WO2022108546A1 - Development of dental cleaning formulation in the form of effervescent tablet - Google Patents

Development of dental cleaning formulation in the form of effervescent tablet Download PDF

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Publication number
WO2022108546A1
WO2022108546A1 PCT/TR2021/050400 TR2021050400W WO2022108546A1 WO 2022108546 A1 WO2022108546 A1 WO 2022108546A1 TR 2021050400 W TR2021050400 W TR 2021050400W WO 2022108546 A1 WO2022108546 A1 WO 2022108546A1
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Prior art keywords
weight
sodium
dental cleaning
effervescent
tablet according
Prior art date
Application number
PCT/TR2021/050400
Other languages
French (fr)
Inventor
Eda TİFTİKÇİ
Hakan EROĞLU
Original Assignee
Hacettepe Üni̇versi̇tesi̇
Serra Dermokozmeti̇k Ve Medi̇kal Ürünler Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇
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Publication of WO2022108546A1 publication Critical patent/WO2022108546A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q11/00—Preparations for care of the teeth, of the oral cavity or of dentures; Dentifrices, e.g. toothpastes; Mouth rinses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/02—Cosmetics or similar toiletry preparations characterised by special physical form
    • A61K8/0216—Solid or semisolid forms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/19—Cosmetics or similar toiletry preparations characterised by the composition containing inorganic ingredients
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
    • A61K8/34—Alcohols
    • A61K8/345—Alcohols containing more than one hydroxy group
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/60—Sugars; Derivatives thereof
    • A61K8/602—Glycosides, e.g. rutin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/72—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
    • A61K8/73—Polysaccharides
    • A61K8/731—Cellulose; Quaternized cellulose derivatives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/72—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
    • A61K8/84—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds obtained by reactions otherwise than those involving only carbon-carbon unsaturated bonds
    • A61K8/86—Polyethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
    • A61K2800/20—Chemical, physico-chemical or functional or structural properties of the composition as a whole
    • A61K2800/22—Gas releasing
    • A61K2800/222—Effervescent

