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Ketotifen fumarate sustained-release capsules and preparation method thereof

A technology of ketotifen fumarate and sustained-release capsules, which is applied in the direction of pharmaceutical formulations, medical preparations of non-active ingredients, and the digestive system. It can solve problems such as poor safety, achieve stable drug release, simple process, and blood drug Concentration stabilization effect

Inactive Publication Date: 2012-07-04
广州科的信医药技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Ketotifen fumarate sustained-release tablet and preparation process thereof (patent number: IL82924, Novartis, Germany), describe the ketotifen fumarate sustained-release tablet and its preparation process of releasing once a day in 24 hours, medicine and Non-functional excipients and sustained-release materials are mixed to make granules and compressed into tablets, which belong to the skeleton-type sustained-release tablets. Local damage and defects of sustained-release tablets during production will lead to sudden release of the entire preparation, so the safety is poor

Method used

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  • Ketotifen fumarate sustained-release capsules and preparation method thereof
  • Ketotifen fumarate sustained-release capsules and preparation method thereof
  • Ketotifen fumarate sustained-release capsules and preparation method thereof

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preparation example Construction

[0031] The preparation method of ketotifen fumarate sustained-release capsule of the present invention comprises the steps:

[0032] 1) preparing a pill core containing medicine;

[0033] 2) package slow-release layer;

[0034] 3) aging;

[0035] 4) Make capsules.

Embodiment 1

[0037] 1. Preparation of drug-containing pill core:

[0038]

[0039] making process:

[0040] Mix ketotifen fumarate and microcrystalline cellulose uniformly by increasing the method in equal amounts, add water to make a soft material, use extrusion-spheronization mechanism pellets, the particle size of the sieve plate is 0.8mm, and dry in an oven at 50°C. Sieve, select 20-40 mesh pill-containing cores, and coat them.

[0041] 2. Package slow-release layer:

[0042]

[0043] Add the prescribed amount of Surelease into water, make it fully dispersed, stir for 45 minutes, place the pill core in a fluidized bed, adjust various process parameters to ensure a fluidized state, and increase the weight of the coating to 10%.

[0044] Process parameters of the fluidized bed: air intake: 20-30HZ, air intake temperature: 25-35°C, atomization pressure: 1.0bar, liquid spray speed: 2-4g / min.

[0045] 3. Curing: Curing in an oven at 50°C for 12 hours.

[0046] 4. Capsules are prep...

Embodiment 2

[0050] 1. Preparation of drug-containing pill core:

[0051]

[0052] making process:

[0053] Mix ketotifen fumarate, lactose, and microcrystalline cellulose evenly by increasing the amount in equal amounts, add water to make a soft material, use extrusion-spheronization mechanism pellets, the particle size of the sieve plate is 0.8mm, and bake in a 50°C oven Drying, sieving, and selecting 20-40 mesh pill-containing cores for coating.

[0054] 2. Package slow-release layer:

[0055]

[0056] Add the prescribed amount of talc powder into the water and stir for 45 minutes, add Eudragit NE30D water dispersion to make it fully dispersed, continue stirring for 45 minutes, and set aside. The pill core containing the drug is placed in a fluidized bed, and various process parameters are adjusted to ensure a fluidized state, and the weight of the coating is increased to 5%.

[0057] Process parameters of the fluidized bed: air intake: 20-30HZ, air intake temperature: 25-35°C,...

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Abstract

The invention discloses ketotifen fumarate sustained-release capsules and a preparation method thereof. The ketotifen fumarate sustained- release capsules comprise sustained-release pellets and hollow capsules, and each sustained-release pellet comprises 75-77% (by weight) of ketotifen fumarate-containing pellet core and 3-35% (by weight) of sustained-release layer. The ketotifen fumarate sustained-release capsules of the invention have uniform pellet diameter and stable drug release, can be released in a sustained manner within 24 hours, and are administered once every day. As the sustained-release pellets in the capsules comprise a plurality of pellets of uniform size, the errors or defects in preparation of individual pellets do not have a strong impact on drug release of the entire preparation, the ketotifen fumarate sustained-release capsules are safer than sustained-release tablets, and have smaller irritation to gastrointestinal tract, more stable blood concentration and higher bioavailability. The preparation method of the invention adopts an extrusion rolling method and a drug coating method to prepare the drug-containing pellet cores, and adopts a fluidized bed to coat the sustained-release coat layers; and has simple process, and is easy for industrial production.

Description

technical field [0001] The invention relates to the technical field of ketotifen fumarate sustained-release preparations, in particular to a ketotifen fumarate sustained-release capsule and a preparation method thereof. Background technique [0002] Ketotifen (Ketotifen) is an oral potent allergic transmitter release agent, commonly used as its fumarate, and is an anti-allergic drug. The drug can not only inhibit the antigen-induced release of histamine and allergic slow-response substance (SRS-A) from mast cells in the lung and bronchial tissue, but also inhibit the induction of eosinophils or neutrophils by antigens, serum or calcium ion transmitters. Slow-reacting substances that release histamine and allergies. The drug has a strong H1 receptor antagonistic effect and can antagonize 5-hydroxytryptamine and allergic slow-response substances. Studies have found that the drug can inhibit non-specific airway hyperresponsiveness in patients with bronchial asthma, and antago...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/52A61K31/4535A61K47/32A61K47/36A61K47/38A61P1/18A61P11/02A61P11/06A61P37/08
Inventor 黎炜烘
Owner 广州科的信医药技术有限公司
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