Tablet comprising abrasive for tooth cleaning

Abstract

Consumable abrasive containing oral hygiene tablets are described. The tablet includes glycine as an abrasive. The average (Mv) particle size of glycine may be greater than 45 [mu] m. The tablet can be used with an oral irrigator, and when placed in the fluid flow path of the irrigator can disintegrate, release the abrasive, and improve the cleaning efficacy of the irrigator.

Description

[0001] This application is a divisional application of the invention patent application with application number 201880023271.5, application date February 1, 2018, and titled "Tablets including abrasives for tooth cleaning".

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims priority to U.S. Provisional Patent Application No. 62 / 453,949, filed on February 2, 2017, the contents of which are incorporated herein by reference in their entirety. Technical Field

[0004] The present disclosure relates to oral hygiene tablets including abrasives and methods of making and using the same. Background Art

[0005] Tooth decay in humans is damage to teeth caused by acid attack. Bacteria in the mouth produce corrosive acids as they attack sugars in the food a person eats. Over time, the acids break down the enamel (the outer layer of the tooth) and even the dentin (the middle layer). The decay can form as holes or cavities.

[0006] Teeth can be stained exogenously from foods such as berries and chocolate, beverages such as coffee, wine, and dark sodas, and smoking. Exogenous stains range from white streaks to light yellow or brown spots and pits.

[0007] Some cavities and stain can be removed by a dental professional using air blasting, a technique that propels fine abrasive particles against the tooth surface using compressed air or gas traveling through a dental handpiece. As the stream of abrasive particles impacts the affected area, small areas of cavities or stain are removed.

[0008] Because the process removes a small portion of the tooth surface, air abrasion can be uncomfortable for patients and can irritate the teeth. Air blasting is also troublesome because the process creates a cloud of fine dust. The fine particles can expose patients and dental professionals to health risks associated with inhalation.

[0009] Powder spray devices that combine an air-abrasive mixture with water and spray the composition onto the teeth may pose a health risk of inhaling fine particles. Abrasive particles also remove small areas of tooth surface.

[0010] Stains can be reduced or removed by bleaching the teeth. A dental professional can apply a light-activated bleaching gel that is held against the teeth in a tray for about 30 to 60 minutes. Home bleaching trays use a weaker bleaching agent. Continuous home bleaching practices can reduce stains over the course of weeks or months. Less harsh, but also less effective, home remedies include whitening gels and strips that are applied to the teeth. Regular brushing can also help prevent or reduce stains, but it can also irritate the teeth.

[0011] The information included in this background section of the specification, including any references cited herein and any description or discussion thereof, is included for technical reference purposes only and is not to be construed as subject matter by which the scope of the present invention as defined in the claims is limited. Summary of the invention

[0012] The technology disclosed herein relates to oral hygiene tablets. The tablets can be used to reduce or remove stains or decay from tooth enamel or dentin or to clean tooth root surfaces while causing no or minimal abrasion of the tooth surface.

[0013] In some embodiments, the tablet comprises one or more of abrasives, fillers, glidants, binders, disintegrants, lubricants, surfactants, sweeteners, and flavoring agents. In some embodiments, the abrasive is an amino acid. In some embodiments, the amino acid is glycine. In some embodiments, the filler is xylitol. In some embodiments, the glidant is silicon dioxide.

[0014] In some embodiments, the glycine has an average particle size greater than 45 μm, as measured by volume distribution. In some embodiments, 35% or less by weight of the glycine particles have a particle size below 45 μm. In some embodiments, 35% or less by weight of the glycine particles have a particle size greater than 100 μm.

[0015] In some embodiments, glycine is present in the tablet at 32 wt% to 48 wt%. In some embodiments, xylitol is present in the tablet at 32 wt% to 48 wt%.

[0016] In some embodiments, the silica is fumed silica. The average particle size of the fumed silica may be greater than 0.03 μm. In some embodiments, the silica is present in the tablet at 0.28 wt% to 0.42 wt%.

[0017] In some embodiments, the tablet includes a lubricant and the lubricant is magnesium stearate. In some embodiments, the tablet includes a surfactant and the surfactant is sodium lauryl sulfate. In some embodiments, the tablet includes a sweetener and the sweetener is sucralose.

[0018] In one embodiment, a method for manufacturing the tablet is provided. The tablet can be formed by granulation and compression.

[0019] In one embodiment, a method of using a tablet, such as to reduce stains on teeth, is provided. The method may include providing a tablet comprising an abrasive and eroding the tablet using a fluid stream to produce suspended particles in the fluid. The particles may be transported to the teeth by the fluid stream.

[0020] In some embodiments, glycine wears away stain from teeth.

[0021] In some embodiments, 2 minutes after applying the fluid carrying particles, the stains show an average increase of 27% in the modified Lobene Stain Index. In some embodiments, 5 minutes after applying the fluid carrying particles, the stains show an average increase of 64% in the modified Lobene Stain Index.

[0022] In some embodiments, this method wears down less dentin than brushing with a toothbrush for 10 times the amount of time.

[0023] In some embodiments, less than 0.2 μm of dentin is abraded 48 seconds after application of the particle-laden fluid.

[0024] In some embodiments, an abrasive such as glycine is entrained in a fluid stream such as water. In some embodiments, the stream is pulsating. In some embodiments, the stream pulsates at approximately 1200 pulses per minute.

[0025] In some embodiments, the pulsation effect is produced by a pump such as a piston pump. In some embodiments, the pulsation effect is produced when the pressurized fluid flows through a valve such as an intermittent valve or an oscillating valve.

[0026] In some embodiments, the stream is ejected from an oral irrigator, a counter-mounted irrigation device, a hand-held irrigation device, or a hose.

[0027] This summary is provided to introduce selected concepts in a simplified form, which are further described in the detailed description below. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. A more extensive presentation of the features, details, utilities, and advantages of the invention as defined by the claims is provided in the following written description of various embodiments of the invention and shown in the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Figure 1 is a front right isometric view of a handle for an oral irrigator connected to a hose connectable to a base unit.

