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Water-free-swallowing taste-masking preparation and preparation method thereof

A preparation and flavoring technology, applied in the field of anhydrous swallowing taste-masking granules and their preparation, can solve the problems of inability to satisfy the taste-masking effect of granules, poor medication compliance, and poor flavoring effect, etc. Effects of uniformity and dissolution rate, improved acceptance, and improved drug taste

Active 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, in order to meet the medication needs of diabetics, the flavoring agent used is not effective and cannot satisfy the taste-masking effect of granules, and the medication compliance of most drug users is poor.

Method used

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  • Water-free-swallowing taste-masking preparation and preparation method thereof
  • Water-free-swallowing taste-masking preparation and preparation method thereof
  • Water-free-swallowing taste-masking preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Example 1. Cefixime Anhydrous Swallowing Taste-masking Granules

[0028] Cefixime is a macrolide antibiotic with a slight specific odor. It is prepared as taste-masking granules swallowed without water through the taste-masking technology of the present invention. The components and their raw material ratios are as follows:

[0029]

[0030]

[0031] The preparation method is:

[0032] 1. Preparation of drug-containing granules

[0033] 1) Preparation of adhesive: The prescribed amount of polyvinylpyrrolidone was prepared into a 5.0% ethanol solution (w / w).

[0034] 2) Preparation of soft material: Weigh the prescribed amount of cefixime, mannitol, fructose, malic acid, and aspartame into a wet granulator. Turn on the low paddle and side paddle, stir evenly, add polyvinylpyrrolidone solution in an atomized manner, and continue stirring until the end of granulation to obtain a soft material.

[0035] 3) Wet sizing: transfer the soft material to a swing sizing ma...

Embodiment 2

[0054] Example 2. Clarithromycin Anhydrous Swallowing Taste-masking Granules

[0055] Clarithromycin is a 14-membered macrolide antibiotic. The raw material drug has a relatively heavy bitter taste. It is prepared as taste-masking granules swallowed without water through the taste-masking technology of the present invention. The components and raw material ratios are as follows:

[0056]

[0057]

[0058] The preparation method is:

[0059] 1. Preparation of drug-containing granules

[0060] 1) Preparation of adhesive: The prescription amount of HPMC E5 was prepared into 3.0% ethanol solution (w / w).

[0061] 2) Preparation of soft material: Weigh the prescribed amount of clarithromycin, fructose, citric acid, and sucralose into a wet granulator. Turn on the low paddle and side paddle, stir evenly, add HPMC E5 solution in the form of atomization, and continue stirring until the end of granulation to obtain soft material.

[0062] 3) Wet sizing: transfer the soft materi...

Embodiment 3

[0081] Example 3. Prednisone anhydrous swallowed taste-masking granules

[0082] Prednisone is a kind of glucocorticoid medicine, has bitter taste, is prepared as the taste-masking granule swallowed without water by the taste-masking technology of the present invention, and the composition and ratio with raw material are as follows:

[0083]

[0084]

[0085] The preparation method is:

[0086] 1. Preparation of drug-containing granules

[0087] 1) Preparation of binder: the prescription amount of sodium carboxymethylcellulose was prepared into a 3.0% aqueous solution (w / w).

[0088] 2) Preparation of soft material: Weigh the prescribed amount of prednisone, mannitol, tartaric acid, and sucralose and place them in a wet granulator. Turn on the low paddle and side paddle, and after stirring evenly, add the CMC-Na solution in the form of atomization, and continue stirring until the end of granulation to obtain soft material.

[0089] 3) Wet sizing: transfer the soft mat...

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Abstract

The present invention belongs to the field of oral solid preparations, and specifically discloses water-free-swallowing taste-masking granules and a preparation method thereof, wherein the water-free-swallowing taste-masking granules are suitable for patients suffering from dysphagia, especially children, can be directly swallow without drinking, and do not have the bad tastes of drugs. Accordingto the present invention, the product contains two parts such as drug-containing granules and flavoring smoothing granules, wherein a ratio of the drug-containing granules to the flavoring smoothing granules is 1:1-3, preferably 1:2. According to the present invention, the granules capable of being directly swallow without drinking and having good taste and fragrance can be obtained by mixing thetwo parts according to the ratio, such that the taste of drugs and the compliance of patients are improved while the medication convenience problem of patients is solved.

Description

technical field [0001] The invention belongs to the field of oral solid preparations, and in particular relates to anhydrous swallowing taste-masking granules suitable for patients with dysphagia, especially children, which can be directly swallowed without drinking water and have no bad taste of medicine, and a preparation method thereof. Background technique [0002] Oral solid preparation is the most commonly used preparation form at present, and its advantages are convenient administration, easy storage, and easy portability. Its specific dosage forms include tablets, capsules, granules, etc. Most of the solid preparations need to be taken with water. [0003] In consideration of improving the compliance and taking characteristics of children and the elderly, many drugs have been developed into dosage forms suitable for children and the elderly, such as granules, dispersible tablets, powders, orally disintegrating tablets, and chewable tablets. However, most of the medi...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K47/38
Inventor 张长青咸小艳
Owner 北京科信聚润医药科技有限公司
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