Definitions

  • the invention relates to the formulation in the form of natural, vegan and environmentally friendly effervescent tablet that provides dosing standardization to be used for dental cleaning and to a production method.
  • US2012175273A1 includes studies on toothpaste tablets.
  • the chewable tablets developed within this scope included binding agent, surfactant, anthiocyanad extract(s), anti-corrosion agent, fluoride and artificial sweetener in the tablet.
  • effervescent tablet formulations of the effervescent tablet or chewable tablets known in the aforementioned art a burning sensation on the tongue from the moment it is taken into the mouth and contact with oral fluid, bitterness depending on the choice of the acid source ratio in the formulation, and the feeling of being removed from the tongue immediately by the user.
  • the differences and insufficiencies in the foaming rates cannot give the user the feeling that the cleaning process is completed, as the user is accustomed to using conventional toothpastes.
  • the feeling of bitterness mentioned in the art has been completely removed, the ratios of acid and base source components in the formulation have been optimized, and taste masking has been successfully performed with the orange, spearmint and strawberry flavors used in the content.
  • the formulation components are completely soluble in water, when the effervescent reaction is completed, there are no solid particles left in the mouth. Accordingly, it does not have any corrosive effect on any tooth enamel.
  • the reaction is completed within 20-30 seconds after contact with the liquid in the mouth and a full and permanent foam is formed in the mouth. In the meantime, no irritating taste, feeling or effect on the tongue that would cause the product to be rejected by the user has been detected.
  • the aromas and natural sweetener used to facilitate use and appeal to different masses leave a pleasant and spacious feeling after rinsing the oral cavity with water after use.
  • the inventive formulation in the form of a tablet has many advantages in terms of both providing personal hygiene and maintaining uniformity of dose between repetitions of use.
  • the upper surface of the personal toothbrushes of different people comes into contact with the end of the tube where the paste is placed, which causes the risk of infection spreading within the same family or between different individuals.
  • a homogeneous and standardized tooth cleaning can be achieved.
  • This product which can be easily transported due to different packaging sizes in environments/conditions, such as long-term travels, long air travels, hotels, hospitals, etc. stands out as user and environmentally friendly.
  • the tablet formulation of this invention which is presented with FSC certified cardboard and secondary packaging in the form of a recyclable cardboard box, is environmentally friendly as it is recyclable.
  • Figure 1 A schematic representation of the production of effervescent tablet formulation containing activated charcoal (with sodium fluoride) used in dental cleaning.
  • Figure 2 A schematic representation of the production of effervescent tablet formulation containing activated charcoal (without sodium fluoride) used in dental cleaning.
  • Figure 3 A schematic representation of the production of a strawberry flavored (with sodium fluoride) effervescent tablet formulation used in dental cleaning.
  • Figure 4 A schematic representation of the production of a strawberry flavored (without sodium fluoride) effervescent tablet formulation used in dental cleaning.
  • Figure 5 A schematic representation of the production of a spearmint flavored (with sodium fluoride) effervescent tablet formulation used in dental cleaning.
  • Figure 6 A schematic representation of the production of a spearmint flavored (without sodium fluoride) effervescent tablet formulation used in dental cleaning.
  • Figure 7 A schematic representation of the production of an orange flavored (with sodium fluoride) effervescent tablet formulation used in dental cleaning.
  • Figure 8 A schematic representation of the production of an orange flavored (without sodium fluoride) effervescent tablet formulation used in dental cleaning.
  • the effervescent tablet formulation used in dental cleaning contains tartaric acid used as an acid source to initiate a rapid effervescent reaction at the time of contact with oral fluid; sodium bicarbonate as the base source; agents used for dental care such as citric acid anhydrate, calcium carbonate and sodium fluoride; microcrystalline cellulose used as a diluent filler in the tablet formulation, which is an auxiliary agent that enables the powder mixture to reach the minimum weight that can be pressed in the punch; stevia glycoside used as a sweetener; orange flavor, strawberry flavor, peppermint essence, spearmint and menthol used as flavoring agents; sodium glutamate derivative selected from sodium lauroyl glutamate or sodium cacoyl glutamate as a surfactant to clean and to create permanent foam; polyethylene glycol 6000 as a surfactant for cleaning, forming a permanent foam, forming tablets under pressure without sticking to the punches and seal during manufacture; and activated charcoal to clean tooth surfaces.