[0029] Figure 2 A-2D show the effect of various treatments on tooth stain removal. DETAILED DESCRIPTION

[0030] Disclosed herein is an oral hygiene tablet for cleaning teeth. The tablet can reduce or remove stains or corrosion from tooth enamel or dentin or clean root surfaces. The tablet can be generally understood to include an abrasive that can clean teeth while causing no or minimal wear of the tooth surface. The abrasive can be glycine, and the tablet can include excipients such as fillers and glidants.

[0031] Milled Tablet Formulation

[0032] Tablet formulations can be generally understood to include abrasives and a variety of adjuvants. Adjuvants can include fillers, binders, disintegrants, glidants, lubricants, surfactants, sweeteners, flavorings, and water. Any given adjuvant can be used as more than one type of adjuvant or can be used for more than one function. For example, a filler can also be a binder. As another example, a sweetener can also be a flavoring.

[0033] The abrasive can be any material capable of polishing or cleaning a natural or artificial tooth surface. Examples of abrasives include aluminum hydroxide, aluminum oxide, boron, calcium carbonate, sodium calcium phosphate, corundum, garnet, glycine, perlite, pumice, silicon carbide, sodium bicarbonate, zirconium oxide, and zirconium silicate.

[0034] In one embodiment, the abrasive is an amino acid. In one embodiment, the abrasive is glycine. The glycine may have a MV (mean diameter of volume distribution) particle size greater than 45 μm, or about 50 μm to about 100 μm, or about 50 μm to about 90 μm, or about 50 μm to about 80 μm, or about 70 μm to about 100 μm, or about 50 μm to about 60 μm. In some embodiments, the glycine particle size (MV) is about 58 μm to about 60 μm. In one embodiment, the glycine particle size is about 59 μm.

[0035] In some embodiments, about 35 weight percent or less of the glycine particles have a particle size below 45 μm. In some embodiments, about 35 weight percent or less of the glycine particles have a particle size greater than 100 μm.

[0036] The size distribution of the glycine particles may be about 1 μm to about 500 μm, or about 1 μm to about 400 μm, or about 1 μm to about 300 μm, or about 2 μm to about 300 μm.

[0037] The glycine particles may not include a surface coating.

[0038] The abrasive may be present in an amount of about 20 weight percent to about 60 weight percent of the tablet, or in an amount of about 20 weight percent to about 55 weight percent of the tablet, or in an amount of about 20 weight percent to about 50 weight percent, or in an amount of about 20 weight percent to about 45 weight percent, or in an amount of about 20 weight percent to about 40 weight percent, or in an amount of about 25 weight percent to about 60 weight percent, or in an amount of about 30 weight percent to about 60 weight percent, or in an amount of about 35 weight percent to about 40 weight percent, or in an amount of about 32 weight percent to about 48 weight percent. In one embodiment, the abrasive is present in an amount of about 40 weight percent of the tablet.

[0039] Glycine is a water-soluble amino acid with a Mohs hardness value of 2. Abrasives used in dental air polishing include sodium bicarbonate (Mohs hardness value 2.5), calcium carbonate (Mohs hardness value 3), and aluminum hydroxide (Mohs hardness value 4). In the design and use of oral hygiene tablets, glycine, which has a Mohs hardness value less than enamel (5.0) or dentin (3.0-4.0), may produce safer or gentler abrasion than known abrasives with higher hardness values. In the design and use of oral hygiene tablets, glycine, as a regularly consumed amino acid, may be safe and non-toxic when ingested.

[0040] A filler or filler can be any material that adds bulk or weight, which can aid in processing or manufacturing and can make the tablet size more practical for the subject. Examples of fillers include starch, maltodextrin, calcium salts, and sugars such as lactose.

[0041] In one embodiment, the filler is xylitol. In one embodiment, the filler is xylitol co-processed with corn dextrin, such as 100DC (Roquette Pharma, Lestrium, France).

[0042] The filler can be present in an amount of about 20 weight percent to about 60 weight percent of the tablet, or in an amount of about 20 weight percent to about 55 weight percent of the tablet, or in an amount of about 20 weight percent to about 50 weight percent of the tablet, or in an amount of about 20 weight percent to about 45 weight percent of the tablet, or in an amount of about 20 weight percent to about 40 weight percent of the tablet, or in an amount of about 25 weight percent to about 60 weight percent of the tablet, or in an amount of about 30 weight percent to about 60 weight percent of the tablet, or in an amount of about 35 weight percent to about 40 weight percent of the tablet, or in an amount of about 32 weight percent to about 48 weight percent of the tablet. In one embodiment, the filler is present in an amount of about 40 weight percent of the tablet.

[0043] In the design and use of oral hygiene tablets, May help produce a harder tablet that dissolves more cleanly. The tablet may dissolve without producing a mushy material. When the tablet is used in a fluid flow path of an oral irrigator, the tablet may dissolve without blocking the flow path or clogging irrigator components such as a screen.

[0044] Binders can be any material that can hold or draw other materials together to form a cohesive whole. Binders can also help tablets form with the desired mechanical strength. Examples of binders include disaccharides such as sucrose and lactose; starches such as corn starch; cellulose; modified celluloses such as microcrystalline cellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, and hydroxypropyl ethylcellulose; sugar alcohols such as xylitol, sorbitol, and maltitol; gelatin; synthetic polymers such as polyvinyl pyrrolidone and polyethylene glycol; and dibasic calcium phosphate.

[0045] In one embodiment, the binder is vinyl pyrrolidone-vinyl acetate copolymer. In one embodiment, the vinyl pyrrolidone-vinyl acetate copolymer is VA64 Fine (BASF Corporation, Florham Park, NJ).

[0046] The binder may be present in an amount of about 0 weight percent to about 12 weight percent of the tablet, or in an amount of about 0 weight percent to about 10 weight percent of the tablet, or in an amount of about 0 weight percent to about 8 weight percent, or in an amount of about 0 weight percent to about 6 weight percent, or in an amount of about 2 weight percent to about 10 weight percent, or in an amount of about 4 weight percent to about 10 weight percent, or in an amount of about 6 weight percent to about 10 weight percent.

