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Composition containing desloratadine citrate disodium

A technology of loratadine and composition, applied in the field of compositions containing desloratadine citrate, can solve problems such as poor water solubility of desloratadine

Inactive Publication Date: 2014-04-16
YANGTZE RIVER PHARM GRP GUANGZHOU HAIRUI PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] The purpose of the present invention is to overcome existing technical defects, provide a kind of desloratadine citrate particle, utilize cyclodextrin inclusion technology to carry out clathrate to desloratadine citrate, solve desloratadine and citrate The incompatibility of acidic substances and excipients such as disaccharides and monosaccharides improves the safety and stability of the drug, and at the same time overcomes the problems of poor water solubility and bitter taste of desloratadine, thereby improving bioavailability and Improve the taste of the drug and increase patient compliance

Method used

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  • Composition containing desloratadine citrate disodium
  • Composition containing desloratadine citrate disodium

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Disposal and preparation method of desloratadine citrate granule

[0026] Desloratadine Citrate 2.2g

[0027] Sucrose 988.3g

[0028] Aspartame 4.5g

[0029] β-cyclodextrin 5g

[0030] Appropriate amount of purified water

[0031] Made into 1000 bags

[0032] 1. Use a pulverizer to crush the sucrose until it can pass through an 80-mesh sieve.

[0033] 2. Add β-cyclodextrin to purified water, stir evenly, then add desloratadine citrate and stir until the solution is clear.

[0034] 3. Add about half of the prescribed amount of sucrose→aspartame→the remaining sucrose into the wet granulator in order, set the stirring blade speed to 25-30HZ, the chopping knife speed to 25-30HZ, and mix for 5 minutes.

[0035] 4. Slowly add the drug solution into the mixture, stir and granulate for 5-7 minutes to make wet and soft materials.

[0036] 5. Pass the wet and soft material prepared above through a 20-mesh sieve with a wet granulator to carry out extrusion granulation.

[...

Embodiment 2

[0041] Disposal and preparation method of desloratadine citrate granules

[0042] Desloratadine Citrate 2.2g

[0043] Sucrose 984.3g

[0044] Stevia 4.5g

[0045] β-cyclodextrin 7.5g

[0046] Strawberry essence 1.5g

[0047] Appropriate amount of purified water

[0048] Made into 1000 bags

[0049] 1. Use a pulverizer to crush the sucrose until it can pass through an 80-mesh sieve.

[0050] 2. Add β-cyclodextrin to purified water, stir evenly, then add desloratadine citrate and stir until the solution is clear.

[0051] 3. Add about half of the prescription amount of sucrose → stevioside, strawberry flavor → remaining sucrose into the wet granulator in order, set the stirring blade speed to 25-30HZ, the chopping knife speed to 25-30HZ, and mix for 5 minutes.

[0052] 4. Slowly add the drug solution into the mixture, stir and granulate for 5-7 minutes to make wet and soft materials.

[0053]5. Pass the wet and soft material prepared above through a 20-mesh sieve with a ...

Embodiment 3

[0058] Disposal and preparation methods of desloratadine citrate granules:

[0059] Desloratadine Citrate 4.4g

[0060] Lactose 901.1g

[0061] Sucralose 4.5g

[0062] β-cyclodextrin 90g

[0063] Appropriate amount of purified water

[0064] Made into 1000 bags

[0065] 1. Use a pulverizer to crush the sucrose until it can pass through an 80-mesh sieve.

[0066] 2. Add β-cyclodextrin to purified water, stir evenly, then add desloratadine citrate and stir until the solution is clear.

[0067] 3. Add about half of the prescription amount of sucrose → sucralose → remaining sucrose into the wet granulator in order, set the speed of the stirring blade at 25-30HZ, the speed of the chopping knife at 25-30HZ, and mix for 5 minutes.

[0068] 4. Slowly add the drug solution into the mixture, stir and granulate for 5-7 minutes to make wet and soft materials.

[0069] 5. Pass the wet and soft material prepared above through a 20-mesh sieve with a wet granulator to carry out extrusi...

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Abstract

The invention relates to a composition containing desloratadine citrate disodium. The composition adopts the dosage form of granules; the combination of cyclodextrin and desloratadine citrate disodium in a specific proportion is adopted; the cyclodextrin is used for wrapping the desloratadine citrate disodium, so as to decrease the degradation of the desloratadine citrate disodium in active auxiliary materials such as monose, and biose, and the stability of the desloratadine citrate disodium is effectively enhanced. Accelerated tests and long term tests prove that the stability of the medicine during the storage process can be soundly ensured, in addition, due to the addition of a proper corrigent, the taste of the medicine is improved. Therefore, the composition is particularly suitable for children or patients suffering from dysphagia.

Description

technical field [0001] The invention belongs to the field of medicine and relates to a composition containing desloratadine citrate. Background technique [0002] Desloratadine citrate is a new salt compound formed by reacting desloratadine with disodium hydrogen citrate. This product is rapidly converted into desloratadine to play a role in the body. Desloratadine is a non-sedating long-acting tricyclic antihistamine, which is the active metabolite of loratadine, and can inhibit various allergic inflammatory processes by selectively blocking peripheral H1 receptors. The release of chemical mediators, such as inhibiting the release of histamine, prostaglandins, interleukins, etc. from mast cells and basophils, relieves symptoms related to allergic rhinitis or chronic idiopathic urticaria. It has the advantages of anti-allergic, anti-histamine, and anti-inflammatory three-in-one, and has the advantages of quick onset, strong potency, no cardiotoxicity, less drug interactions...

Claims

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Application Information

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IPC IPC(8): A61K47/48A61K31/4545A61K9/16A61P37/08A61P29/00A61P17/00A61P11/02
Inventor 夏春森杜松范仁峰刘恩桂
Owner YANGTZE RIVER PHARM GRP GUANGZHOU HAIRUI PHARM CO LTD
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