Oral Care Compositions

Abstract

An oral care composition comprising a base formulation, sodium bicarbonate, and nisin, wherein the oral care composition removes biofilm from tooth surfaces more effectively than a base formulation comprising sodium bicarbonate or nisin alone.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application No. 62 / 840,229, filed April 29, 2019. This application also claims priority to U.S. Application No. 16 / 704,911, filed December 5, 2019, which claims the benefit of and priority to U.S. Provisional Application No. 62 / 840,229, filed April 29, 2019, both of which are incorporated herein by reference. [Background technology]

[0002] The present invention relates to oral care compositions for at least toothpastes, mouthwashes, gels, chewing gums, and lozenges. Summary of the Invention

[0003] One embodiment discloses an oral care composition to aid in cleaning teeth, comprising greater than 0.0% sodium bicarbonate by weight and greater than 0.0% nisin by weight to remove biofilm from dental surfaces more effectively than either sodium bicarbonate or nisin alone.

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

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

[0006] Another embodiment discloses a method of treating teeth comprising applying an oral care composition to a tooth surface, the composition comprising at least 15% by weight sodium bicarbonate and at least 0.000375% by weight nisin, the ratio of sodium bicarbonate to nisin being at least 500 to 1 and not exceeding 200,000 to 1.

[0007] An oral care composition comprising a base formulation, sodium bicarbonate, and nisin, the oral care composition removing biofilm from dental surfaces more effectively than a base formulation comprising sodium bicarbonate or nisin alone.

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

[0009] [Figure 1] FIG. 1 shows the results of experiment 1 graphically. [Diagram 2] FIG. 2 graphically illustrates the results of experiment 2, where sample solutions Nos. 10-13 contain 0.0 wt. % nisin and various concentrations of sodium bicarbonate. [Diagram 3] FIG. 3 graphically illustrates the results of experiment 2, where sample solutions Nos. 14-22 contain various concentrations of nisin and 0.0 wt % sodium bicarbonate. [Figure 4] FIG. 4 graphically illustrates the results of experiment 2, where sample solutions Nos. 23-32 contain various concentrations of nisin and 15.0 wt % sodium bicarbonate. [Diagram 5] FIG. 5 graphically illustrates the results of experiment 2, where sample solutions Nos. 33-42 contain various concentrations of nisin and 51.0 wt % sodium bicarbonate. [Figure 6] FIG. 6 graphically illustrates the results of experiment 2, where sample solutions Nos. 43-52 contain various concentrations of nisin and 75.0 wt. % sodium bicarbonate. [Figure 7]FIG. 7 graphically illustrates the results of experiment 2, where sample solutions Nos. 53-62 contain various concentrations of nisin and 90.0% sodium bicarbonate by weight. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0010] It is to be understood that the invention is not limited in its application to the details set forth in the following description and drawings. Removing and preventing the formation of biofilms is important to maintain oral health. Biofilms can be composed of multiple species of bacteria that secrete a mucus-like substance that adheres to the tooth surface. The most efficient measure to remove biofilms is mechanical scrubbing with a toothbrush. However, it is difficult to effectively mechanically scrub hard-to-reach areas such as interdental spaces or gingival pockets. One embodiment of the oral composition (e.g., toothpaste, dentifrice, gel, mouthwash, lozenges, etc.) includes sodium bicarbonate and nisin. Sodium bicarbonate and nisin together effectively remove plaque. Sodium bicarbonate is widely used in oral care as an anti-plaque (anti-biofilm) and anti-tartar ingredient. Nisin is used as a disinfectant in oral care technology and as a preservative in the food industry due to its antibacterial effect. There are also studies that report the use of nisin in oral care to prevent or reduce biofilms. Sodium bicarbonate and nisin, when used together in an oral care composition, remove plaque more effectively than either of these two ingredients alone.

[0011] The oral care compositions may optionally include surfactants, soothing or desensitizing agents, flavoring agents, sweetening agents, humectants, coloring agents, additional polishing or abrasive agents, additional antimicrobial agents, binders or thickeners, fluoride, preservatives, and water.

[0012] In one aspect, the present disclosure provides an oral care composition comprising a base formulation, sodium bicarbonate, and nisin, the oral care composition removes biofilm from tooth surfaces more effectively than a base formulation comprising sodium bicarbonate or nisin alone. The term "base formulation" refers to a formulation comprising at least one of the oral care ingredients described herein, but not comprising 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 not present in the base formulation. Under the same test conditions, the oral care composition described herein can achieve a higher effect in removing biofilm from tooth surfaces than the base formulation, the base formulation comprising sodium bicarbonate alone, and the base formulation comprising nisin alone.

[0013] Furthermore, the oral care compositions discussed herein may be prepared by any suitable method. EXAMPLES

[0014] Experiment 1 In experiment 1, laboratory-generated biofilms were treated with different samples of oral care solutions shown in Table 1.

