with the BHI medium with 0.5% sucrose to adjust the number of bacteria to 10 ⁸ cfu/ml. This step ensures that the S mutans concentration is consistent for each sample. Then, 200 pL of the resulting S mutans solution was injected into 96-well polystyrene microplates and cultured for 24 hours at 37 degrees Celsius under anaerobic conditions to form the biofilm. The biofilm in each of the wells was washed with phosphate-buffered saline (“PBS”) once. Then, the biofilms in each of the wells were exposed to respective sample solutions 1-9 listed below in Table 1 for 10 minutes, and then the exposed-biofilms were each washed with PBS three times. As shown in the table below, each of the samples has different concentrations of sodium bicarbonate and nisin. Finally, the wells of exposed-biofilm were dissolved with 200 pL IN NaOH, and the efficacy of each solution to remove the biofilm in the respective well was measured using UV-vis spectrophotometric optical density at a wavelength of 550 nm (OD550).

[0024] Table 1 :

[0025] As shown in Table 1, each of the samples has specified concentrations by weight of sodium bicarbonate and nisin. When the samples were applied to the biofilms, which a reduction of biofilm resulted. The percentage of biofilm removal represents the reduction of biofilm as a result of applying the samples to the biofilm. The results from Experiment 1 are presented in graphical form in FIG. 1, which shows that samples including both sodium bicarbonate and nisin are more effective at removing biofilm than the samples with only one of sodium bicarbonate and nisin.

[0026] Experiment 1 was carried out using an aqueous solution having the concentrations reported in Table 1. In actual oral care products using the disclosed combination, the concentrations may vary according to the specific oral care product. For example, when the oral care composition is a toothpaste, the concentrations of sodium bicarbonate and nisin reported in Table 1 may be increased because the toothpaste when used by a user will be diluted by saliva to about as much as 1/2 to 1/5. Alternatively, when the oral care composition is a gel or mouthwash, it may not be diluted as much during use as a toothpaste so the concentrations of sodium bicarbonate and nisin may remain closer to the concentrations reported in Table 1.

Regardless of the type oral care composition, it is believed that the ratios between sodium bicarbonate and nisin will be similar to those shown in the experiment. Although the invention has been described in detail with reference to certain preferred embodiments, variations and modifications exist within the scope and spirit of the invention.

[0027] Experiment 2

[0028] Experiment 2 also treated laboratory-created biofilms with different samples of the oral care solutions as noted in Tables 2-7.

[0029] The experimental set up is the same as the experimental setup for Experiment 1, except for a few differences. First, a streptococcus mutans (“S mutans”) solution was cultured in a brain heart infusion (“BHI”) medium overnight at 37 degrees Celsius and under anaerobic conditions. Then, the S mutans solution was diluted with the BHI medium with 0.5% sucrose to adjust the number of bacteria to 10 ⁸ cfu/ml. This step ensures that the S mutans concentration is consistent for each sample. Then, 200 pL of the resulting S mutans solution was injected into 96-well polystyrene microplates and cultured for 24 hours at 37 degrees Celsius under anaerobic conditions to form the biofilm. The biofilm in each of the wells was washed with deionized water (“DI”) once. Then, the sample solutions were diluted to 1/3 with DI water. This step mimics the dilution of the solution by a user’s saliva, when in use. Then, the biofilms in each of the wells were exposed to respective sample solutions listed below in Tables 2-7 for 10 minutes, and then the exposed-biofilms were each washed with DI water three times. As shown in the Tables 2-7 below, each of the samples 10-62 has different concentrations of sodium bicarbonate and nisin. Finally, the wells of exposed-biofilm were dissolved with 200 pL IN NaOH, and the efficacy of each solution to remove the biofilm in the respective well was measured using UV- vis spectrophotometric optical density at a wavelength of 550 nm (OD550).

[0030] Table 2:

[0031] Table 3:

[0032] Table 4:

[0033] Table 5:

[0034] Table 6:

[0035] Table 7:

[0036] As shown in Tables 2-7, each of the samples has specified concentrations by weight of sodium bicarbonate and nisin. When the samples were applied to the biofilms, a reduction of biofilm resulted. The percentage of biofilm removal represents the reduction of biofilm as a result of applying the samples to the biofilm. The results from Experiment 2 are presented in graphical form in FIGS. 2-7. As shown in FIGS. 4-7, the samples including both sodium bicarbonate and nisin are more effective at removing biofilm than the samples with only one of sodium bicarbonate and nisin. In particular, enhanced results may be observed when the nisin concentration ranges from 0.000375% and 0.03% by weight and the sodium bicarbonate concentration ranges from 15% to 90% by weight, when the nisin concentration ranges 0.0015% and 0.015% by weight and the sodium bicarbonate concentration ranges from 15% to 75% by weight, and when the nisin concentration ranges from 0.003% and 0.015% by weight and the sodium bicarbonate concentration ranges from 15% to 75% by weight. In one preferred embodiment, the nisin concentration may be 0.003% by weight and the sodium bicarbonate concentration may be 51% by weight.

[0037] Experiment 2 was carried out using an aqueous solution having the concentrations reported in Tables 2-7. In actual oral care products using the disclosed combination, the concentrations may vary according to the specific oral care product. Regardless of the type oral care composition, it is believed that the ratios between sodium bicarbonate and nisin will be similar to those shown in the experiment. That is, the ratio of sodium bicarbonate to nisin may range from a ratio of 500 to 1 (e.g., 15% by weight sodium bicarbonate to 0.03% by weight nisin) to a ratio of 200,000 to 1 (e.g., 75% by weight sodium bicarbonate to 0.000375% by weight nisin). More specifically, the ratio of sodium bicarbonate to nisin may range from 1000 to 1 to 25000 to 1, from 2500 to 1 to 17000 to 1, or from 3400 to 1 to 17000 to 1. In one embodiment, for example, the ratio of sodium bicarbonate to nisin may be 5000 to 1. In another embodiment, for example, the ratio of sodium bicarbonate to nisin may be 3400 to 1.

[0038] Exemplary formulations for a toothpaste are given in the tables below.

[0039] Table 8

[0040] Table 9

[0041] Table 10

[0042] Table 11

[0043] Table 12

[0044] Exemplary formulations for a gel are given in the tables below.

[0045] Table 13

[0046] Table 14

[0047] Table 15

[0048] Exemplary formulations for an oral tablet for a denture cleanser are given in the tables below. [0049] Table 16

[0050] Exemplary formulations for a chewable oral cleansing tablet are given in the tables below.

[0051] Table 17

[0052] Table 18

[0053] Exemplary formulations for an effervescent tablet for gargling are given in the table below.

Sorbitol 23.89 18.896

[0054] Exemplary formulations for a chewing gum are given in the tables below.

[0055] Table 19

[0056] Table 20

[0057] Although the invention has been described in detail with reference to certain preferred embodiments, variations and modifications exist within the scope and spirit of the invention.