The present descriptive report relates to an invention patent application proposing a novel chemical composition to obtain a product to remove carious tissue, which is useful in dental treatments as a secondary resource, or to replace cavities removal with the use of drills and conventional instruments.

The patent application in question also relates to the manufacturing process used for manufacturing said removing product.

The current state-of-the-art comprises the existence of at least one product intended to be used to remove dental cavities, which was developed by the present applicant and duly requested as patent on 08/28/2003, being identified as PI 0303435-6. whose title is CHEMICAL COMPOSITION AND PROCESS TO OBTAIN A PRODUCT TO REMOVE CARIOUS TISSUE AND PRODUCT APPLICATION".

The removing product described mentioned in the previous patent application shows the physical constitution of a gel, which shall be applied over the carious tissue and left to rest for a certain period of time, at the end of which it works over that tissue, softening it, and allowing its removal by simple scaling, which operation is followed by a washing step.

The removing product described in patent application PI 0303435-6 does not require the use of anesthetics and motorized drills, making, thus, the cavities removal procedure simpler and less aggressive to the patient, and it is particularly used for dental treatment for children. 6

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Summarizing, the cavities removing product described in the previous patent discloses a composition based on hot water-soiubilized methylparaben. added with the following substances: Papain. Chloramine. Sodium Chloride and Dyes, as well as Sodium Hydroxide and Carboxymethylcellulose. the latter working as thickening agents and contributing to form the gel.

Concerning the manufacturing process for the removing product described in the previous patent application, it starts from the Methylparaben basis hot soiubilized in distilled water. Then a period of time is awaited for the initial solution to cool. After that cooling is obtained. Papain 6Q00Ui/mg 10%, Chloramine T 0.5%, Sodium Chloride 0.2% and blue and yellow dyes (qs. ) are added.

To the above described composition Sodium Hydroxide 0.2% is then progressively added, until the required pH is obtained, which is within the range between 6 5 and 7.0. When the appropriate pH is obtained, Carboxymethylcellulose thickening agent is then added, and the formulation is stirred until gel consistence is obtained.

The product described above, in spite of its corroborated efficiency, required a certain care for storage, with the need of being stored in a fridge, and also, it had an expiration date which, despite being enough (one year), could be increased.

Considering the particularities above related to the product belonging to the state of the art, the applicant continued its development, intending to improve the product stability capacity, so as to exempt it from special care for storage. That development resulted in a new formulation to obtain a product to remove carious tissue, as well as a new process to manufacture that removing product The higher stability condition for storage both concerning the expiration date extension and the elimination of the need of storage in a fridge, has been obtained with the formulation herein disclosed, which comprises the use of: Carbowax 400 (Polyethyieneglycol) - at a range from 15,00% to 30.00%, preferably 28.00%; Carbowax 4000 (Polyethyieneglycol) - at a range from 15.00% to 30.00%, preferably 30.00 %; Chloramine T - within a range from 0.2% to 0.50%, preferably 0.5%; Papain - within a range from 2.00% to 10.00% - preferably 10.00%; Propyleneglycol - within a range from 15.00% to 30.00%, preferably 28.00 %: and Dye CI 74160 - within a range from 0.01 % a 0.05%. preferably 0.02%.

Concerning the herein disclosed manufacturing process for cavities removing product, the raw materials are mixed in the order described as follows: in a glass beaker, with the dye previously solubilized in 20% of the propyleneglycol in the composition.

Separately, in a stainless steel container, Polyethyieneglycol 4000 is administered, and with the help of the heating pi ate, it is melted up to a temperature range of 55 degrees Celsius. The heating plate Is turned off fast and under low stirring, to the still hot and melted product, Polyethyieneglycol 400 is added, and then homogenization is performed. Thereafter, still under low stirring, to the still hot and melted product, the mixture of dye and Propyleneglycol is added, and thereafter homogenization continues.

The remaining portion of the Propyleneglycol is used to ^" wash the beaker, and this Propyleneglycol is added to the Polyethyleneglycols mixture, and thereafter the mixture is homogenized. Under low stirring, Chloramine T is added and once again the formulation homogenization continues, which is kept under low stirring until its temperature reaches 25.5 degrees centigrade, when the Papain is then added under constant stirring, until the mixture is homogeneous and with no clusters.

The container in which the formulation is being prepared is kept on the heating plate in off position, and filling starts before the temperature drops under 25°C and the gel becomes solid.

In the formulation herein proposed, the water and the Carboxymethylcellulose thickening agent were replaced, in the composition, with the Polyethyleneglycols in two different molecular weights, with the purpose of obtaining a product in the gel form, but without using water, as the presence of water made Papain enzyme hydrolysis easier, which reduced the composition expiration date to 1 year and required storage in the fridge to delay hydrolysis.

The formulation herein proposed preserves the enzyme activity for a longer time, and does not require refrigeration.

In addition to no longer requiring storage in a fridge, the chemical composition to obtain a carious tissue remover herein disclosed started having a stability time of two years, representing, thus, a 100% gain wnen compared to the previous composition.