[0047] In the design and use of oral hygiene tablets, VA64 Fine can help produce harder tablets that are less prone to capping during tableting than tablets made with other binders. Tablets made from VA64 Fine may also be less brittle.

[0048] Disintegrants can be any material that promotes or accelerates tablet dissolution. Examples of disintegrants include cellulose derivatives such as low-substituted hydroxypropyl cellulose, carboxymethyl cellulose, calcium carboxymethyl cellulose, and cross-linked sodium carboxymethyl cellulose (crosslinked sodium carboxymethyl cellulose); cross-linked polyvinyl pyrrolidone (crospovidone or copovidone); and chemically modified starches such as carboxymethyl starch, sodium carboxymethyl starch, and sodium starch glycolate.

[0049] In one embodiment, the disintegrant is crospovidone. In one embodiment, the crospovidone is Kollidon CL-F (BASF Corporation, Florham Park, NJ).

[0050] The disintegrant may be present in an amount of about 0 weight percent to about 6 weight percent of the tablet, or in an amount of about 0 weight percent to about 5 weight percent of the tablet, or about 0 weight percent to about 4 weight percent, or about 0 weight percent to about 3 weight percent, or about 1 weight percent to about 6 weight percent, or about 2 weight percent to about 6 weight percent, or about 3 weight percent to about 6 weight percent.

[0051] A glidant may be any material that optimizes the flow of a powder to be tableted. Examples of glidants include colloidal silicon dioxide (fumed silicon dioxide), starch and talc.

[0052] In one embodiment, the glidant is fumed silica. In some embodiments, the fumed silica is not water resistant. In one embodiment, the non-water resistant fumed silica is 200 (Evonik Industries, Essen, Germany).

[0053] The fumed silica may have an average particle size greater than 0.03 μm, or about 0.06 μm to 0.18 μm, or about 0.06 μm to 0.16 μm, or about 0.06 μm to 0.14 μm, or about 0.06 μm to 0.12 μm, or about 0.08 μm to 0.18 μm, or about 0.10 μm to 0.18 μm, or about 0.12 μm to 0.18 μm. In one embodiment, the average particle size is about 0.12 μm.

[0054] The glidant may be present in an amount of about 0 weight percent to about 0.6 weight percent of the tablet, or in an amount of about 0 weight percent to about 0.5 weight percent of the tablet, or in an amount of about 0 weight percent to about 0.4 weight percent of the tablet, or in an amount of about 0 weight percent to about 0.3 weight percent of the tablet, or in an amount of about 0.1 weight percent to about 0.6 weight percent of the tablet, or in an amount of about 0.2 weight percent to about 0.6 weight percent of the tablet, or in an amount of about 0.3 weight percent to about 0.6 weight percent of the tablet. In one embodiment, the glidant is present in an amount of about 0.28 weight percent to about 0.42 weight percent of the tablet. In one embodiment, the glidant is present in an amount of about 0.35 weight percent of the tablet.

[0055] In the design and use of oral hygiene tablets, relatively small 200 particles can help coat larger ingredient particles, thereby reducing the van der Waals attraction between them. Fumed silica particles can also help absorb moisture present on the surface of the powder, thereby minimizing powder agglomeration and aggregation. Fumed silica particles can help optimize powder flow, increase throughput, and improve dose uniformity.

[0056] A lubricant can be any material that prevents ingredients from clumping together or sticking to machinery such as a tablet punch or capsule filling machine. Lubricants can also help reduce friction and thereby aid in die filling, tablet formation, and ejection.

[0057] Examples of lubricants include stearic acid; metal stearates such as calcium stearate or magnesium stearate; talc; colloidal silicon dioxide; silicic acid such as silicic anhydride or silicate hydrate; waxes such as beeswax or spermaceti; glycerol fatty acid esters; hydrogenated vegetable oils; boric acid; adipic acid; sulfates such as sodium sulfate; lauryl sulfates such as sodium lauryl sulfate or magnesium lauryl sulfate; ethylene glycol; fumaric acid; sodium stearyl fumarate; sodium benzoate; and D, L-leucine. In one embodiment, the lubricant is magnesium stearate.

[0058] The lubricant may be present in an amount of about 0.5 weight percent to about 2.5 weight percent of the tablet, or in an amount of about 0.5 weight percent to about 2.25 weight percent of the tablet, or in an amount of about 0.5 weight percent to about 2.0 weight percent, or in an amount of about 0.5 weight percent to about 1.75 weight percent, or in an amount of about 0.5 weight percent to about 1.5 weight percent, or in an amount of about 0.75 weight percent to about 2.5 weight percent, or in an amount of about 1.0 weight percent to about 2.5 weight percent, or in an amount of about 1.25 weight percent to about 2.5 weight percent, or in an amount of about 1.5 weight percent to about 2.5 weight percent. In one embodiment, the lubricant is present in an amount of about 1.5 weight percent of the tablet.

[0059] In the design and use of oral hygiene tablets, magnesium stearate can help prevent the tablet from sticking to the punches. Magnesium stearate can also help create a barrier to moisture during the tableting process and can help the tablet resist deterioration when touched by wet fingers.

[0060] In addition or instead of including a lubricant, tablets may be coated with a coating such as a polymeric coating or a shellac coating. The coating may be water-insoluble and may help the tablet resist deterioration when touched by wet fingers.

[0061] The surfactant can be any material that prevents agglomeration, aids flow, improves wetting, promotes deagglomeration, increases the surface area of ​​the particles available for dissolution, and / or increases the rate of dissolution.

[0062] Examples of surfactants include sodium lauryl sulfate, polyethylene glycol, and polysorbate 80. In one embodiment, the surfactant is sodium lauryl sulfate.

[0063] Surfactant can be present in the weight percentage of about 0.5 weight percent to about 3.0 weight percent of tablet, or in the weight percentage of about 0.5 weight percent to about 2.5 weight percent of tablet, or in the weight percentage of about 0.5 weight percent to about 2.25 weight percent, or in the weight percentage of about 0.5 weight percent to about 2.0 weight percent, or in the weight percentage of about 0.75 weight percent to about 3.0 weight percent, or in the weight percentage of about 1.0 weight percent to about 3.0 weight percent, or in the weight percentage of about 1.25 weight percent to about 3.0 weight percent, or in the weight percentage of about 1.5 weight percent to about 3.0 weight percent, or in the weight percentage of about 1.75 weight percent to about 3.0 weight percent, or in the weight percentage of about 2.0 weight percent to about 3.0 weight percent. In one embodiment, surfactant exists in the weight percentage of about 2.0 weight percent of tablet.