[0015] First, a solution of Streptococcus mutans ("S mutans") was grown overnight in Brain Heart Infusion ("BHI") medium under anaerobic conditions at 37 degrees Celsius. The S mutans solution was then diluted in BHI medium with 0.5% sucrose to obtain a bacterial count of 10 8cfu / ml. This step ensures that the S mutans concentration is consistent in each sample. Next, 200 μL of the resulting S mutans solution was poured into a 96-well polystyrene microplate and incubated at 37 degrees Celsius under anaerobic conditions for 24 hours to form biofilms. The biofilms in each well were washed once with phosphate buffered saline ("PBS"). Next, the biofilms in each well were exposed to each of the sample solutions 1-9 listed in Table 1 below for 10 minutes, and then the exposed biofilms were washed three times with PBS each. As shown in the table below, each sample has a different concentration of sodium bicarbonate and nisin. Finally, the exposed biofilm wells were dissolved with 200 μL of 1N NaOH, and the effectiveness of each solution in removing the biofilm in each well was measured by measuring the optical density (OD) at a wavelength of 550 nm by UV-visible spectroscopy. 550 ) was used for the measurements.

[0016] [Table 1]

[0017] As shown in Table 1, each sample has a specified concentration by weight of sodium bicarbonate and nisin. Application of the sample to the biofilm resulted in a reduction in the biofilm. The percent biofilm removal represents the reduction in biofilm as a result of application of the sample to the biofilm. The results from Experiment 1 are presented in graphical form in FIG. 1, which shows that samples containing both sodium bicarbonate and nisin were more effective at removing biofilm than samples containing only one of sodium bicarbonate or nisin.

[0018] Experiment 1 was conducted using aqueous solutions with the concentrations reported in Table 1. In actual oral care products using the disclosed combinations, the concentrations may vary depending on the particular oral care product. For example, if the oral care composition is a toothpaste, the concentrations of sodium bicarbonate and nisin reported in Table 1 may be increased since toothpaste is diluted by about 1 / 2 to 1 / 5 by saliva when used by the user. Alternatively, if the oral care composition is a gel or mouthwash, the concentrations of sodium bicarbonate and nisin may remain closer to the concentrations reported in Table 1 since it will not be diluted as much as toothpaste when used. Regardless of the type of oral care composition, the ratio between sodium bicarbonate and nisin is believed to be similar to that shown in the experiments. Although the present invention has been described in detail with reference to certain preferred embodiments, variations and modifications exist within the scope and spirit of the invention.

[0019] Experiment 2 In experiment 2, laboratory-produced biofilms were also treated with different samples of oral care solutions shown in Tables 2-7.

[0020] The experimental setup was the same as that of Experiment 1, with minor differences. First, a solution of Streptococcus mutans ("S mutans") was cultured overnight in Brain Heart Infusion ("BHI") medium under anaerobic conditions at 37 degrees Celsius. Then, the S mutans solution was diluted in BHI medium with 0.5% sucrose to obtain a bacterial count of 10 8cfu / ml. This step ensures that the S mutans concentration is consistent in each sample. Then, 200 μL of the resulting S mutans solution was poured into a 96-well polystyrene microplate and incubated at 37 degrees Celsius under anaerobic conditions for 24 hours to form a biofilm. The biofilm in each well was washed once with deionized water ("DI"). The sample solution was then diluted 1 / 3 with DI water. This step mimics the dilution of the solution with the user's saliva during use. Next, the biofilm in each well was exposed to each of the sample solutions listed in Tables 2-7 below for 10 minutes, followed by washing the exposed biofilm three times with DI water each. As shown in Tables 2-7 below, each of Samples 10-62 has a different concentration of sodium bicarbonate and nisin. Finally, the exposed biofilm wells were dissolved with 200 μL of 1N NaOH, and the efficacy of each solution in removing the biofilm in each well was assessed by UV-visible spectroscopy as measured by optical density OD at a wavelength of 550 nm. 550 The measurements were performed using

[0021] [Table 2]

[0022] [Table 3]

[0023] [Table 4]

[0024] [Table 5]

[0025] [Table 6]

[0026] [Table 7]

[0027] As shown in Tables 2-7, each sample has a specified concentration by weight of sodium bicarbonate and nisin. Application of the sample to the biofilm resulted in a reduction in the biofilm. The percentage of biofilm removal represents the reduction in biofilm as a result of applying the sample to the biofilm. The results from Experiment 2 are presented in graphical form in Figures 2-7. As shown in Figures 4-7, samples containing both sodium bicarbonate and nisin are more effective at removing biofilm than samples containing only one of sodium bicarbonate or nisin. In particular, improved results may be seen when the nisin concentration is in the range of 0.000375% to 0.03% by weight and the sodium bicarbonate concentration is in the range of 15% to 90% by weight, when the nisin concentration is in the range of 0.0015% to 0.015% by weight and the sodium bicarbonate concentration is in the range of 15% to 75% by weight, and when the nisin concentration is in the range of 0.003% to 0.015% by weight and the sodium bicarbonate concentration is in the range of 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.

