Preparation method and equipment of clozapine dispersible tablet

A technology of clozapine and loose tablets, which is applied in the field of medicine, can solve the problems of uneven particle size, cumbersome production process, and low bioavailability, and achieve the effects of fast onset of action, high bioavailability, and uniform granulation

Pending Publication Date: 2022-01-28
SHOUGUANG FUKANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The bioavailability of clozapine tablets is low, and it will still face the defects of chemical stability during long-term storage; Clozapine dispersible tablets have the characteristics of rapid and uniform dispersion, short disintegration time, fast drug absorption, high bioavailability, and good stability. And it is convenient to take. However, the traditional clozapine dispersible tablet adopts wet granulation process at present, and the binder is poured in. The size of the obtained particles is uneven, and a drying step is required, and the production process is cumbersome.

Method used

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  • Preparation method and equipment of clozapine dispersible tablet
  • Preparation method and equipment of clozapine dispersible tablet
  • Preparation method and equipment of clozapine dispersible tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] A kind of raw material of clozapine dispersible tablet is shown in the table below:

[0034]

[0035] A preparation method of clozapine dispersible tablet, specifically:

[0036] 1. Preparation of premixed powder: After passing clozapine, carboxymethyl starch sodium, microcrystalline cellulose and aspartame through a 40-mesh sieve, weigh them according to the prescription and mix them evenly to obtain a premixed material;

[0037] 2. Adhesive preparation: Weigh povidone K30 and purified water according to the prescription amount, dissolve povidone K30 in purified water until it is clear and transparent, and obtain the adhesive;

[0038] 3. Granulation: Put the premixed powder into the material chamber of the fluidized bed, turn on the air supply device and the turntable, adjust the turntable speed to 20rpm, set the air inlet temperature to 45°C, and the air inlet volume to 70m 3 / h, the atomization pressure of the spray gun is 0.2MPa, when the set temperature reache...

Embodiment 2

[0043]

[0044] A preparation method of clozapine dispersible tablet, specifically:

[0045] 1. Preparation of premixed powder: After passing clozapine, carboxymethyl starch sodium, microcrystalline cellulose and aspartame through a 40-mesh sieve, weigh them according to the prescription and mix them evenly to obtain a premixed material;

[0046] 2. Adhesive preparation: Weigh povidone K30 and purified water according to the prescription amount, dissolve povidone K30 in purified water until it is clear and transparent, and obtain the adhesive;

[0047] 3. Granulation: Put the premixed powder into the material chamber of the fluidized bed, turn on the air supply device and the turntable, adjust the turntable speed to 20rpm, set the air inlet temperature to 45°C, and the air inlet volume to 70m 3 / h, the atomization pressure of the spray gun is 0.2MPa, when the set temperature reaches 45°C, spray the binder into the material for granulation, the granules are gradually formed, a...

Embodiment 3

[0052]

[0053] A preparation method of clozapine dispersible tablet, specifically:

[0054] 1. Preparation of premixed powder: After passing clozapine, carboxymethyl starch sodium, microcrystalline cellulose and aspartame through a 40-mesh sieve, weigh them according to the prescription and mix them evenly to obtain a premixed material;

[0055] 2. Adhesive preparation: Weigh povidone K30 and purified water according to the prescription amount, dissolve povidone K30 in purified water until it is clear and transparent, and obtain the adhesive;

[0056] 3. Granulation: Put the premixed powder into the material chamber of the fluidized bed, turn on the air supply device and the turntable, adjust the turntable speed to 20rpm, set the air inlet temperature to 45°C, and the air inlet volume to 70m 3 / h, the atomization pressure of the spray gun is 0.2MPa, when the set temperature reaches 45°C, spray the binder into the material for granulation, the granules are gradually formed,...

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Abstract

The invention discloses a preparation method of a clozapine dispersible tablet. The preparation method comprises the steps of preparation of premixed powder, preparation of an adhesive, granulation, total mixing and tabletting. In the granulation step, drying is carried out while granulation is carried out; the bottom of a fluidized bed used in the granulation step is a turntable, and the bottom turntable is provided with an air distribution structure for hot air to pass through, so that granulation and drying are carried out simultaneously; a narrow gap is formed between the turntable and the pot wall, and the width of the narrow gap is controlled within 0.2 mm; a spray gun is mounted on one side of the bottom of the equipment, and the gun head is buried when materials rotate, so that the liquid receiving area of the rotating and rolling materials is large and uniform, and granulation is completed; the granulating technology of the clozapine dispersible tablet is improved, and the fluidized bed is transformed, so that materials flow and are mixed more uniformly, the liquid receiving area of the rotating and rolling materials is large and uniform, the particle growth speed is high, the particle size is uniform, granulating and drying are carried out at the same time, the time cost is saved, and the production efficiency is improved.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a preparation method and equipment for clozapine dispersible tablets. Background technique [0002] Clozapine belongs to the benzodiazepine antipsychotics, and it has a strong blocking effect on 5-hydroxytryptamine (5-HT2A) receptors and dopamine (DA1) receptors in the brain, and also has an inhibitory effect on dopamine (DA4) receptors. Blocking effect, the blocking effect on dopamine (DA2) receptors is weak, in addition to anti-cholinergic (M1), anti-histamine (H1) and anti-a-adrenoceptor effects, extrapyramidal reactions and delay Dyskinesia is mild and generally does not cause increased prolactin in the blood. It can directly inhibit the ascending activation system of the brainstem reticular structure, has a powerful sedative and hypnotic effect, and is used to treat various types of schizophrenia. [0003] In addition, clozapine dispersible tablets are effective not only ...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/551A61K47/36A61K47/38A61K47/32A61K47/18A61P25/18A61P25/20A61J3/10
CPCA61K31/551A61K9/2059A61K9/2054A61K9/2013A61K9/2027A61K9/0056A61K9/2095A61P25/20A61P25/18A61J3/10
Inventor 刘彬李洪程黄亚楠辛兵赵英霞栾学泉郝冠华孙秀娟赵魏魏杨会顺王福洲
Owner SHOUGUANG FUKANG PHARMA
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