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

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...

AI Technical Summary

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 large relative standard deviation of the dissolution curve.

After further research, it is found that the moisture in glucose has a more obvious impact on the formulation, which leads to uneven particle density and poor tablet uniformity

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