[0064] The sweetener may be any material that helps improve the flavor of the tablet or the user's acceptance of the tablet.

[0065] Examples of sweeteners include natural sweeteners such as glucose, lactose, mannitol and sucrose; and artificial sweeteners such as aspartame, sodium cyclamate, saccharin and sucralose. In one embodiment, the sweetener is sucralose.

[0066] Sweetener can be present in about 4 weight percent to about 14 weight percent of tablet, or in about 4 weight percent to about 12 weight percent of tablet, or in about 4 weight percent to about 10 weight percent, or in about 4 weight percent to about 8 weight percent, or in about 6 weight percent to about 14 weight percent, or in about 8 weight percent to about 14 weight percent, or in about 10 weight percent to about 14 weight percent. In one embodiment, sweetener exists in about 9 weight percent of tablet.

[0067] Flavoring agents may be any material that helps to mask unpleasant tasting ingredients and improve user acceptance of the tablet.

[0068] Flavoring agents can be natural or artificial. Examples of flavoring agents include sweeteners such as sodium saccharin and aspartame; sour flavoring agents such as citric acid, malic acid, and tartaric acid; minty flavoring agents such as peppermint and spearmint; and flavors such as menthol, lemon, and orange. In one example, the flavoring agent is a dry mint spray.

[0069] Flavoring agent can be present in about 5 weight percent to about 15 weight percent of tablet, or in about 5 weight percent to about 13 weight percent of tablet, or in about 5 weight percent to about 11 weight percent, or in about 5 weight percent to about 9 weight percent, or in about 7 weight percent to about 15 weight percent, or in about 9 weight percent to about 15 weight percent, or in about 11 weight percent to about 15 weight percent. In one embodiment, flavoring agent is present in about 10 weight percent of tablet.

[0070] In some embodiments, the tablet formulation includes water. The water may be present in an amount of less than about 0% to about 5% by weight, about 0% to about 4% by weight, about 0% to about 3% by weight, about 0% to about 2% by weight, or about 0% to about 1% by weight of the tablet.

[0071] Although reference is made herein to tablets, the disclosed formulations may be prepared in any solid oral dosage form, including pills, capsules, and variations thereof, such as caplets.

[0072] The tablet can be any shape, such as generally cylindrical. In some embodiments, the tablet has opposite ends, and one or both of the ends are round or pointed. In some embodiments, the size and shape of the tablet are configured to fit inside a chamber in an oral irrigator or an oral irrigator tip. In some examples, the tablet can have a thickness of about 7 mm to about 15 mm, or about 7 mm to about 14 mm, or about 7 mm to about 13 mm, or about 7 mm to about 12 mm, or about 7 mm to about 11 mm, or about 8 mm to about 15 mm, or about 9 mm to about 15 mm, or about 10 mm to about 15 mm, or about 11 mm to about 15 mm.

[0073] In another example, the tablet is about 40mm to 50mm wide and about 20mm to about 30mm high (thick). In another example, the tablet is about 80mm to 120mm wide and about 80mm to about 120mm thick.

[0074] The tablet may have a hardness of about 0.5 kilopounds (kp) to about 10 kp, or about 0.5 kp to about 9 kp, or about 0.5 kp to about 8 kp, or about 0.5 kp to about 7 kp, or about 0.5 kp to about 6 kp, or about 1 kp to about 10 kp, or about 2 kp to about 10 kp, or about 3 kp to about 10 kp, or about 4 kp to about 10 kp, or about 5 kp to about 10 kp. In some embodiments, the tablet has a hardness of about 6 kp to about 8 kp or about 7 kp.

[0075] Method for making tablets

[0076] The tablets disclosed herein can be produced by granulating the ingredients and then forming the mixture into tablets. Granulation can be wet granulation or dry granulation. All ingredients can be mixed together at once, or some ingredients (such as abrasives, fillers, and binders) can be granulated together first before mixing with other ingredients (such as lubricants). In some embodiments, the granulated ingredients are dried and sieved for size before adding additional ingredients. The mixture can then be pressed into a solid dosage form, such as a tablet. The tablets can be compressed so that they can withstand packaging, transportation, and storage, but will dissolve when impacted by fluid flowing through the oral irrigator.

[0077] In one example, before adding lubricant, tablet ingredients other than lubricant are dry mixed. The resulting powder is then placed directly into a tablet press, which may have one or both of a long stroke and a pre-compression station. In some examples, additional preparation steps (such as wet granulation, tablet compression or roller compression) are not used. In some examples, one or more additional preparation steps are included, such as wet granulation, tablet compression or roller compression. This can help obtain a more compact tablet on a press with a shorter stroke or obtain a more compact tablet on a press without a pre-compression station.

[0078] In some examples, the tableting pressure and / or binder weight percentage may be varied in order to change the hardness of the tablet and thereby change either or both of the disintegration time and friability of the tablet.

[0079] Tableting pressure (compression force) can be from about 250 pounds to about 10,000 pounds, about 250 pounds to about 9000 pounds, or about 250 pounds to about 8000 pounds, or about 250 pounds to about 7000 pounds, or about 250 pounds to about 6000 pounds, or about 500 pounds to about 10,000 pounds, or about 1000 pounds to about 10,000 pounds, or about 2000 pounds to about 10,000 pounds, or about 3000 pounds to about 10,000 pounds, or about 4000 pounds to about 10,000 pounds, or about 5000 pounds to about 10,000 pounds, or about 6000 pounds to about 10,000 pounds. In some embodiments, the pre-compression force is about 1100 pounds to about 3300 pounds. In some embodiments, the final compression force is about 3200 pounds to about 9600 pounds.

