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

The technology of a preparation and a taste-masking layer is applied in the field of anhydrous swallowing and taste-masking preparations and the preparation thereof, which can solve the problems of prolonged time of the preparation staying in the mouth, unstable active ingredients, low stability of cefixime, etc. Medication compliance, improving the applicable population, and good taste-masking effect

Inactive Publication Date: 2018-01-26
COSCI MED TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] However, the biggest problem with direct swallowing of the non-aqueous solid preparations prepared by the prior art is that the granules or microparticles will produce a certain astringent feeling in the mouth, causing the preparation to stay in the mouth for a longer time instead of quickly entering the esophagus
Unfortunately, this shortcoming is further magnified in patients with dysphagia
[0006] In addition, because most drugs have bad smells such as bitterness and irritancy, the uncomfortable feeling brought to patients when swallowed directly will cause them psychological barriers to taking them, which greatly limits the application of such preparations. Therefore, taste masking is also a direct method. One of the problems that must be solved for swallowing preparations
[0007] At the same time, because some active ingredients of medicines are unstable and easy to degrade in extreme environments, too many component selections also become the cause of instability of active ingredients. It is difficult for ordinary preparation technology to solve the instability problem in the preparation and storage process, CN201010176154.8 Disclosed is a cefixime suspension granule and a preparation method thereof, consisting of pharmaceutical active ingredients, excipients, suspending agents, disintegrating agents, flavoring agents, coloring agents, stabilizers, binders, and spices
However, excessive selection of components has become one of the factors affecting the low stability of cefixime, which is not conducive to clinical use and long-term storage

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Example 1. Cefixime taste-masking coated pellets

[0031] Cefixime is a macrolide antibiotic with poor drug stability. The active drug cefixime is carried in the form of drug-loaded pellets. Cefixime drug-loaded pellets are coated with an isolation layer, a taste-masking layer, and a smooth layer in sequence. The raw materials of each layer and their dosage are as follows:

[0032]

[0033]

[0034] The preparation method is:

[0035] 1. Preparation of loaded pills: use purified water as solvent, prepare hypromellose 603 into a binder solution, then add the prescribed amount of surfactant sodium lauryl sulfate, add in the dissolved solution while stirring Cefixime, stirred to form a uniform suspension, set aside. Use the 0.5-0.6mm sucrose pellet core as the blank pellet core, and use the fluidized bed bottom spray device to apply the solution. During the application process, the temperature of the material is controlled at 40±5°C. After the application is comple...

Embodiment 2

[0047] Example 2. Clarithromycin taste-masking coated granules

[0048] Use clarithromycin drug powder for direct powder coating, and coat the outer layer of the drug with an isolation layer, a taste-masking layer, and a smooth layer in sequence. The raw materials and dosages of each layer are as follows:

[0049]

[0050]

[0051] The preparation method is:

[0052] 1. Packaging of the isolation layer: according to the prescription dosage, hydroxypropyl cellulose, polyethylene glycol 6000 and magnesium stearate are formulated into a 5% aqueous solution. A fluidized bed is used for the coating of the isolation coat, and the coating process controls the material at 40±5°C.

[0053] 2. Packing of the taste-masking layer: Mix the prescribed amount of ethanol and water to make an alcohol-water solvent, add ethyl cellulose under stirring, add hypromellose 603 until dissolved, stir until dissolved, Add triethyl citrate and talcum powder in turn, stir for 20 minutes to form a...

Embodiment 3

[0063] Example 3. Prednisone taste-masking coated pellets

[0064] The active drug prednisone is loaded in the form of drug-loaded pellets, and the prednisone drug-loaded pellets are sequentially coated with an isolation layer, a taste-masking layer, and a smooth layer. The raw materials and dosage of each layer are as follows:

[0065] Drug-loaded pellets:

[0066]

[0067] 1. Preparation of drug-loaded pellets: Dissolve prednisone, citric acid, hypromellose, and Tween 80 in water to make a solution, select fluidized bed coating, and apply drug coating to the sucrose pellet core. During the coating process, the temperature of the material is controlled at 35-45°C, and the drying is continued for 30 minutes after the coating is completed.

[0068] 2. Isolation layer coating: Hypromellose E5 and talcum powder are prepared into a suspension with water, and fluidized bed coating is selected, and the drug-loaded pellets prepared in the first step are coated with an isolation l...

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Abstract

The present invention relates to the field of pharmaceutical preparations, and specifically discloses a water-free-swallowing taste-masking preparation and a preparation method thereof, wherein the water-free-swallowing taste-masking preparation is suitable for patients suffering from dysphagia, especially children, and does not have bitter taste. According to the present invention, the drug active component of the water-free-swallowing taste-masking preparation is coated with at least three layers of coats, wherein the three layers of the coats respectively are a separation layer, a taste masking layer and a smooth layer; through the multi-layer coating technology, the drug active component is subjected to taste masking, the taking taste is improved, and the drug active component is endowed with the good stability, such that the drug can be rapidly released while the good taste is provided, the taste masking effect is good, and the stability of the drug is ensured; and the medicationcompliance is effectively improved, the application population is expanded, and especially the administration to children is easily achieved.

Description

technical field [0001] The invention belongs to the field of oral solid preparations, and in particular relates to an anhydrous swallowing taste-masking preparation which is suitable for patients with dysphagia, especially children, and has no 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 ot...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/50A61K47/38
Inventor 朱广辉赫清雪朱德志
Owner COSCI MED TECH CO LTD
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