CN-121971397-A - Buccal tablet and preparation method thereof

CN121971397ACN 121971397 ACN121971397 ACN 121971397ACN-121971397-A

Abstract

The application belongs to the technical field of foods or medicines, and particularly relates to a buccal tablet and a preparation method thereof. The buccal tablet comprises a first supporting layer, a functional layer and a second supporting layer which are sequentially laminated, wherein the functional layer comprises an active substance, and the first supporting layer and the second supporting layer are exocrine fluid dissolving layers. The support layer in the buccal tablet is an exocrine liquid dissolving layer, has dissolving property in saliva, solves the problem of cast aside after oral administration is finished, and has edible property, so that discomfort and harm can not be generated after unintentional swallowing.

Inventors

HU ZHENG
HE HAIBO
ZHANG BIN
Miao Xiushi
ZHANG CHEN
CHEN ZHICHAO
YAN XINYANG

Assignees

爱奇迹创造有限公司

Dates

Publication Date: 20260505
Application Date: 20260202

Claims (10)

1. The buccal tablet is characterized by comprising a first supporting layer, a functional layer and a second supporting layer which are sequentially laminated; the functional layer comprises an active substance, the first supporting layer and the second supporting layer are exocrine fluid dissolving layers, and at least one of the first supporting layer and the second supporting layer is permeable to saliva.
2. The wafer of claim 1, wherein at least one of the first support layer and the second support layer is provided with a through hole; And/or at least one of the first support layer and the second support layer is a porous layer.
3. The buccal tablet according to claim 2, wherein the aperture of the through hole is 0.08mm to 0.15mm; And/or the distribution density of the through holes is 30/cm <2> -50/cm <2 >; And/or the porosity of the porous layer is 28% -35%.
4. The wafer of claim 1, wherein the exocrine fluid dissolution layer comprises a matrix material and a first auxiliary material; Wherein the first auxiliary material comprises at least one of a dissolution regulator, a viscosity regulator, a lubricant, a cross-linking agent, a first flavoring agent, a bioadhesive agent and a pH regulator.
5. The buccal tablet according to claim 4, wherein the exocrine solution dissolving layer comprises, by mass, 45-55 parts of a framework material, 20-28 parts of a dissolution regulator, 12-18 parts of a viscosity regulator, 0.2-0.4 part of a lubricant, 0.2-0.4 part of a cross-linking agent, 0.1-0.3 part of a bioadhesive, 0.4-0.9 part of a first flavoring agent, and 0.3-0.6 part of a pH regulator.
6. The buccal tablet of claim 4, wherein the matrix material comprises at least one of hydroxypropyl starch, pullulan, hypromellose, and sodium alginate; and/or the dissolution regulator comprises at least one of trehalose, mannitol, lactose and maltodextrin; and/or the viscosity modifier comprises at least one of a mixture of polydextrose and pectin, xanthan gum, carrageenan, guar gum; And/or the lubricant comprises at least one of sodium hyaluronate, magnesium stearate, microcrystalline cellulose and talcum powder; And/or the cross-linking agent comprises at least one of citrate, polyvinyl alcohol, povidone K30 and povidone K90; And/or the bioadhesive comprises at least one of chitosan oligosaccharide, carbomer and hydroxyethyl cellulose; And/or the first flavoring agent comprises at least one of a first essence, a first sweetener, a first cooling agent, a first salty agent and a first sour agent; And/or, the first flavoring agent is a flavor microcapsule; and/or the pH regulator comprises at least one of a mixture of disodium hydrogen phosphate and citric acid and sodium bicarbonate.
7. The buccal tablet of claim 1, wherein the functional layer further comprises a film former and a second adjunct; wherein the second auxiliary material comprises at least one of a hydrophilic regulator, a second flavoring agent and a smoothing agent.
8. The buccal tablet according to any one of claims 1 to 7, wherein the thickness of the exocrine fluid dissolution layer is 0.04mm to 0.07mm; and/or the surface roughness of the exocrine fluid dissolving layer is less than or equal to 0.2 mu m; And/or the thickness of the functional layer is 0.03 mm-0.05 mm; And/or the water content of the buccal tablet is less than or equal to 2%; and/or the area ratio of the exocrine fluid dissolving layer to the functional layer is 1.2-1.5:1.
9. The buccal tablet according to claim 8, wherein the length ratio of the exocrine fluid dissolution layer to the functional layer is (1.10 to 1.22): 1; and/or the width ratio of the exocrine fluid dissolving layer to the functional layer is (1.10-1.22): 1.
10. A method for preparing buccal tablets according to any one of claims 1 to 9, comprising: Preparing a first supporting layer, a second supporting layer and a functional layer; Stacking according to the sequence of the first supporting layer, the functional layer and the second supporting layer, and obtaining a buccal tablet blank body through composite treatment; drying the buccal tablet blank at a low temperature to obtain the buccal tablet; the functional layer comprises an active substance, the first supporting layer and the second supporting layer are exocrine fluid dissolving layers, and at least one of the first supporting layer and the second supporting layer is permeable to saliva.

