PATCH ATTACHABLE TO TEETH

Abstract

The present disclosure provides a patch attachable to the occlusal plane of posterior teeth, which includes: a drug layer; a backing layer in contact with the drug layer; and a removable part in contact with the backing layer. The patch can be provided as a single-sided type or a double-sided type. It may also be provided as a linear type or a symmetric type. The present disclosure is directed to providing a patch that can be easily attached to the occlusal plane of posterior teeth.

Claims

1-26. (canceled)

27. A patch attachable to the occlusal plane of posterior teeth, comprising: a drug layer; a backing layer in contact with the drug layer; and a removable part in contact with the backing layer.

28. The patch attachable to the occlusal plane of posterior teeth according to claim 27, wherein the removable part has an area at least larger than that of the backing layer and the drug layer, and has a protruding handle.

29. The patch attachable to the occlusal plane of posterior teeth according to claim 28, wherein the patch attachable to the occlusal plane of posterior teeth is a symmetric-type patch having one removable part with a protruding handle formed and two remaining parts formed at both ends of the removable part, and each of the both ends of the symmetric-type patch is equipped with a backing layer in contact with the removable part; and a drug layer in contact with the backing layer.

30. The patch attachable to the occlusal plane of posterior teeth according to claim 27, wherein the patch has a structure in which the backing layer and the drug layer are disposed sequentially on the back side of the removable part so that the drug layer can be attached to the occlusal plane of upper posterior teeth and lower posterior teeth at once.

31. The patch attachable to the occlusal plane of posterior teeth according to claim 27, wherein the patch further comprises a wax layer in contact with the backing layer.

32. The patch attachable to the occlusal plane of posterior teeth according to claim 27, wherein the drug layer comprises a pressure-sensitive adhesive polymer.

33. The patch attachable to the occlusal plane of posterior teeth according to claim 27, wherein, after cutting the patch into 1.2 cm×5 cm and attaching 2.5 cm onto the slide glass, when the tackiness was measured with a Zwick DE/1494 universal testing machine at a speed of 5 mm/s, the drug layer has a tackiness of at least 50 gf and the backing layer has an tackiness of 10-20 gf.

34. The patch attachable to the occlusal plane of posterior teeth according to claim 27, wherein the backing layer comprises a water-insoluble polymer, and the water-insoluble polymer is comprised in an amount of 5-15 wt % based on the total weight of the backing layer.

35. The patch attachable to the occlusal plane of posterior teeth according to claim 31, wherein the wax layer comprises one or more wax selected from a group consisting of beeswax, carnauba wax and paraffin wax.

36. The patch attachable to the occlusal plane of posterior teeth according to claim 27, wherein the remaining part of the patch is cut to be split into a plurality of pieces.

37. The patch attachable to the occlusal plane of posterior teeth according to claim 27, wherein the removable part is a PET film.

38. The patch attachable to the occlusal plane of posterior teeth according to claim 36, wherein the removable part is folded at a portion not in contact with the remaining part.

39. A method for delivering a fluorine-containing ingredient for preventing tooth decay to posterior teeth by attaching the patch attachable to the occlusal plane of posterior teeth according to claim 27 to the occlusal plane of posterior teeth.

40. The method for delivering a fluorine-containing ingredient for preventing tooth decay to posterior teeth according to claim 39, wherein the removable part of the patch is removed after the patch is pressed between upper and lower teeth.

41. A multi-layered tooth-attachable patch comprising: a first layer comprising an adhesive polymer and a drug ingredient and attached to the surface of teeth; a second layer formed on the first layer and maintaining the shape of the first layer; and a third layer formed on the second layer and separated from the second layer, wherein the third layer protrudes upward, forward or backward to form one or more handles.

42. The multi-layered tooth-attachable patch according to claim 41, wherein the tooth-attachable patch has a protective layer protecting the first layer formed on one side of the first layer to have an area which is the same as or larger than the area of the first layer, and the protective layer is removed when the first layer is attached to the surface of teeth.