  • tartaric acid used as an acid source to
  • the effervescent dental cleaning tablet according to the invention contains 20-30% tartaic acid, preferably 23.75% tartaic acid; 30-42% sodium bicarbonate by weight, preferably 38.65% sodium bicarbonate by weight; 7.1-9.99% citric acid anhydrate by weight, preferably 9.95% citric acid anhydrate by weight; 3-8% calcium carbonate by weight, preferably 6.06% calcium carbonate; 6-12% microcrystalline cellulose by weight, preferably 8.45% microcrystalline cellulose; 4.0-5.5% polyethylene glycol 6000 by weight, preferably 5.05% polyethylene glycol 6000; 0.2-0.6% stevia glycoside by weight, preferably 0.44% stevia glycoside; 4-8% flavoring agent by weight, preferably 6.34% flavoring agent; 0.7-2.1% sodium glutamate derivative by weight, preferably 1.12% sodium glutamate derivative.
  • the flavoring agent is selected from orange flavor, strawberry flavor, peppermint essence, spearmint and menthol.
  • the dental cleaning tablet of the invention optionally contains 0.1-0.15% sodium fluoride by weight, preferably 0.14% by weight.
  • the dental cleaning tablet of the invention optionally contains 1-2% activated charcoal by weight, preferably 1.25% activated carbon by weight.
  • the sodium glutamate derivative used in the effervescent dental cleaning tablet of the invention can be sodium cacoyl glutamate or sodium lauroyl glutamate.
  • the weight of the tablets to be prepared for this purpose has been determined as 450 mg for use in adults and 300 mg for use in children.
  • the direct press method was preferred as the preparation method of the tablets and the tablets were pressed using the appropriate stamp to be 10 mm in diameter and approximately 4 mm thick. These tablets, which dissolve completely within 20-30 seconds after contact with oral fluid and whose effervescent reaction is completed, should be brushed using a toothbrush in order to have an effect and to ensure a complete dental cleaning.
  • Figures 1-8 show the production process steps of the inventive dental cleaning tablets using different aroma agents.
  • the granulation process step known as improving the flow properties by granulating powder components with poor flow properties has been eliminated since the components are at a sufficient level in terms of flow properties. This situation offers a cost advantage in terms of reducing the production steps.
  • the production process of the inventive dental cleaning tablets generally includes the process steps of;
  • Sodium bicarbonate, citric acid anhydrate, tartaric acid, calcium carbonate, microcrystalline cellulose, sodium fluoride, stevia glycoside, peppermint flavor, sodium lauroyl glutamate are sieved at a screening speed of 300 revolution/min through 1 mm sieve; polyethylene glycol 6000 is passed through a 0.5 mm sieve at a screening speed of 300 revolution/min and sieved into separate containers.
  • Polyethylene glycol 6000 is added to the powder mixture and mixed at a speed of 20 revolution/minutes for 5 minutes.
  • the ambient temperature should be controlled, preferably in the range of 15-25 °C.
  • Relative humidity in the environment should be below 30%, and optimum conditions should be 25% RH and below.
  • Tablet Press 10.0 mm, round, biconcave, notchless punch set is attached to the tablet machine.
  • the tablet machine is adjusted so that the tablet weight is in the range of 427.5-472.5 mg, the average tablet weight is 450 mg, the tablet hardness is in the range of 40-90 N, the target tablet hardness is 60 N.
  • Tablet pressing is started. During tablet pressing, the ambient relative humidity should be between 20-30%.
  • the apparent density of the powder before tablet pressing is 0.8 g/mL.
  • the vessel volume to be used in production and production batch size should be calculated by considering apparent density value.
  • the vessel occupancy rate should be minimum 30% and maximum 75% of the vessel volume.
  • the moisture of the powder Before pressing, the moisture of the powder should be controlled. In the moisture analysis performed at 105 °C in the halogen moisture analyzer, the moisture value of the powder should be at most 4%.
  • the tablets are filled in a suitable form into glass bottles with a volume of 30-90 cc containing desiccant, with 90 tablets in each bottle.
  • the silica apparatus is placed either inside the cap and in an apparatus mounted on the product-facing direction of the cap, or inside the bottle in a lcmx2cm paper package.
  • Tablets should be bottled without waiting time so that the tablets do not absorb moisture and lose their effervescent properties after tablet pressing.
  • the bottles are packed in cardboard boxes.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Birds (AREA)
  • Epidemiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Emergency Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Inorganic Chemistry (AREA)
  • Cosmetics (AREA)
  • Medicinal Preparation (AREA)

