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Taste-masking coating preparation and preparation method thereof

A coating and preparation technology, which can be used in pharmaceutical formulations, medical preparations with non-active ingredients, and medical preparations containing active ingredients, etc. It can solve the problems of dependence on gastric acid environment, release impact, and excessive impact.

Pending Publication Date: 2018-01-26
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

However, with the use of water-insoluble ethylcellulose, the release is still affected
[0009] Eudragit dissolves in acid and swells in water and neutral and alkaline environments. Although it overcomes the shortcomings of ethyl cellulose to a certain extent, it is too much affected by the internal environment and relies too much on the gastric acid environment.

Method used

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  • Taste-masking coating preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Embodiment 1. Prednisone taste-masking coated pellets

[0036] The active drug prednisone is loaded in the form of drug-loaded pellets, and the prednisone drug-loaded pellets are sequentially coated with an acidic protective layer, an isolation layer, and a taste-masking layer. The raw materials and dosage of each layer are as follows:

[0037] Drug-loaded pellets:

[0038] Element

Unit dosage

0.5~0.6mm sucrose core

190mg

Prednisone

5mg

Hypromellose E5LV

5mg

Tween 80

1mg

citric acid

1mg

[0039] Acid protective layer:

[0040] citric acid

5mg

Hypromellose E5LV

1mg

talcum powder

15mg

[0041] Isolation layer:

[0042] Hypromellose E5LV

11.2mg

talcum powder

5mg

[0043] Taste masking layer:

[0044] Eudragit E100

12mg

polyethylene glycol 6000

1.2mg

talcum powder

6mg

[0045] The preparati...

Embodiment 2

[0062] Example 2. Taste-masking coated granules of loratadine

[0063] The loratadine drug powder is used for powder coating directly, and the outer layer of the drug is coated with an acidic protective layer, an isolation layer, and a taste-masking layer in sequence. The raw materials and dosages of each layer are as follows:

[0064] Acid protective layer:

[0065] Element

Unit dosage

tartaric acid

5.5mg

Hypromellose E5LV

1.2mg

stearic acid

13mg

[0066] Isolation layer:

[0067] Hypromellose E5LV

12.0mg

Magnesium stearate

5mg

[0068] Taste masking layer:

[0069] Eudragit E100

11.7mg

polyethylene glycol 6000

1.4mg

Magnesium stearate

5.5mg

[0070] The preparation method is:

[0071] 1. Acidic protective film coating:

[0072] Tartaric acid, hypromellose, and stearic acid are prepared into a suspension with water, and fluidized bed coating is selecte...

Embodiment 3

[0079] Example 3. Cefixime taste-masking coated granules

[0080] Use cefixime drug powder to directly carry out powder coating, and coat the acidic protective layer, isolation layer, and taste-masking layer on the outer layer of the drug in sequence. The raw materials and dosage of each layer are as follows:

[0081] Acid protective layer:

[0082] Element

Unit dosage

malic acid

6.5mg

Hypromellose E5LV

1.2mg

Magnesium stearate

15mg

[0083] Isolation layer:

[0084] Hypromellose E5LV

12.5mg

talcum powder

5mg

[0085] Taste masking layer:

[0086] Eudragit E100

12.5mg

polyethylene glycol 6000

1.1mg

talcum powder

5.5mg

[0087] The preparation method is:

[0088] 1. Acidic protective film coating:

[0089] Malic acid, hypromellose and magnesium stearate are prepared into a suspension with water, and fluidized bed coating is selected, and the dry powder o...

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PUM

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Abstract

The present invention belongs to the field of oral solid preparations, and particularly relates to a taste-masking coating preparation and a preparation method thereof, wherein the taste-masking coating preparation is suitable for patients suffering from dysphagia, and does not have bitter taste. According to the present invention, the drug core is directly subjected to taste masking through a coating technology; the drug active component of the preparation is coated with at least three layers of coats, wherein the three layers of the coats respectively are an acid protection layer, a separation layer and a taste masking layer, such that the drug can be rapidly released while the good taste is provided, the taste masking effect is good, and the taste cannot be released into the oral cavityduring the taking so as not to produce bitterness and other bad tastes; after the preparation enters the stomach environment, the coat membrane is rapidly dissolved, such that the drug is released into the stomach acid environment so as to be absorbed by the body and provide the treatment effect.

Description

technical field [0001] The invention belongs to the field of oral solid preparations, in particular to a taste-masking coating preparation suitable for patients with dysphagia and without bitter taste and a preparation method thereof. Background technique [0002] Oral administration is the most commonly used method of administration. Its advantages lie in its safety and convenience, and it is easy to be accepted and adopted by patients. However, the disadvantage is that it absorbs slowly, and it usually takes half an hour to take effect after oral administration, and it is easily destroyed by the gastrointestinal tract. Drugs that strongly irritate the intestinal tract, or have bad odor, or are poorly absorbed in the gastrointestinal tract and cannot reach the required therapeutic concentration are not suitable for oral preparations. Among them, oral preparations include tablets, capsules, granules, oral liquids and other dosage forms. For children, the elderly and other pa...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/50A61K47/06A61K47/38A61K47/02A61K47/32A61K47/10A61K31/573A61K31/4545A61K31/546
Inventor 陈嘉雷杜航
Owner 北京科信聚润医药科技有限公司
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