43. The multi-layered tooth-attachable patch according to claim 41, wherein the handle formed upward from the third layer is formed as the third layer extends upward or a handle structure is attached upward from the third layer.

44. The multi-layered tooth-attachable patch according to claim 41, wherein the handle formed forward or backward from the third layer is formed as the third layer extends forward or backward or a handle structure is attached forward or backward from the third layer.

45. The multi-layered tooth-attachable patch according to claim 41, wherein the second layer comprises one or more polymer selected from a group consisting of polyethylene, polyvinyl acetate, ethyl cellulose, poly(methyl methacrylate), methacryloyl ethyl betaine/methacrylate copolymer and mixtures thereof and wherein the third layer comprises one or more selected from a group consisting of polyethylene terephthalate (PET), polyethylene (PE), nonwoven, paper, synthetic or natural rubber, nylon and thermoplastic polyurethane.

46. The multi-layered tooth-attachable patch according to claim 41, wherein the tackiness between the second layer and the third layer is 90% or lower as compared to the tackiness between the teeth and the first layer.

Description

DESCRIPTION OF DRAWINGS

[0055] The present disclosure should not be construed as being limited to the following drawings.

[0056] FIG. 1 shows a linear-type patch 1 consisting of a remaining part 12 and a removable part 11.

[0057] FIG. 2 shows a symmetric-type U-shaped patch as an example of a symmetric-type patch 2.

[0058] FIG. 3 shows a symmetric-type V-shaped patch as an example of a symmetric-type patch 2.

[0059] FIG. 4 schematically shows the attachment of a single-sided type patch to the occlusal plane of posterior teeth. A removable part 11 is removed after a drug layer 122 is attached to the occlusal plane of posterior teeth.

[0060] FIG. 5 schematically shows the attachment of a double-sided type patch to the occlusal plane of posterior teeth. A backing layer 121 and a drug layer 122 are formed sequentially on both sides of a removable part 11. After the drug layer 122 comes in contact with upper and lower posterior teeth, the removable part 11 is detached and removed from the each backing layer 121.

[0061] FIG. 6 shows a wax layer 123 disposed between a backing layer and a removable part.

[0062] FIG. 7 shows a wax layer 123 disposed between a backing layer 121 and a drug layer 122 of a remaining part.

[0063] FIG. 8 schematically shows shear testing. (a) and (b) schematically show the testing of the tackiness of a patch.

[0064] FIG. 9 schematically shows 90° peel-off testing.

[0065] FIG. 10 shows a process of preparing a patch consisting of a remaining part and a removable part according to an exemplary embodiment of the present disclosure.

[0066] FIG. 11 shows a process of preparing a patch further including a wax layer according to an exemplary embodiment of the present disclosure. A drug layer is first coated on a substrate (PET), and a backing layer is coated thereon. Separately, a wax layer is coated on the removal part (PET). After that, the backing layer and the wax layer may be laminated and then aged at high temperature.

[0067] FIG. 12 shows a state where a removable part of a linear-type patch is folded.

[0068] FIG. 13 shows states where a removable part of a symmetric-type patch is folded. A shows a state where a removable part is folded symmetrically, and B shows a state where a handle of the removable part is folded along the direction of a remaining part.

[0069] FIG. 14 shows a state where patches attachable to the occlusal plane of posterior teeth are accommodated in a package. A shows that up to a removable part can be accommodated in the package, and B shows that only the portion inserted in the mouth may be accommodated in the package. The package is indicated as a shaded rectangle.

[0070] FIG. 15 shows a patch according to an exemplary embodiment of the present disclosure wherein a remaining part is cut. The remaining part may be cut with grid patterns to have a desired shape for use on teeth.

[0071] FIG. 16 shows a multi-layered patch according to an exemplary embodiment of the present disclosure wherein a handle is formed ‘upward’ from a third layer. In FIG. 16, (a) indicates an upward direction, (b) indicates a forward direction and (c) indicates a backward direction.