[0080] The equipment used in the process of making the tablets may include, for example, a high speed mixer granulator, a fluid bed dryer, an extrusion granulator, a tableting press, or a roller compactor.

[0081] How to use medicines

[0082] By way of example and not limitation, the tablets described herein may be used to reduce or remove stain or decay from tooth enamel or dentin or to clean tooth root surfaces according to the procedures described below.

[0083] The tablet can be inserted into an oral irrigator, such as one produced by Water Pik of Fort Collins, Colorado, so that it is positioned in the fluid flow path of the irrigator. Examples of oral irrigators in which the tablet can be positioned in the fluid flow path include: U.S. Provisional Patent Application No. 62 / 474,438, filed on March 16, 2017, entitled "Oral Irrigator Handle For Use With Oral Hygiene Agent"; and U.S. Provisional Patent Application No. 62 / 516,227, filed on June 7, 2017, entitled "Oral Irrigator Handle For Use With Oral Hygiene Agent", which are incorporated herein by reference in their entirety.

[0084] When the irrigator is turned on, a fluid such as water, mouthwash or oral rinse can flow through the irrigator and impact the tablet. The tablet can disintegrate and release the abrasive. The dissolved tablet particles can be brought into the user's mouth by the fluid ejected from the tip of the oral irrigator. The fluid carrying the abrasive can be directed at the teeth, and the impact of the abrasive can reduce or remove tooth corrosion or stains from the enamel or dentin. The abrasive can also clean the root surface. In general, the tablet can improve the oral cleaning efficiency of the irrigator.

[0085] As described in more detail in the examples, the tablets can help clean teeth while causing no or minimal abrasion of tooth surfaces. Using the tablets in an oral irrigator can remove less tooth surface than an equivalent amount of brushing.

[0086] In some embodiments, the tablets are water soluble and leave a clean or smooth feeling in the mouth. In some embodiments, the tablets are water soluble and do not leave any residual or gritty feeling in the mouth.

[0087] How to use abrasives

[0088] In some embodiments, an abrasive such as glycine disclosed herein is entrained in a fluid stream such as water. In the design and use of glycine in a propelling fluid, the glycine can clean the surface of a tooth or tooth root.

[0089] In some embodiments, the fluid flow is pulsating. In one example, the flow pulsates at about 1200 pulses per minute. A pump or valve can provide a pulsating effect. For example, the pump can be driven by an electric motor and can include a small cylinder with a piston that reciprocates by a Scotch-yoke drive. As another example, a pressurized fluid flowing through an intermittent valve or an oscillating valve can produce a pulsating fluid flow.

[0090] The fluid stream may be ejected directly from a water pipe or from a device such as an oral irrigator, a countertop irrigator, or a handheld irrigator. The water pipe or device may be suitable for a professional setting or a home setting. In some embodiments, the device includes a nozzle having a cross-sectional area of ​​about 0.035, and the nozzle assists in generating the pulses.

[0091] exist Figure 1 An example of an apparatus for generating a fluid flow in which glycine may be carried is shown in FIG.

[0092] The handle 100 of the oral irrigator is fluidly connected to a fluid source, such as a reservoir, through a connector 107 and a hose 108. The handle 100 is also fluidly connected to a removable tip 104, which may have a tip collar 106 that interfaces with the handle 100. When the tip 104 is connected to the handle 100, liquid from the fluid source may be discharged through a tip outlet 105 in the tip 104. The tip 104 is generally configured to be inserted into the mouth of a user and discharge fluid against the user's teeth, gums, tongue, etc.

[0093] A release button 110 positioned in or on the housing 102 can selectively release the tip 104 from the handle 100 or can provide access to an internal chamber into which the presently disclosed tablet can be inserted. Examples of oral irrigator handles with internal chambers include: U.S. Provisional Patent Application No. 62 / 474,438, filed on March 16, 2017, entitled "Oral Irrigator Handle For Use With Oral Hygiene Agent"; and U.S. Provisional Patent Application No. 62 / 516,227, filed on June 7, 2017, entitled "Oral Irrigator Handle For Use With Oral Hygiene Agent", which are incorporated herein by reference in their entirety.

[0094] In some embodiments, a pause actuator 112 positioned in or on the housing 102 selectively interrupts the flow of liquid from the fluid source to the tip 104 .

[0095] exist Figure 1 In the handle 100 depicted in FIG. 1 , the structure that produces the pulsation of the fluid flow (such as a pump or valve) is located in the base unit (not shown). In some examples, the handle 100 is directly connected to the pressurized water pipe and the structure that produces the pulse is a valve located in the handle 100. In some examples, the handle 100 is a separate unit and the structure that produces the pulse is located in the handle 100.

[0096] Example

[0097] The following examples illustrate various aspects of the disclosure and should not be considered limiting.

[0098] Example 1 - Tablet Ingredients and Preparation

[0099] Tablets were prepared from the compositions shown in Table 1. The weight percentages are to be understood as relative proportions and may not necessarily sum to 100 percent due to different manufacturing protocols.

[0100] Table 1

[0101]

[0102] 100DC is granulated xylitol mixed with corn dextrin and was obtained from Roquette Pharma (Lestrheim, France). Silica® 200 is an amorphous anhydrous colloidal silica and was obtained from Evonik Industries (Essen, Germany). VA64 Fine (vinyl pyrrolidone-vinyl acetate copolymer) and CL-F (crospovidone) was obtained from BASF Corporation (Florham Park, NJ). Glycine particles had a mean particle size (Mv) of approximately 59 μm as measured by laser diffraction (Powdersize, Inc., Quarktown, PA).

[0103] The ingredients in Table 1 were dry blended with magnesium stearate added last. The resulting powder blend had the physical properties shown in Table 2.

[0104] Table 2

[0105] Physical properties value Bulk density 0.707g / cc Actual density 1.019g / cc Compressibility Index 30.6 Hausner Ratio 1.44 Loss on drying 0.7％ .

[0106] The resulting powder blend is placed directly into a tablet press with a long stroke and pre-compression station. The tableting pressure is varied to control the hardness of the tablet and thereby the disintegration time and friability of the tablet. As an example, a pre-compression force of 2248 lbs and a final compression force of 6400 lbs are used to compress a 2 wt % VA64 Fine to produce tablets with a hardness of 7 kp (15.43 lbs).