Abstract

The invention relates to the formulation in the form of vegan and environmentally friendly effervescent tablet that provides dosing standardization to be used for dental cleaning and to a production method. The effervescent dental cleaning tablet according to the invention includes tartaric acid, sodium bicarbonate, citric acid anhydrate, calcium carbonate, microcrystalline cellulose, polyethylene glycol 6000, stevia glycoside, flavoring agents such as orange flavor, strawberry flavor, peppermint essence, spearmint and menthol, sodium fluoride, activated charcoal and sodium cocoyl glutamate or sodium lauroyl glutamate.

Description

DEVELOPMENT OF DENTAL CLEANING FORMULATION IN THE FORM OF
EFFERVESCENT TABLET
Technical Field
The invention relates to the formulation in the form of natural, vegan and environmentally friendly effervescent tablet that provides dosing standardization to be used for dental cleaning and to a production method.
Prior Art
In the patent document numbered US4753792A, which is one of the previous studies on dental cleaning, a formulation that is self-foaming and provides self-cleaning as a result of chewing was studied. It is stated that there is no need to use a toothbrush in using this product. Carboxylic acid was used for effervescent properties and carbonate salt as a base source, and sodium lauryl sulfate was used as wetting agent and xanthan gum was used as swelling agent.
In the patent document numbered US3116208A, a chewable tablet formulation containing calcium carbonate and sodium lauryl sulfate has been developed. Also, due to the ease of transport, storage and packaging provided by the tablet form, this formulation study was carried out and it was designed for use with the help of a toothbrush.
In the patent document numbered US3151028A, hexahydric alcohol, calcium and phosphate ions from the group of water-soluble low molecular weight aliphatic hydroxy acid, sorbitol mannitol and a dusitol, were formulated in non-efferve scent, normal structured tablets for dental cleaning. For this purpose, the tablets dispersed after being absorbed were used for dental cleaning.
In the patent document numbered US8192724B2, an effervescent tablet formulation containing water-soluble excipients has been developed to be used for oral care. These tablets contain citric acid, fumaric acid, tartaric acid, malic acid or their mixtures as the acid component; sodium bicarbonate, potassium carbonate, ammonium carbonate, magnesium carbonate or mixtures thereof as carbonate source; and substances such as flavoring agent, binder, and lubricant.
The patent document numbered US2012175273A1 includes studies on toothpaste tablets. The chewable tablets developed within this scope included binding agent, surfactant, anthiocyanad extract(s), anti-corrosion agent, fluoride and artificial sweetener in the tablet.
In effervescent tablet formulations of the effervescent tablet or chewable tablets known in the aforementioned art, a burning sensation on the tongue from the moment it is taken into the mouth and contact with oral fluid, bitterness depending on the choice of the acid source ratio in the formulation, and the feeling of being removed from the tongue immediately by the user. In addition, the differences and insufficiencies in the foaming rates cannot give the user the feeling that the cleaning process is completed, as the user is accustomed to using conventional toothpastes.
In chewable tablet formulations, depending on the preparation of extremely soft tablets, there is dust and crumbling in the package. This situation creates a feeling of inadequacy in users in terms of product quality. In addition, solid particles that are not dissolved in the mouth in chewable tablets may cause tooth enamel to be scratched and sensitivity in the future.
In semi-solid products used for tooth cleaning, presentation is made to the user in plastic package and this situation causes the accumulation of plastic waste that cannot be removed in the nature over the years in terms of sustainability.
Summary and Objects of The Invention
With this invention, the feeling of bitterness mentioned in the art has been completely removed, the ratios of acid and base source components in the formulation have been optimized, and taste masking has been successfully performed with the orange, spearmint and strawberry flavors used in the content. In addition, due to the fact that the formulation components are completely soluble in water, when the effervescent reaction is completed, there are no solid particles left in the mouth. Accordingly, it does not have any corrosive effect on any tooth enamel. In the tablet formulations of the invention, the reaction is completed within 20-30 seconds after contact with the liquid in the mouth and a full and permanent foam is formed in the mouth. In the meantime, no irritating taste, feeling or effect on the tongue that would cause the product to be rejected by the user has been detected. The aromas and natural sweetener used to facilitate use and appeal to different masses leave a pleasant and spacious feeling after rinsing the oral cavity with water after use.