[0072] FIG. 17 shows a multi-layered patch according to an exemplary embodiment of the present disclosure wherein a handle is formed ‘forward’ or ‘backward’ from a third layer.

[0073] FIG. 18 shows a patch having handle modified to have a round shape

[0074] FIG. 19 shows a multi-layered patch according to an exemplary embodiment of the present disclosure in a state where a protective layer is separated before attachment to the surface of teeth.

[0075] FIG. 20 shows a multi-layered patch having a protective layer according to an exemplary embodiment of the present disclosure, wherein the protective layer has a larger area than a first layer.

[0076] FIG. 21 shows a patch according to an exemplary embodiment of the present disclosure wherein a protective layer protecting a first layer and a third layer are extended so that the extended portion of the third layer can function as a handle.

[0077] FIG. 22 shows a patch according to an exemplary embodiment of the present disclosure in a state where the patch having a handle formed upward from a third layer is attached to teeth.

[0078] FIG. 23 shows a patch according to an exemplary embodiment of the present disclosure in a state where the patch having a handle formed forward or backward from a third layer is attached to teeth.

[0079] FIG. 24 shows a patch according to an exemplary embodiment of the present disclosure wherein a handle is formed at one side of a third layer.

BEST MODE

[0080] The present disclosure is described in more detail referring to the following examples. However, they are not intended to limit the scope of the present disclosure. Those having ordinary knowledge in the art will be able make various changes and modifications to the present disclosure within the scope of the present disclosure.

[0081] 1. Preparation of Patch Attachable to Occlusal Plane of Posterior Teeth, Consisting of Remaining Part Consisting of Drug Layer and Backing Layer and Removable Part

[0082] A. Composition and Preparation

[0083] A solution for preparing a drug layer and a solution for preparing a backing layer were prepared according to the compositions described in Table 1. After pouring the backing layer solution on a removable part formed from a PET film, the drug layer solution was poured thereon and then laminated by drying. A hydrophobic plasticizer (castor oil, SPAN80) of the backing layer may be joined on the PET. Subsequently, the PET was cut into a shape of a handle and the unnecessary part was removed. In Table 1, the contents are in wt % units, and the values within parentheses indicate the contents of the ingredients based on total weight of each layer after drying.

TABLE-US-00001 TABLE 1 Content (content Content (content Drug layer after drying) Function Backing layer after drying) Function Sodium .sup. 0.18% (0.22%) Drug ingredient Ethyl cellulose 10% (15%) Film former fluoride Glycerin  3.0% (10%) Wetting agent SPAN80  5% (10%) Surfactant Povidone 15.0% (30%) Film former Castor oil  5% (10%) Plasticizer Pullulan 1.0% (2%) Thickener Glycerin  5% (10%) Wetting agent SLS 2.0% (2%) Foaming agent Ethanol, etc. To 100% Solvent Carbomer 1.0% (1%) PSA HPMC 10% (15%) Film former Silica abrasive  3.0% (10%) Abrasive Povidone 10% (15%) Film former Water, etc. To 100% Solvent PSA: acrylic acid ester, carboxylic acid, polysiloxane, rubber (natural, synthetic, etc.)

[0084] A linear-type patch and a U-shaped patch were prepared according to the above-described method.

[0085] B. Evaluation of Tackiness

[0086] (1) Shear Test (PSTC 107 Standard)

[0087] (a) Test Method

[0088] The patch was cut to a size of 1.0 cm×1.0 cm and attached at the end of a slide glass by pressing for 10 seconds using al kg weight. After cutting a Scotch tape to a size of 1.0 cm×4.0 cm and attaching onto the patch, the portion extending out of the patch (1.0 cm×3 cm) was folded in half and a 500 g weight was hung. Then, the time (seconds) taken until the patch was detached was measured.

[0089] A longer time can be interpreted as higher tackiness of the patch.