[0028] Experiment 2 was conducted using aqueous solutions having the concentrations reported in Tables 2-7. In actual oral care products using the disclosed combinations, the concentrations may vary depending on the particular oral care product. Regardless of the type of oral care composition, the ratio between sodium bicarbonate and nisin is expected to be similar to that shown in the experiments. That is, the ratio of sodium bicarbonate to nisin may range from a ratio of 500:1 (e.g., 15% sodium bicarbonate to 0.03% nisin by weight) to a ratio of 200,000:1 (e.g., 75% sodium bicarbonate to 0.000375% nisin by weight). More specifically, the ratio of sodium bicarbonate to nisin may range from 1000:1 to 25000:1, 2500:1 to 17000:1, or 3400:1 to 17000:1. In one embodiment, for example, the ratio of sodium bicarbonate to nisin may be 5000:1. In another embodiment, for example, the ratio of sodium bicarbonate to nisin may be 3400 to 1.

[0029] Exemplary formulations for toothpaste are shown in the table below.

[0030] [Table 8]

[0031] [Table 9]

[0032] [Table 10]

[0033] [Table 11]

[0034] [Table 12]

[0035] Exemplary formulations for the gel are shown in the table below.

[0036] [Table 13]

[0037] [Table 14]

[0038] [Table 15]

[0039] Exemplary formulations for denture cleanser oral tablets are shown in the table below.

[0040] [Table 16]

[0041] An exemplary formulation for a chewable oral cleansing tablet is shown in the table below.

[0042] [Table 17]

[0043] [Table 18]

[0044] Exemplary formulations for effervescent tablets for mouthwash are shown in the table below.

[0045] [Table 19]

[0046] Exemplary formulations for chewing gum are shown in the table below.

[0047] [Table 20]

[0048] [Table 21]

[0049] Although the invention has been described in detail with reference to certain preferred embodiments, variations and modifications exist which fall within the scope and spirit of the invention.

Claims

1. 1. An oral care composition for assisting in cleaning teeth, comprising: at least 15% by weight sodium bicarbonate and at least 0.000375% by weight nisin, the ratio of sodium bicarbonate to nisin being at least 500 to 1 and not exceeding 200,000 to 1; composition.

2. 10. The oral care composition of claim 1 comprising 15% to 75% by weight of sodium bicarbonate and 0.000375% to 0.03% by weight of nisin.

3. 2. The oral care composition of claim 1 comprising 51% to 75% by weight of sodium bicarbonate and 0.000375% to 0.03% by weight of nisin.

4. 10. The oral care composition of claim 1 comprising 15% to 51% by weight of sodium bicarbonate and 0.000375% to 0.03% by weight of nisin.

5. 10. The oral care composition of claim 1 comprising up to 0.03% by weight nisin.

6. 10. The oral care composition of claim 1 comprising up to 75% by weight of sodium bicarbonate.

7. 10. The oral care composition of claim 1 comprising 0.000375% to 0.03% by weight of nisin.

8. 10. The oral care composition of claim 1 comprising 0.0015% to 0.015% by weight of nisin.

9. 10. The oral care composition of claim 1 comprising 0.003% to 0.015% by weight of nisin.

10. 2. The oral care composition of claim 1, wherein the concentration of the nisin is 0.003% by weight and the concentration of the sodium bicarbonate is 51% by weight.

11. 10. The oral care composition of claim 1, comprising one or more of a surfactant, a soothing agent, a desensitizing agent, a flavoring agent, a sweetening agent, a humectant, a coloring agent, a polishing agent, an abrasive, an antimicrobial agent, a binder, a thickening agent, a fluoride, a preservative, and water.

12. 1. A method of preparing teeth, comprising:

1. A method comprising: applying to a dental surface an oral care composition comprising at least 15% by weight sodium bicarbonate and at least 0.000375% by weight nisin, wherein the ratio of sodium bicarbonate to nisin is at least 500 to 1 and not more than 200,000 to 1.

13. 13. The method of claim 12, wherein the composition comprises 15% to 75% sodium bicarbonate by weight and 0.000375% to 0.03% nisin by weight.

14. 13. The method of claim 12, wherein the composition comprises 0.000375% to 0.03% nisin by weight.

15. 1. An oral care composition for removing biofilm from dental surfaces, comprising:

1. A composition comprising a base formulation, 15% to 75% by weight sodium bicarbonate, and at least 0.000375% by weight nisin, wherein the ratio of sodium bicarbonate to nisin is at least 500 to 1, and said ratio of sodium bicarbonate to nisin does not exceed 200,000 to 1.

16. 16. The oral care composition of claim 15, wherein the ratio of sodium bicarbonate to nisin is in the range of 1000:1 to 25000:

1.

17. 16. The oral care composition of claim 15, wherein the ratio of sodium bicarbonate to nisin is in the range of 2500:1 to 17000:

1.

18. 16. The oral care composition of claim 15, wherein the ratio of sodium bicarbonate to nisin is in the range of 3400:1 to 17000:

1.

19. 16. The oral care composition of claim 15, wherein the ratio of sodium bicarbonate to nisin is 3400 to 1.

20. 16. The oral care composition of claim 15, wherein the oral care composition comprises one or more of a surfactant, a soothing agent, a desensitizing agent, a flavoring agent, a sweetening agent, a humectant, a coloring agent, a polishing agent, an abrasive, an antimicrobial agent, a binder, a thickening agent, a fluoride, a preservative, and water.

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