Azithromycin dry-suspended granule with odor masked and preparation method thereof

Abstract

The invention provides a novel azithromycin preparation and particularly provides an azithromycin dry-suspended granule with odor masked. The dry-suspended granule is composed of a coated micro-pellet and a taste-corrective auxiliary material composition. The coated micro-pellet is composed of a drug-carrier pellet, an isolation layer and an odor-masking layer, wherein the odor-masking layer is mainly prepared from Eudragit L30D-55. The taste-corrective auxiliary material composition is mainly composed of sorbitol and isomaltitol. Through the special method, bitter taste and odor of the azithromycin medicine are masked, so that compliance is improved, and meanwhile, with the special coating layer, the preparation is improved in stability without influence on release degree of the azithromycin.

Description

technical field [0001] The present application provides a new formulation of azithromycin, in particular, a taste-masked dry suspension granule of azithromycin. It belongs to the field of pharmaceutical preparations. Background technique [0002] Azithromycin is a fifteen-membered ring lactone antibiotic that is effective against a variety of sensitive bacteria. Because azithromycin has a special bitter taste and is unstable, the existing oral preparations of azithromycin have defects in mouthfeel, medication compliance and preparation stability, and it is difficult to develop preparations such as dry suspension. [0003] CN1083728A discloses a method for preparing an azalide composition with reduced bitterness. In the preparation method involved, for some medicines whose bitterness is not very obvious, the method of adding sugar and essence can cover up the taste of some medicines. Bitter taste, but the peculiar smell of the drug itself is still very prominent, which cann...

AI Technical Summary

Problems solved by technology

Because azithromycin has a special bitter taste and is unstable, the existing oral preparations of azithromycin have defects in mouthfeel, medication compliance and preparation stability, and it is difficult to develop preparations such as dry suspension

[0003] CN1083728A discloses a method for preparing an azalide composition with reduced bitterness. In the preparation method involved, for some medicines whose bitterness is not very obvious, the method of adding sugar and essence can cover up the taste of some medicines. Bitter taste, but the unique smell of the drug itself is still very prominent, which cannot completely solve the needs of all drug taste masking, and the compliance of children patients is not good

[0004] CN200510061861.1 discloses a preparation method of azithromycin dry suspension granules, the raw material drug is azithromycin, and the auxiliary materials are Eudragit L100, sodium carboxymethylcellulose, xanthan gum, sodium phosphate, silicon dioxide, sucrose, Mannitol and essence, the preparation method is as follows, the polymer binder Eudragit L100 is used to dissolve in ethanol, the granulated materials azithromycin, sucrose, mannitol, and sodium phosphate are placed in a fluidized bed, and the fluidized bed is used to viscose The mixture solution is used to granulate azithromycin, and after the granulation is finished, the particles of the required particle size are screened, and then the remaining auxiliary materials are mixed to obtain the final product. During the granulation process, azithromycin was not fully covered by Eudragit, so the bitterness of the prepared granules was still obvious, and phosphate was added to the prescription, and the taste was not good after being made into a suspension. Medication adherence still needs to be improved

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