[0090] (For reference, the maximum biting force of molars is 122 kg/cm.sup.2 on average for male adults (V Jain et al. (2014), A preliminary study to find out maximum occlusal bite force in Indian individuals, Indian Journal of Dental Research, 25(3), 325-330).

[0091] (b) Test Result

[0092] The shear test result is shown in Table 2. As can be seen from Table 2, the patch showed tackiness of 20 seconds or longer on average.

TABLE-US-00002 TABLE 2 No. 1 2 3 4 5 6 7 Mean Time (sec) 25 26 31 23 15 17 18 22

[0093] (2) 90° Peel-Off Test

[0094] (a) Test Method

[0095] The patch was cut to a size of 1.2 cm×5 cm and 2.5 cm of the side of the drug layer was attached onto a slide glass. Then, after pressing with a 1 kg weight for 10 seconds, the force required to remove the drug layer by pulling the portion of the patch not attached to the slide glass at a speed of 5 mm/s was measured using a Zwick DE/1494 universal testing machine.

[0096] (b) Test Result

[0097] The peel-off test result is shown in Table 3. As can be seen from Table 3, the drug layer of the patch had a tackiness of 50 gf or higher and 100 gf or lower on average.

TABLE-US-00003 TABLE 3 No. 1 2 3 4 5 6 Mean Force (gf) 53.24 52.9 46.55 68.2 47.33 42.6 51.80

[0098] 2. Preparation of Patch Attachable to Occlusal Plane of Posterior Teeth, Consisting of Remaining Part Consisting of Drug Layer, Backing Layer and Wax Layer and Removable Part

[0099] A wax layer may be formed between a drug layer and a backing layer or between the backing layer and a removable part. In this example, a patch having a wax layer formed between a backing layer and a removable part was prepared.

[0100] The tackiness of the patch further including the wax layer was evaluated.

[0101] Test method: After sufficiently applying a dye on model molars, the drug layer of the patch was placed thereon and then pressed with a force of 5 kg/cm.sup.2 for 5 seconds. Then, after removing the molars from the patch, the area of the dye remaining on the patch was measured.

[0102] A patch prepared by the existing solvent casting method has the problem that, if the thickness is 2 mm or larger, there is a risk of skinning phenomenon and it is difficult to maintain the shape. When a wax layer is included in the patch, the thickness may be increased and superior attachability may be achieved due to the flexibility of the wax material.

[0103] The depth on the uneven surface of the molars was set to 2.05±0.3 mm (A Arruda et al. (2007), Occlusal Fossae Depth of Permanent First Molars Assessed by Visual Examination: An In Vitro Approach, Pediatric Dentistry, 30(1), 19-24).

[0104] The result of evaluating the attachability of the uneven surface is shown in Table 4. As can be seen from Table 4, the patch having the drug layer had a tackiness of 50 gf or higher and 100 gf or lower. The attachability was improved as the thickness was larger.

TABLE-US-00004 TABLE 4 Thickness of patch including wax layer 300 μm 2000 μm Area of attachment (%) 30.7 ± 7.3 74.8 ± 4.4

[0105] 2. Preparation of Patch Attachable to Occlusal Plane of Posterior Teeth, Consisting of Remaining Part Consisting of Drug Layer, Backing Layer and Wax Layer and Removable Part

[0106] A wax layer may be formed between a drug layer and a backing layer or between the backing layer and a removable part. In this example, a patch having a wax layer formed between a backing layer and a removable part was prepared.

[0107] 3. Difference in Tackiness of Drug Layer and Backing Layer of Patch to Occlusal Plane

[0108] A patch was prepared without a removable part such that the tackiness of a drug layer was 2 times or higher as compared to the tackiness of a backing layer. Then, 90° peel-off test was performed on the drug layer and the backing layer of the patch. The difference in tackiness is shown in Table 5.

