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Leponex orally disintegrating tablet and preparation method thereof

A technology of orally disintegrating tablets and clozapine, which is applied in the technical field of improving oral preparations of clozapine, can solve problems such as low dissolution rate, slow disintegration speed, and non-recording

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.
[0004] Orally disintegrating tablet is a new type of oral preparation. More than a dozen products have been launched at home and abroad, but this dosage form is not recorded in the pharmacopoeia of various countries.

Method used

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  • Leponex orally disintegrating tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] Clozapine 100.0g

[0043] Sodium carboxymethyl starch 14.0g

[0044] Microcrystalline Cellulose 60.0g

[0045] Micronized silica gel 5.0g

[0046] Aspartame 0.5g

[0047] Magnesium stearate 0.9g

[0048] Made into 1000 pieces

[0049] Clozapine, microcrystalline cellulose, sodium carboxymethyl starch, micropowder silica gel, and magnesium stearate were all passed through a 100-mesh sieve.

[0050] Weigh 100.0 grams of clozapine, first mix with 14.0 grams of sodium carboxymethyl starch in equal increments, then add 60.0 grams of microcrystalline cellulose and mix thoroughly, then mix with 5.0 grams of micropowder silica gel, 0.5 grams of aspartame Sweetened and mixed with 0.9 g of magnesium stearate. Detect the percentage content of clozapine in the mixed powder, calculate the weight of the tablet, and press it into a tablet. In this way, 1000 orally disintegrating tablets of clozapine can be compressed.

[0051] Its disintegration t...

Embodiment 2

[0053] Clozapine 85.0g

[0054] Sodium carboxymethyl starch 10.3g

[0055] Microcrystalline Cellulose 55.8g

[0056] Micronized silica gel 3.9g

[0057] Aspartame 0.3g

[0058] Magnesium Stearate 2.7g

[0059] Made into 1000 pieces

[0060] Clozapine, microcrystalline cellulose, sodium carboxymethyl starch, micropowder silica gel, and magnesium stearate were all passed through a 100-mesh sieve.

[0061] Weigh 85.0 grams of clozapine, first mix it with 10.3 grams of sodium carboxymethyl starch in equal increments, then add 55.8 grams of microcrystalline cellulose and mix thoroughly, then add 3.9 grams of micropowder silica gel, 0.3 aspartame Mix with 2.7 grams of magnesium stearate. Detect the percentage content of clozapine in the mixed powder, calculate the weight of the tablet, and press it into a tablet. In this way, 1000 orally disintegrating tablets of clozapine can be compressed.

[0062] Its disintegration time is 32 seconds, ...

Embodiment 3

[0064] Clozapine 87.0g

[0065] Sodium carboxymethyl starch 7.3g

[0066] Microcrystalline Cellulose 47.6g

[0067] Micronized silica gel 2.9g

[0068] Aspartame 0.1g

[0069] Magnesium stearate 0.1g

[0070] Made into 1000 pieces

[0071] Clozapine, microcrystalline cellulose, sodium carboxymethyl starch, magnesium stearate, and micropowder silica gel were all passed through a 100-mesh sieve.

[0072] Weigh 87.0 grams of clozapine, first mix with 7.3 grams of sodium carboxymethyl starch in an equal amount, then add 47.6 grams of microcrystalline cellulose and mix thoroughly, then successively 2.9 grams of micropowder silica gel, 0.1 grams of aspartame Mix with 0.1 gram of magnesium stearate. Detect the percentage content of clozapine in the mixed powder, calculate the weight of the tablet, and press it into a tablet. In this way, 1000 orally disintegrating tablets of clozapine can be compressed.

[0073] Its disintegration time ...

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Abstract

The invention discloses a clozapine oral disintegrating tablet, which is prepared from 50.0-60.0 wt% of clozapine, 5.0-10.0.0wt% of sodium carboxymethylstarch, 30.0-40.0.0wt% of crystalline cellulose, 2.0-5.0wt% of miropowdered silica gel, 0.1-2.0wt% of magnesium stearate and 0.1-0.5 wt% of Aspartame through disintegrating and passing through 100 mesh sieve, mixing homogeneously, and carrying out powder direct pelleting method to obtain the composition.

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 drug, which 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 ...

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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