Azithromycin water-free deglutible odor masking granule

A technology of azithromycin and taste-masking granules, which is applied in the field of azithromycin anhydrous swallowing and taste-masking granules to achieve the effects of solving bitter odor, improving the applicable population and facilitating administration

Active Publication Date: 2016-10-05
北京科信聚润医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

There are no reports and applications of oral granule pharmaceutical preparations swallowed without water

Method used

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  • Azithromycin water-free deglutible odor masking granule
  • Azithromycin water-free deglutible odor masking granule
  • Azithromycin water-free deglutible odor masking granule

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Example 1: Azithromycin anhydrous swallowing taste-masking granules

[0022] List of Prescribing Units:

[0023]

[0024]

[0025] making process:

[0026] 1. Preparation of loaded pills:

[0027] The drug-loaded pellets are prepared by extrusion and spheronization.

[0028] 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.

[0029] 1.2 Extrusion of soft material: use 0.5mm extrusion screen to extrude the material to obtain an extrudate of appropriate length.

[0030] 1.3 Shot blasting: When the shot blasting machine is running, add extrudates, the speed of the shot blasting machine follows the principle of slow ...

Embodiment 2

[0050] Embodiment 2: Azithromycin anhydrous swallowing taste-masking granules

[0051] 1. Preparation of loaded pills:

[0052]

[0053]

[0054] 2. The preparation and packaging process of the isolation layer solution

[0055]

[0056] 3. The preparation and packaging process of the taste-masking layer solution

[0057]

[0058] The preparation process of the taste-masking layer solution:

[0059] Heat the purified water of the formulated amount to 70-80°C, add Tween 80, propylene glycol, and glyceryl monostearate into hot water, disperse for 10 minutes with a high-speed disperser, stir the above emulsion to room temperature, and mix the Slowly pour the suspension into the Eudragit dispersion, and at the same time stir with a stirring paddle for 20 minutes, and filter it with a 60-mesh sieve before use.

[0060] Encapsulation parameters of the taste masking layer

[0061]

[0062] Experimental investigation on the effect of different barrier layer weight ga...

Embodiment 3

[0068] Embodiment 3: comparative test

[0069] Investigate the effect of different taste-correcting and smoothing adjuvant compositions (sweeteners and smoothing agents) on the anhydrous swallowing effect.

[0070] Compare different sweeteners such as sorbitol, sucrose, dextrose, xylitol, mannitol, lactose, isomaltose, maltose, fructose.

[0071] Compare different slip agents: Hypromellose, Hypromellose, Carbomer, Sodium Carboxymethylcellulose, Xanthan Gum.

[0072] method:

[0073] The above different sweeteners and smoothing agents are mixed according to the fixed prescription, and other components in the prescription are mixed, and the same batch of blank coated pellets is used for mixing with the flavoring material.

[0074] 20 volunteers compared the taste of different mixtures and the effect of swallowing without water within 2 minutes.

[0075] Results: Comparing the above components, it can be concluded that only when the mixture of sorbitol and sodium carboxymethyl...

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Abstract

The invention provides an azithromycin water-free deglutible odor masking granule, which is prepared by mixing coated pellets containing azithromycin and flavoring smooth auxiliary materials, and is characterized in that the flavoring smooth auxiliary materials consist of sorbitol, sodium carboxymethylcellulose, optionally existing essence and/or sweetening agents and optionally existing lubricating agents. The invention provides a novel azithromycin oral solid granule; the problems of bitter taste and foreign odor of azithromycin are solved; unexpectedly, the azithromycin water-free deglutible odor masking granule can be swallowed without water drinking during medicine taking, so that the medicine compliance is improved; and the medicine use range of medicine is enlarged.

Description

technical field [0001] The invention provides anhydrous azithromycin taste-masking granules for swallowing. It belongs to the field of pharmaceutical preparations. Background technique [0002] The existing azithromycin oral pharmaceutical preparations produce unpleasant bitter taste and peculiar smell immediately after taking the patient, the taste is extremely bad, and the compliance of taking the medicine is poor. Convenient patient, also there is the problem of taking medicine inconvenience. [0003] The oral granules of the prior art basically all need to be taken with water when taken. There are no reports and applications of oral granular pharmaceutical preparations swallowed without water. Contents of the invention [0004] In order to overcome the defects of the prior art, the present invention provides a kind of azithromycin anhydrous swallow taste-masking granules, compared with the existing azithromycin products, it not only overcomes the bitter taste and pe...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K31/7052A61K47/10A61K47/38A61K47/32A61K47/12A61K47/18
Inventor 王锦刚蒋海松朱德志朱广辉
Owner 北京科信聚润医药科技有限公司
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