Taste-masking azithromycin pellet composition and preparation method thereof

A technology of azithromycin and composition, which is applied in the field of pharmaceutical composition and its preparation, can solve the problems of incomplete encapsulation of drugs, low drug loading and encapsulation efficiency, and strong sensitivity to bitterness, etc., and achieves improved bioavailability, good Good reproducibility and compliance

Inactive Publication Date: 2016-12-07
ZHONGSHUAI PHARMA SCI & TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Some azithromycin dosage forms for children currently on the market have some shortcomings, such as dry suspensions and granules. Due to insufficient treatment of the drug, it has a unique smell of the drug. Adding a large amount of flavoring agent cannot fundamentally solve this problem. For example, adding A large amount of sweeteners, even if the human body feels sweet at the beginning, but then feels bitter, the main reason is that the sensitive part of the human body to sense bitterness is the root of the tongue, and the root of the tongue is very sensitive to bitterness, and there is a safety risk when taking a large amount of flavoring agents
[0005] Therefore, many researchers use encapsulation techniques such as physical and chemical methods to prep

Method used

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  • Taste-masking azithromycin pellet composition and preparation method thereof
  • Taste-masking azithromycin pellet composition and preparation method thereof
  • Taste-masking azithromycin pellet composition and preparation method thereof

Examples

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Effect test

Embodiment 1

[0055] The preparation method of embodiment 1 azithromycin dry suspension

[0056] Prepare azithromycin drug-containing fine pellets, coat the isolation layer, and then coat the slow-release layer to prepare azithromycin taste-masking fine pellets, add auxiliary materials according to the characteristics of the dry suspension, and mix evenly.

[0057] (1) Preparation process of azithromycin drug-containing fine pellets

[0058] Azithromycin-containing fine pellets formula: (Particle size: 0.05-0.10mm) 300g, azithromycin 150g (100 mesh), HPMC (E5) 10g, talcum powder 5g, 85% ethanol 3000mL.

[0059] Preparation process of medicinal solution: Add 10.0 g of HPMC (E5) to 3000 mL of 85% ethanol under stirring, dissolve until clear, add 150 g of azithromycin, continue stirring for 1 hour, add 5 g of talcum powder, and stir for 15 minutes to obtain a drug-containing solution.

[0060] Preparation of drug-containing fine pellets: the particle size is 0.05-0.10mm 300g, put it into ...

Embodiment 2

[0071] The preparation method of embodiment 2 azithromycin dry suspension

[0072] Prepare azithromycin drug-containing fine pellets, coat the isolation layer, and then coat the slow-release layer to prepare azithromycin taste-masking fine pellets, add auxiliary materials according to the characteristics of the dry suspension, and mix evenly.

[0073] (1) Preparation process of azithromycin drug-containing fine pellets

[0074] Azithromycin-containing fine pellets formula: (Particle size: 0.08-0.10mm) 200g, azithromycin 100g (100 mesh), HPMC (E5) 6g, talcum powder 5g, 85% ethanol 2000mL.

[0075] Preparation process of medicinal solution: Add 6.0 g of HPMC (E5) to 2000 mL of 85% ethanol under stirring, dissolve until clear, add 100 g of azithromycin, continue stirring for 1 hour, add 5 g of talcum powder, and stir for 15 minutes to obtain a drug-containing solution.

[0076] Preparation of drug-containing fine pellets: take 150-200 (Particle size: 0.08-0.10mm) 200g, put i...

Embodiment 3

[0087] The preparation method of embodiment 3 azithromycin dry suspension

[0088] Prepare azithromycin drug-containing fine pellets, coat the isolation layer, and then coat the slow-release layer to prepare azithromycin taste-masking fine pellets, add auxiliary materials according to the characteristics of the dry suspension, and mix evenly.

[0089] (1) Preparation process of azithromycin drug-containing fine pellets

[0090] Azithromycin-containing fine pellets formula: (Particle size: 0.05-0.075mm) 300g, azithromycin 150g (100 mesh), HPMC (E5) 10g, talcum powder 5g, 85% ethanol 2000mL.

[0091] Preparation process of medicinal solution: Add 10.0 g of HPMC (E5) to 2000 mL of 85% ethanol under stirring, dissolve until clear, add 150 g of azithromycin, continue stirring for 1 hour, add 5 g of talcum powder, and stir for 15 minutes to obtain a drug-containing solution.

[0092] Preparation of drug-containing fine pellets: take 150-200 (Particle size: 0.05-0.075mm) 300g, put...

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Abstract

The invention relates to a composition of azithromycin taste-masking fine pellets and a preparation method thereof. The composition is composed of drug-containing fine pellets and a coating layer, wherein the drug-containing fine pellets are composed of azithromycin, a blank pellet core, a binder, and an anti-sticking agent. The drug-containing fine pellets are coated with a coating material to obtain the taste-masking fine pellets. The particle diameter of the taste-masking fine pellets is 0.08-0.20mm. The weight percentage of each component of the taste-masking fine pellets composition is as follows:

Description

technical field [0001] The invention relates to a pharmaceutical composition and a preparation method thereof, in particular to a composition of azithromycin taste-masking fine pellets with a small particle size prepared by fluidized bed coating technology and a preparation method thereof, and azithromycin taste-masking fine pellets in the preparation field applications. Background technique [0002] Macrolide drugs mainly refer to macrolide antibiotics. Macrolide antibiotics in a broad sense refer to macrocyclic biologically active substances with lactone bonds produced by microorganisms, including general macrolides (narrowly defined macrolides), polyene macrolides, ANSA macrolides and lipopeptides, etc. At present, many new varieties of macrolide antibiotics have been developed, such as azithromycin. Azithromycin is the second-generation macrolide drug, which is mainly used to treat respiratory and reproductive tract infections, and can treat children and adults caused b...

Claims

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Application Information

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IPC IPC(8): A61K9/50A61K47/38A61K47/32A61K31/7052A61P31/04
CPCA61K9/5078A61K9/5026A61K9/5047A61K31/7052
Inventor 孙卫东董永生李锐李攀
Owner ZHONGSHUAI PHARMA SCI & TECH CO LTD
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