Description

Buccal tablet and preparation method thereof Technical Field The application belongs to the technical field of foods or medicines, and particularly relates to a buccal tablet and a preparation method thereof. Background The core functions of the buccal bag are to wrap the content, control the release rate and prevent the leakage of the content, so the material of the outer layer film needs to meet the requirements of saliva resistance, tearing resistance and insolubility in oral environment, and therefore, the mouth bag needs to be artificially cast aside after eating. Moreover, the contents of the buccal pouch are generally water-soluble substances, so that the rate of onset is faster during oral administration, and the outer layer is insoluble, so that the inner solution is easily exploded when dissolved to some extent, thereby increasing the waste in the oral cavity. Disclosure of Invention The application aims to provide a buccal tablet and a preparation method thereof, which are used for solving the problems that cast aside and fiber residues are needed for the outer layer film of the traditional buccal bag. In order to solve the technical problems, the application provides a buccal tablet, which comprises a first supporting layer, a functional layer and a second supporting layer which are sequentially laminated, wherein the functional layer comprises an active substance, the first supporting layer and the second supporting layer are exocrine liquid dissolving layers, and at least one of the first supporting layer and the second supporting layer can permeate saliva. In one embodiment, at least one of the first support layer and the second support layer is provided with a through hole, and/or at least one of the first support layer and the second support layer is a porous layer. In one embodiment, the diameter of the through holes is 0.08-0.15 mm, and/or the distribution density of the through holes is 30-50/cm 2, and/or the porosity of the porous layer is 28-35%. In one embodiment, the exocrine fluid dissolution layer comprises a matrix material and a first auxiliary material, wherein the first auxiliary material comprises at least one of a dissolution regulator, a viscosity regulator, a lubricant, a cross-linking agent, a first flavoring agent, a bioadhesive, and a pH regulator. In one embodiment, the exocrine fluid dissolving layer comprises, by mass, 45-55 parts of a framework material, 20-28 parts of a dissolution regulator, 12-18 parts of a viscosity regulator, 0.2-0.4 part of a lubricant, 0.2-0.4 part of a cross-linking agent, 0.1-0.3 part of a bioadhesive, 0.4-0.9 part of a first flavoring agent and 0.3-0.6 part of a pH regulator. In one embodiment, the matrix material comprises at least one of hydroxypropyl starch, pullulan, hypromellose, sodium alginate, and/or the dissolution regulator comprises at least one of trehalose, mannitol, lactose, maltodextrin, and/or the viscosity regulator comprises at least one of a mixture of polydextrose and pectin, xanthan gum, carrageenan, guar gum, and/or the lubricant comprises at least one of sodium hyaluronate, magnesium stearate, microcrystalline cellulose, talc, and/or the cross-linking agent comprises at least one of citrate, polyvinyl alcohol, povidone K30, povidone K90, and/or the bioadhesive comprises at least one of chitosan oligosaccharide, carbomer, hydroxyethylcellulose, and/or the first flavoring agent comprises at least one of a first essence, a first sweetener, a first cooling agent, a first salty agent, and/or the first flavoring agent comprises at least one of sodium hyaluronate, sodium bicarbonate, a flavoring agent, and/or a mixture of sodium bicarbonate and a second flavoring agent. In one embodiment, the functional layer comprises a film forming agent and a second auxiliary material, wherein the second auxiliary material comprises at least one of an active substance, a hydrophilic regulator, a second flavor and a smoothing agent. In one embodiment, the thickness of the exocrine fluid dissolving layer is 0.04-0.07 mm, and/or the surface roughness of the exocrine fluid dissolving layer is less than or equal to 0.2 mu m, and/or the thickness of the functional layer is 0.03-0.05 mm, and/or the water content of the buccal tablet is less than or equal to 2%, and/or the area ratio of the exocrine fluid dissolving layer to the functional layer is 1.2-1.5:1. In one embodiment, the length ratio of the exocrine fluid dissolution layer to the functional layer is (1.10-1.22): 1, and/or the width ratio of the exocrine fluid dissolution layer to the functional layer is (1.10-1.22): 1. The application further provides a preparation method of the buccal tablet, which comprises the steps of preparing a first supporting layer, a second supporting layer and a functional layer, stacking the first supporting layer, the functional layer and the second supporting layer according to the sequence, obtaining a buccal tablet blank through composite treatment, and