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Sustained release tablet of quetiapine fumarate composition and preparation method of sustained release tablet

A technology for quetiapine fumarate and sustained-release tablets, which is applied in the direction of drug combinations, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., and can solve the problem of tablet weight, controllability and storage Problems such as stability defects, gel skeleton damage, and slow-release effect effects, etc., to achieve stable storage, simplified operation, and good tolerance

Inactive Publication Date: 2011-10-19
QINGDAO HUANGHAI PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the sustained release of quetiapine can be achieved, the polyacrylic acid resin has a short biological half-life and is mainly absorbed in the stomach, so it is suitable for making sustained-release preparations in the stomach; the above-mentioned several cellulose derivatives are mostly used as coating materials Or enteric coating materials can form a gel matrix in the stomach to achieve a sustained release effect, but it is easy to dissolve in the intestine, the gel matrix is ​​easily destroyed, and the sustained release effect will inevitably be affected
And due to its mostly low viscosity, the manufactured tablets still have deficiencies in unit dosage form weight, controllability and storage stability

Method used

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  • Sustained release tablet of quetiapine fumarate composition and preparation method of sustained release tablet
  • Sustained release tablet of quetiapine fumarate composition and preparation method of sustained release tablet
  • Sustained release tablet of quetiapine fumarate composition and preparation method of sustained release tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Sustained-release tablet of the present invention is formulated by the raw and auxiliary materials of following weight ratio:

[0019]

[0020] Among them, hypromellose (K4M) and hypromellose (K100M) are sustained-release materials, sodium citrate is an organic acid salt, lactose, and microcrystalline cellulose are fillers, and polyvinylpyrrolidone K30 is a binder. agent, micronized silica gel and magnesium stearate are lubricants.

[0021] The raw materials are crushed according to the pharmaceutical grade and passed through a 80-mesh sieve; quetiapine fumarate, organic acid salts, slow-release materials and other pharmaceutical excipients except binders and lubricants are mixed according to the formula amount and placed in one step In the granulator, evenly spray the formulated amount of binder to carry out one-step granulation. After the granulation is completed, the granules are sieved with a 22-mesh sieve, and the prepared granules and the formulated amount of m...

Embodiment 2

[0023] Sustained-release tablet of the present invention is formulated by the raw and auxiliary materials of following weight ratio:

[0024]

[0025] Among them, hypromellose (K15M) and hypromellose (K100M) are slow-release materials, sodium tartrate is an organic acid salt, lactose and microcrystalline cellulose are fillers, polyvinylpyrrolidone K30 is a binder, Magnesium stearate is a lubricant.

[0026] The raw materials are crushed according to the pharmaceutical grade and passed through a 80-mesh sieve; quetiapine fumarate, organic acid salts, slow-release materials and other pharmaceutical excipients except binders and lubricants are mixed according to the formula amount and placed in one step In the granulator, evenly spray the formulated amount of binder to carry out one-step granulation. After the granulation is completed, the granules are sieved with a 22-mesh sieve, and the prepared granules and the formulated amount of micropowder silica gel and magnesium stear...

Embodiment 3

[0028] Sustained-release tablet of the present invention is formulated by the raw and auxiliary materials of following weight ratio:

[0029]

[0030] Among them, hypromellose (K4M) and hypromellose (K100M) are slow-release materials, sodium citrate is organic acid salt, microcrystalline cellulose, lactose and powdered sugar are fillers, polyvinylpyrrolidone K90 As a binder, magnesium stearate is a lubricant.

[0031] The raw materials are crushed according to the pharmaceutical grade and passed through a 100-mesh sieve; quetiapine fumarate, organic acid salts, slow-release materials and other pharmaceutical excipients except binders and lubricants are mixed according to the formula amount and placed in one step In the granulator, evenly spray the formulated amount of adhesive to carry out one-step granulation. After the granulation is completed, 22 mesh sieves are used to sieve the granules, and the prepared granules and the formulated amount of micropowder silica gel and ...

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Abstract

The invention discloses a sustained release tablet of a quetiapine fumarate composition, comprising the following components in percentage by weight: 25 to 40% of quetiapine fumarate, 2 to 8% of organic acid salt, 5 to 30% of a sustained release material and the balance of other pharmaceutical adjuvants, wherein the sustained release material is K type hydroxypropyl methylcellulose. The sustained release material is the K type hydroxypropyl methylcellulose and the organic acid salt is added, therefore, a stable sustained release skeleton can be formed by few sustained release materials, the raw material can be saved, the weight of unit preparation can be reduced, and the problem of difficulty in swallowing caused by large size of the preparation can be released and / or solved; the hydroxypropyl methylcellulose with different viscosities are used as the material of the skeleton so that the preparation can reach formulated sustained release effects and has the characteristics of strong controllability and stability in storage. By use of the preparation method capable of granulating in one step, the operation is simplified and the production efficiency can be improved.

Description

technical field [0001] The invention relates to a pharmaceutical preparation, specifically a slow-release tablet of a quetiapine fumarate composition for treating adult schizophrenia and bipolar depression, and a preparation method of the slow-release tablet. technical background [0002] Schizophrenia is a major mental illness, quetiapine fumarate is currently the only atypical antipsychotic approved for the treatment of affective episodes associated with bipolar disorder, quetiapine fumarate is a phenothiazine antipsychotic Drugs can block a variety of neurotic receptors in the brain, mainly by blocking the central dopamine and other receptors. However, quetiapine is absorbed quickly after oral administration, and the plasma concentration reaches the peak in about 1.0 to 1.8 hours. The elimination half-life is short, which is not conducive to the treatment of patients. Therefore, it is important to develop a slow-release dosage form that can continuously and steadily rele...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K31/554A61K47/38A61P25/18A61P25/24
Inventor 李振霞高义才吴立明陈颖曹瑞山于华芝
Owner QINGDAO HUANGHAI PHARM CO LTD
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