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Bitter masked clarithromycin pellet preparation and preparation method thereof

A technology of clarithromycin and taste-masking pellets, which is applied in the direction of pharmaceutical formulations, medical preparations containing active ingredients, block delivery, etc., can solve the problems of low effective bioavailability, large packaging volume, etc., and improve biological Utilization and stability, small dispensing volume, and the effect of ensuring product quality

Inactive Publication Date: 2015-04-01
湖北潜龙药业有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, in view of the fact that the subpackage of clarithromycin drug in the prior art is too large and the effective bioavailability is low, the present invention provides a superfine clarithromycin taste-masked pellet preparation and a preparation method thereof

Method used

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  • Bitter masked clarithromycin pellet preparation and preparation method thereof
  • Bitter masked clarithromycin pellet preparation and preparation method thereof
  • Bitter masked clarithromycin pellet preparation and preparation method thereof

Examples

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preparation example Construction

[0051] (1) Preparation of Clarithromycin Taste-Masked Pellets

[0052] 1) Dry powder mixing:

[0053] Weigh the clarithromycin, sucrose and sodium saccharin in the prescribed amount, put them into the mixing wet granulator, start stirring, the speed is 800rpm / min, and the time is 10min.

[0054] 2) Soft materials:

[0055] Add adhesive to the above mixed material, and at the same time turn on the shear, the speed is 2400rpm / min, the time is 5min, fully mix evenly, and make it have moderate viscoelasticity and plasticity.

[0056] 3) Soft material extrusion:

[0057] The soft material prepared above is extruded through an extruder, and the extrudate is bent into strips under the action of gravity or cut and broken into short branches of irregular length, generally 2 to 3 times its diameter, and the surface smooth.

[0058] 4) Extrusion spheronization:

[0059] Immediately move the above-mentioned extruded product into the centrifugal coating granulator, use the sucrose aqu...

Embodiment 1

[0085]

[0086]

Embodiment 2

[0088]

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Abstract

The invention relates to a bitter masked clarithromycin pellet preparation. The bitter masked clarithromycin pellet preparation comprises a clarithromycin pellet and a coating layer, wherein the mean grain size of the clarithromycin pellet is 180 mu m-220 mu m; the mean thickness of the coating layer is 10 mu m-115 mu m; and the mean grain size of the bitter masked clarithromycin pellet preparation is 200 mu m-410 mu m. Compared with common particles, the prepared product can mask medicine bitterness very well, can reduce sub-packaged amount of medicine, can improve compliance of children and old patients, is convenient to take and improves bioavailability; and on the other hand, the product adopts an advanced technology and is applicable to industrial production, and the stability and quality of the preparation are remarkably improved.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular, the invention relates to a clarithromycin taste-masked pellet preparation and a preparation method thereof. Background technique [0002] Clarithromycin (compound shown in formula I) is a derivative of erythromycin, successfully developed by Japan Taisho Company in the early 1990s, and registered under the trade name Clarith. Afterwards, Dazheng Company first transferred its technology to Abbott of the United States for production; it was launched in Ireland and Italy in 1990, and was approved by the FDA in October 1991 as a Class IB new drug. It has been launched in more than 50 countries around the world, and its market usage has grown steadily, and it has played an important role in clinical practice. Currently produced clarithromycin formulations are tablets, granules, dispersible tablets, sustained-release tablets, injections and dry suspensions. [0003] [000...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K31/7048A61P31/04
Inventor 王晓星钱丽娜刘大鹏姜建国贺俊峰陆少玲
Owner 湖北潜龙药业有限公司
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