TABLE-US-00005 TABLE 5 Layer Drug layer Backing layer Tackiness (gf) 51.80 13.8

[0109] If the tackiness of the drug layer is not 2 times or higher as compared to the tackiness of the backing layer, the drug layer of the patch may remain on PET without being attached to the occlusal plane of posterior teeth when chewed. The patch of the present disclosure was detached well from the PET and attached well to the surface of teeth.

[0110] 4. Preparation of Patch for Whitening Teeth Having Handle

[0111] A. Composition and Preparation

[0112] (1) Preparation of Patch 1 (a Patch for Whitening Teeth Having Handle)

[0113] A solution for preparing a first layer (drug layer) and a solution for preparing a second layer (backing layer) were prepared according to the compositions described in Table 6. After pouring the second layer (backing layer) solution on a third layer formed from a PET film and drying the same, the first layer (drug layer) solution was poured thereon and then laminated by drying. A hydrophobic plasticizer (castor oil, SPAN80) of the second layer may be joined on the PET. Subsequently, the PET was cut into a shape of a handle and the unnecessary part was removed. In Table 6, the contents are in wt % units, and the values within parentheses indicate the contents of the ingredients based on total weight of each layer after drying. A patch for whitening teeth having a handle was prepared according to the above-described method.

TABLE-US-00006 TABLE 6 Content (content Content (content First layer after drying) Function Second layer after drying) Function Hydrogen 10.5% (3%)  Drug Ethyl cellulose 10% (15%) Film former peroxide ingredient Glycerin  3.0% (10%) Wetting agent SPAN80  5% (10%) Surfactant Povidone 15.0% (30%) Film former Castor oil  5% (10%) Plasticizer Pullulan 1.0% (2%) Thickener Glycerin  5% (10%) Wetting agent SLS 2.0% (2%) Foaming agent Ethanol, etc. To 100% Solvent Carbomer 1.0% (1%) PSA polymer HPMC 10% (15%) Film former Silica abrasive  3.0% (10%) Abrasive Povidone 10% (15%) Film former Water, etc. To 100% Solvent PSA: acrylic acid ester, carboxylic acid, polysiloxane, rubber (natural, synthetic, etc.)

[0114] (2) Preparation of Patch 2 (Patch for Whitening Teeth Having Handle)

[0115] A solution for preparing a first layer (drug layer) and a solution for preparing a second layer (backing layer) were prepared according to the compositions described in Table 6. After pouring the second layer (backing layer) solution on a PET film (third layer) with a handle disclosed in FIG. 17 and drying the same, the first layer (drug layer) solution was poured thereon and then laminated by drying to prepare a tooth-attachable patch for whitening teeth with a handle formed.

[0116] (3) Preparation of Patch for Whitening Teeth Having No Handle

[0117] A patch for whitening teeth with no handle was prepared according to the compositions described in Table 6.

[0118] The patches for whitening teeth 1 and 2 with handles prevented the drug from adhering to fingers when attached the surface of teeth and could be removed conveniently owing to the handles.

DETAILED DESCRIPTION OF MAIN ELEMENTS

[0119] 1: Linear-type patch [0120] 2: Symmetric-type patch [0121] 11: Removable part of linear-type patch [0122] 12: Remaining part of linear-type patch [0123] 121: Backing layer of patch [0124] 122: Drug layer of patch [0125] 123: Wax layer of patch [0126] 21: Removable part of symmetric-type patch [0127] 22: Remaining part of symmetric-type patch [0128] 100: First layer [0129] 200: Second layer [0130] 300: Third layer [0131] 400: Protective layer [0132] 301: Handle formed upward from third layer of patch [0133] 311: Handle formed forward from third layer of patch [0134] 321: Handle formed as third layer extends to have larger area than second layer [0135] 331: Handle formed at one side forward from third layer of patch [0136] 410: Protective layer with increased area

INDUSTRIAL APPLICABILITY

[0137] The present disclosure provides a patch that can effectively deliver a drug ingredient to molars. The present disclosure provides a patch having a handle, which can be easily removed from teeth.