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

A technology of azithromycin and dry suspension, applied in the field of new azithromycin preparations and dry suspension granules, can solve the problems of improved medication compliance, instability, and prominent drug odor of patients, so as to improve medication compliance, improve the applicable population, The effect of improving stability

Inactive Publication Date: 2016-10-05
COSCI MED TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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...

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0056] Example 1: Azithromycin taste-masked dry suspension granules

[0057] List of prescriptions per unit formulation of azithromycin taste-masked dry suspension granules:

[0058]

[0059]

[0060] making process:

[0061] 1. Preparation of loaded pills:

[0062] The drug-loaded pellets are prepared by extrusion and spheronization.

[0063] 1.1 Preparation of soft materials: Put the prescribed amount of microcrystalline cellulose 101, azithromycin, and glucose in a wet granulator, start the granulator and stir evenly, and add an appropriate amount of purified water while the materials are stirring, and the purified water Add in the form of atomization and continue to stir for a certain period of time to obtain the desired soft material.

[0064] 1.2 Extrusion of soft material: use 0.5mm extrusion screen to extrude the material to obtain an extrudate of suitable length.

[0065] 1.3 Shot blasting: When the shot blasting machine is running, add extrudates, the speed...

Embodiment 2

[0081] Embodiment 2: the azithromycin dry suspension pellet drug evaluation that embodiment 1 makes

[0082] 1. Taste evaluation method and results: According to the ratio of drug to water of 11:3, the dry suspension pellets of azithromycin prepared in Example 1 were made into dry suspension syrup. Tasted by volunteers, the taste was good without bad taste.

[0083] 2. Release test

[0084] (1) Determination method: take this product, according to the dissolution test method (Chinese Pharmacopoeia 2010 edition two appendix XC second method), with phosphate buffer (pH6.0) (weigh potassium dihydrogen phosphate 6.805g, hydrogen Add 0.224g of sodium oxide to 1L of degassed water, adjust to pH6.0) 900ml is the dissolution medium, the rotating speed is 75 revolutions per minute, operate according to the law, after 30 minutes, take 5ml of the solution, filter, and take the subsequent filtrate as the test sample solution. In addition, accurately weigh an appropriate amount of azithr...

Embodiment 3

[0108] Example 3: Investigation test on the influence of the weight gain of different isolation layers on the release rate

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PUM

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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...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K31/7052A61K47/32A61K47/38A61P31/04
CPCY02A50/30
Inventor 王锦刚蒋海松朱德志朱广辉
Owner COSCI MED TECH CO LTD
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