[0107] Example 2A - Removal of stains by tablet in an oral irrigator

[0108] The effectiveness of the tablet of Example 1 in removing stains from teeth was tested by Salus Research, Inc. (Fort Wayne, Indiana) according to the following procedure.

[0109] Male and female adults aged 18 to 65 years with at least 16 natural teeth (including all 4 natural lower incisors) in good condition without excessive overlap or crowding were recruited. At least 3 of the 4 incisors in each subject did not have complete crowns or restorations. Each subject had mandibular anterior stains on the facial proximal and marginal areas of the teeth.

[0110] Before and after study participation, the subjects' dental stains were scored by experienced dental examiners using the MacPherson-modified Lobene stain index, which assesses the intensity and area of ​​stains present in the mesial and distal regions of each tooth. Each incisor was divided into the following 4 parts: gingival or margin (a 2-mm wide strip extending parallel to the gingival margin); the limit towards the incisor margin given by the end of the interdental papilla; the body (the buccal aspect between the gingiva and the distal mesial part extending to the central area of ​​the incisor margin); the mesial score (the visible area between the line angle and the adjacent teeth ending at the interdental papilla, i.e., the beginning of the gingival part); and the distal score (the visible area between the line angle and the adjacent teeth ending at the interdental papilla, i.e., the beginning of the gingival part).

[0111] Each section was scored for the area of ​​the stain according to the following scale: 0 = no stain present, natural tooth color; 1 = fine line stain, which may be discontinuous; 2 = thick line stain or stripe stain; and 3 = stain covering the entire area. Each section was scored for the intensity of the stain according to the following scale: 0 = no stain; 1 = faint stain, visible on close inspection; 2 = moderate stain, clearly visible and aesthetically unacceptable; and 3 = strong dark stain, obvious and aesthetically unacceptable. The total proximal stain score for each subject was calculated by multiplying the individual area and intensity scores and averaging them.

[0112] Before and after study participation, the subjects' oral soft tissue health was assessed by visual inspection of the oral cavity by a dental examiner using a dental light and mirror. Structures examined included the gingiva, hard and soft palate, oropharynx, oral and labial mucosa, tongue, floor of mouth, and lips. The site, size, and severity of any lesions were recorded, as well as the provisional diagnosis (if possible). After the study, the examiner also assessed whether any abnormalities were attributable to treatment.

[0113] The subjects did not use any other dental devices or oral care products during the course of the study.

[0114] The test tablets were placed in a prototype tip inserted into an oral irrigator (Water Pik, Fort Collins, Colorado). The subjects used the oral irrigator according to the manufacturer's instructions for 1 minute each time, up to 5 times. The test tablets were dissolved in water that was sprayed from the oral irrigator into the subject's mouth and onto the facial surfaces of the mandibular anterior teeth.

[0115] After oral rinsing, the dental examiner again rated the stain area, stain intensity and oral soft tissue health. The stain data are shown in Table 3 as the average score of exogenous stain using the modified Lobene stain index. The first row of data represents the average results of 4 subjects who completed at least 3 minutes of treatment. The second row of data represents the average results of 2 subjects who completed 5 minutes of treatment.

[0116] No soft tissue damage was reported or observed.

[0117] Table 3

[0118]

[0119] The results indicate that the tablet of Example 1 is safe to teeth and soft tissues when dissolved in water sprayed from an oral irrigator into the mouth of a subject.

[0120] The results showed that after using the tablet / oral irrigator for a total of 2 minutes, extrinsic tooth stain was reduced by about 27%, after a total of 3 minutes, by about 37%, after a total of 4 minutes, by about 54%, and after a total of 5 minutes, by about 64%.

[0121] Glycine is a water soluble amino acid and is expected to be completely dissolved in the water sprayed from the oral irrigator. Any teeth cleaning benefits of glycine or its particles are not expected to be retained after entrainment of the glycine in the fluid stream.

[0122] Example 2B - Removal of stains by tablet in an oral irrigator

[0123] The effectiveness of the tablet of Example 1 in removing stain from teeth was tested as described in Example 2A, but with the following changes.

[0124] Fifteen subjects were randomly assigned to 3 study groups: tablets and oral irrigator; oral irrigator only; and brushing with a standard toothbrush (Oral B indicator 35). Subjects performed their assigned oral hygiene regimen daily for 2 weeks.

[0125] The stain data are presented in Table 4 as the mean score of exogenous stain using the modified Lobene stain index.

[0126] No soft tissue damage was reported or observed.

[0127] Table 4

[0128]

[0129] The results indicate that the tablet of Example 1 is safe to teeth and soft tissues when dissolved in water sprayed from an oral irrigator into the mouth of a subject.

[0130] The results showed that the tablet of Example 1 reduced total stain more after daily use over 2 weeks compared to brushing with a standard toothbrush.

[0131] Glycine is a water soluble amino acid and is expected to be completely dissolved in the water sprayed from the oral irrigator. Any teeth cleaning benefits of glycine or its particles are not expected to be retained after entrainment of the glycine in the fluid stream.

[0132] Example 3 – Wear of dentin

[0133] The effect of the tablet of Example 1 on dentin was studied by Dental Product Testing (Noblesville, IN) according to the following procedure.

[0134] Erupted or unerupted human permanent teeth without carriers with a preparable dentin surface of at least 3 mm x 5 mm were selected. Soft tissue was removed by scraping, and the teeth were disinfected with sodium hypochlorite for at least 24 hours and then stored in a suitable medium (e.g., sterile 0.9% saline). Teeth were sectioned at the enamel-cementum junction with a dental drill or dental tray, and the nerve root section was used for dentin samples.

[0135] The sample is mounted in a cubic mold (10 mm x 10 mm x 10 mm) sized to fit the test device. The mold is made of a flexible material, such as that used for dental impressions. The mold is filled with methacrylate and the sample is placed on top as flat as possible. The acrylate is then allowed to cure.