When evaluated in terms of use compared to pasty formulations known in the art, the inventive formulation in the form of a tablet has many advantages in terms of both providing personal hygiene and maintaining uniformity of dose between repetitions of use. In paste-type formulations, the upper surface of the personal toothbrushes of different people comes into contact with the end of the tube where the paste is placed, which causes the risk of infection spreading within the same family or between different individuals. In addition, with the same dose of components to be taken each time, a homogeneous and standardized tooth cleaning can be achieved.
This product, which can be easily transported due to different packaging sizes in environments/conditions, such as long-term travels, long air travels, hotels, hospitals, etc. stands out as user and environmentally friendly.
In addition to the glass container and metal cover used as primary packaging, the tablet formulation of this invention, which is presented with FSC certified cardboard and secondary packaging in the form of a recyclable cardboard box, is environmentally friendly as it is recyclable.
Descriptions of Figures
Figure 1: A schematic representation of the production of effervescent tablet formulation containing activated charcoal (with sodium fluoride) used in dental cleaning.
Figure 2: A schematic representation of the production of effervescent tablet formulation containing activated charcoal (without sodium fluoride) used in dental cleaning.
Figure 3: A schematic representation of the production of a strawberry flavored (with sodium fluoride) effervescent tablet formulation used in dental cleaning.
Figure 4: A schematic representation of the production of a strawberry flavored (without sodium fluoride) effervescent tablet formulation used in dental cleaning.
Figure 5: A schematic representation of the production of a spearmint flavored (with sodium fluoride) effervescent tablet formulation used in dental cleaning.
Figure 6: A schematic representation of the production of a spearmint flavored (without sodium fluoride) effervescent tablet formulation used in dental cleaning.
Figure 7: A schematic representation of the production of an orange flavored (with sodium fluoride) effervescent tablet formulation used in dental cleaning.
Figure 8: A schematic representation of the production of an orange flavored (without sodium fluoride) effervescent tablet formulation used in dental cleaning.
Detailed Description of the Invention
For the effervescent tablet formulation developed for dental cleaning, excipients used by the pharmaceutical industry and called as "pharma grade" were selected.
The effervescent tablet formulation used in dental cleaning contains tartaric acid used as an acid source to initiate a rapid effervescent reaction at the time of contact with oral fluid; sodium bicarbonate as the base source; agents used for dental care such as citric acid anhydrate, calcium carbonate and sodium fluoride; microcrystalline cellulose used as a diluent filler in the tablet formulation, which is an auxiliary agent that enables the powder mixture to reach the minimum weight that can be pressed in the punch; stevia glycoside used as a sweetener; orange flavor, strawberry flavor, peppermint essence, spearmint and menthol used as flavoring agents; sodium glutamate derivative selected from sodium lauroyl glutamate or sodium cacoyl glutamate as a surfactant to clean and to create permanent foam; polyethylene glycol 6000 as a surfactant for cleaning, forming a permanent foam, forming tablets under pressure without sticking to the punches and seal during manufacture; and activated charcoal to clean tooth surfaces. The effervescent dental cleaning tablet according to the invention contains 20-30% tartaic acid, preferably 23.75% tartaic acid; 30-42% sodium bicarbonate by weight, preferably 38.65% sodium bicarbonate by weight; 7.1-9.99% citric acid anhydrate by weight, preferably 9.95% citric acid anhydrate by weight; 3-8% calcium carbonate by weight, preferably 6.06% calcium carbonate; 6-12% microcrystalline cellulose by weight, preferably 8.45% microcrystalline cellulose; 4.0-5.5% polyethylene glycol 6000 by weight, preferably 5.05% polyethylene glycol 6000; 0.2-0.6% stevia glycoside by weight, preferably 0.44% stevia glycoside; 4-8% flavoring agent by weight, preferably 6.34% flavoring agent; 0.7-2.1% sodium glutamate derivative by weight, preferably 1.12% sodium glutamate derivative.
In the invention, the flavoring agent is selected from orange flavor, strawberry flavor, peppermint essence, spearmint and menthol.
The dental cleaning tablet of the invention optionally contains 0.1-0.15% sodium fluoride by weight, preferably 0.14% by weight.
The dental cleaning tablet of the invention optionally contains 1-2% activated charcoal by weight, preferably 1.25% activated carbon by weight.
The sodium glutamate derivative used in the effervescent dental cleaning tablet of the invention can be sodium cacoyl glutamate or sodium lauroyl glutamate.
The weight of the tablets to be prepared for this purpose has been determined as 450 mg for use in adults and 300 mg for use in children.
