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Leponex dispersible tablet and preparation method thereof

A clozapine and dispersible tablet technology, applied in the technical field of improvement of clozapine oral preparations, can solve the problems of low bioavailability, low dissolution rate, slow disintegration speed and the like

Inactive Publication Date: 2006-07-26
马晶
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The currently clinically used oral preparation of clozapine is clozapine tablet, and its bioavailability is low, which is related to its slow disintegration speed and low dissolution rate.

Method used

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Embodiment Construction

[0027] The present invention will be further described below in the form of embodiments, and the implementation details of the present invention will be given, but it is not intended to limit the protection scope of the present invention.

[0028] First micronize clozapine, aspartame, microcrystalline cellulose, sodium carboxymethyl starch, magnesium stearate, etc. to pass through a 100-mesh sieve;

[0029] Weigh 5.0 g of polyvinylpyrrolidone and 0.6 g of sodium lauryl sulfate, and prepare a mixed aqueous solution for subsequent use.

[0030] Weigh 100.0 grams of micronized clozapine, first mix it with 4.0 grams of carboxymethyl starch sodium in equal increments, then add 60.0 grams of microcrystalline cellulose and mix thoroughly, then add 0.5 grams of aspartame for grinding and mixing , sieved, mixed, and added to the above mixed solution to make a soft material. Use a 30-mesh sieve to wet granulate, dry at 40°C, and then granulate with a 30-mesh sieve to make disintegratin...

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Abstract

The invention discloses a clozapine dispersion tablet, which is prepared from 50.0-65.0 wt% of clozapine, 1.0-3.0.0wt% of sodium carboxymethylstarch, 25.0-40.0.0wt% of crystalline cellulose, 0.1-0.5.0wt% of Aspartame, 0.2-1.0.0wt% of magnesium stearate, 0.1-0.5wt% of sodium dodecyl sulfate, 2.0-4.0% of polyvinylpyrrolidone and 1.0-3.0% of miropowdered silica gel through disintegrating and passing through 100 mesh sieve, mixing homogenously, adjusting sheet weight, tabletting so as to obtain the dispersible tablets.

Description

Technical field: [0001] The invention relates to a pharmaceutical composition containing clozapine, and relates to an improved technique for oral preparations of clozapine. technical background: [0002] Clozapine is an atypical antipsychotic that has been widely used clinically since it was put on the market in the 1970s. It is effective for both positive and negative symptoms of schizophrenia, especially treatment-resistant schizophrenia. It is better for patients' social adaptability, quality of life and employment potential. It is the only drug found so far that can improve cognitive function, especially in language memory. It is not only suitable for the treatment of the acute phase of schizophrenia, but also for the long-term maintenance treatment. In addition, it is also used in the treatment of mental disorders caused by other diseases. In recent years, Clozapine has also been used to reduce suicidal tendencies in patients with schizophrenia. Clozapine can be used...

Claims

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Application Information

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IPC IPC(8): A61K31/551A61K9/20A61P25/18
CPCA61K31/5513
Inventor 马晶
Owner 马晶
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