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Risperidone dispersible tablet and preparation method thereof

A technology of risperidone and dispersible tablets, which is applied in the field of medicine, can solve problems such as complex process, long dispersion time, and influence on drug dissolution, and achieve the effect of simple preparation process and short disintegration time

Active Publication Date: 2015-05-27
宁波大红鹰药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

There are some defects in this drug taste masking method: (1) The raw materials need to be micronized, and the particles need to be wetted with an alcohol solution containing coating materials after drying, and then sieved after being slightly dried. The process is complicated and the "slightly dry" process It is not easy to grasp; (2) the selection of excipients is limited to water-insoluble fillers; (3) after drying the granules between No. 3 drug sieve and No. 6 drug sieve, the coating will produce obvious gritty feeling when patients take it, reducing the compliance
Conventional suspending agents such as sodium carboxymethylcellulose, hydroxypropylmethylcellulose, and xanthan gum have good suspending effects, but because of their high viscosity and long dispersion time, they affect the dissolution of drugs.

Method used

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  • Risperidone dispersible tablet and preparation method thereof
  • Risperidone dispersible tablet and preparation method thereof
  • Risperidone dispersible tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024]

[0025] Preparation Process:

[0026] Dissolve the prescribed amount of risperidone in absolute ethanol, add the prescribed amount of Kollidon CL-M, stir evenly, dry at 50°C to remove the ethanol, pass through a 30-mesh sieve to obtain drug-loaded granules; then mix the drug-loaded granules with 100 Mesh sieved microcrystalline cellulose, lactose, micropowder silica gel and magnesium stearate are evenly mixed, and pressed into tablets.

Embodiment 2

[0028]

[0029]

[0030] Preparation Process:

[0031] Dissolve the prescribed amount of risperidone in absolute ethanol, add the prescribed amount of Kollidon CL-M, stir evenly, dry at 55°C to remove the ethanol, and pass through a 30-mesh sieve to obtain drug-loaded granules; then mix the drug-loaded granules with 80 Mesh sieved microcrystalline cellulose and magnesium stearate are mixed evenly and compressed into tablets.

Embodiment 3

[0033]

[0034] Preparation Process:

[0035] Dissolve the prescribed amount of risperidone in absolute ethanol, add the prescribed amount of Kollidon CL-M, stir evenly, dry at 60°C to remove the ethanol, pass through a 30-mesh sieve to obtain drug-loaded granules; then mix the drug-loaded granules with 60 Mesh sieved microcrystalline cellulose and magnesium stearate are mixed evenly and compressed into tablets.

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Abstract

The invention discloses a risperidone dispersible tablet and a preparation method thereof. The preparation is formed by evenly mixing and tabletting medicine-carrying particles and pharmaceutically acceptable auxiliary ingredients, the medicine-carrying particles are prepared by adopting the following method: dissolving risperidone into absolute ethyl alcohol, adding Kollidon CL-M, drying, removing ethanol, and sieveing. The risperidone dispersible tablet is short in disintegration time, the settling volume ratio meets the specification, and the risperidone dispersible tablet can be dissolved out completely.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a risperidone dispersible tablet and a preparation method thereof. Background technique [0002] Risperidone is a new type of atypical antipsychotic, which has a strong central 5-HT receptor antagonistic effect, and its curative effect on positive symptoms is similar to that of typical drugs. The curative effect is good, the sedative effect is small, and there is no obvious anticholinergic adverse reaction. [0003] At present, the commonly used clinical dosage forms of risperidone are ordinary tablets, oral liquid, and orally disintegrating tablets. Ordinary tablets are difficult to swallow, and children and elderly patients are not suitable for taking such dosage forms; although orally disintegrating tablets solve the above problems to a certain extent, because orally disintegrating tablets are easy to absorb moisture, it is difficult for production and packaging....

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K47/32A61K31/519A61P25/18
Inventor 不公告发明人
Owner 宁波大红鹰药业股份有限公司