The direct press method was preferred as the preparation method of the tablets and the tablets were pressed using the appropriate stamp to be 10 mm in diameter and approximately 4 mm thick. These tablets, which dissolve completely within 20-30 seconds after contact with oral fluid and whose effervescent reaction is completed, should be brushed using a toothbrush in order to have an effect and to ensure a complete dental cleaning.
Figures 1-8 show the production process steps of the inventive dental cleaning tablets using different aroma agents. In the process of the present invention, the granulation process step known as improving the flow properties by granulating powder components with poor flow properties has been eliminated since the components are at a sufficient level in terms of flow properties. This situation offers a cost advantage in terms of reducing the production steps.
The production process of the inventive dental cleaning tablets generally includes the process steps of;
• weighing sodium bicarbonate, citric acid anhydrate, tartaric acid, calcium carbonate, microcrystalline cellulose, stevia glycoside, sodium glutamate derivative, flavoring agent and polyethylene glycol 6000,
• passing sodium bicarbonate, citric acid anhydrate, tartaric acid, calcium carbonate, microcrystalline cellulose, stevia glycoside, sodium glutamate derivative and flavoring agent through a 1 mm sieve at a screening speed of 300 revolution/min; sieving polyethylene glycol 6000 through a 0.5 mm sieve at a screening speed of 300 revolution/min,
• mixing * of sodium bicarbonate, calcium carbonate, microcrystalline cellulose, stevia glycoside, flavoring agent, sodium glutamate derivative at a speed of 20 revolution/min for 10 minutes, then adding * of sodium bicarbonate, citric acid anhydrate and tartaric acid and mixing at a speed of 20 revolution/mins for 10 minutes,
• adding polyethylene glycol 6000 to the powder mixture and mixing at a speed of 20 revolution/min for 5 minutes,
• Pressing tablets by setting the tablet machine such that the tablet hardness is in the range of 40-90 N in an environment where the humidity is between 20-30%.
All process steps are described in detail below:
Weighing Sodium bicarbonate, citric acid anhydrate, tartaric acid, calcium carbonate, microcrystalline cellulose, sodium fluoride, stevia glycoside, mint flavor, sodium cacoyl glutamate or sodium lauroyl glutamate and polyethylene glycol 6000 are weighed separately.
• Sieving
Sodium bicarbonate, citric acid anhydrate, tartaric acid, calcium carbonate, microcrystalline cellulose, sodium fluoride, stevia glycoside, peppermint flavor, sodium lauroyl glutamate are sieved at a screening speed of 300 revolution/min through 1 mm sieve; polyethylene glycol 6000 is passed through a 0.5 mm sieve at a screening speed of 300 revolution/min and sieved into separate containers.
• Mixing
* of the sodium bicarbonate, calcium carbonate, microcrystalline cellulose, sodium fluoride, stevia glycoside, peppermint flavor, sodium cacoyl glutamate or sodium lauroyl glutamate are added to the mixing vessel, respectively and mixed for 10 minutes at 20 revolution/minutes.
* of sodium bicarbonate, citric acid anhydrate and tartaric acid are added to the same mixing vessel and mixed for 10 minutes at 20 revolution/minutes.
• Lubrication
Polyethylene glycol 6000 is added to the powder mixture and mixed at a speed of 20 revolution/minutes for 5 minutes.
In the production area where sieving, mixing and tablet pressing processes will be carried out, the ambient temperature should be controlled, preferably in the range of 15-25 °C. Relative humidity in the environment should be below 30%, and optimum conditions should be 25% RH and below.
Tablet Press 10.0 mm, round, biconcave, notchless punch set is attached to the tablet machine. The tablet machine is adjusted so that the tablet weight is in the range of 427.5-472.5 mg, the average tablet weight is 450 mg, the tablet hardness is in the range of 40-90 N, the target tablet hardness is 60 N. Tablet pressing is started. During tablet pressing, the ambient relative humidity should be between 20-30%.
The apparent density of the powder before tablet pressing is 0.8 g/mL. The vessel volume to be used in production and production batch size should be calculated by considering apparent density value. The vessel occupancy rate should be minimum 30% and maximum 75% of the vessel volume.
Before pressing, the moisture of the powder should be controlled. In the moisture analysis performed at 105 °C in the halogen moisture analyzer, the moisture value of the powder should be at most 4%.
• Bottling
The tablets are filled in a suitable form into glass bottles with a volume of 30-90 cc containing desiccant, with 90 tablets in each bottle. As a desiccant, the silica apparatus is placed either inside the cap and in an apparatus mounted on the product-facing direction of the cap, or inside the bottle in a lcmx2cm paper package.
Tablets should be bottled without waiting time so that the tablets do not absorb moisture and lose their effervescent properties after tablet pressing.
• Packaging
The bottles are packed in cardboard boxes.
• Storing
They are stored at room temperature below 25 °C and in its original packaging.