[0136] Once cured, the block surface with exposed dentin was successively ground and polished on silicon carbide disks. All six sides of the sample block were polished using 320 grit wet Al 2 O 3 Sandpaper was polished on a gem wheel. The face with the sample was polished until the dentin was just exposed. The sample surface was then polished with 600 and 800 grit wet aluminum oxide until it was well polished. The sample was further hand-polished with 3 μm and 1 μm diamond slurry until the Ra (surface roughness) determined by profilometry was less than 0.1 μm.

[0137] The specimen was made plane-parallel by measuring edge-to-edge in each dimension across the cube using a micrometer. If the difference between the four measurements was greater than 100 μm, the hand polishing was repeated until satisfactory results were obtained.

[0138] Once the planes are parallel, place the sample on a profilometer (Mitutoyo Surftest SV-2000 (Aurora, IL) or similar instrument with a sensitivity of <0.1 μm) and make 5 evenly spaced marks on the surface. The Ra of the sample is less than 0.1 μm and the difference between the highest and lowest points does not exceed 10 μm. In addition, there are no concave or wavy contours.

[0139] Once smoothness and plane parallelism are determined, the sample is placed on a hardness microtester and four readings are taken on the sample edge to determine the Vickers Hardness Number (VHN) of the sample. Dentin ranges between 30 VHN and 70 VHN.

[0140] The samples were kept hydrated during the preparation, grinding and measurement process.

[0141] Eight samples were selected for each group. For the control (toothbrush) group, two pieces of PVC or polyester tape were placed parallel to each other on each sample to expose a dentin window approximately 3-4 mm wide. This tape-sticking method leaves 0.5-1 mm on each side of the 5 mm sample for use as a reference point. For the test group, two additional tapes were placed perpendicular to the first strip, leaving a dentin window of approximately 2 mm × 2 mm. The small exposed surface makes it easier to place the tip in the same area after removing the oral irrigator tip to load the abrasive tablet in the irrigator again.

[0142] Eight ISO toothbrushes (see ISO 11609, Appendix A: A.3.4.: Toothbrushes) were selected and soaked in deionized water for 24 hours. The brushes were mounted on a V8 horizontal brush machine (see ISO 11609, Appendix A: A.3.2.1). The brushes were preconditioned by brushing any substrate for 20,000 brushing strokes while the substrate (not just the tooth substrate) was fixed to the sample holder with a tension of 150 g.

[0143] After brush pretreatment, eight prepared dentin specimens from the control group were mounted on the toothbrush machine. The brush head was aligned over the specimen so that the center row of bristles was centered on the specimen. The arm to which the brush was attached was moved to its highest point, and the brush head was positioned so that the front row of bristles disengaged from the specimen at the shortest point of the reciprocating motion.

[0144] For the test set, a reference dilution of 0.5% CMC (carboxymethylcellulose based artificial saliva) in 10% glycerol solution was prepared (described in ISO 11609, Annex A: A.3.5). A reference abrasive slurry was prepared by mixing 10 g calcium pyrophosphate in 50 ml of 0.5% reference diluent (described in ISO 11609, Annex A: A.3.1 & A.3.6).

[0145] The reference slurry was mixed well to ensure uniform suspension and then applied to the head of the toothbrush machine. The toothbrush force was 1.5 N (150 g) and the total brushing time was 5000 double brushing strokes. After treatment, 70% ethanol was used to remove the binder from the sample and clean the sample. The toothbrush machine was also cleaned between runs to prevent carryover.

[0146] Surface profile measurements were collected no more than 15 minutes after removal of the sample from the water.

[0147] For the test group, an oral irrigator (WaterPik, Fort Collins, CO) was used instead of a toothbrush.

[0148] The specimens were held on top of a scissor lift in the clay to provide stability to the specimens. The specimens were positioned on the clay so the spray from the irrigator would not be trapped on them. The entire setup was placed in the bottom of a deep pool of water to catch overspray. The distance between the irrigator and specimens was maintained by clamping the oral irrigator tip in a ring holder and measuring the distance between the tip and the dentin with a feeler gauge (2 mm).

[0149] Tablets were prepared according to Example 1, and one tablet was inserted into an oral irrigator so that it was positioned in the flow path of the irrigator. The irrigator reservoir was filled with water. The irrigator was set to maximum power and floss mode. The tip was positioned on the exposed dentin window. The oral irrigator ran a programmed cycle (30 seconds on, short pause, 18 seconds on). Profile measurement data (also described below) were collected after 48 seconds of treatment (which simulated 6 months of use (described below)). The tape was then reapplied and the sample returned to its study position. A new tablet was inserted into the irrigator and the reservoir was filled with clean water. The tip was returned to the same position on the exposed window and the treatment was repeated for a total of 7 minutes and 12 seconds (7×1-minute (30 seconds on, short pause, 30 seconds on) + 12 seconds), which simulated 5 years of use. The adhesive was removed from the samples, and they were rinsed clean with water and placed in a humid environment until analysis was performed.

[0150] Profile measurement data was collected from the treated (taped) area of ​​each sample. Surface measurements were taken from within the area just before tape was applied on the exposed window and into the opposite area just before tape was applied. The profile measurement software calculated the average value from at least 100z values ​​on the scan. Five scans were taken from different points along the exposed area and the average of the five readings was calculated. The average depth of the five traces of each sample was determined. The average wear depth of each group was then determined from eight separate sample values ​​within the group.

[0151] The comparability of the toothbrushing and oral irrigating treatments was determined as follows. The oral irrigator tip was moved along the gingiva using a 1 mm diameter spray for a distance of 228 mm per dental arch, including both the inner and outer surfaces. The total treatment area was therefore 456 mm 2 Considering that the processing time is 60 seconds, the resulting exposure is 0.132 s / mm 2 . Twice a day, 365 days a year = any given mm 2 96 seconds per year.

