Method for preparing clotrimazole buccal tablets on basis of all-powder direct pressing of modified glucose

A technology of glucose and clotrimazole, applied in the field of medicine, can solve the problems of unstable reproducibility, poor tablet uniformity, poor tableting uniformity, etc., and achieves improved dissolution and uniformity, stable quality, and improved compressibility. Effect

Active Publication Date: 2015-11-11
南京泽恒医药技术开发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, during the formulation process, it was found that the uniformity of the prepared tablets was very poor, and the reproducibility was also unstable, resulting in a large difference in the disintegration time limit and a l...

Method used

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  • Method for preparing clotrimazole buccal tablets on basis of all-powder direct pressing of modified glucose
  • Method for preparing clotrimazole buccal tablets on basis of all-powder direct pressing of modified glucose

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Clotrimazole 10g

[0023] Modified glucose 830g

[0024] Microcrystalline cellulose 50g

[0025] Croscarmellose Sodium 100g

[0026] Povidone K301.3g

[0027] Magnesium stearate 10g

[0028] Weigh the prescription amount of clotrimazole and the modified glucose after sizing, and after croscarmellose sodium and microcrystalline cellulose are thoroughly mixed uniformly, add magnesium stearate and mix for 10 minutes. Tableting: Press the DP30A single-punch tablet machine according to the tablet weight range, the rotating speed is 10-12rpm, and the hardness is about 8-15kgf.

Embodiment 2

[0030] Clotrimazole 10g

[0031] Glucose 830g

[0032] Microcrystalline cellulose 50g

[0033] Croscarmellose Sodium 100g

[0034] Povidone K301.3g

[0035] Magnesium stearate 20g

[0036] Weigh the prescription amount of clotrimazole and the modified glucose after sizing, and after croscarmellose sodium and microcrystalline cellulose are thoroughly mixed uniformly, add magnesium stearate and mix for 10 minutes. Tableting: Press the DP30A single-punch tablet machine according to the tablet weight range, the rotating speed is 10-12rpm, and the hardness is about 8-15kgf.

Embodiment 3

[0038] Clotrimazole 10g

[0039] Modified glucose 830g

[0040] Microcrystalline cellulose 100g

[0041] Croscarmellose Sodium 50g

[0042] Povidone K302.5g

[0043] Magnesium stearate 10g

[0044] Weigh the prescription amount of clotrimazole and the modified glucose after sizing, and after croscarmellose sodium and microcrystalline cellulose are thoroughly mixed uniformly, add magnesium stearate and mix for 10 minutes. Tableting: Press the DP30A single-punch tablet machine according to the tablet weight range, the rotating speed is 10-12rpm, and the hardness is about 8-15kgf.

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Abstract

The invention belongs to the technical field of pharmaceuticals and relates to a method for preparing clotrimazole buccal tablets on basis of all-powder direct pressing of modified glucose. The clotrimazole buccal tablets are composed of the modified glucose, filler, lubricant and disintegrant. The modified glucose is prepared from dextrose monohydrate and binder; the binder is povidone K30. The percentage by weight of the povidone K30 is 0.1% to 0.1% of that of the modified glucose, preferably 0.1% to 0.5% and more preferably 0.1% to 0.3%. Water and ethyl alcohol are used as solvents for the povidone K30 and are subjected to granulating, drying and size stabilizing with the dextrose monohydrate, and water content of the modified glucose is 0.5% to 3%. A single dose of the clotrimazole buccal tablets contains 10mg of an active ingredient, clotrimazole.

Description

Technical field [0001] The invention belongs to the technical field of medicine and relates to a method for preparing clotrimazole buccal tablets by adopting a modified glucose whole powder direct compression method. Background technique [0002] Oral candidiasis (oropharyngealcandidiasis, OPC) is an acute, subacute or chronic fungal infection of the oral mucosa caused by Candida. The clinical symptoms include diffuse erythema and white curd-like plaques or plaques that appear as discrete lesions on the buccal mucosa, throat, tongue, and gum surface. With the widespread clinical use of corticosteroids, broad-spectrum antibiotics and other immunosuppressive agents, coupled with the emergence of acquired immunodeficiency syndrome and the development of organ transplantation, flora imbalance or reduced immunity occurs, causing internal organs, skin, The number of mucosa infected by fungi is increasing, and the incidence of oral mucosal candidiasis is also increasing. [0003] Pyrro...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K47/26A61K31/4174A61P31/10A61P1/02
Inventor 张自强郑娣曲国威
Owner 南京泽恒医药技术开发有限公司
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