Claims

1. An effervescent dental cleaning tablet, characterized by comprising 20-30% tartaic acid by weight, 30-42% sodium bicarbonate by weight, 7.1-9.99% citric acid anhydrate by weight, 3-8% calcium carbonate by weight, 6-12% microcrystalline cellulose by weight, 4.0-5.5% polyethylene glycol 6000 by weight, 0.2-0.6% stevia glycoside by weight, 4-8% flavoring agent by weight, and 0.7-2.1% sodium glutamate derivative by weight.
2. The effervescent dental cleaning tablet according to claim 1, characterized in that the flavoring agent is orange flavor, strawberry flavor, peppermint essence, spearmint and/or menthol.
3. The effervescent dental cleaning tablet according to claim 1, characterized by comprising 0.1-0.15% sodium fluoride by weight.
4. The effervescent dental cleaning tablet according to claim 1, characterized by comprising 1-2% activated charcoal by weight.
5. The effervescent dental cleaning tablet according to claim 1, characterized in that the sodium glutamate derivative is sodium cacoyl glutamate or sodium lauroyl glutamate.
6. The effervescent dental cleaning tablet according to claim 1, characterized by comprising 23.75% tartaic acid by weight, 38.65% sodium bicarbonate by weight, 9.95% citric acid anhydrate by weight, 6.06% calcium carbonate by weight, 8.45% microcrystalline cellulose by weight, 5.05% polyethylene glycol 6000 by weight, 0.44% stevia glycoside by weight, 6.34% flavoring agent by weight, and 1.12% sodium glutamate derivative by weight.
7. The effervescent dental cleaning tablet according to claim 6, characterized in that the flavoring agent is orange flavor, strawberry flavor, peppermint essence, spearmint and/or menthol.
8. The effervescent dental cleaning tablet according to claim 6, characterized in that the
9 sodium glutamate derivative is sodium cacoyl glutamate or sodium lauroyl glutamate. The effervescent dental cleaning tablet according to claim 6, characterized by comprising 0.14% sodium fluoride by weight. The effervescent dental cleaning tablet according to claim 6, characterized by comprising 1.25% activated charcoal by weight. A method of producing the effervescent dental cleaning tablet according to any of the above claims, comprising the process steps of; weighing sodium bicarbonate, citric acid anhydrate, tartaric acid, calcium carbonate, microcrystalline cellulose, stevia glycoside, sodium glutamate derivative, flavoring agent and polyethylene glycol 6000, sieving by passing sodium bicarbonate, citric acid anhydrate, tartaric acid, calcium carbonate, microcrystalline cellulose, stevia glycoside, sodium glutamate derivative and flavoring agent through a 1 mm sieve at a screening speed of 300 revolution/min; sieving polyethylene glycol 6000 through a 0.5 mm sieve at a screening speed of 300 revolution/min, mixing * of sodium bicarbonate, calcium carbonate, microcrystalline cellulose, stevia glycoside, flavoring agent, sodium glutamate derivative at a speed of 20 revolution/min for 10 minutes, right after adding * of sodium bicarbonate, citric acid anhydrate and tartaric acid and mixing at a speed of 20 revolution/mins for 10 minutes, adding polyethylene glycol 6000 to the powder mixture and mixing at a speed of 20 revolution/min for 5 minutes, pressing tablets by setting the tablet machine such that the tablet hardness is in the range of 40-90 N in an environment where the humidity is between 20-30%.
PCT/TR2021/050400 2020-11-23 2021-04-28 Development of dental cleaning formulation in the form of effervescent tablet WO2022108546A1 (en)

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US4812306A (en) * 1986-01-17 1989-03-14 Cocherell Francis E Toothpaste or dental cream composition and method of preparing same
WO2013072932A2 (en) * 2011-09-30 2013-05-23 Rubicon Research Private Limited Oral care compositions
CN105982835A (en) * 2016-03-24 2016-10-05 成都悟道科技有限公司 Compound solid mouth wash effervescent tablet and preparation method thereof
CN106726710A (en) * 2016-12-22 2017-05-31 北京刷新活力健康科技有限公司 A kind of effervescent tablet containing polylysine and parahydroxyacet-ophenone and preparation method and application
CN107280981A (en) * 2017-04-24 2017-10-24 南昌登特科技有限公司 A kind of activated carbon tooth powder
CN110314110A (en) * 2019-06-04 2019-10-11 中国人民解放军第四军医大学 A kind of effervescent tablet type mouthwash and preparation method thereof
CN110522714A (en) * 2019-08-29 2019-12-03 哈尔滨医科大学 A kind of dark plum mouthwash effervescent tablet and preparation method thereof with rush salivary secretion effect

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4812306A (en) * 1986-01-17 1989-03-14 Cocherell Francis E Toothpaste or dental cream composition and method of preparing same
WO2013072932A2 (en) * 2011-09-30 2013-05-23 Rubicon Research Private Limited Oral care compositions
CN105982835A (en) * 2016-03-24 2016-10-05 成都悟道科技有限公司 Compound solid mouth wash effervescent tablet and preparation method thereof
CN106726710A (en) * 2016-12-22 2017-05-31 北京刷新活力健康科技有限公司 A kind of effervescent tablet containing polylysine and parahydroxyacet-ophenone and preparation method and application
CN107280981A (en) * 2017-04-24 2017-10-24 南昌登特科技有限公司 A kind of activated carbon tooth powder
CN110314110A (en) * 2019-06-04 2019-10-11 中国人民解放军第四军医大学 A kind of effervescent tablet type mouthwash and preparation method thereof
CN110522714A (en) * 2019-08-29 2019-12-03 哈尔滨医科大学 A kind of dark plum mouthwash effervescent tablet and preparation method thereof with rush salivary secretion effect

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