[0152] The average brushing time is 1 minute, or 30 seconds per dental arch, or 15 seconds per quadrant. Each oral quadrant has 5 surfaces (molar lingual, molar occlusal, molar buccal, incisor lingual, and incisor buccal). When brushing each quadrant for 15 seconds, each surface receives approximately 3 seconds of brushing time. The brushing speed is approximately 5 brushing strokes per second. Due to the length of the brush head, the middle teeth on any given surface can receive 15 brushing strokes. Brushing twice a day × 15 brushing strokes per tooth × 365 days per year = 10,950 brushing strokes per tooth per year.

[0153] The standard tooth brushing test uses 5000 brushing strokes, which corresponds to approximately 6 months of brushing (i.e., 1 / 2 of 10,950 brushing strokes per tooth per year). For an oral irrigator, 48 seconds corresponds to approximately 6 months of use (i.e., at any given mm 2 Therefore, oral irrigator data was collected after 48 seconds of use (corresponding to 6 months of brushing) and after 8 minutes of use (corresponding to 5 years of twice-daily brushing).

[0154] The results are shown in Table 5.

[0155] Table 5

[0156]

[0157] The results of Table 5 show that brushing with a regular toothbrush wears away significantly more dentin than applying a fluid stream carrying the dissolved tablet of Example 1. The loss of dentin material caused by brushing in a simulated 6 months (5000 brushing strokes) was significantly (p<0.001) greater than the loss of dentin material caused by an oral irrigator using the tablet in a simulated 6 months (48 seconds). The loss of dentin material caused by brushing in a simulated 6 months was significantly (p<0.001) greater than the loss of dentin material caused by an oral irrigator using the tablet in a simulated 5 years (8 minutes).

[0158] Comparison of the two tablet groups by Student's t-test showed a significant difference (p<0.001). This difference suggests that there is a dose response to tablet treatment.

[0159] Relative dentin abrasion (RDA) values ​​were calculated from the profilometry measurements and are shown in Table 6. In a standard brushing model, the RDA value of the reference toothpaste was considered to be 100. Deviations from the standard model (ie, using an oral irrigator) affect the calculation and comparison of RDA values.

[0160] Table 6

[0161] deal with RDA Tablet in oral irrigator, 48 seconds 1.3 Tablet in oral irrigator, 8 minutes 5.2 Brush your teeth with a toothbrush (5,000 brushing strokes) 100.0 .

[0162] The data in Table 6 demonstrate that oral irrigators using the disclosed tablets have much less abrasiveness than standard toothbrushing.

[0163] Example 4 – Effect of tablet distance from tip

[0164] The effectiveness of tablet performance based on distance from the end of the oral irrigator tip (i.e., nozzle) has been studied. Figure 2 A) The water spray is about 3.5 inches ( Figure 2 B), about 5 inches ( Figure 2 C) or about 30 inches ( Figure 2 D) after contacting the tablet of Example 1 with the water sprayed from the nozzle. For each treatment, the water pressure and the distance between the water outlet and the test color spot were the same. The results are shown in Figure 2 A-2D.

[0165] Regardless of the distance between the tablet and the nozzle, the tablet of Example 1 ( Figure 2 B-2D) are more effective in removing stains from teeth than water alone ( Figure 2 a). When the distance between the tablet and the nozzle tip is about 3.5 inches ( Figure 2 B) to about 5 inches ( Figure 2 C), the tablet of Example 1 was approximately equally effective in removing stain from the teeth. When the distance between the tablet and the nozzle tip was increased to about 30 inches ( Figure 2 D), and a shorter distance ( Figure 2 B and Figure 2 C), the stain removal efficiency was reduced compared to

[0166] The results show that glycine of a given particle size is effective at a given distance from the nozzle, and the effectiveness decreases as the distance from the nozzle increases. If the fluid flow rate remains constant, the exposure time between the tablet particles (e.g., glycine) and the fluid increases as the distance between the tablet and the nozzle increases. The increased exposure can reduce the size of the entrained particles so that the user does not feel residual hard particles in the mouth or on surrounding surfaces (such as the face or bathroom counter).

[0167] Although various embodiments have been described above with a certain degree of particularity or with reference to one or more separate embodiments, those skilled in the art may make many changes to the disclosed embodiments without departing from the spirit or scope of the present disclosure. Therefore, other embodiments are contemplated. The material contained in the above description is only illustrative of specific embodiments and is not restrictive. Changes may be made in detail or structure without departing from the essential elements described herein.

Claims

1. An oral hygiene tablet, comprising: an abrasive, wherein the abrasive is glycine, wherein the glycine is 32 wt % to 48 wt % of the oral hygiene tablet, the glycine has a mean (Mv) particle size of 50 μm to 90 μm, and the glycine does not include a surface coating, A filler, the filler comprising xylitol and corn dextrin, the filler being 32 wt % to 48 wt % of the oral hygiene tablet; a glidant, the glidant comprising fumed silica having an average particle size of 0.06 μm to 0.18 μm; and one or more of a binder, a disintegrant, a lubricant, a surfactant or a flavoring agent; wherein 35% or less by weight of the glycine has a particle size less than 45 μm, and 35% or less by weight of the glycine particles has a particle size greater than 100 μm; and Wherein, the tablet is water-soluble.

2. The tablet according to claim 1, wherein The average particle size of the fumed silica was 0.12 μm.

3. The tablet according to claim 1 or 2, wherein The tablet includes a disintegrant and the disintegrant is crospovidone.

4. The tablet according to claim 1 or 2, wherein The tablet includes a lubricant and the lubricant is magnesium stearate.

5. The tablet according to claim 1 or 2, wherein The tablet includes a surfactant and the surfactant is sodium lauryl sulfate.

6. The tablet according to claim 1, wherein The tablet includes a sweetener.

7. The tablet according to claim 1 or 2, wherein The tablet includes a sweetener and the sweetener is sucralose.

8. The tablet according to claim 1, wherein The glycine in the tablet is configured to dissolve in a linear distance of thirty inches or less when entrained in a fluid stream.

9. The tablet according to claim 1, wherein The tablets have a hardness of about 0.5 kilopounds (kp) to about 10 kp.

10. The tablet according to claim 1, wherein The tablets have a hardness of about 5 kilopounds (kp) to about 10 kp.

11. The tablet according to claim 1, wherein The glidant is less than 0.6 wt % of the tablet.

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